The System Handbook provides instructions and information how to run the ReadyToProcess WAVE 25 bioreactor system. It also includes relevant guidance for practical handling and maintenance of the system units. The ReadyToProcess WAVE 25 system is intended to be used as laboratory and manufacturing equipment for cell cultivation. The system, composed of the rocker, ReadyToProcess CBCU and ReadyToProcess Pump 25, enables measurement and control of pH, DO, weight and media distribution, and provides different gas flow and gas mixing possibilities.

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The System Handbook provides instructions and information how to run the ReadyToProcess WAVE 25 bioreactor system. It also includes relevant guidance for practical handling and maintenance of the system units. The ReadyToProcess WAVE 25 system is intended to be used as laboratory and manufacturing equipment for cell cultivation. The system, composed of the rocker, ReadyToProcess CBCU and ReadyToProcess Pump 25, enables measurement and control of pH, DO, weight and media distribution, and provides different gas flow and gas mixing possibilities. | Manualzz

ReadyToProcess WAVE ™ 25

System Handbook

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Table of Contents

Table of Contents

1 Introduction ..........................................................................................................

1.1

Important user information .............................................................................................................

1.2

Important concepts .............................................................................................................................

1.3

User documentation ...........................................................................................................................

2 System description ..............................................................................................

2.1

System overview ...................................................................................................................................

2.2

ReadyToProcess WAVE 25 rocker .................................................................................................

2.3

ReadyToProcess CBCU .......................................................................................................................

2.4

ReadyToProcess Pump 25 ................................................................................................................

2.5

Cellbag bioreactor ................................................................................................................................

2.6

UNICORN software overview ..........................................................................................................

2.6.1

General UNICORN operation .....................................................................................................

2.6.2

The UNICORN help .........................................................................................................................

3 The UNICORN software .......................................................................................

3.1

Administration ........................................................................................................................................

3.2

System control .......................................................................................................................................

3.3

Methods in UNICORN ..........................................................................................................................

3.3.1

3.3.2

Method editor ..................................................................................................................................

Method creation .............................................................................................................................

3.3.3

3.3.4

3.3.5

3.3.6

Work with methods .......................................................................................................................

Text instructions .............................................................................................................................

Save a method ................................................................................................................................

Scouting .............................................................................................................................................

3.3.7

Method queues ...............................................................................................................................

3.4

Evaluation in UNICORN ......................................................................................................................

3.4.1

3.4.2

Evaluation .........................................................................................................................................

Open and view results .................................................................................................................

3.4.3

3.4.4

3.4.5

3.4.6

Run documentation ......................................................................................................................

Generate and print a predefined report format ...............................................................

Create a new report format ......................................................................................................

Edit an existing report format ..................................................................................................

4 System control description ................................................................................

4.1

Single and dual operation modes .................................................................................................

4.2

Temperature measurement and control ...................................................................................

4.3

pH and DO measurement and control ......................................................................................

4.3.1

4.3.2

pH and DO measurement principles .....................................................................................

pH and DO control principles ....................................................................................................

4.4

pH control .................................................................................................................................................

4.4.1

4.4.2

4.4.3

pH control schemes ......................................................................................................................

CO2 control mode ..........................................................................................................................

Acid/Base control mode ..............................................................................................................

4.4.4

pH control transition delays ......................................................................................................

113

114

115

116

117

119

122

123

124

126

129

12

13

17

26

29

32

36

37

38

7

8

10

11

40

94

99

101

111

83

87

88

90

58

65

73

77

41

42

50

51

54

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 3

Table of Contents

4.5

DO control ................................................................................................................................................

4.5.1

4.5.2

DO control schemes ......................................................................................................................

O2 control mode .............................................................................................................................

4.5.3

4.5.4

Speed control mode ......................................................................................................................

O2/Speed control scheme ..........................................................................................................

4.6

Media control ..........................................................................................................................................

4.6.1

Weight measurement ..................................................................................................................

4.6.2

4.6.3

4.6.4

4.6.5

Media addition ................................................................................................................................

Perfusion ............................................................................................................................................

Deviation alarm ..............................................................................................................................

Media control inactivation .........................................................................................................

4.7

Recommended operating conditions ..........................................................................................

4.8

System verification ..............................................................................................................................

5 Operation ..............................................................................................................

5.1

Set up the system .................................................................................................................................

5.1.1

5.1.2

5.1.3

Select the tray and Cellbag bioreactor .................................................................................

Attach and detach tray ................................................................................................................

Prepare pH and DO sensors ......................................................................................................

5.1.4

5.1.5

5.1.6

Attach the Cellbag bioreactor ...................................................................................................

Prepare the pump ..........................................................................................................................

Connect gas to the system ........................................................................................................

5.2

Start and configure the system .....................................................................................................

5.2.1

5.2.2

5.2.3

Start the system and log on to UNICORN ...........................................................................

Connect to the system .................................................................................................................

Configure system properties .....................................................................................................

5.2.4

5.2.5

Configure system settings ..........................................................................................................

Start a run .........................................................................................................................................

5.3

Prepare for cultivation ........................................................................................................................

5.3.1

Inflate the Cellbag bioreactor ...................................................................................................

5.3.2

5.3.3

5.3.4

Adjust pump parameters ...........................................................................................................

Final checks before cultivation .................................................................................................

Add and equilibrate culture medium .....................................................................................

5.3.5

Prepare the sensors ......................................................................................................................

5.4

Perform cultivation ..............................................................................................................................

5.4.1

5.4.2

Inoculate the culture .....................................................................................................................

Monitor and control the cultivation ........................................................................................

5.4.3

End a run ...........................................................................................................................................

153

173

174

175

177

179

181

186

187

188

189

190

154

155

156

159

162

164

169

193

196

197

198

203

130

131

132

134

135

136

137

138

139

143

144

145

148

6 Maintenance .........................................................................................................

6.1

Calibration ................................................................................................................................................

6.2

Pump calibration ...................................................................................................................................

6.3

Cleaning ....................................................................................................................................................

205

206

208

210

7 Troubleshooting ...................................................................................................

7.1

ReadyToProcess WAVE 25 system ................................................................................................

7.2

ReadyToProcess WAVE 25 rocker .................................................................................................

7.3

ReadyToProcess CBCU .......................................................................................................................

7.4

ReadyToProcess Pump 25 ................................................................................................................

211

212

213

217

231

4 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

Table of Contents

7.5

Cellbag bioreactor ................................................................................................................................

7.6

Software problems ...............................................................................................................................

7.6.1

7.6.2

Troubleshooting Method editor ...............................................................................................

UNICORN System Control ...........................................................................................................

7.6.3

Troubleshooting Evaluation .......................................................................................................

8 Reference information ........................................................................................

8.1

System specifications .........................................................................................................................

8.2

Component specifications ................................................................................................................

8.3

Client computer specifications .......................................................................................................

8.4

Chemical resistance ............................................................................................................................

8.5

Control settings .....................................................................................................................................

8.5.1

Rocking control ...............................................................................................................................

8.5.2

8.5.3

8.5.4

8.5.5

8.5.6

8.5.7

8.5.8

Heating control ...............................................................................................................................

Gas flow control .............................................................................................................................

CO

O

2

2 mix control ...............................................................................................................................

mix control ..................................................................................................................................

Pump control ...................................................................................................................................

pH measurement ...........................................................................................................................

pH control ..........................................................................................................................................

8.5.9

DO measurement ...........................................................................................................................

8.5.10

DO control .........................................................................................................................................

8.5.11

Media control ...................................................................................................................................

8.6

Digital and analog I/O connections .............................................................................................

8.7

Ordering information .........................................................................................................................

Index .......................................................................................................................

241

253

254

256

257

258

261

263

269

271

275

242

243

246

248

249

250

277

280

282

232

234

235

237

240

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 5

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1 Introduction

1 Introduction

Purpose of this manual

The System Handbook provides you with instructions and information how to run the

ReadyToProcess WAVE 25 bioreactor system. It also includes relevant guidance for practical handling and maintenance of the system units.

Scope of this document

This manual covers the ReadyToProcess WAVE 25 system, including the rocker, gas mixer and DO/pH controller (CBCU), pump, UNICORN™ software and accessories.

In this chapter

This chapter includes important user information, intended use of the system, and lists of important concepts and user documentation.

This chapter contains the following sections:

Section

1.1 Important user information

1.2 Important concepts

1.3 User documentation

See page

8

10

11

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 7

8

1 Introduction

1.1 Important user information

1.1

Important user information

Read the Operating Instructions before operating the product

All users must read the entire separate Operating Instructions before installing, operating, or maintaining the product.

Always keep the Operating Instructions at hand when operating the product.

Do not operate the product in any other way than described in the user documentation.

If you do, you may be exposed to hazards that can lead to personal injury and you may cause damage to the equipment.

Intended use

The ReadyToProcess WAVE 25 system is intended to be used as laboratory and manufacturing equipment for cell cultivation. The system may not be used for clinical or diagnostic purposes.

Prerequisites

In order to follow this manual and use the system in the intended manner, it is important that:

• you have a general understanding of how the client computer and Microsoft dows

® operating systems work.

®

Win-

• you are acquainted with the use of general laboratory equipment and with handling of biological materials.

• you have read and understood the Safety instructions chapter in the Operating

Instructions.

• the system is installed according to the instructions in the Operating Instructions.

• a user account has been created according to UNICORN Administration and Technical

manual.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

1 Introduction

1.1 Important user information

Safety notices

This user documentation contains safety notices (WARNING, CAUTION, and NOTICE) concerning the safe use of the product. See definitions below.

WARNING

WARNING indicates a hazardous situation which, if not avoided, could result in death or serious injury. It is important not to proceed until all stated conditions are met and clearly understood.

CAUTION

CAUTION indicates a hazardous situation which, if not avoided, could result in minor or moderate injury. It is important not to proceed until all stated conditions are met and clearly understood.

NOTICE

NOTICE indicates instructions that must be followed to avoid damage to the product or other equipment.

Notes and tips

Note:

Tip:

A note is used to indicate information that is important for trouble-free and optimal use of the product.

A tip contains useful information that can improve or optimize your procedures.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 9

1 Introduction

1.2 Important concepts

1.2

Important concepts

Concepts and abbreviations used in this manual are explained in the table below.

Explanation Concept/ abbreviation

Cellbag™ bioreactor

DO

DO sensor

Single mode

Dual mode pH sensor

ReadyToProcess™ CBCU

ReadyToProcess Pump 25

ReadyToProcess WAVE 25 rocker

Tray

The disposable container in which the cells are cultured.

Dissolved oxygen.

Optical sensor for measurement of dissolved oxygen.

Attached to DO configured Cellbag bioreactors.

Operating mode with one Cellbag bioreactor on the rocker.

Operating mode with two Cellbag bioreactors on the same rocker. Cultivation is monitored and controlled independently in the two bioreactors.

Optical sensor for pH measurement. Attached to pH configured Cellbag bioreactors.

Control unit for gas mix, pH and DO control.

The pump.

The rocker.

ReadyToProcess WAVE 25

The ReadyToProcess WAVE

25 system

The bioreactor system

UNICORN

Tray for Cellbag, mounted on the rocker. Different tray sizes are available for different culture capacities.

The entire bioreactor system, including rocker,

CBCU(s), and pump(s), together with Cellbag bioreactor(s) and filter heater(s).

The software used for controlling and monitoring the system.

10 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

1 Introduction

1.3 User documentation

1.3

User documentation

The table below describes the user documentation for ReadyToProcess WAVE 25, which is available from the Help menu in UNICORN or on the user documentation CD.

Document

ReadyToProcess WAVE 25

Operating instructions

ReadyToProcess WAVE 25

System Handbook

ReadyToProcess WAVE 25 Cue

Card

UNICORN Administration and

Technical manual

UNICORN Online Help

User Documentation CD

Main contents

Instructions needed to install, operate and maintain

ReadyToProcess WAVE 25 in a safe way. Includes basic UNICORN system control functions.

Detailed system descriptions and instructions on how to run, maintain and troubleshoot

ReadyToProcess WAVE 25. Includes UNICORN system control functions, method creation and handling, together with evaluation and presentation of data.

Brief instructions providing an overview of how to run the system.

Overview and detailed description of network setup and complete software installation. Administration of UNICORN and the UNICORN database.

Dialog descriptions for UNICORN.

CD containing the listed manuals and translated versions of ReadyToProcess WAVE 25 Operating

instructions.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 11

2 System description

2 System description

In this chapter

This chapter gives an overview of ReadyToProcess WAVE 25 and describes the different bioreactor system units.

This chapter contains the following sections:

Section

2.1 System overview

2.2 ReadyToProcess WAVE 25 rocker

2.3 ReadyToProcess CBCU

2.4 ReadyToProcess Pump 25

2.5 Cellbag bioreactor

2.6 UNICORN software overview

See page

13

17

26

29

32

36

12 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

2 System description

2.1 System overview

2.1

System overview

Introduction

ReadyToProcess WAVE 25 is intended for cell cultivation. A disposable Cellbag bioreactor is placed on a rocker and filled with gas, partially filled with culture medium, and inoculated with cells. Gas transfer and mixing of culture is accomplished by wave-induced agitation, performed by the rocker unit.

The cell culture volume range per Cellbag bioreactor is 0.3 to 25 L depending on bioreactor size, and working volume may be expanded up to 10 times during one cultivation.

The system, composed of the rocker, ReadyToProcess CBCU and ReadyToProcess Pump

25, enables measurement and control of pH, DO, weight and media distribution, and provides different gas flow and gas mixing possibilities.

• In single mode, the system supports culture in one Cellbag bioreactor at one time.

The rocker is connected to one ReadyToProcess CBCU and up to three

ReadyToProcess Pump 25 units.

In dual mode, the system supports culture in two Cellbag bioreactors placed on the same tray. The rocker is connected to up to two ReadyToProcess CBCU units and up to three ReadyToProcess Pump 25 units for independent control of culture conditions in the two bioreactors.

The system is controlled from a PC running UNICORN software version 6.3.2 or later. The system can also be controlled from a supervisory control and data acquisition (SCADA) system, such as the Emerson DeltaV™ control system, using the integrated OPC server.

Contact GE for instructions and guidance for OPC.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 13

2 System description

2.1 System overview

Illustration of the system

The illustration below shows the main system units for use in single mode with one

ReadyToProcess Pump 25. Dual mode uses two ReadyToProcess CBCU units for controlling the two Cellbag bioreactors independently. Both single and dual modes can support up to three ReadyToProcess Pump 25 units.

1

2 3 4

14

6

7

4

5

8

2

3

Part

1

8

7

Description

ReadyToProcess Pump 25

Hatch

Filter heater

Cellbag bioreactor

ReadyToProcess WAVE 25 rocker

Tray

Lid

ReadyToProcess CBCU

6 5

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

2 System description

2.1 System overview

Illustration of wave motion

2

4

1

3

3

4

Stage

1

2

Description

Inflowing gas from the CBCU enters the Cellbag bioreactor through the inlet vent filter. The gas flow inflates the bag and oxygenates the culture.

Metabolic waste gases leave the Cellbag bioreactor through the outlet vent filter. The pressure control valve maintains a constant overpressure inside the Cellbag bioreactor.

The rocking mechanism sets the rocking platform in motion.

Wave motions are induced by the rocking. The culture is cautiously mixed, and gases are transferred into the culture.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 15

2 System description

2.1 System overview

Available control parameters

The table below describes the control parameters for the fully configured bioreactor system. The control parameters of your configuration may vary from the list below. In dual mode, all parameters except rocking speed, angle and motion may be controlled independently in the two Cellbag bioreactors.

Control of

Temperature

Rocking speed

Rocking angle

Rocking motion

Gas flow

Media distribution pH

DO

CO

O

2

2

Description

The system has a capacity to control temperature between room temperature plus 5°C and 40°C.

Rocking speed can be set between 2 and 40 rpm.

Rocking angle can be set between 2 and 12 degrees.

Rocking motion can be set between 15% and 100%, and is by default set to 30%. A rocking motion of 15% gives a uniform motion with almost constant angular velocity throughout the movement, and 100% gives a smooth, completely sinusoidal motion.

The system has a capacity to control the gas flow into the cellbag between 0.02 and 1.00 lpm.

The system has a capacity to control culture medium addition and removal. Two different modes exist, media addition and perfusion.

pH is measured and controlled between pH 6 and pH 8. Three different modes of pH regulation exist, with CO

2

, CO

2

/base, and acid/base.

DO is measured between 0% and 250% and controlled between

0% and 100% air saturation. Three different modes of DO regulation exist, with O

2

, speed, and O

2

/speed.

CO

2 concentration in gas mix can be controlled between 0% and

15% and measured between 0% and 20%.

O

2 concentration in gas mix can be measured between 0% and

50%, and controlled between 0% and 50% with N

2

21% and 50% with air.

and between

16 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

2 System description

2.2 ReadyToProcess WAVE 25 rocker

2.2

ReadyToProcess WAVE 25 rocker

Introduction

The rocker is the main unit of the system. Through the rocker, weight is measured, and temperature, rocking speed, rocking angle and rocking motion are controlled. The rocker contains four load cells for monitoring the weight of the Cellbag bioreactor and content. The placement of the load cells allows independent weight measurement of the two Cellbag bioreactors in dual mode. The rocker also contains an embedded microprocessor, which allows the system to be controlled independently of the performance of the connected network and client computer.

For rocker specifications, see Rocker specifications, on page 243.

Rocking parameters

The adjustable rocking parameters are rocking speed, rocking angle and rocking motion.

These factors, in combination with the cell culture volume have a direct impact on the oxygen transfer rate and mixing time in the Cellbag bioreactor.

The rocking motion sets how large part of the rocking cycle that has a sinusoidal angular velocity. It can be adjusted to be more or less sinusoidal. The minimum value, 15%, gives a uniform motion with almost constant angular velocity throughout the movement, resulting in a step-wise rocking. The maximum value, 100%, gives a sinusoidal motion with slower angular velocity in the end positions and faster in the middle of the movement, resulting in a smoother rocking.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 17

2 System description

2.2 ReadyToProcess WAVE 25 rocker

Front view of the rocker

The illustration below shows the front view of the rocker.

1 2

18

3

4

5

4

5

2

3

Part

1

Description

Rocker platform

Temperature sensors

Rocker base

Power switch

Location of adjustable foot

Power switch

The power switch indicates the status of the rocker according to the list below.

Light indicator

No light

Green flashing light

Green steady light

Description

The power is off.

The rocker is starting up.

The power is on and the rocker is operational.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

2 System description

2.2 ReadyToProcess WAVE 25 rocker

Light indicator

Red flashing light

Red steady light

Description

The rocker failed to connect to other components in the system.

Indicates an error of the rocker.

Adjustable foot

The adjustable foot is placed in the front right corner of the rocker base when viewed from the front. It is used to distribute weight evenly over the four rocker feet.

Use the supplied adjustable foot wrench to adjust the foot.

Rear view of the rocker

The illustration below shows the rear panel of the rocker.

Part

1

2

Description

15-pin D-sub connector, used for digital and analog I/O signals

Filter heater connectors

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 19

2 System description

2.2 ReadyToProcess WAVE 25 rocker

6

7

4

5

Part

3

Description

Tray connector

UniNet-9 ports

USB ports

Ethernet connector

Power connector

Note:

The rocker is fitted with internal electrical fuses that are not user-replaceable.

Tray and lid sizes

Trays and lids are available in the different sizes listed below:

Trays

Tray 10

Tray 20

Tray 50

Lids

Lid 10

Lid 20

Lid 50

20 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

2 System description

2.2 ReadyToProcess WAVE 25 rocker

Illustrations of tray and lid

The illustration below shows the rocker with Tray 50 attached.

1

2

4

3

2

3

Part

1

4

Description

Bag clamp (upper)

Bag clamp opener (one in each upper corner)

Bag clamp opener (one in each lower corner)

Bag clamp (lower)

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 21

2 System description

2.2 ReadyToProcess WAVE 25 rocker

The illustration below shows the rocker with Tray 50 and Lid 50 mounted.

4 5

3

2

1

4

5

2

3

Part

1

Description

Rocker base

Lid

Tray

Tubing exit

Hatch

22 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

2 System description

2.2 ReadyToProcess WAVE 25 rocker

Prepare for tilt

When the system enters END mode, the tray prepares for tilt if System Settings:Rock-

er:Prepare for tilt at END is set to Yes. This moves the rocker to the mechanical end position, which is 14 degrees from horizontal. This position can also be set by executing the manual instruction Rocker:Prepare for tilt. See illustration below.

Tilt position

In order to facilitate tray change in system setup and sampling and harvest during and after cell cultivation, it is possible to position the tray with the attached Cellbag bioreactor(s) into an upright position called tilt position. Follow the steps below to put the tray into tilt position.

The tray is shown without attached Cellbag bioreactor in the images below.

NOTICE

Take care when tilting the rocker tray with full Cellbag bioreactor(s) attached.

Step

1

Action

Prepare for tilt as described above or select the largest possible angle in

UNICORN. Do not tilt the tray from an angle lower than 12°.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 23

2 System description

2.2 ReadyToProcess WAVE 25 rocker

Step

2

Action

Hold the textured grip area on each side of the tray and pull the tray towards you.

The illustration below shows the tilt position:

24 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

2 System description

2.2 ReadyToProcess WAVE 25 rocker

Illustration of filter heater

The filter heater prevents condensation and clogging of the outlet vent filter on the

Cellbag bioreactor.

1

2

3

2

3

Part

1

Description

Filter heater

Connector for connection to the rocker

Filter heater stand

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 25

2 System description

2.3 ReadyToProcess CBCU

2.3

ReadyToProcess CBCU

Introduction

The control unit, ReadyToProcess CBCU, is connected to the rocker via a UniNet-9 connector. The full configuration mixes air/N

2

, O

2

, and CO

2 gas, and contains O

2 and CO

2 sensors, a mass flow controller, an optical pH sensor reader, and an optical DO sensor reader. Three configurations are available:

ReadyToProcess CBCU pH: CO

2

, O

2 and pH.

ReadyToProcess CBCU DO: CO

2

, O

2 and DO.

ReadyToProcess CBCU Full: CO

2

, O

2

, pH and DO.

For CBCU specifications, see ReadyToProcess CBCU specifications, on page 244.

Front view of ReadyToProcess

CBCU

The illustration below shows the front panel of a fully configured CBCU. The configuration of your CBCU may vary from the configuration shown below.

26

1

2

3 4

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

2 System description

2.3 ReadyToProcess CBCU

2

3

Part

1

4

Component

pH port

GAS MIX OUT

Status LED

DO port

Description

Connector for pH sensor fiber cable.

Gas outlet for connection to Cellbag bioreactor.

Indicates the CBCU operating status.

Connector for DO sensor fiber cable.

Status LED

The status LED indicates the CBCU operating status according to the following table.

Light indicator

Steady green light

Green flashing light

Red flashing light

Steady red light

Description

The CBCU is ready for operation.

The CBCU is operating.

Indicates an internal error, but the CBCU is still operating.

Indicates an internal error, and the CBCU is not operating.

Rear view of ReadyToProcess

CBCU

The illustration below shows the rear panel of a fully configured CBCU.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 27

2 System description

2.3 ReadyToProcess CBCU

4

5

6

2

3

Part

1

Component

UniNet-9 port

CAN indicator LED

CAN ID switch

O2 IN

CO2 IN

AIR/N2

Description

Power connection to the rocker.

Indicates system connection status.

Switch for setting the CBCU unit number for system recognition.

Inlet connection for O

2 supply.

Inlet connection for CO

2 supply.

Inlet connection for air or N

2 supply.

CAN ID

The CAN ID is a unit number used by UNICORN to recognize the CBCU that is connected to the system.

The CAN ID is set by turning a switch on the CBCU rear panel (see illustration above). The

CAN ID should always be set to position 1 for use in single mode. For dual mode, set the

CAN ID to 1 for the CBCU connected to the left Cellbag bioreactor, and to 2 for the CBCU connected to the right Cellbag bioreactor.

Tubing and connectors

Tubing and connectors for gas flow as listed below are delivered with the ReadyToProcess

CBCU. Tubing and connectors for liquid flow must be obtained separately.

Tubing

Item

Tygon™ E3603

Silicone

Inner diameter

1/8" (3.2 mm)

3/16" (4.8 mm)

Outer diameter

1/4" (6.4 mm)

3/8" (9.5 mm)

Length

147.6" (375 cm)

7.9" (20 cm)

Connectors

Item

Reducer connector, gas tubing

Connector, CBCU

Inner diameter

1/8" to 3/16" (3.2 to 4.8 mm)

1/8" (3.2 mm)

28 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

2 System description

2.4 ReadyToProcess Pump 25

2.4

ReadyToProcess Pump 25

Introduction

The ReadyToProcess Pump 25 is a peristaltic pump unit that includes two roller pump heads. The function of a given pump head is set in the UNICORN software. Up to three pump units are supported in both single and dual mode.

For pump specifications, see ReadyToProcess Pump 25 specifications, on page 245.

Front view of the pump

The illustration below shows the front panel of the pump.

1

2

3

Part

1

2 3

Description

Pump head flip top

Pump head

Status LEDs for pumping function per pump head

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2 System description

2.4 ReadyToProcess Pump 25

Status LEDs

The status LEDs indicate the pumping function status according to the following table.

Light indicator

Steady green light

Green flashing light

Red flashing light

Steady red light

Description

The pumping function is ready for operation.

Pumping is ongoing.

Indicates an internal error, but the pump is still operating.

Indicates an internal error, and the pump is not operating properly.

Rear view of the pump

The illustration below shows the rear panel of the pump.

1 2

3

29-0320-03

Code no: 29000704

Serial no: XXXXXXX

Mfg Year: 2013

Voltage: 32 V DC UniNet-9

Max Power: 32 W

Protection Class: IP21

Made in Sweden

GE Healthcare Bio-Sciences AB

751 84 Uppsala Sweden

2

3

Part

1

Component

UniNet-9 port

CAN indicator LED

CAN ID switch

Description

Power connection to the rocker.

Indicates system connection status.

Shows the unit number of the pump for recognition by the system.

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2 System description

2.4 ReadyToProcess Pump 25

CAN ID

The CAN ID is a unit number used by UNICORN to recognize the particular pump unit that is connected. If more than one pump unit is connected, the units are distinguished by their CAN IDs.

The CAN ID is set by turning a switch on the pump rear panel (see illustration above).

The switch has four CAN ID positions, marked 1, 2, 3, and 4, respectively. The CAN ID should be set to position 1 for the first pump, position 2 for the second pump and so on.

Tip:

The pumps are identified in UNICORN by their CAN ID. Label each pump unit with its CAN ID to simplify identification of the physical pump.

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2 System description

2.5 Cellbag bioreactor

2.5

Cellbag bioreactor

Introduction

Cell cultivation is performed inside the Cellbag bioreactor. The Cellbag bioreactor is delivered gamma irradiated and ready for use. It is intended for single use only and should be discarded after use.

Cellbag bioreactor options

The Cellbag bioreactors are available in different configurations, of varying sizes and equipped with various ports. Cellbag bioreactors with internal cell retention filters are available for perfusion culture. If required, it is possible to customize the Cellbag bioreactors. The following bag sizes are available for ReadyToProcess WAVE 25:

2 L

10 L

20 L (single mode only)

• 22 L

• 50 L (single mode only)

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2 System description

2.5 Cellbag bioreactor

Illustration of Cellbag bioreactor

The illustration shows a general Cellbag bioreactor. The configuration of your Cellbag bioreactor may vary from the configuration shown below.

1 2 3 4 5

3

4

Part

1

2

9 8 7 6

Component

pH bag sensor port

Outlet vent filter with pressure control valve

Inlet vent filter

Addition port

Description

The pH bag sensor port is located on the underside of the bag and holds an optical sensor for online pH control of the cell culture.

The filter prevents contamination of the bag contents by airborne particles of 0.2 µm or larger.

The pressure control valve maintains a constant overpressure inside the Cellbag bioreactor.

The filter removes airborne particles of

0.2 µm or larger from the gas flow before it enters the Cellbag bioreactor.

Addition port equipped with a Luer quick connector.

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2 System description

2.5 Cellbag bioreactor

Part

5

6

7

8

9

Note:

Component

DO bag sensor port

Cellbag rod

CLAVE™ sampling port

Addition port

Addition/harvest port

Description

The DO bag sensor is located on the underside of the bag and holds an optical sensor for online dissolved oxygen control of the cell culture.

The Cellbag rod fixes the Cellbag bioreactor to the tray.

Sampling port equipped with a self-sealing

Luer fitting.

Addition port equipped with a Luer quick connector.

Addition/harvest port equipped with a MPC quick connector.

The inlet and outlet vent filters are distinguished by the pressure control valve on the outlet filter.

pH and DO sensors

The Cellbag bioreactor may be equipped with optical sensors for monitoring pH and dissolved oxygen (DO). The sensors are light sensitive and should be protected from excessive light. The sensors are located in the center of a sensor port on the Cellbag bioreactor and must be coupled to a sensor adapter, see table below.

Part

Bag sensor port

Description

The sensor port is located on the underside of the Cellbag bioreactor.

The actual sensor (white/yellow for pH, pink/black for DO is located in the center (1) of the sensor port, see image below.

The sensor adapter is attached to the sensor port by the four pins (2).

1

2

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2 System description

2.5 Cellbag bioreactor

Part

Sensor adapter

Description

The sensor adapter is located at one end of an optical fiber cable.

The optical lens of the fiber cable is located in the center of the sensor adapter. The fiber cable is connected to a sensor reader in the CBCU.

The fiber cable is connected to the pH or DO port on the CBCU front panel.

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2 System description

2.6 UNICORN software overview

2.6

UNICORN software overview

In this section

This section gives an overview of the general operation of the UNICORN software: a complete package for control, supervision and evaluation of cell cultivation runs. It also

describes how to access the help utility that is included in UNICORN. Refer to Chapter 3

The UNICORN software, on page 40 for more information.

This section contains the following subsections:

Section

2.6.1 General UNICORN operation

2.6.2 The UNICORN help

See page

37

38

Note:

Software illustrations in these instructions are examples, and may differ from your software in some details.

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2 System description

2.6 UNICORN software overview

2.6.1 General UNICORN operation

2.6.1

General UNICORN operation

UNICORN modules overview

UNICORN consists of four modules: System Control, Evaluation, Administration and

Method Editor.

The main functions of the modules are described in the table below.

Module

System Control

Evaluation

Administration

Method Editor

Main functions

Start, view and control runs.

Open results, evaluate runs and create reports.

Perform user and system setup, system log and database administration.

Create and edit methods.

Enter a UNICORN module

To enter a module:

• click the Taskbar button of the module of interest, or

• choose the module of interest in the Tools menu in any of the other software modules.

The illustration below shows the Tools menu of the Evaluation module.

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2 System description

2.6 UNICORN software overview

2.6.2 The UNICORN help

2.6.2

The UNICORN help

Access the help utility

A comprehensive help utility is included in the UNICORN software. The table below describes how to access the different parts of the help utility.

If you want to...

find information about a UNICORN module

then...

select Help:Help for... in the UNICORN module of interest find information about the item currently selected and in focus (e.g., a pane, a dialog, or a method phase)

• press the F1 key with the item of interest selected and in focus or

• click the Help icon in the open dialog navigate the online help

• select Help:Help for... in any of the UNICORN modules

(see illustration above)

• in the TOC (Table of contents) pane, expand the headings of interest to navigate the content structure

• click the heading of interest to open a section search for a specific term in the online help

• select Help:Help for... in any of the UNICORN modules

(see illustration above)

• in the Search pane, enter the term of interest in the input field

• click the Search button

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2 System description

2.6 UNICORN software overview

2.6.2 The UNICORN help

If you want to...

access manuals in PDF format find information about an instruction

then...

• select Help:Help for... in any of the UNICORN modules

(see illustration above)

• in the TOC pane, expand the heading UNICORN online

documentation portal and select Documentation

overview

• in the PDF manuals section, click one of the text links

In the Method Editor module:

• open a method

• select the instruction of interest in the Instruction box in the Text instruction pane

• press the F1 key

In the System Control module:

• select Manual:Execute Manual Instructions

• expand a heading and select the instruction of interest

• press the F1 key

or

click the Help icon in the dialog

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3 The UNICORN software

3 The UNICORN software

In this chapter

This chapter gives an overview of how to work with the four UNICORN modules. Detailed information about the UNICORN software is available in the UNICORN user documentation and in the UNICORN Online Help.

This chapter contains the following sections:

Section

3.1 Administration

3.2 System control

3.3 Methods in UNICORN

3.4 Evaluation in UNICORN

See page

41

42

50

87

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3 The UNICORN software

3.1 Administration

3.1

Administration

Introduction

The Administration module is used to administer all functions of the UNICORN software.

Refer to UNICORN Administration and Technical manual for more information.

Icons in the Administration module

The table below shows the Administration module icons.

Icon Function

User Setup is used to administer the user access to UNICORN.

Access Groups and Network Users is used to administer access groups and network users.

E-mail Setup is used to set up an e-mail account for automated system messages.

UNICORN and System Log provides the system administrator with records of usage and activity.

System Properties is used to define the system and edit system properties.

Database Management is used for maintenance of the database.

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3 The UNICORN software

3.2 System control

3.2

System control

Introduction

The System Control module is used to start, view, and control a manual or a method run.

System Control panes

As illustrated below, two tabs are available in the System Control module by default.

The Process Picture tab allows manual interactions with the system and provides feedback on run parameters. The Chart tab shows a graphical presentation of data throughout the run. Process picture, charts, run logs, and run data can be displayed either as separate tabs or as docked panes in the same window.

More details of how to work with the process picture may be found in the sections listed in the table below:

Section

Section 5.4 Perform cultivation, on page 196

Section 5.4.2 Monitor and control the cultivation, on page 198

Content

Information on how to perform a run.

Working with the process picture during a run.

Refer to Section 5.4 Perform cultivation, on page 196 for information on how to perform

a run.

Tip:

To get more information than is shown in the Process Picture, select View:Run

Data to open the Run Data pane which presents current data in numerical values.

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3 The UNICORN software

3.2 System control

Items in the process picture reflect the components included in the system (for example, the illustration above shows a system in single mode equipped with three pumps).

In dual mode, the process picture shows two Cellbag bioreactors on the rocker picture, with separate control icons for the individually controlled parameters in each bioreactor.

Icons for the right-band bioreactor are in the upper half of the process picture and icons or the right-hand bioreactor in the lower half.

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3 The UNICORN software

3.2 System control

44

Identifying system components in the process picture

This section describes how to identify the units in the process picture with respect to the

Cellbag bioreactors in single and dual mode.

The left- and right-hand Cellbag bioreactors in dual mode are controlled by the CBCU units with CAN ID 1 and 2 respectively. They are shown on the left and right sides of the tray in the process picture. To avoid confusion, place the physical CBCU units on the left and right sides of the tray as viewed from the front of the rocker.

• Connections between the Cellbag bioreactor(s) and the respective monitor and active control units are indicated by connection lines in the process picture.

Pump units are identified in the process picture as 1, 2 or 3 according to their CAN

ID setting, and the pump heads on each unit are designated A (left) and B (right).

In dual mode, pump roles for the left and right Cellbag bioreactors are labelled L and

R respectively.

Examples:

Pump 25: 1B refers to the right-hand pump head on the pump unit with CAN ID 1.

Pump 25: 2A refers to the left-hand pump head on the pump unit with CAN ID 2.

Tip:

Label the CBCU and pump units with their CAN ID settings to simplify correlation of the physical units with the process picture.

In dual mode, place the pumps connected to the left and right Cellbag bioreactors on the left and right sides of the rocker respectively.

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3.2 System control

Actions in the Process Picture pane

It is possible to interact with the Process Picture pane in the following ways:

If you want to...

Activate or deactivate pH and DO measurement and control

then...

Hold the cursor over the right-hand side of the button, and turn Reading and/or Control on or off as required.

You can only switch the Control setting if Reading is on, and you cannot turn Reading off if Control is on.

Activate or deactivate other functions

Click on the right-hand side of the button. The text on the button shows the current value of the function.

Open the settings for a function

Click on the left-hand side of the button.

The example below shows the settings for dissolved oxygen, DO.

Adjust the settings Enter appropriate values in the Settings dialog and click

OK or press enter.

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3 The UNICORN software

3.2 System control

System Control toolbar icons

The table below shows the System Control toolbar icons that are referred to in this

System Handbook.

Icon Function

Open Method Navigator: Opens the Method Navigator where available methods are listed.

Run: Starts a method run.

Hold: Suspends the method run.

Continue: Resumes for example a method run that is on hold.

End: Permanently ends the method run.

Customize: Opens the Customize dialog where curve settings, run data groups and run log contents can be set.

Connect to Systems: Opens the Connect to Systems dialog where systems can be connected, and currently connected users are displayed.

Curves

46

Monitor signals and instrument settings are shown in the chart as curves. The curves are also saved in a result file, which can be opened in the Evaluation module. The default view shows the most commonly used curves. The user may customize which curves to display and the color and style of the displayed curves.

Note:

All curves are saved in the result file regardless of the curves displayed.

Note:

The complete ranges of the signals are saved in the result file regardless of used factors, such as scaling and zooming, during the run.

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3.2 System control

The table below describes how to customize which curves to show in the chart. Refer to the online help for further information about the tabs in the Customize dialog.

Step

1

Action

In the System Control module:

• click the Customize icon

2 or

• select Tools:Customize...

Result: The Customize dialog opens.

Select the Curves tab.

3 Check the boxes for the curves you want to show in the chart and then click

OK.

System settings

Each installed instrument has a set of default parameter values, called system settings.

The System Settings dialog in System Control is used to view and edit the system setting for the currently selected instrument before the run is started. Follow the instructions below to change the System Settings.

Available settings are described in Section 8.5 Control settings, on page 249.

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3 The UNICORN software

3.2 System control

Step

1

Action

In the System Control module, select System:Settings.

Result: The System Settings dialog opens with the Instructions displayed.

An example is shown below.

2

3

4

Select the instruction to edit from the list. Click the + symbol to show the instructions for each category. The instructions in each category differ depending on the instrument configuration.

Select settings and choose parameter values for the selected instruction.

Click OK. Settings will apply until they are changed.

To return to the default values defined in the instrument configuration, click

Set Parameters To Strategy Default Values.

Manual instructions

It is possible to manually interact with an ongoing run using Manual instructions. Follow the instructions below to perform manual instructions.

Note:

It is also possible to interact with the system manually directly from the Process

Picture.

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Step

1

Action

In the System Control module:

• select Manual:Execute Manual Instructions

or

• use the shortcut Ctrl+M.

Result: The Manual instructions dialog opens.

3 The UNICORN software

3.2 System control

2

3

4

In the Manual instructions dialog:

Click the + symbol to show the instructions for the instruction group that you want to modify.

Select the instruction that you want to modify.

Enter the new values for the instruction.

To execute several instructions at the same breakpoint, select and edit an instruction and click Insert. Repeat for several instructions.

Note:

To update parameter fields during run, check the Auto update... box.

To perform the instructions, click Execute.

Run data

The Run Data pane shows the current values of some parameters, for example rocking motion and accumulated time. To change the Run Data display, select View:Run Data, right click in the Run Data pane and:

• select Run Data Groups:Detailed to show more details or

• select Customize to customize the appearance of the Run Data pane.

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3 The UNICORN software

3.3 Methods in UNICORN

3.3

Methods in UNICORN

In this section

This section describes how to create methods and work with predefined methods and text instructions. For information about dialogs in the Method Editor that are not described in this manual, refer to the online help.

This section contains the following subsections:

Section

3.3.1 Method editor

3.3.2 Method creation

3.3.3 Work with methods

3.3.4 Text instructions

3.3.5 Save a method

3.3.6 Scouting

3.3.7 Method queues

See page

51

54

58

65

73

77

83

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3 The UNICORN software

3.3 Methods in UNICORN

3.3.1 Method editor

3.3.1

Method editor

Introduction

In the UNICORN software, the instructions to control a bioreactor run can be defined in a method. The Method Editor module is used to create or edit such methods.

User defined methods and phases

A method consists of a number of phases, and each phase consists on turn of a number of instructions.

Refer to the UNICORN Online Help for more information about methods and phases and how to create a method.

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3 The UNICORN software

3.3 Methods in UNICORN

3.3.1 Method editor

Method Editor panes

As illustrated below, three panes are shown in the Method Editor by default. The available

User Defined phase is found in the Phase Library (1), and an overview of the phases included in the active method is displayed in a Method Outline (2). Information about the method is presented in the right pane (3), containing the two tabs Phase Properties and

Text Instructions.

Method Editor toolbar icons

The table below shows the Method Editor toolbar icons that are referred to in this System

Handbook.

Icon Function

New Method: Opens the New Method dialog where methods can be created.

Open Method Navigator: Opens the Method Navigator where available methods are listed.

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3.3 Methods in UNICORN

3.3.1 Method editor

Icon Function

Save: Saves the active method.

Print: Opens the Print dialog from where a method can be printed.

Start protocol: Opens the Start Protocol dialog, where settings for the start protocol can be made.

Method notes: Opens the Method Notes dialog, where notes can be added to the method.

Scouting: Opens the Scouting Variables dialog, which is used to repeat a series of method runs.

New method queue: Opens the Method Queue dialog.

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3 The UNICORN software

3.3 Methods in UNICORN

3.3.2 Method creation

3.3.2

Method creation

Predefined method

The table below describes how to create a new method using a predefined method as template:

Step

1

Action

In the Method Editor:

• click the Create a new method icon in the Toolbar

or

• select File:New Method...

Result: The New Method dialog opens.

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Step Action

3 The UNICORN software

3.3 Methods in UNICORN

3.3.2 Method creation

2 In the New Method dialog:

• select a System

• select a Predefined Method

• click OK

Result: The Method Outline pane shows the mandatory Method Settings phase for the chosen method and the Text Instructions pane shows all the instructions that defines the method. The Phase Properties pane shows the default settings for the currently highlighted phase.

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3 The UNICORN software

3.3 Methods in UNICORN

3.3.2 Method creation

Empty method

The table below describes how to create a new empty method:

Step

1

Action

In the Method Editor:

• click the Create a new method icon in the Toolbar

or

• select File:New Method...

Result: The New Method dialog opens.

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Step

2

Action

3 The UNICORN software

3.3 Methods in UNICORN

3.3.2 Method creation

In the New Method dialog:

• select a System

• select the Empty Method radio button

• click OK

Result: An empty method that consists of the mandatory Method Settings phase is created.

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3 The UNICORN software

3.3 Methods in UNICORN

3.3.3 Work with methods

3.3.3

Work with methods

Open a method

The table below describes how to open an existing method in the database:

Step Action

1 In the Method Editor:

Click the Open Method Navigator icon in the Toolbar

or

• select File:Open...

or

• select View:Method Navigator

2

Result: The Method Navigator is displayed.

Select the method to be opened in the Folder name column.

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Step

3

3 The UNICORN software

3.3 Methods in UNICORN

3.3.3 Work with methods

Action

To open the method,

Click the Open button located in the toolbar of the Method Navigator pane

or

• double-click the selected method

or

• right-click on the method name and select Open from the context menu.

Result: The method is opened and displayed in the Method Outline pane with included phases. You can continue to edit the phases of the method using Phase Properties, or manually text edit the method in the Text Instruc-

tions pane".

Add a user defined phase to the method outline using drag-and-drop

The table below describes how to add a user defined phase to the method outline using drag-and-drop:

Step Action

1 Select the User Defined phase in the Phase Library pane and drag-anddrop the phase to the requested position in the Method Outline pane.

Result: The phase is included in the method at the requested position.

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3.3 Methods in UNICORN

3.3.3 Work with methods

Step

2

Action

When the User Defined phase has been added to the Method Outline, the phase name is enabled for editing.

Type a name for the phase and press the Return keyboard key.

Note:

The User Defined phase is marked with the letter T, meaning that it is text edited. This phase contains only Base and End_Block instructions, so any functional instructions must be added by hand. To include instructions for the

User Defined phase, select the Text Instructions tab. The Phase Properties

tab will only show the variables used in this phase. See Section 3.3.4 Text instructions, on page 65 for information about how to work with instructions

in the Text Instructions pane.

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3.3 Methods in UNICORN

3.3.3 Work with methods

Rearrange phases within a method

The table below describes how to rearrange phases within a method:

Step Action

1

2

Select the phase to be moved in the Method Outline pane.

Drag-and-drop the phase to the requested position in the Method Outline pane.

Result: The phase is moved to the requested position.

or

Right-click the phase and select Move up or Move down.

Result: The phase is moved one step up or down in the Method Outline.

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3 The UNICORN software

3.3 Methods in UNICORN

3.3.3 Work with methods

Set up a Start Protocol

The table below describes how to set up a Start Protocol to be displayed before the method run starts.

Step Action

1 In the Method Editor:

• click the Start Protocol icon or

• select Tools:Start Protocol...

2 or

• click the Method Settings phase and click the Start Protocol... button in the Phase Properties tab

Result: The Start Protocol dialog opens.

In the Start Protocol dialog:

Select items to display at method start. When selecting a method item, a description is shown to the right. Result Name and Location is selected by default.

Click OK to confirm and close the dialog.

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3.3 Methods in UNICORN

3.3.3 Work with methods

Add/edit Method Notes

The table below describes how to add/edit notes to a method.

Step

1

Action

In the Method Editor:

• click the Method Notes icon or

• select Edit:Method Notes... or

• click the Method Settings phase and click the Method Notes... button in the Phase Properties tab

Result: The Method Notes dialog opens.

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3.3 Methods in UNICORN

3.3.3 Work with methods

Step

2

Action

In the Method Notes dialog:

Enter/edit notes about the method. If notes already have been entered, it is possible to search for specific words using the Find... button.

Click OK to confirm and close the dialog.

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3.3 Methods in UNICORN

3.3.4 Text instructions

3.3.4

Text instructions

Introduction

When a user defined phase in the Method Editor is selected, the corresponding phase block is selected in Text Instructions when changing to the Text Instructions tab.

Changes made in the Phase Properties pane are automatically updated in the Text In-

structions pane.

Text editing a method

Adding, editing or deleting any blocks or instructions in a phase in the Text Instructions area means text editing of the method. When a method has been text edited, one or several of the phases displayed in the Method Editor window are affected depending on the type of editing performed.

The letter T next to the phase name in the Method Editor window indicates that the phase has been text edited.

Help texts for the instructions

It is possible to display help texts for the instructions in the Instruction Box.

The table below describes how to display the help text for an instruction:

Step Action

1

2

In the Instruction Box, select the appropriate instruction for which to display help text.

Press F1 on the keyboard.

Result: A dialog with help text for the selected instruction will be displayed.

Insert a new instruction

The table below describes how to insert a new text instruction in the Text Instructions area:

Step

1

2

Action

Select a block and display the instructions within the block.

Select the instruction in the block after which you want to add the new instruction.

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3.3 Methods in UNICORN

3.3.4 Text instructions

Step

3

Action

Open the Instruction Box if it is hidden. Do the following:

1

Set the appropriate breakpoint in the Breakpoint box.

Note:

A Breakpoint defines when an instruction will be executed. The time set is relative to the start of the block.

2

Choose the instruction type and the instruction in the Instructions field.

For basic help on each instruction, select the instruction and press F1.

3

Type values for instruction parameters in the Parameters text boxes.

The allowed range is shown in brackets beside the text box. If a scroll bar appears at the right side of the Parameters field, additional parameters are available.

66

4 Click the Insert button.

Result: The instruction will be inserted in the block:

• at the position of the breakpoint of the new instruction, if there are no other instructions at that breakpoint

• immediately after the currently highlighted instruction, if the highlight is at the same breakpoint as the new instruction

• as the first or last instruction, if none of the instructions at the desired breakpoint is highlighted. The insertion point depends on the breakpoint value of the currently selected instruction. For example, if the breakpoint for the current instruction is lower than that for the new instruction it is inserted as the first instruction at that breakpoint.

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3.3 Methods in UNICORN

3.3.4 Text instructions

Define new variables

Only one variable that affects block length (breakpoint) may be defined within each block.

However, any number of parameters may be defined as variables within a block. The table below describes how to define a new variable.

Step

1

Action

Select the instruction where you want to define the variable in the Text In-

structions area.

Result: The parameters for the instruction are shown in the Instruction Box.

2

Locate the breakpoint or the required parameter in the Instruction box.

Click the Var... button.

Result: The New Variable dialog opens.

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3.3 Methods in UNICORN

3.3.4 Text instructions

Step

3

4

Action

Type a name for the variable.

Select the Visible in details only checkbox if you want to set the variable as a detailed variable. Detailed variables become visible in the Variable

List if the Show details checkbox is selected. This option can be used to simplify the workflow later.

Click OK.

Result: The Var... button changes to VAR... to confirm the new variable.

Note:

If a breakpoint is defined as a variable, changing the variable value in the

Variable List tab when the method run is started will shift other instruction breakpoints accordingly.

Click Change.

Result: The variable is saved and displayed in the Text Instructions area.

Identifying variables in the instruction box

Parameters that are defined as variables in the text method are also indicated in the

Instruction Box for the selected instruction in the Text Instructions area.

When the instruction is shown in the Instructions field of the Instruction Box, the text on the button to the left of the parameter field is displayed as VAR.... The button text for parameters not having associated variables is Var....

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3.3.4 Text instructions

Edit variables

Editing a variable includes renaming and deleting the variable and choosing whether the variable should be a detailed variable or not.

Edit a variable using the Edit variable button

The table below describes how to edit a variable using the Edit Variable button:

Step Action

1

In the Instruction Box, click Edit Variable....

Alternatively select the Phase Properties tab to display the phase variables, select the variable and click Edit Variable....

Result: The Edit Variable dialog opens displaying all variables (if opened from the Text Instructions pane) or the phase variables (if opened from the

Phase Properties tab).

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3.3.4 Text instructions

Step

2

Action

Select the variable to be edited (if not already selected). Do one or several of the following as appropriate:

70

Type in a new name in the New name field and click Rename.

Check the Set visible in details only if the variable should be a detailed variable. Uncheck the box to set it to a normal variable.

Click Delete to delete the variable.

Confirm that you want to delete the variable in the dialog that appears.

Click Close to close the dialog.

3

Edit a variable using the VAR.. button in the Instruction Box

The table below describes how to edit a variable using the Instruction Box:

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3.3.4 Text instructions

Action

Select the instruction containing the variable to be edited in the Text Instruc-

tions area.

Result: The parameters for the instruction are shown in the Instruction Box.

2 Click the VAR... button for the appropriate variable.

Result: The Edit Variable dialog opens.

3 Do one or several of the following as appropriate:

Type in a new name in the Variable name field.

Check the Visible in details only if the variable should be a detailed variable. Uncheck the box to set it to a normal variable.

Click Clear to delete the variable.

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3.3.4 Text instructions

Step

4

5

Action

Click OK.

To save the changes, click Change in the Instruction Box.

Result: The text instruction is updated.

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3.3.5 Save a method

3.3.5

Save a method

Introduction

Methods and phases are saved in the UNICORN database.

Individual, edited phases may be saved to the Phase Library for later use in other methods on systems having the same instrument configuration and component configuration.

Save a method

The table below describes how to save a method in UNICORN.

Step Action

1

Click the Save the Method icon or

• select File:Save or File:Save As.

Result:

If the method has been named and saved previously, the changes are saved immediately.

If not

• the Save As dialog opens. Proceed with steps 2-4 below.

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3.3.5 Save a method

Step

2

Action

Browse for an appropriate folder, or create a new one.

74

3

4

Select the folder in which to save the method.

Enter a method Name.

Select for which System to save the method

Click Save.

Result: The method is saved in the database.

Note:

For some systems an error message will appear if you are trying to save the method for:

• a system using another instrument configuration and/or another component configuration than the method originally was created for and

• the settings in the method depend on the component configuration.

It will still be possible to save the method but the phases in the method will be marked with an error symbol. In order to be able to subsequently run the method, either the method must be text edited or the component configuration of the system changed in the Administration module.

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3.3.5 Save a method

Save a phase

The instruction below describes how to save a phase to the Phase Library:

Step

1

Action

Select the phase to be saved in the method outline.

Note:

A Method Settings phase cannot be saved as a separate phase with a new name. If properties for the Method Settings phase are changed, the changes will be saved with the method.

2

• click the Save Phase... button below the Method Outline pane

or

• select Phases:Save Phase...

or

• right-click the phase and select Save Phase...

Result: The Save Phase to Phase Library dialog opens.

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3.3.5 Save a method

Step

3

4

5

Action

Type a Phase name

or

Choose a phase from the Phase name drop-down list. This phase will be replaced by the phase with the new settings.

In the For system field, the system that was selected when the current method was set up will be displayed by default. To save the phase for another system, choose the appropriate system from the For system drop-down list.

Note:

Only systems using the same instrument configuration and component configuration as the system that was selected when the current method was set up will be displayed in the For system field.

Select if the phase shall be Global (available for all users) or Personal

(for your own use only).

Click OK.

Result: The phase is saved and is available in the Global Phases or Personal

Phases panel of the Phase Library.

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3.3.6 Scouting

3.3.6

Scouting

Introduction

Scouting is used to repeat a series of method runs automatically using different settings or with predetermined changes in the values for one or more Variables. A Scouting

scheme is defined as part of the method. This chapter gives an overview of scouting and the scouting workflow and describes how to set up and edit a Scouting scheme.

Scouting is ideal for relatively simple variable combinations.

Set up a scouting scheme

The table below describes how to set up a Scouting scheme where a variable is varied.

In this example, the rocking speed is varied.

Note:

The Start protocol will only be displayed before the first run in the Scouting experiment.

Step Action

1 Create a method and decide appropriate run parameters to be varied in the experiment. The run parameters to be varied should be defined as Variables in your method.

See Section 3.3.2 Method creation, on page 54 for information about how to

create methods.

See Edit variables, on page 69 for information about how to define new

variables.

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3.3.6 Scouting

Step

2

Action

In the Method Editor:

Click the Scouting icon in the toolbar

or

Select Tools:Scouting

Result: The Scouting dialog opens with the Scouting Variables dialog displayed on top.

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Note:

When editing a scouting scheme, only the Scouting dialog is displayed.

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3.3.6 Scouting

Action

In the Scouting Variables dialog, select the appropriate variables to be varied by checking the appropriate boxes.

-

Check the Show details box if you want to display variables defined as detailed variables in your method. These are rarely used as scouting variables.

-

Check the Show unused variables box if you want to display variables currently not used in the method.

Click OK.

Result: The Scouting dialog is updated with the selected variables and their default values.

It is possible to insert runs one by one (see step 4) or insert series of runs

(see step 5).

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3.3.6 Scouting

Step

4

Action

To insert runs one by one:

In the Scouting dialog, select a row in the Scouting parameters table and click .

Result: A new row is added below the selected run. The variable value from the selected row is copied to the new run. Each chosen variable is displayed in a separate column.

In this example, click in the Rocking Speed {RPM} column for the appropriate run and edit the rocking speed value.

Note:

Changing variable values in the scouting scheme does not change the values in the Variable List in the Duration and Variables dialog accessed from the Method Editor or in the text instructions. The actual variable values used for each run in the scouting scheme are saved in the result file. To change the default values, the variable values must be edited in the Phase Properties pane.

Repeat until all runs are included using the correct variable values.

Note:

The scouting scheme can also be edited just prior to starting the method run in the Start Protocol. Here variable values can be changed and individual runs included or excluded.

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3.3.6 Scouting

Action

To insert a series of runs:

Click in the appropriate variable column in the Scouting parameters table and click . This button is activated for variables with continuous values, such as flow rates or pressure limits.

Result: The Insert Series dialog for the selected variable opens.

6 In the Insert Series dialog:

Enter Start value:, Step by: and Number of runs:. In this example, 20, 2 and 5.

Click OK.

Result: The Scouting parameters table is updated.

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3.3.6 Scouting

Step

7

Action

Alternatively, to enter either consecutive or non-consecutive integer values:

Check the Set as integer values box in the Insert Series dialog.

Result: The following alternative Insert Series dialog for the selected variable opens.

Enter the appropriate range, for example: 20-23,25-28

Click OK.

Result: The Scouting parameters table is updated.

8 Click OK in the Scouting dialog to save the scouting scheme.

Save the method.

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3.3.7 Method queues

3.3.7

Method queues

Introduction

This section describes how to create and edit method queues in UNICORN. For information

on how to create and edit individual methods, see Section 3.3.2 Method creation, on

page 54.

A method queue in UNICORN is a linked set of methods to be run. The method queue can contain methods to be run on up to three different systems. Each system may have up to ten methods queued.

Create a method queue

The following table describes how to create a method queue.

Step Action

1 In the Method Editor:

• click the New Method Queue icon in the Toolbar

or

Select File:New Method Queue...

Result: The Method Queue dialog opens.

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3.3.7 Method queues

Step

2

Action

In the Method Queue dialog, choose the Number of included systems from the drop down list.

3

Result: A separate method queue block will be added to the dialog for each additional system if required.

Choose a system for each method queue block from the System drop down list.

4 Choose a Method to add to a method queue by pressing the browse button.

84

5

Result: The Select Method dialog opens.

In the Select Method dialog, browse to the required method and click OK.

Result: The method is added to the method queue.

Note:

For reasons of system compatibility, the individual methods should be saved for the system on which they are queued.

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3.3.7 Method queues

Action

Select a Start Condition for the method from the drop-down list.

Note:

The first Method for the first System will always have its Start Condition set to At queue start.

Available Start Conditions are:

At queue start

The method will begin at the start of the method queue. Only available for the first method for each system.

Immediately after the previous method has ended

The method will start when the previous has ended on the queue for that system.

Wait...

The method will start after a specified Wait time has elapsed since the previous method in the queue for the system has ended. A separate dialog will open where the Wait time can be specified in Hours and Min-

utes. The delay time will be shown in the Method Queue dialog once entered.

At ready command...

The method will start when a Ready instruction in a method on another system has been executed. Using this start condition it is possible to connect methods running on different systems. A separate dialog will open where the System and Method can be chosen.

7 Repeat steps 4 to 6 to add further methods to the Method list for each required system.

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3.3.7 Method queues

Step

8

Action

Click Save or Save As to save the completed method queue.

Note:

An error dialog will be displayed if any of the methods are incompatible with the system on which they are queued.

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3.4

Evaluation in UNICORN

In this section

The Evaluation module in UNICORN includes the basic functionality needed to evaluate the results of a run. How to use the Evaluation module is described in the integrated

Getting Started view and in tool tips in the software.

This section describes how to use the Evaluation Classic module which includes additional features and requires a separate license.

This section contains the following subsections:

Section

3.4.1 Evaluation

3.4.2 Open and view results

3.4.3 Run documentation

3.4.4 Generate and print a predefined report format

3.4.5 Create a new report format

3.4.6 Edit an existing report format

See page

88

90

94

99

101

111

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3.4.1 Evaluation

3.4.1

Evaluation

Evaluation panes

As illustrated below, the Evaluation module contains two panes. When a result is opened from the Result Navigator (1) the Chart pane (2) is displayed. In the Evaluation module it is also possible to view the complete documentation of the results, and to generate reports. Refer to the UNICORN Online Help for more information about result evaluation.

Evaluation toolbar icons

The table below shows the Evaluation toolbar icons that are referred to in this System

Handbook.

Icon Function

Open Result Navigator: Opens the Result Navigator where available results are listed.

Save: Saves the changes made to the current result.

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3.4.1 Evaluation

Icon Function

Print: Opens the Print charts dialog from where a chart can be printed.

Report: Opens the Create report dialog where a report of the result can be created.

View Documentation: Opens the Documentation dialog that contains the complete documentation for a manual or a method run.

Customize: Opens the Customize dialog where for example curve settings can be set.

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3.4.2 Open and view results

3.4.2

Open and view results

Introduction

All contents of the result files are opened in the Evaluation module where you can analyze the results and compile reports. The Evaluation module user interface and toolbar icons

are described in Section 3.4.1 Evaluation, on page 88.

This section also describes how to highlight curves in a chart, read curve values using a marker and save curve data as a Snapshot.

Open a result in the Evaluation module

Click the Open Result Navigator icon to access the result files that are located in folders accessible to you.

There are four ways to open a result from the Result Navigator:

Select a result and click the Enter key or

Double-click a result or

• Right-click a result and choose Open from the shortcut menu or

• Select a result and click the Open toolbar icon in the Result Navigator.

90

Result: The result is opened in the chart pane.

Only one result at a time may be opened this way. If you open a new result, the previous result will automatically close. However, you may open several charts from different results using File:Open to Compare. Refer to Online help for furhter information.

Note:

When working in a network environment, it is not possible to edit the same result file from two different locations simultaneously. If the result is already open at another network workstation, you can only open it in read-only mode.

A message similar to the illustration below will open.

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3.4.2 Open and view results

Highlight or select a curve

You can highlight or select an individual curve in the chart. The table below describes the differences:

If you...

hold your mouse pointer over a curve segment hold your mouse pointer over a curve name click a curve segment or a curve name

Then...

a pop-up box will display the curve name.

the curve and the short line segment in front of the curve name become bold.

the Y-axis shows the values for this specific curve.

Insert a vertical marker

The vertical marker is used to measure the values for a specific curve position. Rightclick in the chart and choose Vertical marker. Move the marker along the X-axis and read the X-axis and Y-axis values of the selected curve in the box in the top left corner of the chart.

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3.4.2 Open and view results

Note:

The marker will measure the curve that currently is selected if several curves are displayed in the chart. The marker will have the same color as the selected curve.

Set marker reference

You can use the vertical marker for more measurements than just the readings from a specific curve position. The table below describes how to use the marker to determine

Delta and Mean Y-axis values.

Step Action

1

Position the marker where you want to begin the measurement.

Right-click and choose Set vertical marker reference point.

Result: The reference point is set to the position shown in the box in the top left corner of the chart.

2

Drag the marker to the point where you want the measurement to end.

Result: The measured area is colored as illustrated below:

3

Read the Delta and Mean values from the box:

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Snapshots

You can take a Snapshot of all the curve values at the marker position. The table below describes this:

Step Action

1

Insert a vertical marker where you want to take the Snapshot.

Right-click and choose Snapshot from the shortcut menu.

Result: The Snapshot dialog opens.

2

3

Note:

Click the Save button to save the Snapshot

Result: The Save As dialog opens and you can save the Snapshot as a text file.

or

Click the Print button to print the Snapshot

Result: The Print dialog opens and you can print the Snapshot using the selected printer.

Note:

Snapshots taken during the method run are saved directly to the result and can be accessed by clicking the Snapshot sub-tab in the Result Information tab of the Documentation dialog.

Click the Close button to close the Snapshot dialog.

The snaphot will record only the values of curves that are displayed. Curves that are filtered will not be recorded.

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3.4.3 Run documentation

3.4.3

Run documentation

Introduction

The full documentation for a run is stored in the result. This section contains:

• an instruction how to view and print the run documentation,

• a list and short descriptions of the contents of the run documentation,

• an instruction how to save the text instructions from a method run as a new method.

View and print the run documentation

The table below describes how to view and print the run documentation.

Step Action

1

2

Open a result in the Evaluation module.

Choose View: Documentation or

Click the view Documentation icon.

3

Result: The Documentation dialog opens.

See further information about the tabs and contents below.

Click the Print button.

Result: The Print dialog opens.

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3.4.3 Run documentation

Action

Select the documentation items you want to print.

Note:

Items that do not contain any information cannot be selected. If you select a group heading (e.g., Result information) all sub-headings that contain information will automatically be selected.

5 Click the OK button to print the selected items.

The documentation tabs

The table below describes the contents of the Run Documentation tabs. Refer to the online help for more information about each tab.

Note:

Some of the items listed below may be excluded from the Run Documentation.

Tabs will be shown only for items that have been included in the method.

Documentation tab

Result Information

Contents

The Result Information tab contains general information about the result.

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Documentation tab

Method Information

Start Protocol

System Information

Calibration

Run Log

Evaluation Log

Variable List

Contents

The Method Information tab shows the general Properties of the method:

Name

When and by whom the method was created

When and by whom the method was last modified

The system and Instrument Configuration that the method was created for

Click the Details button to view comprehensive information about the Instrument Configuration.

The Method Information tab also contains a listing of all the electronic signatures that have been added to the method, under the sub-tab Signatures.

The Start Protocol tab shows the method items that were included in the Start Protocol at the start of the method run.

The System Information tab shows the system settings during the method run, for example

Heating settings

• pH and DO sensor settings

Pump setup

The Calibration tab shows a calibration report for the system.

The Run Log tab shows selected log entries and feedback.

The Evaluation Log tab lists all of the evaluation operations that have been performed for the result during all sessions, including at the end of the method run. The log also shows when the result has been accessed without editing after the end of the method run.

The Variable List tab shows all the method variables and corresponding values, listed by the method block where they appear.

The list can show detail and/or unused variables. At this stage, the variable values are no longer possible to edit.

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Documentation tab

Scouting

Text Instructions

Notes

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3.4.3 Run documentation

Contents

The Scouting tab shows the scouting parameter settings.

This tab corresponds to the Scouting settings in the

Method Editor.

The Text Instructions tab shows all the text method instructions from the method.

These instructions can be saved as a new method. This is

described in Save the method used for the run as a new

method, on page 98 in this section.

The Notes tab shows all notes that have been made regarding the method, the method run and the subsequent evaluation. The notes are divided into the following subtabs:

Method Notes

Start Notes

Run Notes

Evaluation Notes

You can add new notes on the Evaluation Notes sub-tab.

Note:

Click the Find button to search for specific text in the Notes.

Search for log entries

The table below describes how to find specific text in the logs.

Step Action

1

2

Select the log tab where you want to perform your search.

Click the Find button.

Result: The Find dialog opens.

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3.4.3 Run documentation

Step

3

4

Action

Type the text you want to locate in the Find what: textbox.

Note:

Your previous search text may be shown in this box if you have used the search function before.

Select additional search criteria:

-

Match whole word only

-

Match case

-

Search Up

-

Search Down

Click the Find Next button.

Result: The first log entry where the search text is found is marked.

Save the method used for the run as a new method

You can save the method with the variables that were used for the run as a new method, as described below.

Step Action

1

2

Select the Text Instructions tab.

Click the Save as button.

Result: The Save As dialog box opens.

3

Select the appropriate destination folder.

Type a name in the Name text box.

Select a system from the System droplist.

4

Click OK.

Result: The method is saved.

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3.4.4 Generate and print a predefined report format

3.4.4

Generate and print a predefined report format

Introduction

This section describes how to generate and print a report using a format that has been defined and saved.

Should you need to store your reports in an electronic format you can also save them as PDF files. This section describes how to do this.

Generate and print the report

The table below describes how to select a format and print the report:

Step Action

1

Choose File:Report.

or

Click the Report icon.

2

Result: The Generate Report dialog opens.

Select a Format for the report.

Note:

Global report formats are noted by the text Global before the report format name in this list.

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3.4.4 Generate and print a predefined report format

Step

3

Action

Click the Preview button to view the report in the Customize Report window and click the Print icon

4

5

Note:

or

Click the Print button.

Result: The Print dialog opens.

Select a printer from the Printer droplist.

Select a Print Range, all pages or just selected pages.

Select a number of copies.

Click the OK button.

Result: The report is printed on the selected printer.

Select Edit mode in Customize Report to change the layout. You can either print the edited format from this mode and exit Customize Report without saving the changes or save the edits when you exit.

Save the report in PDF format

The generated report can be saved as a PDF file as described below:

2

3

Step

1

Action

Perform steps 1 to 2 in the Generate and print the report, on page 99 instruc-

tion above.

Click the Preview button to view the report in the Customize Report window

Select File:Save As PDF.

Result: The Save As dialog opens.

4

Browse for a folder and File name for the report.

Click Save.

Result: The report is created as a PDF file and saved in the location specified in the dialog.

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3.4.5 Create a new report format

3.4.5

Create a new report format

Introduction

This section describes how to create a new, customized report format. You can choose from a variety of objects to include in a report, including charts, methods, documentation, free text and more. You can also place, align and size the objects as you please.

Note:

Click the Preview/Edit mode button to toggle between the Preview mode which is for view only, and the Edit mode where you can edit the report items.

The editing actions in this section are only available in the Edit mode.

Open the Customize Report window

The table below describes how to open the Customize Report in Edit mode to create a new report format.

Step Action

1

2

Open a result in the Evaluation module.

Select File:Report.

or

Click the Report icon.

3

Result: The Generate Report dialog box opens.

Click the New button.

Result: The Customize Report window opens in Edit mode.

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The Edit mode window

The illustration below shows the Customize Report window in Edit mode with a blank report open:

Toolbar commands in the

Customize Report window

The table below describes the different functions of the toolbar command buttons in the Customize Report window:

Toolbar button

Preview/Edit mode

Prev Page

Next Page

One Page/Two Pages

Function

This button toggles between a print preview of the report and the Edit mode.

This button displays the previous page or pair of pages (if there is more than one page).

This button displays the next page or pair of pages (if there is more than one page).

This button toggles between single page view and pairs of pages view (if there is more than one page).

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Function

Select the magnification of the view in this droplist.

Add Page

Delete Page

Exit

Note:

This button adds a blank page to the report.

This button deletes the current page from the report.

This button closes the Customize Report window.

The general toolbar icons are described below. The toolbar icons for specific formatting operations are described in the instructions for how to use the functions.

General toolbar icons

The table below describes the different functions of the general toolbar icons in the

Customize Report window:

Toolbar icon

Function

Opens a new, blank report.

Note:

You can also choose the File:New menu command.

Opens the Open Report Format dialog. You can choose to open a previously defined format for editing.

Note:

You can also choose the File:Open menu command.

Saves the edited report format.

Note:

You can also choose the File:Save menu command.

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3.4.5 Create a new report format

Toolbar icon

Function

Cuts the selected object from the report.

Note:

You can also choose the Edit:Cut menu command.

Copies the selected object in the report.

Note:

You can also choose the Edit:Copy menu command.

Pastes a copied or cut object from the clipboard into the report.

Note:

You can also choose the Edit:Paste menu command.

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Change the page layout

The page layout is changed in the Page Setup dialog. The table below describes how to set up the page layout:

Step Action

1

Double-click anywhere on the report page (not on an object) or

Right-click (not on an object) and choose Properties from the shortcut menu or

Choose the Edit:Page setup menu command.

Result: The Page Setup dialog box opens.

2

Type new values for the Margins if necessary.

Select the appropriate Settings and Unit.

Note:

An extra Header tab will appear if you de-select the option to have the same header on all pages. The First Header tab is used for the first page header only, and the Header tab is used for all subsequent pages.

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Step

3

4

5

6

7

Action

Click the First Header tab.

Select all the items you want to include in the header from the Select

Items list.

Click the Font button to change the font for all items if necessary.

Type header text in the Free text box and click the Font button to alter the default font if necessary. This text will be placed on top of the header.

Type the report title in the Report title box and click the Font button to alter the default font if necessary. The title is centered immediately above the page contents.

If you want to have a line under or over the header, select the appropriate option in the Layout field.

Repeat steps 3 to 5 on the Footer tab and the subsequent pages Header tab.

Note:

All Header and Footer tabs contain the same options. You can have all information in either the header or footer or split information between the header and footer as required.

Click OK to apply the changes.

Report items toolbar icons

The table below describes the different functions of the report items toolbar icons in the

Customize Report window:

Toolbar icon

Function

Adds free text.

Adds a picture.

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Toolbar icon

Function

Adds a chart.

Includes a method.

Adds documentation.

Adds an evaluation log.

Add objects to the report

The table below describes how to add objects to the report.

Step

1

Action

Click the appropriate icon in the Report items toolbar.

or

Choose an object from the Insert menu.

2

Press and hold the left mouse button on the report page, and drag out a box to the size of the item you want to insert.

Note:

The mouse pointer shows a symbol for the type of item you have selected.

Release the mouse button.

Result: A Setup dialog opens. The dialog is specific to the type of item that you want to insert. For more information about the setup dialogs for each object, refer to the online help.

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3.4.5 Create a new report format

Step

3

Note:

Action

Select the desired Settings, for example Start on new page, and click

OK.

Result: The object is inserted onto the page.

If you want to edit an object later, double-click the object box.

The size of the object in Edit mode does not always correspond to the size in the printed report. Click Preview in the toolbar for a print preview.

Move and resize objects freely

The table below describes how to select, move and resize objects freely:

If you want to...

select a single object,

then...

• click the Select icon, select several objects, move the selected object(s), resize the selected object(s),

• click the object of interest.

• click the Select icon,

• press and hold the Ctrl key while you click the objects.

click on the objects, hold down the left mouse button and drag the object(s) to the new position.

click one of the object border anchors, either in the corners or in the middle of a border, and drag the box to the new size.

Note:

Some Text objects cannot be resized.

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3.4.5 Create a new report format

Alignment toolbar icon functions

Objects can be placed in exact positions and sized in relation to other objects. The table below describes the function of the Alignment toolbar icons in the Report Editor:

Toolbar icon

Function

Align left

Matches the left alignment of all selected objects to that of the highlighted object.

Align right

Matches the right alignment of all selected objects to that of the highlighted object.

Align top

Matches the top alignment of all selected objects to that of the highlighted object.

Align bottom

Matches the bottom alignment of all selected objects to that of the highlighted object.

Adjust to margins

Stretches the selected object(s) to the left and right margins.

Adjust to left margin

Adjusts the selected object(s) to the left margin.

Adjust to right margin

Adjusts the selected object(s) to the right margin.

Adjust to center

Adjusts the selected object(s) to the center of the page.

Make same size

Adjusts the selected objects to the same size as the highlighted reference object.

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3.4.5 Create a new report format

Toolbar icon

Function

Make same width

Adjusts the selected objects to the same width as the highlighted reference object.

Make same height

Adjusts the selected objects to the same height as the highlighted reference object.

Note:

The Make same size and Make same width functions can only be used to resize the width of charts, free text and picture objects.

Save the report format

The table below describes how to save the finished report format:

Step

1

Action

Choose File:Save.

or

Click the Save icon.

2

3

Result: The Save Report Format dialog box opens.

Type a name for the format.

Select if you want to save the format for global use.

Select if you want to save the format as default.

Note:

The name for the default format will automatically be changed to

DEFAULT

.

Click OK to save the format.

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3.4.6 Edit an existing report format

3.4.6

Edit an existing report format

Introduction

This section describes how to edit an existing report format.

Note:

Click the Preview/Edit mode button to toggle between a print preview of the report and an editing mode. The editing actions are only available in the Edit

mode.

Edit a saved report format

The table below describes how to edit a saved report format in the Evaluation module.

Step Action

1

2

Open a result file.

Select File:Report or

Click the Report icon.

3

4

5

Result: The Generate Report dialog opens.

Select a report format to edit.

Click the Edit button.

Result: The Customize Report window opens.

Make the necessary changes to the report format.

Note:

Once you have made a change, the title bar of the window will add the word Modified to the report format name.

Select File:Save or

Click the Save icon.

Result: The edited format is saved.

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3.4.6 Edit an existing report format

Step

6

7

Note:

Action

To return to the Evaluation module window:

Select File:Exit or

Click the Exit button.

Click the Close button to close the Generate Report dialog.

or

Select another report format to edit.

See Section 3.4.5 Create a new report format, on page 101 for instructions

about how to add or edit report items. You can also select File:Save As in the

Customize Report window, to save the edited format under another name and keep the original report format unchanged.

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4 System control description

4 System control description

In this chapter

This chapter describes important differences between single and dual mode, together with details of pH, DO and media control. It also contains recommended operating conditions and verification procedures for the system functions.

This chapter contains the following sections:

Section

4.1 Single and dual operation modes

4.2 Temperature measurement and control

4.3 pH and DO measurement and control

4.4 pH control

4.5 DO control

4.6 Media control

4.7 Recommended operating conditions

4.8 System verification

See page

114

115

116

122

130

136

145

148

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4 System control description

4.1 Single and dual operation modes

4.1

Single and dual operation modes

ReadyToProcess WAVE 25 supports cell cultivation in single and dual modes:

In single mode, the system supports culture in one Cellbag bioreactor at one time.

The rocker is connected to one ReadyToProcess CBCU and up to three

ReadyToProcess Pump 25 units.

In dual mode, the system supports culture in two Cellbag bioreactors placed on the same tray. The rocker is connected to up to two ReadyToProcess CBCU units and up to three ReadyToProcess Pump 25 units for independent control of culture conditions in the two bioreactors.

To configure the system for single or dual mode, access the system properties as de-

scribed in Section 5.2.3 Configure system properties, on page 177 and uncheck or check

Dual respectively.

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4.2 Temperature measurement and control

4.2

Temperature measurement and control

Heating is provided by the tray heater plate, and controlled through sensors integrated in the rocker. The heater power output is automatically adjusted according to the Cellbag bioreactor size and media volume, to provide accurate, stable and fast temperature control. To minimize the risk for overheating, heating is only active when the rocker is in motion.

When using a Cellbag bioreactor that only covers half the tray in single mode (for example, a 10 L bag on Tray 20), place the bioreactor on the left-hand side of the tray.

In dual mode, different temperature setpoints can be used for the two Cellbag bioreactors, provided they are not too widely separated. A difference of 10°C between the setpoints can be maintained at an ambient temperature of 21°C. The difference is reduced by 1°C for every °C increase in the ambient temperature (for example, a difference of 6°C can be maintained at ambient temperature 25°C).

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4 System control description

4.3 pH and DO measurement and control

4.3

pH and DO measurement and control

In this section

This section describes the pH and DO measurement and control principles of the

ReadyToProcess WAVE 25 system.

This section contains the following subsections:

Section

4.3.1 pH and DO measurement principles

4.3.2 pH and DO control principles

See page

117

119

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4 System control description

4.3 pH and DO measurement and control

4.3.1 pH and DO measurement principles

4.3.1

pH and DO measurement principles

Introduction

In order to monitor and control pH and DO of a culture using ReadyToProcess WAVE 25, it is necessary to use Cellbag bioreactors equipped with optical pH and DO sensors. The optical pH and DO sensors comprise a luminophoric dye immobilized on a substrate that is integrated into the Cellbag bioreactor. Pulses of light from a LED on the pH monitor produce a responsive light signal from the sensor that indicates the pH or DO surrounding the sensor. An optical fiber cable transfers the light signals.

Light and temperature sensitivity

The optical sensors are subject to photobleaching, which means its properties are affected by light. This includes ambient light as well as the light from the LED. To reduce photobleaching avoid unnecessary exposure of the Cellbag bioreactor to light. For example:

Keep the Cellbag in its protective black bag until shortly before use.

Use the Rocker lid.

The LED output is automatically regulated to provide suitable amplitude for optimal performance and life time of the sensor. The sensor is also temperature sensitive. The pH and DO modules include temperature compensation for use within a few ºC around the calibration temperature as printed on the Cellbag label.

Sensor calibration

Calibration parameters for the pH and DO sensors are printed on the Cellbag label. The

calibration principles are described in pHOPT calibration values, on page 261 and DOOPT

calibration values, on page 269. Calibration should be adjusted before each run as de-

scribed in Section 5.3.5 Prepare the sensors, on page 193.

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4 System control description

4.3 pH and DO measurement and control

4.3.1 pH and DO measurement principles

DO air saturation and atmospheric pressure

DO is measured as percent air saturation. 100% air saturation represents the oxygen content of a certain solution at the current temperature and atmospheric pressure when it has been equilibrated in an environment of air. Air saturation is a relative measurement.

The oxygen content measured in for example mg/L depends on factors such as the composition of the solution, temperature and atmospheric pressure due to different weather conditions or altitude.

If a DO sensor is calibrated for 100% air saturation under equilibrated conditions at one atmospheric pressure, such as 950 mbar, it will not show 100% air if the same content is later equilibrated at another atmospheric pressure, say 1050 mbar. The difference is approximately 1% air saturation/10 mbar.

At delivery, the DO configured Cellbag bioreactors have sensors that are factory calibrated at a certain atmospheric pressure. This pressure is stated on the DO label as Calp and shall be entered together with the other calibration values for DO. To compensate for differences in atmospheric pressure from where the bag was calibrated to where the cell culture will be performed, it is possible to adjust the DO calibration. To do this select

System:Calibrate:DO sensor in UNICORN.

O

2

measurement and altitude

The O

2 sensor measures the relative O

2 concentration in terms of volume percent (vol%).

The O

2 concentration in the atmosphere is 21 vol% independently of altitude above sea level and weather conditions. Since the most relevant parameter from a cell cultivation perspective is the dissolved oxygen expressed as mg/L, different cell growth conditions will be obtained depending on the ambient pressure.

For instance, at 2000 m above sea level the ambient pressure is 0.8 bar (800 hPa). The relative O

2 concentration is 21 vol%, but compared to the conditions at sea level, where the ambient pressure is 1.013 bar (1013 hPa), the absolute O

2 concentration in ambient air at 2000 m corresponds to (800/1013) × 21 = 16.6 vol% of that at sea level.

Different growth conditions will therefore be obtained at high altitudes as compared to sea level.

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4 System control description

4.3 pH and DO measurement and control

4.3.2 pH and DO control principles

4.3.2

pH and DO control principles

Introduction

pH and DO can be regulated through different control schemes as described in this section. Each control mode can be either automatic or manual.

The reading and control cycle

Reading cycle time

The reading cycle time is the time between two consecutive measurements.

The reading Cycle time is set from the Process Picture under Settings:pH and Set-

tings:DO, or with the manual instructions Set pH reading cycle time or Set DO reading

cycle time.

When the control is off, the reading cycle time setting defines time between measurements. When the control is on, the reading cycle time will be overridden by the control cycle time.

Note:

Using DO reading with a short cycle time will shorten the lifetime of the sensor.

For cultivations lasting more than 3 days, a cycle time of at least 60 s is recommended.

Measurements and control actions are synchronized. When a control is started, the measurement cycle time is set by the control and overrides any previously entered reading cycle time. The control is executed after each new measurement.

When the pH control executes, it sets the CO

2 setpoint for the next control cycle (CO2 mode), or starts the acid or base pump (Acid/Base mode) for a limited time (0%-75% of the next control cycle).

When the DO control executes, it sets the O

2 setpoint for the next control cycle (O2 mode), or sets the rocking speed setpoint for the next control cycle (Speed mode).

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4 System control description

4.3 pH and DO measurement and control

4.3.2 pH and DO control principles

Automatic and manual mode

The pH and DO control software automatically calculates the following parameters suitable for the actual control case, taking into account the bag size and gas flow setpoint:

Cycle time

PID parameters

• Acid and base flow for pH control

Transition delay time between CO

2

O

2 and base in the CO2/Base control scheme and and speed in the O2/Speed control scheme

The automatic parameters can be overridden with manually entered values. If any of the automatically computed values are overridden, a hand symbol ( ) appears close to the relevant icon in the Process Picture. A tool tip shows which parameters are overridden when the cursor is placed over the symbol.

Deviation alarms

If the reading has been outside the specified deviation limits of the setpoint for a certain time, a deviation alarm is activated by default.

The deviation alarm can be deactivated from the process picture using the checkbox under the pH or DO settings or with the manual instruction pH control (general) or DO

control (general).

After a change of the setpoint, the deviation alarm check is inactive until the reading is within the deviation limits of the new setpoint. If the interval within the deviation limits is not reached within a time limit computed by the pH or DO control, the deviation alarm is triggered.

In the pH control CO2 mode, the time limit is equal to 40 times the automatically computed control cycle time. In Acid/Base mode, the time limit is equal to 90 minutes.

In the DO control O2 mode, the time limit is equal to 40 times the automatically computed control cycle time. In Speed mode, the time limit is equal to 180 minutes.

Inactivation

If any of the conditions for running the pH or DO control is not fulfilled, the control will be stopped. In this state the control remains inactive until all the necessary conditions are fulfilled.

If the control is stopped, a red or orange frame will be visible around the pH/DO icon in the process picture, and a message dialog will show why the control is inactive.

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4.3 pH and DO measurement and control

4.3.2 pH and DO control principles

An orange frame indicates that the inactivation is due to a user or system action, like entering sampling mode or feed/harvest auto calibration.

• A red frame indicates that the inactivation is due to an error.

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4 System control description

4.4 pH control

4.4

pH control

In this section

ReadyToProcess WAVE 25 has automated pH control. In general, PID parameters and cycle times do not need to be entered or tuned, acid and base flow rates do not need

to be calibrated or tuned. Refer to Section 8.5.7 pH measurement, on page 261 and Sec-

tion 8.5.8 pH control, on page 263 for information about pH control settings.

This section contains the following subsections:

Section

4.4.1 pH control schemes

4.4.2 CO2 control mode

4.4.3 Acid/Base control mode

4.4.4 pH control transition delays

See page

123

124

126

129

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4 System control description

4.4 pH control

4.4.1 pH control schemes

4.4.1

pH control schemes

pH control operates according to one of three schemes, constructed from two control modes alone or in combination. The table below summarizes the control schemes.

Control modes are described in detail in the sections that follow.

Control scheme

CO2

Acid/Base

CO2/Base

Description

pH control by change of CO

2 tion in the gas mix.

concentrapH control by addition of acid and base.

Control modes used

CO2

• pH control by change of CO addition.

2 concentration in the gas mix, and by base

Control starts in CO2 mode and then switches automatically between CO2 and Acid/Base mode as required.

In Acid/Base mode, acid is blocked.

Acid/Base

CO2

Acid/Base (acid blocked)

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4 System control description

4.4 pH control

4.4.2 CO2 control mode

4.4.2

CO2 control mode

Introduction

At every execution of the CO

2 next control cycle. The CO

2 control, a PID regulator computes the CO

2 setpoint for the setpoint is by default limited to the range 0.0% to 15.0%. This range can be narrowed using the manual instruction pH control (CO2).

Note:

If CO

2 is delivered by a source with pulsed supply, the resulting variations in inlet pressure to the CBCU may lead to fluctuations in the CO

2 mix. For example, with a CO2 setpoint of 7.5%, the actual CO and 8%.

2 levels may fluctuate between 7%

PID parameters and cycle time

The control dynamics vary with Cellbag bioreactor size and depend on the gas flow rate.

The PID-parameters and the cycle time are therefore automatically computed with respect to the bag size and gas flow setpoint.

To optimize the control behavior, the automatic PID parameters are not the same when approaching a new setpoint as when keeping the setpoint. The automatic D parameter is always zero.

Tuning PID parameters and cycle time

If further tuning of PID parameters and/or cycle time is needed, follow these steps:

Step

1

2

Action

Open Tools:Customize and select the tab Run Data Groups.

Select the Auto pH CO2 P, Auto pH CO2 I and Auto pH CO2 D and click OK.

Result: The automatic PID parameters are shown as Run Data.

Register the values both when approaching the new setpoint, and when keeping the setpoint.

Tip:

The automatically computed values are a good starting point for the tuning.

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Step

3

4 System control description

4.4 pH control

4.4.2 CO2 control mode

Action

Open the manual instruction pH control (advanced):pH control (advanced

CO2) and select Manual PID parameter mode and/or Cycle time mode and enter the desired values.

When elaborating with a manual I parameter, remember that increasing the I parameter will reduce the integrating effect and vice versa.

Click Execute.

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4 System control description

4.4 pH control

4.4.3 Acid/Base control mode

4.4.3

Acid/Base control mode

Introduction

At every control execution in Acid/Base control mode, a PI regulator computes the pump run time. The pump run time is given in percent of the cycle time in the range -75 to 75, where the negative part corresponds to the acid pump, and the positive part corresponds to the base pump. When using the CO2/Base control scheme, the control output range is restricted to 0 to 75, to only allow base.

In the Acid/Base control mode, the flow rates of the acid and base pumps are adaptive to the actual control case. They are automatically and individually set by the software, based on the weight of the content in the Cellbag bioreactor and the molarity of the acid and base. The flow rate is further discussed below.

PI parameters and cycle time

The automatically computed PI-parameters are static in the Acid/Base control mode.

They can be seen as default parameters. The same holds for the automatic cycle time.

These automatic values should be good enough for most cases, and no tuning is expected to be needed.

In the acid/base controller, the I-part of the output is only updated when the pH measurement is close to the setpoint. When elaborating with a manual I-parameter, remember that increasing the I-parameter will reduce the integrating effect and vice versa.

Tuning of PI parameters and cycle time

If tuning of the PI parameters or cycle time is needed, follow these steps:

Step

1

2

Action

Open Tools:Customize and select the tab Run Data Groups.

Select the Auto pH acid/base P and Auto pH acid/base I and click OK.

Result: The automatic PI parameters are shown as Run Data.

Open the manual instruction pH control (advanced):pH control (advanced

acid/base) and select Manual PID parameter mode and/or Cycle time mode and enter the desired values.

Click Execute.

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4 System control description

4.4 pH control

4.4.3 Acid/Base control mode

Flow rate

ReadyToProcess WAVE 25 automatically computes flow rates for acid and base. There is no need for calibration or tuning of acid/base flow rates.

To make this automation work, the following input data needs to be correct:

The molarity of the acid and base used, entered as equivalents of HCl or NaOH concentrations. If weaker acids or bases are used, enter the estimated equivalent molarity of HCl or NaOH.

The weight measurement, corresponding to the weight of the content of the Cellbag.

Make sure the scale is tared correctly.

The inner diameter of the acid and base tubing, allowing the flow rate to be converted to pump speed in rpm. A pump calibration will make the relation more precise, but entering the tube diameter is normally sufficient for pH acid/base control.

If the automatically computed flow rate is outside the range that can be achieved with the entered tube diameter, the pH control software will inform the user that a different tubing size is required for optimal control.

If desired, manual flow rates for acid and base can be entered using the manual instruction pH control (advanced acid/base). This will override the automatically computed flow rates.

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4 System control description

4.4 pH control

4.4.3 Acid/Base control mode

Dead band

A dead band zone is defined for acid and base individually. When the control output is in the dead band zone, the pumps will not run.

The dead band removes all acid/base additions with a pump run time less than or equal to a given percentage of the cycle time. The default dead band is set to 2.0%, which means that only pump run times greater than 2.0% of the cycle time will be executed.

The dead band prevents the control from switching between small acid and base additions. Using dead band values close to zero will give a precise control, but also risk unnecessary switching between acid and base. Increasing the dead band values will result in less precise control, and may in extreme cases lead to the setpoint never being reached.

The default value of 2.0% has been found to be a good compromise.

The dead band can be changed in the manual instruction pH control (advanced

acid/base).

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4.4 pH control

4.4.4 pH control transition delays

4.4.4

pH control transition delays

CO2/Base control scheme

The CO2/Base control scheme combines the CO2 and Base control modes. It always starts in CO2 mode and can then switch back and forth between CO2 and Base mode as long as the control is on. To avoid unnecessary switching between CO2 and Base mode, the transitions between the modes are delayed. This delay is called transition delay time.

The condition for transition must be fulfilled for a certain time before the transition takes place. The transition delay times are set automatically and individually by the pH control.

The values can be overridden with manual values using the manual instruction pH

control (transition delays).

If the pH CO

2 controller is at its minimum CO

2 setpoint, and the pH reading is below the pH setpoint, a time counter is started. When the time counter reaches the set CO2 to

base transition delay time, the transition to base mode takes place. If the pH base controller is at its minimum output (0%), and the pH reading is above the pH setpoint, a time counter is started. When the time counter reaches the Base to CO2 transition delay

time, the transition to CO

2 mode takes place.

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4 System control description

4.5 DO control

4.5

DO control

In this section

ReadyToProcess WAVE 25 has automated of DO control using O

2

. In general, PID param-

eters and cycle times do not need to be entered or tuned. Refer to Section 8.5.9 DO

measurement, on page 269 and Section 8.5.10 DO control, on page 271 for information

about DO control settings.

This section contains the following subsections:

Section

4.5.1 DO control schemes

4.5.2 O2 control mode

4.5.3 Speed control mode

4.5.4 O2/Speed control scheme

See page

131

132

134

135

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4 System control description

4.5 DO control

4.5.1 DO control schemes

4.5.1

DO control schemes

DO control operates according to one of three schemes, constructed from two control modes alone or in combination. The table below summarizes the control schemes.

Control modes are described in detail in the sections that follow.

Note:

Dual mode does not support control schemes involving rocker speed, since the speed cannot be adjusted independently for the two bioreactors.

Control scheme

O2

Speed

O2/Speed

Description Control modes used

O2

DO control by change of O

2 tion in the gas mix.

concentra-

DO control by change in rocking speed.

DO control by change of O

2 concentration in the gas mix, and by changing the rocking speed.

Control starts in O2 mode and then switches automatically between 02 and Speed mode as required.

Speed

O2

Speed

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4 System control description

4.5 DO control

4.5.2 O2 control mode

4.5.2

O2 control mode

Introduction

At every execution of the O

2 control, a PID regulator computes the O

2 next control cycle. There are two different O

2 setpoint for the setpoint ranges. If compressed air is selected as gas source to the CBCU the range is 21% to 50%, if N

50%.

2 is selected, the range is 0% to

PID parameters and cycle time

The control dynamics differ between the different bag sizes and depend on the rate of gas flow. The PID-parameters and the cycle time are therefore automatically computed with respect to the bag size and gas flow setpoint.

To optimize the control behavior, the automatic PID parameters are not the same when approaching a new setpoint as when keeping the setpoint. The automatic D parameter is always zero.

Tuning PID parameters and cycle time

If further tuning of PID parameters and/or cycle time is needed, follow these steps:

Step Action

1

2

Open Tools:Customize and select the tab Run Data Groups.

Select the Auto DO O2 P, Auto DO O2 I and Auto DO O2 D and click OK.

Result: The automatic PID parameters are shown as Run Data.

Register the values both when approaching the new setpoint, and when keeping the setpoint.

Tip:

These automatic values are a good starting point for the tuning.

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Step

3

4 System control description

4.5 DO control

4.5.2 O2 control mode

Action

Open the manual instruction DO control (advanced):DO control (advanced

O2) and select Manual PID parameter mode and/or Cycle time mode and enter the desired values.

When adjusting a Manual I parameter, remember that increasing the I parameter will reduce the integrating effect and vice versa.

Click Execute.

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4 System control description

4.5 DO control

4.5.3 Speed control mode

4.5.3

Speed control mode

Introduction

At every execution of the speed control, the DO reading is compared with the DO setpoint.

If the DO reading is below the DO setpoint, the rocking speed setpoint is increased. If the

DO reading is above the DO setpoint, the rocking speed setpoint is decreased.

The settings of the DO speed mode can be set from the Process Picture or by using the manual instruction DO control (speed).

Speed control cannot be used in dual mode.

Speed step

The Speed step parameter defines the size of the change of the rocking speed setpoint.

Maximum and minimum rocking speed

The Max and Min speed parameters define the interval in which the DO controller can set the rocking speed setpoint.

Dead band

The upper and lower dead band parameters defines the dead band interval around the

DO setpoint. When the DO reading is in that interval, no change of the rocking speed setpoint will take place.

Cycle time

The cycle time parameter sets the cycle time of the DO speed control. This cycle time will override the DO reading cycle time when the DO control is on.

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4.5 DO control

4.5.4 O2/Speed control scheme

4.5.4

O2/Speed control scheme

Description

The O2/Speed control scheme combines the O2 and Speed control modes. It always starts in O2 mode and can then switch back and forth between O2 and Speed mode as long as the control is on. To avoid unnecessary switching between O2 and Speed mode, the transitions between the modes are delayed. This delay is called transition delay time.

The O2/Speed control cannot be used in dual mode.

Transition delays

The condition for transition must be fulfilled for a certain time before the transition takes place. The transition delay times are set automatically and individually by the DO control.

The values can be overridden with manual values using the manual instruction DO

control (advanced):DO control (transition delays).

If the DO O

2 controller is at its maximum O

2 setpoint 50%, and the DO reading is below the DO setpoint, a time counter is started. When the time counter reaches the set O2 to

speed transition delay time, the transition to Speed mode takes place. If the DO speed controller is at its minimum rocking speed setpoint, and the DO reading is above the DO setpoint, a time counter is started. When the time counter reaches the Speed to O2

transition delay time, the transition to O

2 mode takes place.

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4 System control description

4.6 Media control

4.6

Media control

In this section

The media control has two modes: Media addition and Perfusion, as described in the following sections. A complete description of all settings and output data is found in

Section 8.5.11 Media control, on page 275.

Media control can be used in dual mode, but the accuracy will be lower than in single

mode (see Section 4.6.1 Weight measurement, on page 137).

This section contains the following subsections:

Section

4.6.1 Weight measurement

4.6.2 Media addition

4.6.3 Perfusion

4.6.4 Deviation alarm

4.6.5 Media control inactivation

See page

137

138

139

143

144

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4 System control description

4.6 Media control

4.6.1 Weight measurement

4.6.1

Weight measurement

Media control relies on continuous measurement of the weight of the bioreactor contents, and maintains the weight at the setpoint by controlled addition of media using the feed pump.

Principles of weight measurement

Cellbag bioreactor and cell culture weights are measured by four load cells, placed at the corners of the rocker unit. In dual mode, the separate weight of each Cellbag bioreactor is calculated from the weight distribution between the load cells. It is important for correct weight measurements that the rocker is placed on a flat stable surface, and

that the measurements are tared before each cultivation. See Tare the scale, on page 190

for instructions on how to tare the weight measurement.

The load cells are temperature-sensitive. It is important that a constant ambient temperature is maintained for the duration of a run.

Limitations in dual mode

In single mode, all four load cells contribute to the weight measurement of the single

Cellbag bioreactor. In dual mode, the separate weights of the two bioreactors are calculated from the weight distribution between the load cells, with a predominant contribution from two of the load cells for each bioreactor. The accuracy of the total weight measurement is the same as in single mode, but the accuracy od separate Cellbag weights is slightly reduced.

Dual weight measurements are primarily used to support regulation of temperature and pH, and the reduced accuracy is adequate for this purpose. Media control of culture in dual mode will have somewhat reduced accuracy compared with single mode.

The left and right bioreactor weights are displayed in the process picture with a resolution of 0.1 kg. This is useful, for example, when filling the bioreactor with medium, but cultivation in single mode or the use of an external scale is recommended if high weighing accuracy is required.

The accuracy of separate weight measurements also depends on the position of the

Cellbag bioreactors on the tray. A sideways displacement of a bioreactor by 10 mm may add about 3% of the load to the weighing error. Since the bioreactor may move during rocking, it is important to make sure that the bench (and therefore the rocker) is stable and horizontal.

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4 System control description

4.6 Media control

4.6.2 Media addition

4.6.2

Media addition

Media addition principles

The media addition mode will fill the Cellbag bioreactor by running the feed pump at the desired flow rate until the weight setpoint is reached.

To keep the desired feed rate, the media control uses a transitional weight setpoint, that is ramped towards the given weight setpoint. It is called momentary weight setpoint, and the ramping speed corresponds to the feed rate.

The feed flow is adjusted by a regulator to keep the weight measurement at the momentary weight setpoint.

When the weight setpoint is reached, the feed pump is stopped but the control is still on and will start the feed pump again if the weight decreases.

Pump calibration

The feed pump flow is regulated to keep the momentary weight setpoint. No precise calibration of the feed pump is necessary, but it is important that the correct inner diameter of the tubing is set.

Calibrating the pump before running media addition can give more accurate measurement of the accumulated feed volume.

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4.6 Media control

4.6.3 Perfusion

4.6.3

Perfusion

Introduction

In perfusion mode the feed pump will add medium at a desired flow rate, and the harvest pump flow rate is controlled by a regulator to maintain the weight at the setpoint.

Correct feed flow rate depends on accurate pump calibration. To assist calibration and to compensate for tubing wear, auto calibration of the feed and harvest pumps is enabled by default.

Perfusion principles

When media control is started, either the feed or harvest pump will first run alone until the weight setpoint is reached. When the setpoint is reached, "normal perfusion" starts and both pumps will run simultaneously in continuous mode. If the weight setpoint is changed while in "normal perfusion", one of the pumps will run alone until the new setpoint is reached.

The figure below shows a run where the control is started with the measured weight below the weight setpoint. After a while, the setpoint is decreased.

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4 System control description

4.6 Media control

4.6.3 Perfusion

Pump calibration

In perfusion mode, the actual feed flow rate depends on the accuracy of pump calibration.

When auto calibration is not used, at least the feed pump must be calibrated manually.

It is however recommended to also calibrate the harvest pump, since unnecessary warnings for harvest filter clogging may otherwise be issued. The accumulated volume will also be more precisely computed if the pumps are calibrated.

For a detailed description of pump calibration see Section 6.2 Pump calibration, on

page 208.

Auto calibration

The auto calibration function provides a convenient and precise option for automatic calibration of the feed and harvest pumps. The steps in auto calibration are listed below.

6

7

8

4

5

2

3

Step

1

Action

A message is sent to inform the user that auto calibration has started.

The pumps stop.

The system pauses for 15 seconds.

Weight measurements are averaged over a period of 30 seconds.

The harvest pump runs at the perfusion flow rate setpoint for 2 to 30 minutes depending on the setpoint value.

The system pauses for 15 seconds.

Weight measurements are averaged over a period of 30 seconds.

A calibration command is sent to the harvest pump, calculating the pumped volume from the measured weight difference between the second and the first weight average (assuming a density equal to 1).

9

10

11

12

The feed pump runs at the perfusion flow rate setpoint for 2 to 30 minutes depending on the setpoint value.

Weight measurements are averaged over a period of 30 seconds.

A calibration command is sent to the feed pump, calculating the pumped volume from the measured weight difference between the third and the second weight average (assuming a density equal to 1).

The results of auto calibration can be seen in the the feed and harvest calibration factor curves in the curve data chart.

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4.6 Media control

4.6.3 Perfusion

An advantage of auto calibration compared with manual procedures is that it is performed on the system as set up for the run, with no open tubing ends or manual measurement of pumped volume.

Auto calibration calculates volume flow rates from measured weight using a liquid density equal to 1. If the density of the medium differs from 1, the flow rate given in L/day should be read as kg/day instead.

If perfusion is running at the weight setpoint with both pumps operating and the auto calibration disabled, enabling auto calibration will trigger an immediate auto calibration.

Note:

During auto calibration, it is important that the weight measurements are not disturbed by external influences such as touching the system or instability of the bench. If an auto-calibration is disturbed, disable and re-enable the function to trigger a new auto calibration.

The accuracy of auto calibration may be slightly lower in dual mode than in

single mode (see Limitations in dual mode, on page 137).

Auto calibration cycle

The figure below shows auto calibrations during a perfusion run. The first auto calibration is done when the weight setpoint is reached. This calibration replaces the manual calibration needed before starting if auto calibration is disabled. After that, the auto calibration is repeated with the interval given in the manual instruction Media control (general).

When changing the flow rate or the weight setpoint, a new auto calibration will be done.

Thereafter they will continue with the given frequency.

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4 System control description

4.6 Media control

4.6.3 Perfusion

Auto calibration criteria

The calibration volume is depending on the flow rate, and is computed to make an optimal compromise between pump time and accuracy. The pump calibration run time is limited between 2 and 30 minutes for each pump. A low flow rate will give a long calibration time and a high flow rate will give a short calibration time.

If the flow rate setpoint is below 3.43 L/day, no auto calibration can be done, since achieving a volume large enough to get the desired accuracy would demand a pump run time longer than 30 minutes.

If auto calibration is enabled, and the criteria above cannot be fulfilled, the media control cannot start unless the flow rate is increased or the auto calibration is disabled.

Recommended weight setpoints

The media control will not start if the weight setpoint is outside the possible range shown in the table below.

Cellbag size

(L)

2

10

20

22

50

Recommended weight setpoint

(kg)

0.5 to 1.0

2.5 to 5.0

5.0 to 10.0

5.0 to 10.0

12.5 to 25.0

Permitted weight setpoint (kg)

(SW limited)

0.2 to 1.0

1.0 to 5.0

2.0 to 10.0

2.0 to 10.0

5.0 to 25.0

For the perfusion to work satisfactorily, it is important to ensure that the harvest filter and harvest out-port is completely covered by liquid through the whole rocking cycle.

If the harvest out-port is not always covered by liquid, unnecessary warnings for harvest filter clogging might be issued. If auto calibration is enabled, the harvest pump will not be correctly calibrated.

Emergency stop of pumps

To avoid overfilling or draining the Cellbag due to for example lack of feed media, harvest filter clogging or tubing error, the feed or harvest pump will stop when the weight measurement deviates more than 10% from the weight setpoint. The stopped pump will start again when the setpoint is reached.

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4.6 Media control

4.6.4 Deviation alarm

4.6.4

Deviation alarm

By default, a deviation alarm is activated. It will send a message when the weight reading has been outside the specified toleration limits of the weight setpoint for a certain time.

The deviation alarm can be deactivated using the manual instruction Media control

(general).

During media addition, the deviation alarm is acting on the momentary weight setpoint.

During perfusion, the deviation alarm is active only in normal perfusion when both pumps are running.

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4 System control description

4.6 Media control

4.6.5 Media control inactivation

4.6.5

Media control inactivation

If any of the conditions for running the Media control is suddenly not fulfilled when running the control, the control will turn into inactive state. In this state the control is not doing anything until all the necessary conditions are fulfilled again. Then the control will then start again.

When the control inactivate, a red or orange frame will be visible around the Media control icon in the process picture. A message dialog will show why the control is inactive.

An orange frame indicates that the inactivation is due to sampling mode.

• A red frame indicates that the inactivation is due to an error.

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4 System control description

4.7 Recommended operating conditions

4.7

Recommended operating conditions

Introduction

This section includes recommendations for gas flow, rocking speed and rocking angle.

Suitable settings for temperature, pH, DO, CO

2 and O

2 are selected depending on the application and system configuration. For more information about rocker control settings,

refer to Section 8.5.1 Rocking control, on page 250.

Rocking speed and angle

The optimal agitation for a process is determined by the cell culture oxygen demand and the cellular shear sensitivity. Rocking speed and angle should be set so that sufficient mixing and oxygen transfer is provided without excessive foaming.

Note:

Cells cultivated at low rocking speed and angle may form a sediment on the sensors in the Cellbag bioreactor, reducing the reliability of the sensors.

The culture volume affects mixing and oxygen transfer rate. Lower volumes give faster oxygen transfer and mixing.

Increasing the rocking speed and angle will result in faster oxygen transfer and mixing.

• If no clear wave appears inside the Cellbag bioreactor, increase the rocking speed.

(If the speed is limited by other parameters, try decreasing the speed slightly.)

For cultures with high oxygen demand, such as a suspension CHO cells, rocking speed and angle can be increased up to for example 30 rpm and 8 degrees, respectively.

• For shear sensitive cells, such as adherent cells on microcarriers, rocking speed and/or angle can be decreased down to 10 rpm and 4 degrees, if sufficient oxygen transfer and mixing is maintained.

Each new cell line and process requires optimization of operating conditions. The table below shows typical rocking speed and gas flow settings for suspension cell culture.

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4 System control description

4.7 Recommended operating conditions

Cellbag bioreactor size (L)

2

10

20

50

Note:

Culture volume (L)

1

10

5

25

0.3

1

0.5

5

Rocking speed (rpm)

10 to 20

20 to 30

10 to 20

20 to 30

10 to 20

20 to 30

10 to 20

20 to 30

Rocking angle

(°)

2 to 4

6 to 8

2 to 4

6 to 8

2 to 4

6 to 8

2 to 4

6 to 8

Gas flow

(Lpm)

0.05 to 0.2

0.05 to 0.2

0.1 to 0.3

0.1 to 0.3

0.2 to 0.5

0.2 to 0.5

0.5 to 1.0

0.5 to 1.0

When cultivating in a 50 L Cellbag bioreactor at maximum working volume of 25 L, rocking speed and angle multiplied should not exceed 240 rpm degrees.

For example, if the rocking angle is set to 8 degrees, the rocking speed should not be set higher than 30 rpm.

Rocking motion

The rocking motion factor determines how much of the rocking cycle is used for accelerating and decelerating the rocker motion at the turning points. For example, with the default setting of 30%, 15% of the rocking cycle is used for accelerating after the turning point and 15% for decelerating before the turning point. The rocking speed is constant for the remaining 70% of the cycle. The rocking motion factor can be set between 15% and 100%. A lower factor will give slightly higher oxygen transfer rate and mixing capacity whereas higher factors profiles can reduce shear forces, which is especially important when cultivating adherent cells on microcarriers.

Gas flow

The gas flow rate has little effect on oxygen transfer and can therefore be kept constant throughout the entire run.

When setting the gas flow rate the following should be taken into consideration:

• A high gas flow can cause unnecessary evaporation

• A low gas flow can slow down pH and DO control when using CO

2 and O

2 gas.

A too low gas flow can lead to insufficient inflation of the Cellbag bioreactor.

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4.7 Recommended operating conditions

Refer to Gas flow table for recommendations on suitable gas flow rates.

Recommendations to reduce foaming

To reduce foaming, the following should be taken into consideration:

• Higher agitation rates can contribute to excessive foaming. This can be reduced by adding antifoam, or by decreasing the rocking speed and/or angle.

Excessive foaming occurs if the Cellbag bioreactor is not rigidly inflated. Check that the gas flow is sufficient and that the pressure relief valve is functioning.

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4 System control description

4.8 System verification

4.8

System verification

Introduction

This section describes verification procedures for the rocker function, temperature control and gas flow. Before verification, set up and start the system. System verification is recommended before the first cultivation, and if the system has not been used for a long period.

Use the same verification procedures in dual mode, applied to each Cellbag bioreactor where appropriate.

For more information about system control settings, see Section 8.5 Control settings, on

page 249.

Verification of rocker function

Follow the instructions below to verify that the rocker operates correctly.

Step Action

1 Start the rocking by clicking the right-hand side of the Rocking button.

Result: The rocking is activated and the Rocking button gets green.

2

3

Follow these instructions to make sure that the rocking speed functions properly:

1

Enter the desired speed in Settings:Rocking:Speed in the Process Picture.

Click OK.

Result: The rocking speed changes to the set value.

2

Try some different setpoints of the rocking speed, and make sure that the rocking speed changes.

Follow these instructions to make sure that the rocking angle functions properly:

1

While the tray is rocking, enter the desired rocking angle in Settings:Rock-

ing:Angle in the Process Picture. Click OK.

Result: The rocking angle changes to the set value.

2

Try some different setpoints of the rocking angle, and make sure that the rocking angle changes.

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4 System control description

4.8 System verification

Step

4

5

6

Action

Follow these instructions to make sure that the rocking motion functions properly:

1

While the tray is rocking, select Manual:Execute Manual Instructions, and open the instruction Rocker:Set rocking motion. Enter the desired

rocking motion factor (see Rocking motion, on page 146). Click OK.

Result: The rocking motion changes to the set value.

2

Try some different setpoints of the rocking motion and make sure that the motion changes.

If the rocking speed, rocking angle or rocking motion appear not to function

correctly, refer to Section 7.2 ReadyToProcess WAVE 25 rocker, on page 213.

Stop the rocking by clicking the right-hand side of the Rocking button.

Verification of temperature control

Follow the instructions below to verify that the temperature control is functioning correctly.

Step Action

1

2

3

4

Attach a Cellbag bioreactor and fill with at least the minimum volume of liquid.

Make sure that the Temp button in the Process Picture displays the ambient temperature.

Make sure that the rocking is on. Heat will not be applied to a motionless rocker to avoid local overheating in the Cellbag bioreactor.

Start the heating by clicking the right-hand side of the Temp button.

Result: The heating is activated and the Temp button gets green.

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4 System control description

4.8 System verification

6

7

8

9

Step

5

Action

Enter the temperature 40.0 in Settings:Temp:Setpoint in the Process Picture.

Click OK.

Result: The temperature starts to increase to the set temperature value.

CAUTION

To avoid overheating, do not operate the heater without liquid in the Cellbag bioreactor on the tray.

Select the Chart tab and make sure that the temperature curve shows the increase in temperature.

If the temperature control appears not to function correctly, refer to Sec-

tion 7.2 ReadyToProcess WAVE 25 rocker, on page 213.

Stop the heating by clicking the right-hand side of the Temp button.

Stop the rocking by clicking the right-hand side of the Rocking button.

Verification of gas flow

Follow the instructions below to verify that the gas flow is functioning correctly.

Step Action

1 Make sure that the desired gas supplies are connected to the system. Refer

to Section 5.1.6 Connect gas to the system, on page 169.

2

3

4

In the Process Picture, click the Compressed Air button to select compressed air, or the N2 button to select N

2

.

Enter the gas flow setpoint 0.50 in Settings:Gas control:Gas flow:Setpoint in the Process Picture. Click OK.

Start the gas flow by clicking the right-hand side of the Gas flow button.

Result: The gas flow starts to increase to the gas flow setpoint.

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4.8 System verification

Step

5

6

Action

Verify that the overpressure alarm is functioning by blocking the gas flow in the Gas mix tubing.

Result: After about 5 seconds an overpressure alarm should be activated and the gas flow should stop automatically.

If the gas flow appears not to function correctly, refer to Section 7.3

ReadyToProcess CBCU, on page 217.

Stop the gas flow by clicking the right-hand side of the Gas flow button.

Verification of CO

2

Follow the instructions below to verify that CO

2 is functioning correctly.

Step Action

1

2

3

4

Start the gas flow by clicking the right-hand side of the Gas flow button.

Enter a gas flow setpoint, for example 0.2 L/min, in Settings:Gas control:Gas

flow:Setpoint. Click OK.

Enter a CO

2

Click OK.

setpoint, for example 5%, in Settings:Gas control:CO2:Setpoint.

Wait for a few minutes and verify that the Process Picture shows a correct measurement.

If the gas flow appears not to function correctly, refer to Section 7.3

ReadyToProcess CBCU, on page 217.

Verification of O

2

Follow the instructions below to verify that O

2 is functioning correctly.

Step Action

1

2

Enter an O

2 setpoint, for example 30%, in Settings:Gas control:O2:Setpoint.

Click OK.

Wait for a few minutes and verify that the Process Picture shows a correct measurement.

If the gas flow appears not to function correctly, refer to Section 7.3

ReadyToProcess CBCU, on page 217.

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4 System control description

4.8 System verification

Verification of fast fill function

Follow these instructions to make sure that the Fast fill functions properly:

Step

1

2

Action

Open Settings:Gas control:Gas flow from the Process Picture in System

Control.

Set Fast fill to On.

3

4

Start the gas flow by clicking the right-hand side of the Gas flow button in the Process Picture.

Result: The gas flow is maximized to 3 L/min for 20 minutes or until Fast fill is manually turned off. The cellbag is inflated.

Stop the gas flow when the cellbag has been fully inflated, by clicking the right-hand side of the Gas flow button.

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5 Operation

5 Operation

In this chapter

This chapter describes how to operate ReadyToProcess WAVE 25.

This chapter contains the following sections:

Section

5.1 Set up the system

5.2 Start and configure the system

5.3 Prepare for cultivation

5.4 Perform cultivation

See page

154

173

186

196

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5 Operation

5.1 Set up the system

5.1

Set up the system

In this section

This section describes how to prepare the bioreactor system for cell cultivation. For illus-

trations and descriptions of the system, refer to Chapter 2 System description, on page 12.

This section contains the following subsections:

Section

5.1.1 Select the tray and Cellbag bioreactor

5.1.2 Attach and detach tray

5.1.3 Prepare pH and DO sensors

5.1.4 Attach the Cellbag bioreactor

5.1.5 Prepare the pump

5.1.6 Connect gas to the system

See page

155

156

159

162

164

169

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5 Operation

5.1 Set up the system

5.1.1 Select the tray and Cellbag bioreactor

5.1.1

Select the tray and Cellbag bioreactor

Select the Cellbag bioreactor size and corresponding tray according to application requirements and system configuration. See the table below for guidelines.

Culture volume/ bioreactor (L)

0.3 to 1

0.5 to 5

1 to 10

1 to 10

5 to 25

Note:

Note:

Cellbag bioreactor size (L)

2

10

20

22

50

Tray

Single mode

Tray 10, Tray 20

Tray 10, Tray 20

Tray 20

Tray 50

Tray 50

Dual mode

Tray 20

Tray 20

N/A

Tray 50

N/A

To use a 20 L or 40 L Cellbag bioreactor, the system must be configured for single mode.

Depending on application and configuration it might be possible to cultivate below the recommended minimum volume. However, it is highly recommended to stay above this volume for applications that require high agitation, and pH and DO control. The temperature, pH, and DO sensors need to be submerged in liquid throughout the complete rocking cycle to function correctly.

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5 Operation

5.1 Set up the system

5.1.2 Attach and detach tray

5.1.2

Attach and detach tray

This section describes how to attach and detach a tray to and from the rocker platform.

These operations should preferably be performed without a Cellbag bioreactor on the tray.

CAUTION

Due to the size and weight of Tray 50, at least two persons are recommended for installing the tray.

Attach tray

The tray can be attached to the rocker platform in tilt position and in normal position.

Tilt position is recommended, as described in the instructions below.

Step Action

1 Tilt the rocker platform by pulling the upper edge towards you.

156

2 Lift the tray into the same angle as the rocker platform.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

Step

3

5 Operation

5.1 Set up the system

5.1.2 Attach and detach tray

Action

Fit the tray on to the rocker platform. The attachment pins on the tray engage with the holes in the platform. Attach the pins on the upper edge first, then slide the tray down making sure that the lower pins engage with the respective holes.

Note:

Make sure that the holes for the temperature sensors on the rocker platform fit into the holes in the tray.

4 Make sure that the connector on the tray is plugged into the tray connector on the back of the rocker platform.

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5 Operation

5.1 Set up the system

5.1.2 Attach and detach tray

Detach tray

The tray can be detached from the rocker platform in tilt position and in normal position.

Tilt position is recommended, as described in the instructions below.

Step Action

1 Hold the textured grip area on each side of the tray and slide it upwards so that the attachment pins on the tray disengage from the holes in the rocker platform.

2 Pull the tray towards you.

158

Note:

If the tray is detached with the rocker in normal position, you will need to lift the tray by the upper edge before sliding it away from you.

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5 Operation

5.1 Set up the system

5.1.3 Prepare pH and DO sensors

5.1.3

Prepare pH and DO sensors

Instructions

Follow the instructions below to connect the sensor adapters to the pH and DO bag sensor ports.

NOTICE

Be careful to connect the sensors to the correct ports on

ReadyToProcess CBCU. Identification stickers are provided to label the connectors.

NOTICE

In dual mode, be careful to connect the sensors for the left and right Cellbag bioreactors to the correct ReadyToProcess CBCU. This is easier if the respective ReadyToProcess CBCU units are placed on the left and right sides of the rocker respectively.

Step

1

Action

Remove the Cellbag bioreactor from its protective cover bag.

NOTICE

Exposure to intense light will cause deterioration of the optical sensors on the Cellbag bioreactor. To avoid unnecessary light exposure, remove the protective cover bag just prior to use.

2 Place the Cellbag bioreactor on a steady surface with the bag sensor ports facing upwards.

The optical sensor spots have different colors. The spot on the pH sensor bag port is white/yellow and the spot on the DO sensor port is pink/black. If both pH and DO sensors are used, a separate fiber cable is needed for each sensor.

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5 Operation

5.1 Set up the system

5.1.3 Prepare pH and DO sensors

Step

3

Action

Attach the sensor adapter, with the optical lens facing the sensor port, by inserting the four pins of the port into the corresponding holes of the adapter.

4

Note:

The sensor adapter can be fastened in any of four orthogonal directions. Select the most convenient direction.

Rotate the sensor adapter clockwise to fix the pins on the sensor port to the adapter. A distinct "click" will indicate that the adapter is securely fastened.

160

Note:

When rotating the sensor adapter, make sure not to exert any force on the fiber cable.

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Step

5

5 Operation

5.1 Set up the system

5.1.3 Prepare pH and DO sensors

Action

Place the Cellbag bioreactor on the tray with the optical sensors facing downwards.

NOTICE

Make sure that the optical fiber cables are not placed between the Cellbag bioreactor and the temperature sensor on the tray. This could lead to erroneous temperature reading and control, resulting in overheating.

6

7

8

To keep track of the optical fiber cables, mark the cables with the supplied stickers.

Bundle the optical fiber cables on one side of the tray. Fit the lid and make

sure the tubing and cables are placed in the tubing exit. See Illustrations of

tray and lid, on page 21.

Connect the pH sensor cable to the pH port on the CBCU front panel.

9 Connect the DO sensor cable to the DO port on the CBCU front panel.

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5 Operation

5.1 Set up the system

5.1.4 Attach the Cellbag bioreactor

5.1.4

Attach the Cellbag bioreactor

Instructions

Follow the instructions below to attach the Cellbag bioreactor to the tray.

Note:

When using a Cellbag bioreactor that only covers half of the tray in single mode, such as a 10 L bag on Tray 20, position the bag on the left side of the tray.

Note:

In dual mode, ensure that each Cellbag bioreactor is centrally positioned on the respective grey heating pad. Weight measurement resolution will be compromised if the bioreactor is not correctly placed.

Step Action

1 Push the bag clamp openers in the upper corners of the tray downwards.

This opens the upper bag clamps.

Note:

For a Cellbag bioreactor that covers the whole tray, open both bag clamps.

In dual mode or with a bioreactor that covers only half the tray, only one clamp needs to be opened.

162 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

Step

2

5 Operation

5.1 Set up the system

5.1.4 Attach the Cellbag bioreactor

Action

Insert the upper Cellbag rod into the opened bag clamp.

3 If the clamp does not close automatically, gently push the bag clamp opener upwards to secure the upper end of the Cellbag bioreactor. Do not use force. Gently pull on the bioreactor to make sure it is attached.

4

5

Repeat the above steps to attach the lower Cellbag rod to completely secure the Cellbag bioreactor on the tray.

Mount the lid on top of the tray.

NOTICE

Keep the Cellbag bioreactor covered with the lid throughout the cultivation to protect the optical sensors from excessive light exposure.

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5 Operation

5.1 Set up the system

5.1.5 Prepare the pump

5.1.5

Prepare the pump

Tubing holder positions

The pump head has two different holder positions to accommodate tubing with different sizes. The inner position is for small tubing and the outer position is for large tubing (see

Pump tubing sizes, on page 164).

Inner position for small tubing.

Outer position for large tubing

Pump tubing sizes

The table below lists tubing sizes supported by ReadyToProcess Pump 25, with the range of flow rates provided by each size. The wall thickness of the tubing should be 1.6 mm

(1/16").

Note:

Pump tubing is not supplied with the system. Suitable tubing must be purchased separately.

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5 Operation

5.1 Set up the system

5.1.5 Prepare the pump

Tubing inner diameter

Millimetres Inches

3.2

4.0

4.8

0.5

0.8

1.6

2.4

1/50

1/32

1/16

3/32

1/8

5/32

3/16

Tubing holder position

Inner

Inner

Inner

Inner

Inner

Outer

Outer

Flow rate range

(mL/min)

1

0.01 to 4.6

0.02 to 8.6

0.07 to 28

0.15 to 58

0.24 to 95

0.34 to 135

4.3 to 170

1

Flow rates are limited in media control. Maximum flow rates can be achieved in manual control.

NOTICE

Using larger tubing with the tubing holder in its inner position will reduce flow rate and tubing life.

Using smaller tubing with the tubing holder in its outer position will not secure the tubing correctly and may lead to rupture.

Adjust tubing holder position

Use a pointed tool such as a ball pen to adjust the tubing holder positions on both sides of the pump head. Follow the instructions below to change the tubing holder position.

Step

1

2

Action

Make sure that the pump is not running.

Open the flip top of the pump head completely.

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5 Operation

5.1 Set up the system

5.1.5 Prepare the pump

Step

3

Action

Place the pointed tool in the small depression in the tubing holder on one side of the pump head.

4 Press down and move the tubing holder to the required position until it clicks into place.

5 Release the pressure. The tubing holder rises into the new position.

166

6 Repeat the above steps to adjust the tubing holder on the other side of the pump head.

NOTICE

Make sure that the tubing holder position is the same on both sides of the pump head.

NOTICE

Make sure that the tubing holder position is not caught in between the inner or outer position, as this may cause erroneous flow rates and abnormal tube wear.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

5 Operation

5.1 Set up the system

5.1.5 Prepare the pump

Load tubing

1

2

Follow the instructions below to load tubing in the pump head and connect tubing to the Cellbag bioreactor.

Step Action

Make sure that the pump is switched off.

Open the flip top of the pump head completely.

3

4

Check that the tubing holder is adjusted to the correct position for your size of tubing. See instructions above.

Place the tubing between the rotor rollers and the track, pressed against the inner wall of the pump head.

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5 Operation

5.1 Set up the system

5.1.5 Prepare the pump

Step

5

Action

Lower the flip top until it clicks into its fully closed position.

6

Note:

Connect inlet and outlet tubing to the Cellbag bioreactor, for example acid, base, feed and harvest.

The pumping direction is indicated by the arrow on the pump head.

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5 Operation

5.1 Set up the system

5.1.6 Connect gas to the system

5.1.6

Connect gas to the system

Gas mix

The Cellbag bioreactor requires gas flow to stay inflated and to provide ventilation. The

CBCU enables different gas mixing possibilities. Compressed air or N

2

CO

2 and/or O

2 to obtain the desired gas mix.

can be mixed with

Compressed air or N

2 is connected to AIR/N2 on the CBCU. CO to CO2 IN and O2 IN, respectively, on the CBCU rear panel.

2 and O

2 are connected

NOTICE

In dual mode, be careful to connect the air and gas for the left and right Cellbag bioreactors to the correct CBCU. This is easier if the respective CBCU units are placed on the left and right sides of the rocker respectively.

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5 Operation

5.1 Set up the system

5.1.6 Connect gas to the system

Set up aeration and gas supply

Follow the instructions below to connect gas to the bioreactor system.

Step

1

Action

Attach the filter heater to the outlet vent filter of the Cellbag bioreactor. In dual mode, make sure that the filter heaters are correctly placed with respect to the left and right bioreactors.

Note:

The inlet and outlet vent filters are distinguished by the pressure control valve on the outlet filter (indicated by an arrow in the illustration below. Do not attach the filter heater to the inlet vent filter.

The image below shows the filter heater mounted on the stand on the Cellbag bioreactor.

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Step

2

5 Operation

5.1 Set up the system

5.1.6 Connect gas to the system

Action

Connect tubing from the GAS MIX OUT on the CBCU front panel to the inlet vent filter of the Cellbag bioreactor.

3 Connect the desired gas source, air or N

2

, at 1.0 to 1.5 bar to AIR/N2 on the

CBCU rear panel.

4 If applicable, connect the CO

2

CBCU rear panel.

gas source at 1.0 to 1.5 bar to CO2 IN on the

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5 Operation

5.1 Set up the system

5.1.6 Connect gas to the system

Step

5

Action

If applicable, connect the O

2

CBCU rear panel.

gas source at at 1.0 to 1.5 bar to O2 IN on the

NOTICE

Make sure to keep the inlet pressures within the stated limits (1.0

to 1.5 bar). Excessive pressure may cause internal tubing to loosen.

NOTICE

An unsteady inlet pressure will affect the speed of the gas flow and also the gas mix.

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5 Operation

5.2 Start and configure the system

5.2

Start and configure the system

Introduction

This section describes how to start the system, log on to UNICORN, connect the system to UNICORN and configure the system in the software.

This section contains the following subsections:

Section

5.2.1 Start the system and log on to UNICORN

5.2.2 Connect to the system

5.2.3 Configure system properties

5.2.4 Configure system settings

5.2.5 Start a run

See page

174

175

177

179

181

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 173

5 Operation

5.2 Start and configure the system

5.2.1 Start the system and log on to UNICORN

5.2.1

Start the system and log on to UNICORN

Follow the instructions below to start the system and log on to UNICORN. The workstation must have a valid e-license.

For more information about e-licenses, refer to Operating Instructions.

Step Action

1

2

3

Switch on the client computer.

Start the UNICORN software.

Provide your User Name and Password to log on to UNICORN. Access credentials are assigned by your UNICORN administrator. According to the properties of your user account, you may be able to select an Access Group.

4

Note:

If Use Windows Authentication is checked, you may log on using your Windows username and password.

Switch on the rocker. The power button flashes green during start-up.

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5 Operation

5.2 Start and configure the system

5.2.2 Connect to the system

5.2.2

Connect to the system

Follow the instructions below to connect the system to UNICORN.

Step Action

1 When the indicator light on the rocker front panel shows a steady green light, click the Connect to Systems icon in the System Control module.

Result: The Connect to Systems dialog opens.

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5 Operation

5.2 Start and configure the system

5.2.2 Connect to the system

Step

2

Action

In the Connect to Systems dialog:

Select the system.

Select Control mode.

Click OK.

Result: The Process Picture appears.

176

Note:

The detailed appearance of the process picture will vary according to your system setup.

Tip:

If UNICORN is unable to connect to the selected system, see Section 7.6.2

UNICORN System Control, on page 237.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

5 Operation

5.2 Start and configure the system

5.2.3 Configure system properties

5.2.3

Configure system properties

Edit the system properties whenever the configuration of the system is changed, for example, to

• switch between single and dual modes.

• change the system setup, for example if a CBCU or pump has been added or removed.

• change the Instrument Configuration of the system.

The Instrument Configuration is the system specific control software. It is provided on a DVD with the system, and is also available for download. Contact your GE representative if you need help to download the Instrument Configuration.

Follow the instructions below to edit the system properties.

Step Action

1

2

Open the Administration module in the Tools menu.

Click System Properties.

Select your system in the System Properties dialog and click Edit.

Note:

Only systems that are switched on and connected to the computer can be edited.

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5 Operation

5.2 Start and configure the system

5.2.3 Configure system properties

Step

3

4

Action

All available components are shown in the Component selection list.

Click the check-boxes to select or de-select components.

Make sure the components selected match the units connected to the system.

Click OK to apply the changes.

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5 Operation

5.2 Start and configure the system

5.2.4 Configure system settings

5.2.4

Configure system settings

Pump roles need to be assigned to the individual pump heads before starting a run. This is done in System Settings, which also allows definition of other system parameters such as:

• whether heating should be automatically enabled when the rocking starts

• whether calibration values for pH and/or DO sensors should be reset at the end of the run

• whether rocking, gas mix and temperature control should be resumed on restart after power loss

• whether voltage or current should be used for analogue inputs

The instructions below describe the details of how to assign pump roles. See System

settings, on page 47 for general instructions on how to configure the system settings.

Step

1

2

Action

Select System:Settings in the System Control module.

Select Pump setup from the list and click the + symbol to view the available pump heads.

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5 Operation

5.2 Start and configure the system

5.2.4 Configure system settings

Step

3

4

5

Action

Assign roles to pump heads according to the requirements of the cultivation process.

In single mode, available roles are Acid, Base, Feed1, Harvest, Feed2, Feed3 and Feed4.

In dual mode, available roles are Acid, Base, Feed1, Harvest, Feed2, Feed3 for the left and right functions separately, identified by the suffix L and R.

Note:

Media addition in media control and perfusion mode uses only Feed1 of the available Feed roles. Do not select other Feed roles for pump heads intended for these purposes.

For pH control using acid and base in single mode, assign to one pump head and to another.For pH control using acid and base in dual mode, assign and to separate pump heads for the left bioreactor, and and to separate pump heads for the right bioreactor.For media addition in dual mode, assign to a pump head for the left bioreactor, and to a pump head for the right bioreactor.

Examples:

For pH control using acid and base in single mode, assign Acid to one pump head and Base to another.

For pH control using acid and base in dual mode, assign Acid L and

Base L to separate pump heads for the left Cellbag bioreactor, and Acid R and Base R to separate pump heads for the right bioreactor.

For media addition in dual mode, assign Feed1 L to a pump head for the left Cellbag bioreactor, and Feed1 R to a pump head for the right bioreactor.

A given pump role cannot be assigned to more than one pump head. If a role that is already assigned to a pump head is given to a second pump head, the second assignation will apply and the the first pump head will be set to Not defined.

Check the assignment of all pump heads to make sure that there are no conflicts before clicking OK.

To return to the default values defined in the instrument configuration, click

Set Parameters To Strategy Default Values.

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5 Operation

5.2 Start and configure the system

5.2.5 Start a run

5.2.5

Start a run

Introduction

This section describes how to start a manual or method-controlled run. Data collection begins when the run starts.

For further information on methods, refer to Section 3.3 Methods in UNICORN, on page 50.

Note:

Pressing the power button on the rocker while the rocker is switched on will shut down the system and stop any ongoing run.

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5 Operation

5.2 Start and configure the system

5.2.5 Start a run

Start a manual run

The instructions below describe how to start a manual run.

Step

1

Action

Change the Cellbag settings as required. In dual mode, make sure the settings are correctly entered for both bioreactors.

1

Click the Cellbag icon. In dual mode, click the appropriate side of the icon.

2

If pH and/or DO control will be used, enter the appropriate calibration data (printed on the Cellbag label).

182

3

Click OK.

Result: The Start Protocol dialog for the manual run opens.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

5 Operation

5.2 Start and configure the system

5.2.5 Start a run

Step Action

2 On the displayed page in the Start Protocol:

1

Type the Result name and click Browse to change the Location of where the result is saved if necessary.

2

Select the correct Bag size (two sizes are listed in dual mode).

3

Click OK.

Result: The manual run starts.

Start a method run

The instruction below describes how to start a method run.

Tip:

The system can be controlled manually from the Process Picture after the method run has been started.

Step Action

1 Open the System Control module and click the icon Open Method Navigator.

Result: The Method Navigator pane opens.

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5 Operation

5.2 Start and configure the system

5.2.5 Start a run

Step

2

Action

Select the method to run, and click the Run icon.

3

Result: The Start Protocol dialog for the method run opens.

On the displayed page in the Start Protocol, add requested input and make appropriate changes if necessary. Click Start.

Result: The method run starts.

Hold or stop the run

To interrupt a method during a run you may use the Hold or End icons in System Control.

A held method run can be resumed by using the Continue icon. See the instructions in the table below.

At the end of a method the run stops automatically. All functions stop, including rocking and data logging, and an acoustic end signal sounds and End is displayed in the Run

Log. This also applies when ending a manual run.

Tip:

In System Settings, it is possible to set Prepare for Tilt at END.

If you want to...

temporarily hold the method

then...

click the Hold icon.

resume a method run

Note:

When a method is put on hold, the system control is maintained, but no new instructions are given.

click the Continue icon.

Note:

An ended method cannot be continued.

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5 Operation

5.2 Start and configure the system

5.2.5 Start a run

If you want to...

resume a method run or a manual run after the system has entered the

Error and Alarm state

then...

click the Continue icon.

permanently end the run click the End icon.

Note:

When you end a method run prematurely, you will be prompted to save or discard the partial result.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 185

5 Operation

5.3 Prepare for cultivation

5.3

Prepare for cultivation

In this section

This section describes the how to prepare the system for cell cultivation. For illustrations

and descriptions of the system, refer to Chapter 2 System description, on page 12.

This section contains the following subsections:

Section

5.3.1 Inflate the Cellbag bioreactor

5.3.2 Adjust pump parameters

5.3.3 Final checks before cultivation

5.3.4 Add and equilibrate culture medium

5.3.5 Prepare the sensors

See page

187

188

189

190

193

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5 Operation

5.3 Prepare for cultivation

5.3.1 Inflate the Cellbag bioreactor

5.3.1

Inflate the Cellbag bioreactor

Follow the steps below to inflate the Cellbag bioreactor.

Step Action

1

2

3

Make sure that all ports on the Cellbag bioreactor are closed and that inlet and outlet filters are open.

Open Settings:Gas control:Gas flow from the Process Picture in System

Control.

Enable Fast fill. This will maximize the gas flow during the first 20 minutes.

Note:

Fast fill is disabled in the illustration below.

4 Turn on Gas flow from the Process Picture by pressing the right-hand side of the Gas flow button.

Result: The Cellbag is inflated.

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5 Operation

5.3 Prepare for cultivation

5.3.2 Adjust pump parameters

5.3.2

Adjust pump parameters

Follow the steps below to adjust the pump parameters.

Step Action

1 Adjust the pump parameters for each pump under Settings:Cellbag pumps.

Enter the Tube inner diameter and if the pump function is acid or base, enter the molarity.

Note:

The acid/base control is tuned with NaOH and HCl. If you are using acid or base with a different pK value you should set the Molarity parameter to the equivalent molarity of NaOH or HCl for optimal pH control.

188

2 If you are preparing a perfusion cultivation, enable auto-calibration or calibrate the feed and harvest pumps to reach optimal precision.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

5.3.3

Final checks before cultivation

5 Operation

5.3 Prepare for cultivation

5.3.3 Final checks before cultivation

5

6

7

Follow the instructions below to verify the system before filling the Cellbag bioreactor with medium.

Step

1

Action

Verify that the tray is correctly attached to the rocker platform.

2

3

4

Verify that the lid is mounted on the tray to protect the optical sensors on the Cellbag bioreactor from excessive light.

If using both pH and DO sensors, verify that the optical fiber cables are not mixed up. Mark the cables with the supplied stickers.

Verify that the pH or DO sensor cables are not positioned betweeen the temperature sensor and the Cellbagbioreactor.

8

Verify that the pH and DO sensor adaptors are connected correctly.

Verify that the filter heater is connected.

Verify that the Cellbag bioreactor is firmly inflated and secured to the tray.

The Cellbag bioreactor should be taut but not creased.

Verify that gas flow is released through the outlet pressure relief valve. This may be done by attaching a piece of tubing with one end submerged in a beaker of water to the pressure relief valve. Formation of gas bubbles in the water will confirm the relief valve function.

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5 Operation

5.3 Prepare for cultivation

5.3.4 Add and equilibrate culture medium

5.3.4

Add and equilibrate culture medium

Tare the scale

Tare the scale with all the equipment on the tray, such as lid, Cellbag bioreactor, and filter heater before starting a run. For optimal control, the measured weight should be the same as the weight of the culture. The weight measurement is used as input for the regulation of temperature, pH, and media control.

In dual mode, it is important for correct weight measurement to tare the scale, even if the weight distribution appears to be even.

Note:

Load cells are temperature-sensitive. Keep the ambient temperature constant to minimize effects on weight measurement.

Follow the instructions below to tare the scale.

Step Action

1

2

Set the rocker stop angle to 0° and check that the tray is in a horizontal position.

Open Settings:Weight from the Process Picture in System Control.

190

4

5

3

In dual mode, the weights of the two bioreactors are displayed separately.

Check that the weight distribution is even by reading the weight percentage values for the rocker feet. The values should not differ more than ±5%, and the optimal weight distribution is 25% on each load cell. Turn the adjustable

foot if necessary, see Adjustable foot, on page 19.

Make sure that the lid and all other equipment that will be used during the run is placed on the tray, and that no tubing weighs down the tray.

Click Tare.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

5 Operation

5.3 Prepare for cultivation

5.3.4 Add and equilibrate culture medium

Add culture medium

Follow the instructions below to fill the Cellbag bioreactor with culture medium.

Note:

The high pressure alarm may be triggered as the bioreactor is filled, depending on gas and liquid flow rates. The alarm may be ignored provided that it is no longer active when filling is complete.

Step

1

2

3

Action

Open Rocking from the Process Picture.

Set the Stop Angle to 12.0 and click OK.

Note:

The risk that air bubbles are trapped by the optical sensors is minimized with the tray at an angle. The angle can be adjusted to make sure that the medium reaches all optical sensors during filling. Using medium at room temperature or culture temperature reduces the risk of air bubble formation.

Slowly transfer the desired volume of medium into the Cellbag bioreactor using a pump or gravity flow.

Tip:

To automatically fill the bag to a desired weight, use Media Addition from

Settings:Media control in the Process Picture.

Check if there are visible gas bubbles on the optical sensors. See pH reading

and DO reading, respectively, in Section 7.3 ReadyToProcess CBCU, on

page 217 for advice on how to remove bubbles.

Note:

Such bubbles may be difficult to see. For the pH sensor, an indication of gas bubbles is that the initial pH reading deviates more than about 0.5 units from a reference measurement.

Equilibrate to operating conditions

Follow the steps below to equilibrate the medium to operating conditions.

For recommendations on operating conditions, refer to Section 4.7 Recommended oper-

ating conditions, on page 145.

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5 Operation

5.3 Prepare for cultivation

5.3.4 Add and equilibrate culture medium

Step

1

Action

Set the desired rocking speed and angle in Settings:Rocking in the Process

Picture. Start the rocking by clicking the right-hand side of the Rocking button.

2

3

4

5

6

Note:

When using Tray 50, the value of rocking speed multiplied by rocking angle may not exceed 240 (e.g., with a rocking angle of 12° the rocking speed is limited to 20 rpm).

Set the desired gas flow in Settings:Gas control:Gas flow in the Process

Picture. Start the gas flow by clicking the right-hand side of the Gas flow button.

If applicable, turn on CO

2 mixing by clicking the right-hand side of the CO2 button in the Process Picture.

Set the required temperature setpoint.

Click the right-hand side of the Temp button to start heating.

Equilibrate the medium for at least 2 hours.

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5 Operation

5.3 Prepare for cultivation

5.3.5 Prepare the sensors

5.3.5

Prepare the sensors

Important

Do not start pH or DO reading until the medium is fully equilibrated to operating conditions. The sensors do not give reliable measurements until then.

Equilibrate the culture medium with 100% air to calibrate DO sensors for 100% air saturation. If you use air mixed with 0% to 10% CO

2

, the sensors can be calibrated over the range 100% to 90% air saturation.

Do not calibrate DO sensors for 100% air saturation if N

2 is used instead of air.

Note:

CO

2 regulation is slow, so it takes some time before the CO reaches the setpoint.

2 concentration

NOTICE

Do not move the rocker during a run, since this could damage the scale function and disturb the weight measurement.

Prepare the DO sensor

Follow the instructions below to prepare the DO sensor.

Note:

In dual mode, adjust the sensor calibration on each Cellbag bioreactor separately.

5

6

7

2

3

4

Step

1

Action

When the medium is equilibrated to operating conditions, move the cursor over the DO sensor icon in the Process Picture, and set Reading On in the menu that appears.

Wait until the value is stable.

Select System:Calibrate in System Control.

Select DO sensor in the Monitor to calibrate drop down menu.

Enter percentage of air saturation (90% to 100% depending on CO

2 tration) in the Enter reference DO field.

concen-

Click Calibrate.

Close the Calibration dialog.

Select Settings:DO in the Process Picture.

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5 Operation

5.3 Prepare for cultivation

5.3.5 Prepare the sensors

Step

8

9

Action

Enter the desired values for Control and Setpoint. Check the Deviation

Alarm and set the alarm limits if desired.

Click OK.

Prepare the pH sensor

Follow the instructions below to prepare the pH sensor.

Note:

In dual mode, adjust the sensor calibration on each Cellbag bioreactor separately.

Step Action

1

2

3

When the medium is equilibrated to operating conditions, move the cursor over the pH sensor icon in the Process Picture, and set Reading On in the menu that appears.

Wait until the value is stable.

Click the right-hand side of the Sampling button to prepare for sampling.

Result: The system will enter sampling mode.

Note:

The system will be in sampling mode as many minutes as set in Settings:Rock-

ing:Sampling:Pause and at an angle set in Settings:Rocking:Sampling:Stop

angle in the Process Picture.

Take a sample to verify that the pH value shown by the system matches the pH measured with a calibrated reference instrument. If the deviation is larger than approximately 0.5 pH units, make sure that no air bubble is present.

For instructions on how to remove air bubbles, see pH reading, on page 222.

4

7

8

5

6

9

10

Continue with the calibration adjustment only if the deviation is less than

0.5 pH units.

Select System:Calibrate in System Control.

Select pH sensor in the Monitor to calibrate drop down menu.

Enter the actual pH value in the Enter reference pH field.

Click Calibrate.

Close the Calibration dialog.

Select Settings:pH in the Process Picture.

194 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

Step

11

12

5 Operation

5.3 Prepare for cultivation

5.3.5 Prepare the sensors

Action

Enter the desired values for Control and Setpoint. Check the Deviation

Alarm and set the alarm limits if desired.

Click OK.

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5 Operation

5.4 Perform cultivation

5.4

Perform cultivation

In this section

This section describes the basics of performing a cultivation. During the cultivation, key parameters are monitored and the settings can be adjusted.

This section contains the following subsections:

Section

5.4.1 Inoculate the culture

5.4.2 Monitor and control the cultivation

5.4.3 End a run

See page

197

198

203

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5 Operation

5.4 Perform cultivation

5.4.1 Inoculate the culture

5.4.1

Inoculate the culture

Instructions

3

4

Follow the instructions below to inoculate the Cellbag bioreactor.

Note:

Make sure that the key culture parameters pH, DO and temperature are stable before inoculation.

Step

1

Action

Make sure that the inlet tubing and the tubing connected to the inoculum container are clamped.

2 Using sterile techniques, connect tubing from the inoculum container to the inlet tubing, using e.g. tube fusing equipment or a ReadyMate™ connector.

Unclamp the inlet tubing and inoculum container tubing.

Transfer the desired volume of inoculum into the bag using a pump or gravity flow.

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5 Operation

5.4 Perform cultivation

5.4.2 Monitor and control the cultivation

5.4.2

Monitor and control the cultivation

System status

You may follow and control the ongoing run in the System Control module. The current system status is shown in the System state panel in the Run Data pane. For example, it may show Ready, Manual Run or Method Run.

Process picture

The Process Picture displays the real-time process parameters during a run, and can be used to control the run. An example of the Process Picture is shown in the illustration below. Details vary according to the system configuration.

198

The button colors indicate the current state of the respective function as shown in the table below.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

Color

White

Gray

Green

Orange

Red

5 Operation

5.4 Perform cultivation

5.4.2 Monitor and control the cultivation

Indication

The function is inactive.

The function is disabled due to higher level control

The function is active and is working normally.

The function needs attention. Click on the button to open the related settings and to see more information.

The function is not working properly. Click on the button to open the related settings and to see an explanation of the problem.

Sample the culture

Samples may be taken several times during the run using the same sampling connector.

Before taking a sample, make sure that the sampling connector is firmly attached to the luer-lock coupling of the cellbag bioreactor by screwing it clock-wise.

Follow the instruction below to take samples from the Cellbag bioreactor.

Step Action

1

2

Stop the rocking motion from the Process Picture.

Click the right-hand side of the Sampling button to prepare for sampling.

Result: The system will enter sampling mode.

Note:

The system will remain in sampling mode for the number of minutes set in

Settings:Rocking:Sampling:Pause, at an angle set in Settings:Rocking:Sam-

pling:Stop angle. The time remaining in sampling mode is displayed in a countdown timer.

Note:

For small culture volumes, it may be necessary to position the tray into tilt position during sampling.

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5 Operation

5.4 Perform cultivation

5.4.2 Monitor and control the cultivation

Step

3

Action

Remove the cap from the blue sampling connector.

4 Wipe the top of the sampling connector with 70% alcohol, or equivalent.

5 Attach a sterile disposable syringe with luer connector onto the sampling connector.

200

6

7

8

9

Release the tubing clamp and withdraw a sample into the syringe.

Remove the syringe and wipe the top of the sampling connector again with

70% ethanol and replace the cap.

Pinch the sampling connector tubing a few times to ensure that any liquid in the tubing drains back into the Cellbag bioreactor.

Close the tubing clamp. Sampling mode duration is set from Settings:Rock-

ing:Sampling:Pause in the Process Picture.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

5 Operation

5.4 Perform cultivation

5.4.2 Monitor and control the cultivation

Scale up cultivation

Cellbag bioreactors have a large range in operating volume. This allows efficient scaleup and eliminates tedious sequential transfers. Start at low volume and add fresh medium to the Cellbag bioreactor as the cells grow. Up to a 1:10 expansion is possible in one single bag.

Example of an inoculum expansion sequence is described below.

Step Action

1

2

3

4

Start with 300 mL medium in a 2 L Cellbag bioreactor. Add inoculum.

When cells reach approximately 3 × 10

6 cells/mL, add culture medium up to a volume of 1 liter.

When the cells again reach 3 × 10

6 cells/mL, transfer using a tube-fuser to a 20 L Cellbag bioreactor containing 2 liters of culture medium.

When the cells in the 20 L Cellbag bioreactor reach 3 × 10

6 cells/mL, add culture medium up to a volume of 10 liters and continue cultivation.

Exchange culture medium

Follow the instructions below to exchange culture medium in the Cellbag bioreactor, for example when working with microcarriers.

Note:

To avoid oxygen depletion, the culture medium exchange should be performed in less than one hour.

Step Action

1

2

3

4

5

6

7

Stop the gas flow by clicking the right-hand side of the Gas flow button in the Process Picture.

Stop the rocking by clicking the right-hand side of the Rocking button in the

Process Picture.

Clamp off the inlet and outlet vent filters.

Select Manual:Execute Manual Instructions, and send the instruction

Rocker:Prepare for tilt.

Hold the textured grip area on each side of the tray, and pull the tray upwards and against you to position the tray into tilt position.

Allow particulates (including cells and microcarriers, if applicable) 10 to 15 minutes to settle.

Connect tubing to the harvest port on the Cellbag bioreactor. The other end of the tubing should be connected to a sterile harvest vessel.

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5 Operation

5.4 Perform cultivation

5.4.2 Monitor and control the cultivation

Step

8

9

10

11

12

Action

Using a pump or gravity flow, remove the desired amount of supernatant culture liquid by manually manipulating the flexible wall of the Cellbag bioreactor.

Disconnect the tubing and reconnect fresh culture medium to refill the

Cellbag bioreactor.

Open the inlet and outlet vent filter clamps.

Start the rocking by clicking the right-hand side of the Rocking button in the

Process Picture.

Start the gas flow by clicking the right-hand side of the Gas flow button in the Process Picture.

Perfusion culture

During perfusion culture, cell-free harvest/waste is withdrawn and fresh medium is added continuously.

Requirements:

Cellbag bioreactors with internal perfusion filter or connected to external retention filters

Harvest and feed pump

See Section 4.6.3 Perfusion, on page 139 for information on perfusion mode, Contact a

GE application specialist for advice on setting up perfusion culture.

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5 Operation

5.4 Perform cultivation

5.4.3 End a run

5.4.3

End a run

End cultivation and harvest the culture

To end the run and harvest the culture, follow the instructions below.

Step

1

2

Action

Prepare the harvest vessel.

Click the stop button in the toolbar in System Control to stop the run.

3

4

5

6

When asked if you want to end the run, click OK.

Note:

By default, the tray will prepare for tilt at the end of the run. This setting can be changed in System Settings:Rocker:Prepare for tilt at END.

Hold the textured grip area on each side of the tray, and in one movement, pull the tray upwards and against you to position the tray into tilt position.

Connect tubing from the Cellbag bioreactor to the harvest vessel.

Empty the Cellbag bioreactor using a pump or gravity flow.

Disconnect the tubing from the Cellbag bioreactor to the harvest vessel.

Procedures after harvest

Follow the instructions below when the cultivation is finished and the culture is harvested.

Step Action

1

2

3

4

Clamp off the inlet and outlet vent filters of the Cellbag bioreactor.

Disconnect the tubing from the inlet vent filter on the Cellbag bioreactor.

Disconnect any other tubing and cables still connected to the Cellbag bioreactor.

Release and remove the empty Cellbag bioreactor from the tray by pressing down the bag clamp opener.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 203

5 Operation

5.4 Perform cultivation

5.4.3 End a run

Step

5

6

Action

Follow applicable national and/or local regulations for disposal of the Cellbag bioreactor.

Turn off all gas supplies.

Shut down the system

Follow the instructions below to shut down the system.

Step Action

1

2

Disconnect the software from the system in UNICORN.

Press the power button on the rocker front panel. The light flashes green while shutting down.

Note:

If the rocker fails to shut down, keep the power button pressed in more than

4 seconds to force a shutdown.

3 Clean the bioreactor system units.

204 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

6 Maintenance

6 Maintenance

In this chapter

This chapter describes the required maintenance procedures for ReadyToProcess WAVE

25. It also gives an overview of the calibration procedures needed for the system to function properly.

Maintenance manager

The maintenance manager in UNICORN keeps track of the usage of different components and shows alerts when it is time for maintenance and service. For detailed information about the maintenance manager, refer to UNICORN Administration and Technical manual.

Section

6.1 Calibration

6.2 Pump calibration

6.3 Cleaning

See page

206

208

210

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 205

6 Maintenance

6.1 Calibration

6.1

Calibration

Calibration schedule

For the system to function properly, several calibrations may be performed. See tables below.

Before each cultivation

Perform the following calibrations and adjustments before each cultivation

Calibration

Pump

DO sensor pH sensor

Instruction

Enter tubing inner diameter in the Settings:Cellbag pumps dialog.

For perfusion cultivation, enable auto-calibration or calibrate the feed and harvest pumps.

see Section 5.3.2 Adjust pump parameters, on page 188.

Adjust the calibration, see Section 5.3.5 Prepare the sensors, on

page 193.

Adjust the calibration, see Section 5.3.5 Prepare the sensors, on

page 193.

Repeat the calibration adjustment during cultivation if required.

When required

Perform the following calibrations when required or at least once a year.

Calibration

Scale

Temperature

CO

2 sors and O

2 sen-

Instruction

Contact GE service personnel for assistance if needed.

Note:

Scale calibration is recommended after moving the rocker, or when the load is changed considerably. For Calibrate High point, use a weight that is as close as possible to the load that will be applied to the tray during use.

Contact GE service personnel for assistance if needed. Service personnel use special equipment to achieve more accurate calibration.

Calibration of CO

2 and O

2 sensors requires special competence and may impair system performance if performed incorrectly.

Contact GE service personnel for assistance.

206 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

6 Maintenance

6.1 Calibration

Calibration instruction

Follow the instructions below to perform a calibration. The example is a scale calibration.

Note:

For OPC users, calibration can be accessed from the manual instruction dialog by selecting the OPC component.

Step Action

1 Select System:Calibrate in System Control.

Result: The Calibration dialog opens.

2

3

4

Select the appropriate monitor in the Monitor to calibrate drop down menu.

Follow the instructions in the right-hand field and enter the correct values in the Calibration procedure field, and click Calibrate for each value.

Close the Calibration dialog.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 207

6 Maintenance

6.2 Pump calibration

6.2

Pump calibration

Introduction

Pump calibration is normally not necessary for pH and media control purposes, provided that the inner diameter of the pump tubing is correctly set. Calibration is however recommended if high precision is required or when running perfusion with auto calibration disabled.

Tube inner diameter

Always set the tube inner diameter correctly. If the tube inner diameter is not set correctly, the following can happen:

The requested flow may be out of range for the given tube diameter. This will prevent the media control from starting and result in warnings in pH control.

The pH and media control performance may deteriorate.

It may not be possible to calibrate the pump, since the calibration result will be too far from the expected value.

Pump calibration procedure

The pumps can be calibrated at a desired flow or RPM. Before calibration, the pump head must be set in desired rate mode (flow or RPM), and the flow or RPM setpoint be set to desired value.

Follow the steps below to calibrate a pump. Parameters may be set either in the process picture or using manual instructions.

Step Action

1

2

3

4

5

Enter the inner diameter of tubing used.

Set Rate mode to Flow or rpm. Calibration will be performed in terms of flow rate or pump speed according to this setting.

Enter the desired setpoint (as flow rate or rpm according to the Rate mode setting).

Click Settings:Calibrate and choose which pump to calibrate.

Enter the desired calibration run time and click Start pump. Run the calibration for sufficient time to collect a reliably measurable volume of liquid.

208 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

6 Maintenance

6.2 Pump calibration

Step

6

Action

When the pump stops, enter the collected volume and click Finish calibra-

tion.

Calibration factor

After calibrating a pump (either manually or using auto calibration), the calibration factor is recalculated. The calibration factor is the relation between the expected flow to rpm conversion for the selected tube diameter and the result of the calibration. This value is shown for each pump head in the curve data chart.

Warning and rejection limits

The pumps will give a warning if the observed calibration volume is outside the range

-30% to 10% of the expected value. The calibration will be rejected if the observed calibration volume is outside the range -60% to 30% of the expected value.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 209

6 Maintenance

6.3 Cleaning

6.3

Cleaning

Cleaning procedure

To prevent microbial or cross contamination, ReadyToProcess WAVE 25 should be cleaned after each cultivation. The system must be turned off and unplugged before cleaning.

• Clean the exterior of the system units with a damp cloth and a suitable cleaning agent.

Make sure to clean the temperature sensor arms on the underside of the rocker platform. If dirt accumulates in these arms, they may not function properly, which could cause incorrect temperature regulation.

Recommended cleaning agents

All system units can be cleaned with ethanol, isopropanol and Virkon™ at suitable con-

centrations. Refer to Section 8.4 Chemical resistance, on page 248.

210 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

7 Troubleshooting

7 Troubleshooting

In this chapter

This chapter describes troubleshooting and corrective actions for ReadyToProcess WAVE

25.

If the suggested actions in this guide do not solve the problem or if the problem is not covered by this guide, contact your GE representative for advice.

This chapter contains the following sections:

Section

7.1 ReadyToProcess WAVE 25 system

7.2 ReadyToProcess WAVE 25 rocker

7.3 ReadyToProcess CBCU

7.4 ReadyToProcess Pump 25

7.5 Cellbag bioreactor

7.6 Software problems

See page

212

213

217

231

232

234

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 211

7 Troubleshooting

7.1 ReadyToProcess WAVE 25 system

7.1

ReadyToProcess WAVE 25 system

Alarm messages

For many of the problems that may occur, UNICORN displays an alarm message on the screen. Follow the instruction shown to resolve the problem.

System units not recognized

Error symptom

CBCU not recognized by UNICORN.

Pump not recognized by UNICORN.

CBCU and/or pump not recognized by

UNICORN.

Possible cause

Incorrect CBCU CAN ID.

CBCU is not selected as a component.

Incorrect pump CAN ID.

Pump is not selected as a component.

Gap between occupied

UniNet-9 ports on the rocker rear panel.

One or more connected pumps is not defined in

UNICORN.

Corrective action

Check and if necessary change CAN ID using the

switch on the CBCU rear panel. See CAN ID, on

page 28 for details. The system must be switched

off before the CAN ID is changed, and then restarted.

Click Edit in System Properties in the Administra-

tion module and add the CBCU as a component.

Check and if necessary change CAN ID using the

switch on the pump rear panel. See CAN ID, on

page 31 for details. Each pump must have a

unique CAN ID value. The system must be switched off before the CAN ID is changed, and then restarted.

Click Edit in System Properties in the Administra-

tion module and add the pump as a component.

Reposition the connectors or insert jumpers in the unused positions between the occupied ports.

Read the displayed message when you connect to the system in System Control. Make sure all available components are selected for the system.

See Section 5.2.3 Configure system properties, on

page 177.

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7 Troubleshooting

7.2 ReadyToProcess WAVE 25 rocker

7.2

ReadyToProcess WAVE 25 rocker

Rocking

Error symptom

Rocker does not initialize properly.

When starting the run, the rocker moves too slowly during the first cycle.

Rocker is not rocking.

Possible cause

Faulty safety fuses.

It takes a while for the rocker to initialize after turning on the power.

Corrective action

Try to restart the system a few times.

If the system still does not initialize properly, shut it down and contact GE service personnel.

None. This is normal.

Rocker stops rocking.

Incorrect rocking angle.

Rocking speed varies.

Rocker is in an error state.

Check the current alarms.

Reset power to the unit.

If you still get motor alarms, contact GE service personnel.

Tray is in tilt position.

Rocker is mechanically restricted from moving.

Make sure that the tray is in normal position.

If this does not help, contact GE service personnel.

Locate and remove the restricting object.

DO control using speed is enabled. If the DO deviates from the setpoint, the rocking speed changes.

This is normal when DO control is enabled. If not required, disable DO control from the process picture.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 213

7 Troubleshooting

7.2 ReadyToProcess WAVE 25 rocker

Error symptom

Power button flashes red.

System does not shut down when the power button is pressed.

Rocking starts when sending another command than Start rock-

ing.

Possible cause

Rocker does not have any connection to the

UNICORN database.

System units such as

CBCU or pump defined in the system setup in

UNICORN are not connected to the rocker.

An internal error has occured in the embedded computer of the rocker.

The embedded computer of the rocker fails to shut down.

Corrective action

Verify the connection between the rocker and the client computer or network.

Disable the missing components in UNICORN. See

Section 5.2.3 Configure system properties, on

page 177.

Connect the missing components to the rocker.

Read any warning message carefully and follow the instructions. If problem persists, contact GE service personnel.

At the first command sent to the system, the system enters Run state and the rocker is initialized and makes a few movements.

Wait one minute. If the system still does not shut down, keep pressing the power button to force system shut down.

If problem persists, contact GE service personnel.

None. This is normal.

Temperature

Error symptom

No heating although heating is enabled in

UNICORN. Frame around the temperature button is orange.

Possible cause

Rocker is not rocking.

Corrective action

Make sure that the rocker is rocking. The heater is automatically turned off when rocking is turned off.

Contact GE service personnel.

The tray size is not recognized.

Bag size is not set.

The heater is in an error state.

Set the bag size in Settings:Cellbag in the Process

Picture.

Contact GE service personnel.

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7 Troubleshooting

7.2 ReadyToProcess WAVE 25 rocker

Error symptom

Too slow or too fast heating.

Possible cause

Bag size setting is incorrect.

Corrective action

Check and if necessary reset the bag size setting.

When changing the bag size, the rocking must be turned off.

Incorrect weight measurement.

Make sure that the rocker is placed in a horizontal position.

Check that the weight shown in the Process

Picture matches the actual weight of the culture medium. If not, tare the scale with the weight of the content in the Cellbag entered as Net Weight.

Temperature control is not functioning or displayed temperature appears to be incorrect.

Temperature sensor is not in contact with the culture medium.

Temperature sensor needs calibration.

Make sure that there is enough culture medium in the Cellbag bioreactor to cover the temperature sensor, also when the rocker is rocking.

Check that no crease with resulting air pocket has formed on the Cellbag bioreactor film covering the sensor.

Make sure that the pH or DO cables are not in contact with the temperature sensor.

Calibrate the temperature sensor. See Section 6.1

Calibration, on page 206. If needed, contactGE ser-

vice personnel.

Weight

Error symptom

No weight reading.

Possible cause

Scale does not function properly.

Corrective action

Contact GE service personnel.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 215

7 Troubleshooting

7.2 ReadyToProcess WAVE 25 rocker

Error symptom

Incorrect weight displayed.

Incorrect readings in dual mode.

Weight reading fluctuates or drifts.

Possible cause

The weight distribution on the rocker feet is not even.

Corrective action

Use the tare functionality and even the weight

distribution according to the instructions in Sec-

tion 5.3.4 Add and equilibrate culture medium, on

page 190.

Place the rocker on a horizontal surface.

The rocker is not placed on a horizontal surface.

The tare was not done before adding the load

(Cellbag bioreactor etc.).

Mechanical obstructions to the rocker.

Cellbag bioreactors not centred on the respective halves of the tray.

Tare omitted or incorrectly performed.

Rocker support unstable.

Enter correct net weight and press tare. If correct weight is unknown remove all load (Cellbag bioreactor etc.) from tray and tare (zero) the scale.

Scale needs calibration.

Check that the tray is firmly locked in position.

Check that no tubing is pulling on the Cellbag bioreactor during rocking.

Check that the movement of the rocker is not obstructed.

Calibrate the scale. See Section 6.1 Calibration, on

page 206. If needed, contactGE service personnel.

Check bioreactor placement.

Tare the scale before or after filling the Cellbag

bioreactors. See Tare the scale, on page 190.

Check that the table is rigid, flat and horizontal.

216 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

7 Troubleshooting

7.3 ReadyToProcess CBCU

7.3

ReadyToProcess CBCU

General

Error symptom

Status LED flashes red.

Status LED shows a steady red light.

CAN indicator LED flashes.

Possible cause

An internal error has occurred, but the CBCU is still operating.

An internal error has occurred, and the CBCU is not operating.

An internal error has occurred, and the CBCU is not operating properly.

Note:

This is normal the first seconds during power up.

Corrective action

Check any warning message and follow the instruction. If problem persists, contact GE service personnel.

Check any warning message and follow the instruction. If problem persists, contact GE service personnel.

Contact GE service personnel.

Gas flow

Error symptom

No gas flow, or fluctuating gas flow, and a high pressure alarm is activated.

Possible cause

Gas flow has shut down or is restricted due to high pressure caused by blockage in gas tubing or vent filters.

Clogged Cellbag bioreactor outlet vent filter.

Corrective action

Make sure that all inlet and outlet lines are open.

Disconnect the N

2

/Air and Gas mix out tubing and locate the blockage.

Check that the Filter heater functions properly.

If the outlet gas flow is blocked by foam, reduce the rocking angle or decrease the rocking speed.

If problem persists, transfer the contents to another Cellbag bioreactor.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 217

7 Troubleshooting

7.3 ReadyToProcess CBCU

Error symptom

External gas source is connected but the gas flow shows zero.

Possible cause

Blocked gas tubing.

External gas source is connected but the tube regulator is not opened.

Corrective action

Disconnect the N

2

/Air and Gas mix out tubing and locate the blockage.

Open the external gas tube regulator.

CO

2

mix

Error symptom

No CO

2 reading or the communication with the CO

2 sensor does not work.

No immediate response when CO

2 mix is started or when setpoint is changed.

Display shows a CO

2 concentration in air which deviates from the expected value

(0.0%).

CO

2 reading keeps drifting down.

Erratic CO

2 control.

Possible cause

CO

2 sensor is broken.

It takes up to several minutes for the CO

2 control to reach the new setpoint.

Minor deviations can appear, for example due to temperature variations.

CO

2 gas supply pressure is too low.

CO

2 supply is not properly connected.

Connections for CO

2

,

O

2

, N

2 or air have been mixed up.

Incorrect setpoint.

Corrective action

Contact GE service personnel.

This is normal. Wait 5 to 10 minutes.

If the deviation is large, the offset CO

2 concentration can be adjusted. Contact GE service personnel.

Check that the CO

2 and 1.5 bar.

supply pressure is between 1.0

Check that the CO

2 gas is properly connected and at the correct pressure (between 1.0 and 1.5 bar).

Check the setpoint.

218 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

7 Troubleshooting

7.3 ReadyToProcess CBCU

O

2

mix

Error symptom

No O

2 reading.

Display shows an O

2 concentration in air which deviates from the expected value

(21.0%).

O

2 reading keeps drifting down.

Erratic O

2 control.

Possible cause

O

2 sensor is broken.

Minor deviations can appear, for example due to temperature variations.

O

2 gas supply pressure is too low.

O

2 supply is not properly connected.

Incorrect setpoint.

Incorrect gas supply (air or N

2

) is connected.

O

2 sensor is broken.

Corrective action

Contact GE service personnel.

If the deviation is large, the O

2 offset can be adjusted, contact GE service personnel.

Check that the O

2 and 1.5 bar.

supply pressure is between 1.0

Check that the O

2 gas is properly connected and at the correct pressure (between 1.0 and 1.5 bar).

Check the setpoint.

Check that the gas supply chosen in UNICORN matches the connected gas supply (air or N

2

).

Contact GE service personnel.

pH control

Error symptom

pH control does not start.

Possible cause

Some of the criteria for starting the pH control are not fulfilled.

Corrective action

Read the message in the pop-up dialog. If possible, take action according to the information and try again.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 219

7 Troubleshooting

7.3 ReadyToProcess CBCU

Error symptom

pH control using CO

2 seems to react too slow or too fast (undershooting/overshooting).

Possible cause

The bag size setting is incorrect which will optimize the control for another gas volume.

The control is using manually entered control parameters not optimal for the actual case.

The CO

2 narrow.

range is too

The automatically selected control parameters are not optimal for the actual case.

Corrective action

Set the bag size to the correct value.

Use the manual instruction pH control (ad-

vanced):pH control (advanced CO2) to set PID

parameter mode and Cycle time mode to Auto.

See Manual instructions, on page 48.

Use the manual instruction pH control:pH control

(CO2) to set the desired CO

2 range for pH control.

Use the manual instruction pH control (ad-

vanced):pH control (advanced CO2). Set PID pa-

rameter mode and/or Cycle time mode to Manual, and enter desired values for PID parameters and

cycle time. See Manual instructions, on page 48.

To get an initial suggestion of the PID parameters, look at the automatically selected parameters by selecting them as run data under Tools:Customize.

220 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

7 Troubleshooting

7.3 ReadyToProcess CBCU

Error symptom

pH control using acid or base seems to react too slow or too fast

(undershooting/overshooting).

Possible cause

The molarity of acid or base is not entered correctly.

The inner diameter of the tubing used for acid and base is not entered correctly.

The weight measured by the system is not corresponding to the weight of the cell culture medium.

The control is using manually entered control parameters not optimal for the actual case.

The automatically selected control parameters are not optimal for the actual case.

pH control using acid or base is doing too many small injections instead of doing larger ones more seldom.

pH control using acid or base is doing large injections with long time distance, instead of doing smaller ones more often.

Corrective action

Enter the correct molarity of the acid and base

used. See Flow rate, on page 127 and Section 5.3.2

Adjust pump parameters, on page 188 for more in-

formation.

Enter the correct inner diameter of the tubing used for acid and base.

Make sure that the rocker scale is tared, so that the measured weight corresponds to the weight

of the cell culture medium. See Section 5.3.4 Add

and equilibrate culture medium, on page 190 for

more information.

Use the manual instruction pH control (ad-

vanced):pH control (advanced acid/base) to set

PID parameter, cycle time and flow mode to Auto.

See Manual instructions, on page 48.

The deadband is set too low.

The deadband is set too high.

Use the manual instruction pH control (ad-

vanced):pH control (advanced acid/base). Set PID

parameter mode, Cycle time mode and/or Flow

mode to Manual, and enter desired values for PID

parameters, cycle time and flow. See Manual in-

structions, on page 48.

To get an initial suggestion of the PID parameters, look at the automatically selected parameters by selecting them as run data under Tools:Customize.

Check what the actual deadband values are by selecting them as run data under Tools:Customize.

Use the manual instruction pH control (ad-

vanced):pH control (advanced acid/base). Increase the deadband value for acid and/or base.

See Manual instructions, on page 48.

Check what the actual deadband values are by selecting them as run data under Tools:Customize.

Use the manual instruction pH control (ad-

vanced):pH control (advanced acid/base). Decrease the deadband value for acid and/or base.

See Manual instructions, on page 48.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 221

7 Troubleshooting

7.3 ReadyToProcess CBCU

Error symptom

In control scheme

CO2/Base, the transitions between CO

2 base are longer or and shorter than desired.

pH control is inactive.

Possible cause

The automatically computed transition delay time is not optimal for the actual cell culture.

Corrective action

Check what the actual trasition delay time values are by selecting them as run data under

Tools:Customize. Use the manual instruction pH

control (advanced):pH control (transition delay).

Set CO2/Base transition delay mode to Manual and enter desired values for transition delays. See

Manual instructions, on page 48.

Use the manual instruction pH control (ad-

vanced):pH control (transition delay). Set

CO2/Base transition delay mode to Auto. See

Manual instructions, on page 48.

The control is using a manually entered transition delay time not optimal for the actual case.

Some of the criteria for running the pH control are no longer fulfilled.

Rocker is in sampling mode.

Auto calibration of feed and harvest pumps is active.

Read the message in the pop-up dialog. If possible, take action according to the information and make sure that the control turns active again.

None. If the pH control is using acid or base, it is inactive while the rocker is in sampling mode.

None. If the pH control is using acid or base, it is inactive during auto calibration.

pH reading

Error symptom

No pH reading (Off is displayed).

Possible cause

pH reading is not started.

Corrective action

Open Settings:pH from the Process Picture, and set Reading to On.

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7 Troubleshooting

7.3 ReadyToProcess CBCU

Error symptom

pH reading is inactive

(0.0 is displayed, and the frame around the

Process Picture button is red).

Possible cause

Repeated errors from the the sensor has turned the reading into an inactive state. New reading attempts are made with asked reading frequency until a valid reading is returned, or the reading is stopped.

pH sensor cable is not connected properly or is defective.

Corrective action

Read the warning messages for more information.

Check the possible causes and corrective actions below.

Check both ends of the cable. Make sure that all four pins of the sensor port is gripping the sensor adapter and that the fiber cable is properly connected to the PH port on the CBCU front panel.

If both pH and DO sensors are used, check that the sensor cables are not mixed up. If so, correct the connections of the pH and DO sensors. Note that it may take one reading cycle before correct values are shown.

Check that the correct calibration values as stated

on the Cellbag have been entered. See Sec-

tion 5.3.4 Add and equilibrate culture medium, on

page 190 for more information.

Note:

The value CpH0 may have changed after recalibration. This is normal.

Turn off the pH reading until the culture medium is equilibrated.

Temperature of the culture medium has not reached process temperature.

pH inside the Cellbag bioreactor is outside the readable range (appr. pH 5 to 9).

If possible, adjust the Cellbag bioreactor conditions to a pH within the working range.

Note:

It is a risk that the pH sensor has been damaged, especially if the pH has been above pH 10.

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7 Troubleshooting

7.3 ReadyToProcess CBCU

Error symptom

Initial pH reading is unstable and/or deviates considerably (i.e., more than approximately 0.5

pH units from an offline measurement).

Fluctuating pH.

Variation in pH caused by the rocking should be less than 0.05 pH units.

Incorrect pH reading.

Possible cause

A gas bubble may be trapped on the pH sensor.

The rocking disturbs the pH readings.

Corrective action

Tap the pH sensor from the underside to remove the bubble. This may require forceful manipulation, and the Cellbag bioreactor may need to be partly disconnected from the tray.

Note:

The gas bubble may be very difficult to see.

Check that the fiber cables are not pinched or moving excessively. Place all the fiber cables in the tubing exit. Stop the rocking and observe the pH readings.

Check that the volume in the Cellbag bioreactor is not less than the specified minimum volume.

Check the pH label on the bag, enter the correct values and perform an offset calibration.

Entered pH calibration values are not correct for the bag used.

The pH sensor is degraded due to long use, light exposure or presence of substances that are harmful to the sensor, like strong bases or ethanol.

A gas bubble may be trapped on the pH sensor.

The sensor is no longer useful for pH measurement. Automatic pH control can no longer be performed.

Tap the pH sensor from the underside to remove the bubble. This may require forceful manipulation, and the Cellbag bioreactor may need to be partly disconnected from the tray.

Note:

The gas bubble may be very difficult to see.

DO control

Error symptom

DO control does not start.

Possible cause

Some of the criteria for starting the DO control are not fulfilled.

Corrective action

Read the message in the pop-up dialog. If possible, take action according to the information and try again.

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7 Troubleshooting

7.3 ReadyToProcess CBCU

Error symptom

DO control using O

2 seems to react too slow or too fast (undershooting/overshooting).

DO control using O

2 not using O

2 is concentrations below 21% to lower the DO, although

N

2 is connected to

CBCU.

Possible cause

The bag size setting is incorrect which will optimize the control for another gas volume.

The control is using manually entered control parameters not optimal for the actual case.

The automatically selected control parameters are not optimal for the actual case.

A gas bubble might be present on the DO sensor.

The setting for gas source is not set to N2.

Corrective action

Set the bag size to the correct value.

Use the manual instruction DO control (ad-

vanced):DO control (advanced O2) to set PID pa-

rameter mode and Cycle time mode to Auto. See

Manual instructions, on page 48.

Use the manual instruction DO control (ad-

vanced):DO control (advanced O2). Set PID param-

eter mode and Cycle time mode to Manual, and enter desired vaules for PID parameters and cycle

time. See Manual instructions, on page 48.

To get an initial suggestion of the PID parameters, look at the automatically selected parameters by selecting them as run data under Tools:Customize.

Tap the DO sensor from the underside to remove the bubble. This may require forceful manipulation, and the Cellbag bioreactor may need to be partly disconnected from the tray.

Note:

The gas bubble may be very difficult to see.

Select N

2 handle O

2 as gas source so that the DO control can setpoints below 21%.

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7 Troubleshooting

7.3 ReadyToProcess CBCU

Error symptom

DO control using speed seems to react too slow or too fast (undershooting/overshooting).

In control scheme

O2/Speed, the transitions between O

2 and speed are longer or shorter than desired.

DO control is inactive.

Possible cause

The entered parameters for cycle time, speed step, max/min speed and deadband are not optimal for the actual case.

A gas bubble might be present on the DO sensor.

Corrective action

Laborate with the parameters. There is no automatical parameter mode for DO control using speed.

The automatically computed transition delay time is not optimal for the actual cell culture.

The control is using a manually entered transition delay time not optimal for the actual case.

Some of the criteria for running the DO control are no longer fulfilled.

Tap the DO sensor from the underside to remove the bubble. This may require forceful manipulation, and the Cellbag bioreactor may need to be partly disconnected from the tray.

Note:

The gas bubble may be very difficult to see.

Check what the actual transition delay time values are by selecting them as run data under

Tools:Customize. Use the manual instruction DO

control (advanced):DO control (transition delay).

Set O2/Speed transition delay mode to Manual and enter desired values for transition delays. See

Manual instructions, on page 48.

Use the manual instruction DO control (ad-

vanced):DO control (transition delay). Set

O2/Speed transition delay mode to Auto. See

Manual instructions, on page 48.

Read the message in the pop-up dialog. If possible, take action according to the information and make sure that the control turns active again.

DO reading

Error symptom

No DO reading (Off is displayed).

Possible cause

DO reading is not started.

Corrective action

Open Settings:DO from the Process Picture, and set Reading to On.

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7 Troubleshooting

7.3 ReadyToProcess CBCU

Error symptom

DO reading is inactive

(0.0 is displayed, and the frame around the

Process Picture button is orange).

Possible cause

Repeated errors from the the sensor has turned the reading into an inactive state. New reading attempts are made with asked reading frequency until a valid reading is returned, or the reading is stopped.

Temperature of the culture medium has not reached process temperature.

DO fiber optical cable is not connected properly or is defective.

Corrective action

Read the warning messages for more information.

Check the possible causes and corrective actions below.

Turn off the DO reading until the culture medium is equilibrated.

The initial DO reading is much higher than expected (approximately

300% air saturation when 100% air saturation is expected).

DO fiber optical cable is not connected properly or is defective.

Check that the correct calibration values as stated

on the Cellbag have been entered. See Sec-

tion 5.3.4 Add and equilibrate culture medium, on

page 190 for more information.

Note:

The value Clhp and Clht may have changed after recalibration.

Check both ends of the fiber cable. Make sure that all four pins of the sensor port is gripping the sensor adapter and that the fiber cable is properly connected to the DO port on the CBCU front panel.

If both pH and DO sensors are used, check that the fiber cables are not mixed up. If so, correct the connections of the pH and DO sensors. Note that it may take one reading cycle before correct values are shown.

Check that the correct calibration values as stated

on the Cellbag have been entered. See Sec-

tion 5.3.4 Add and equilibrate culture medium, on

page 190 for more information.

Note:

The value Clhp and Clht may have changed after recalibration.

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7 Troubleshooting

7.3 ReadyToProcess CBCU

Error symptom

The initial DO reading deviates from what is expected, error is typically around 10% air saturation.

Incorrect DO reading.

Possible cause

This is normal and may be caused by differences in temperature, atmospheric pressure and composition of the gas.

A gas bubble may be trapped on the DOOPT

II sensor.

Corrective action

1

2

Check that the correct calibration values have been entered.

If problem persists, perform an offset calibration.

Note:

If for example 5% CO

2 is added to air flowing through the Cellbag the DO will be reduced with approximately the same percentage value.

Tap the DOOPT II sensor from the underside to remove the bubble. This may require forceful manipulation, and the Cellbag bioreactor may need to be partly disconnected from the tray.

Media control

Error symptom

Media control does not start.

Media control is inactive.

In Perfusion mode, only the feed pump is running.

Possible cause

Some of the criteria for starting the Media control are not fulfilled.

Rocker is in sampling mode.

Some of the criteria for running the Media control are no longer fulfilled.

The weight is below the setpoint when the media control is started.

Auto calibration is enabled, and the feed pump is calibrating.

The measured weight is more than 10% below the weight setpoint.

Corrective action

Read the message in the pop-up dialog. If possible, take action according to the information and try again.

None. The media control is inactive while the rocker is in sampling mode.

Read the message in the pop-up dialog. If possible, take action according to the information and make sure that the control turns active again.

None. This is normal. The harvest pump will start when the setpoint is reached.

None. This is normal.

None. This is normal. The harvest pump will start when the setpoint is reached.

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7 Troubleshooting

7.3 ReadyToProcess CBCU

Error symptom

In Perfusion mode, only the harvest pump is running.

In Perfusion mode, no pump is running.

Auto calibration is set to On, but no auto calibration takes place.

The second auto calibration does not seem to occur.

After auto calibration, the flow of one or both of the pumps is no longer correct.

Possible cause

The weight is above the setpoint when the media control is started.

Auto calibration is enabled, and the harvest pump is calibrating.

The measured weight is more than 10% above the weight setpoint.

Auto calibration is enabled, and pumps are stopped for the auto calibration algorithm to measure the weight.

The weight setpoint has not yet been reached.

Media additon is selected as control mode.

The Auto calibration

cycle is set to a long cycle time that has not yet elapsed.

The weight measurements done by the auto calibration routine might have been disturbed by something, for example streched tubing, or someone touching the system.

Corrective action

None. This is normal. The feed pump will start when the setpoint is reached.

None. This is normal.

None. This is normal. The feed pump will start when the setpoint is reached.

None. This is normal.

Wait for the setpoint to be reached, then the auto calibration will start.

Auto calibration is only done in perfusion mode.

Check what the actual Auto calibration cycle is, by selecting it as run data under Tools:Customize.

Use the manual instruction Media control:Media

control (general) and set Auto calibration cycle to desired value.

Also select Auto calibration cycle timer as run data under Tools:Customize to see how many hours that are left to the next auto calibration.

Recalibrate the pump/pumps by first disabling, then enabling the auto calibration in the Process

Picture. A new auto calibration will then start.

During the auto calibration, be sure that nothing interfers with the system.

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7 Troubleshooting

7.3 ReadyToProcess CBCU

Error symptom

The media control is automatically turned off.

Possible cause

None of the pumps started by the media control are no longer running.

Corrective action

Start media control again.

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7 Troubleshooting

7.4 ReadyToProcess Pump 25

7.4

ReadyToProcess Pump 25

Error symptom

Pump flow appears to differ from set flow.

Status LED on the pump rear panel flashes red.

Status LED on the pump rear panel shows a steady red light.

CAN indicator LED flashes.

Possible cause

Incorrect pump holder position for the tubing used.

The setting for tubing inner diameter is incorrect.

Pump needs calibration.

An internal error has occurred, but the pump is still operating.

An internal error has occurred, and the pump is not operating.

An internal error has occurred, and the CBCU is not operating properly.

Note:

This is normal the first seconds during power up.

Corrective action

Check and adjust pump holder position. See Sec-

tion 5.1.5 Prepare the pump, on page 164.

Reset the tubing inner diameter to correct value.

Calibrate the pump. See Section 6.1 Calibration, on

page 206.

Check any warning message and follow the instruction. If problem persists, contact GE service personnel.

Check any warning message and follow the instruction. If problem persists, contact GE service personnel.

Contact GE service personnel.

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7 Troubleshooting

7.5 Cellbag bioreactor

7.5

Cellbag bioreactor

Overinflation

Error symptom

Cellbag bioreactor appears to be overinflated.

Possible cause

Too high gas flow.

Faulty relief valve.

Corrective action

Check that the gas flow to the Cellbag bioreactor does not exceed 1 Lpm and that the Fast fill function is turned off.

Check that gas flows through the pressure control valve:

Attach a short length of tubing to the outlet valve.

Place the tubing end into water to 1 cm depth.

Result: Bubbles indicate flow.

If no bubbles are observed, remove the pressure control valve.

The pressure control valve may be blocked and removing it may allow continued operation.

Outlet filter is closed off or blocked.

Faulty Cellbag bioreactor.

Make sure that the outlet filter is not closed off or blocked.

If the outlet filter is clogged with foam, take action to reduce the foam. Decrease the rocking speed and/or rocking angle, add antifoam and/or slightly increase the gas flow rate.

If the Cellbag bioreactor continues to overinflate, transfer the contents to another Cellbag bioreactor.

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7 Troubleshooting

7.5 Cellbag bioreactor

Underinflation

Error symptom

The Cellbag bioreactor appears to be underinflated.

Possible cause

Too low gas flow.

Inlet gas supply incorrectly connected.

The Cellbag bioreactor is underinflated and an alarm message in the pop-up dialog indicates blockage of gas flow.

Missing pressure control valve.

Clogged inlet filter.

Corrective action

Check that there is sufficient gas flow to the

Cellbag bioreactor.

Check that you have connected the inlet gas supply to the inlet filter (does not have the pressure control valve).

Check that the pressure control valve is present on the outlet filter.

Check that the gas inlet flow path is unobstructed.

Tip:

A small amount of condensate in the inlet filter is normal. However, if excessive condensate is formed:

Decrease the gas flow.

Insulate the tubing to the pressure control valve.

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7 Troubleshooting

7.6 Software problems

7.6

Software problems

In this section

This section describes troubleshooting and corrective actions for UNICORN. Refer to

UNICORN Administration and Technical manual for more troubleshooting.

This section contains the following subsections:

Section

7.6.1 Troubleshooting Method editor

7.6.2 UNICORN System Control

7.6.3 Troubleshooting Evaluation

See page

235

237

240

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7 Troubleshooting

7.6 Software problems

7.6.1 Troubleshooting Method editor

7.6.1

Troubleshooting Method editor

Instructions in a method are marked with a red dot

Red instructions (instructions marked with a red dot) in a method are syntax errors and may have several causes. A phase containing syntax errors is marked in the method outline with an error symbol (a white cross on a red, circular background). The table below describes some solutions to syntax error problems.

Problem description

The method instructions do not correspond to the components you have chosen for your system.

Syntax errors are not corrected by changing the component configuration.

Syntax errors appear because the method was connected to the wrong system. That is, the instrument configuration of the system is incompatible with the method.

Syntax errors appear because the system's instrument configuration has been updated with a new instrument configuration that differs in the instruction set.

Solution

Check your system components under System Proper-

ties in the Administration module and that the correct instrument configuration is selected.

Close and reopen the method.

Edit the method so it can be run on the currently chosen system.

Save the method for a system that has all components installed.

Note:

The red instructions must be replaced or removed.

Reselect the required component under System

Properties in the Administration module (if the component is actually present on the system). Reopen the method and replace the red instructions with the corresponding instruction for the added component.

Select the red instruction and either delete it or replace it with a corresponding instruction (if available) from the

Instruction box. Repeat this for all red instructions before saving the method.

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7 Troubleshooting

7.6 Software problems

7.6.1 Troubleshooting Method editor

Export of a method to a network drive fails

Problem description

Export of a method to a network drive fails.

Solution

Ensure that the destination network drive is mapped and that you have the appropriate access rights.

Method cannot be created after new Instrument Configuration installation

Problem description

A new instrument configuration is installed. After this, it is still impossible to create a new method.

Solution

The Method Editor must be restarted after importing the new instrument configuration.

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7 Troubleshooting

7.6 Software problems

7.6.2 UNICORN System Control

7.6.2

UNICORN System Control

User Access

Problem description

Username and password not accepted.

The log on dialog is inactive and a password cannot be entered.

Solution

The UNICORN administrator should check if the user account is locked (for example after too many unsuccessful log on attempts).

The UNICORN administrator can try to set a new password.

If a password reset does not work, the user profile may have to be deleted and a new profile created.

1

Verify that no UNICORN window or module is opened.

2

Log off from Windows and log on again.

Access to UNICORN functions

Problem description

The Execute manual instruction menu command in the System Control module is gray. This means that you can establish a connection but cannot control the system.

Solution

Check that no other user has a control mode connection.

Check that you have access rights to control the system manually.

The help viewer cannot be opened using help buttons or the F1 key.

1

Open the MadCap help viewer from the Windows desktop icon. This is described in The

help viewer application in UNICORN

Administration and Technical manual.

2

Try the help button or F1 key again.

The Microsoft Office Document Image Writer causes UNICORN to terminate.

A user without access to the function Method End may still end a method using a Timer instruction.

This writer application will not work. Choose another option, for example a PDF writer application.

Access to the Timer instruction must also be disabled if users are not allowed access to the

Method End function.

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7 Troubleshooting

7.6 Software problems

7.6.2 UNICORN System Control

Problem description

A manual run is started. A method run is then started and a start protocol opens. Before the start protocol is finished, an alarm is caused by the manual run. The start protocol cannot be completed and the method run cannot start at this point.

This is because the alarm must be acknowledged first, but no message about this is issued.

Solution

Either stop the manual run which will allow the method run to start, or start another method. This will add the second method to the list of running methods and the first method is allowed to start.

System connections

Problem description

The connections are not available, i.e.

the selection check-box is grayed out.

The connections are not available even though

• the connection between the PC and system appears to be correct, and

• the power is turned on.

A system is not available when you attempt to establish a connection.

Solution

Check if the system has been deactivated.

Check that the power to the system is turned on.

Check that the rocker power button shows a steady green light.

Check the connection between the client computer and the system.

Check the firewall settings on the client computer. Refer to

UNICORN Administration and Technical manual.

1

Switch off the system.

2

Exit UNICORN.

3

Restart the system.

4

Log on to UNICORN.

Check that you have access rights to the system. Access rights are not automatically assigned for a newly defined system.

The system may not be active.

Log off and log on again for access rights changes to be applied.

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7 Troubleshooting

7.6 Software problems

7.6.2 UNICORN System Control

Problem description

You receive the error message “Cannot connect to system...” in a network installation.

You receive the error message

"Warning, system occupied" when trying to connect.

Solution

Check that the rocker power button shows a steady green light.

Check that the computer from which you try to establish a connection is logged on to the network.

Check that the limit of five simultaneous connections to the system has not been exceeded.

Check the firewall settings on the client computer. Refer to

UNICORN Administration and Technical manual.

This error message is displayed if a system is defined and active in two different UNICORN database instances and is already connected in the other instance. It is not recommended to have a system defined and active in more than one UNICORN database instance.

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7 Troubleshooting

7.6 Software problems

7.6.3 Troubleshooting Evaluation

7.6.3

Troubleshooting Evaluation

Maximum number of curves exceeded

Problem description

The maximum number of curves (100) is exceeded when importing curves.

Solution

Delete any unnecessary curves before importing more curves.

Export of archived result

Problem description

The export function is available when an archived result is selected.

However, it is not possible to export an archived result. Instead the result that was selected before the archived result will be exported.

Solution

Do not export an archived result.

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8 Reference information

8 Reference information

In this chapter

This chapter contains system and component specifications for ReadyToProcess WAVE

25. For a list of semi-wetted materials, see the ReadyToProcess WAVE 25 Product Docu-

mentation.

This chapter contains the following sections:

Section

8.1 System specifications

8.2 Component specifications

8.3 Client computer specifications

8.4 Chemical resistance

8.5 Control settings

8.6 Digital and analog I/O connections

8.7 Ordering information

See page

242

243

246

248

249

277

280

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 241

8 Reference information

8.1 System specifications

8.1

System specifications

The table below lists the system specifications of ReadyToProcess WAVE 25.

Parameter

System configuration

Control system

Rocker embedded PC operating system

Connection between PC and instrument

Power supply

Power consumption

Enclosure protective class

External air supply (per CBCU)

External CO

External O

2

2 supply (per CBCU) supply (per CBCU)

Operating ambient temperature range

Operating humidity range

Data

Benchtop system, external computer

UNICORN 6.3.2 or higher version

Windows embedded standard 7

Ethernet or network

100 to 240 V ~, 50 to 60 Hz

Note:

The rocker is fitted with internal electrical fuses that are not user-replaceable.

Maximum 1500 VA

IP 21

1.0 to 1.5 bar

Normal use: 1.3 L/min

Fast fill: 3.5 L/min

1.0 to 1.5 bar

Normal use: 0.2 L/min

Fast fill: 0.5 L/min

1.0 to 1.5 bar

Normal use: 0.7 L/min

Fast fill: 1.7 L/min

15°C to 32°C

20% to 80% relative humidity (noncondensing)

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8 Reference information

8.2 Component specifications

8.2

Component specifications

Equipment dimensions and weight

The table below lists the outer dimensions and weights of the bioreactor system units.

System unit

Rocker

CBCU

Pump

Tray 10

Tray 20

Tray 50

Lid 10

Lid 20

Lid 50

Dimensions, W x H x D (mm)

404 x 205 x 560

276 x 117 x 360

275 x 115 x 280

475 x 60 x 43

740 x 70 x 480

800 x 70 x 610

475 x 230 x 430

740 x 245 x 480

800 x 260 x 610

4.5

7.3

9.5

1.7

Weight (kg)

24.0

4.8

3.8

3.3

3.9

Rocker specifications

The table below lists the system specifications of the Rocker.

Parameter

Rocking speed control range

1

Rocking angle control range

1

Rocking speed profile range

Media weight control range

Data

2 to 40 rpm

2° to 12°

15% to 100%

The % value refers to the fraction of the angular displacement function that is sinusoidally shaped

15% gives an almost constant angular velocity

100% gives a sinusoidal rocking

0.5 to 25 kg

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 243

8 Reference information

8.2 Component specifications

Parameter

Scale, absolute accuracy (single mode)

Scale, left/right absolute accuracy (dual mode)

Temperature sensor

Temperature measurement range

Temperature setpoint difference (dual mode)

Temperature control range

Temperature control accuracy (excl.

measurement error)

Data

±(0.050 + 1% of load) kg

±(0.1 + 6% of load) kg

Pt100 Class A

2°C to 50°C

Max 10°C at ambient 21°C

Setpoint difference reduced by 1°C for each °C increase in ambient temperature

(e.g., at ambient 25°C, max setpoint difference is 6°C)

(Ambient temperature + 5°C) to 40°C

±0.2°C

1

For Tray 50, the product of rocking speed and rocking angle should not exceed 240 (e.g., with a rocking angle of 12° the rocking speed should not exceed 20 rpm).

ReadyToProcess CBCU specifications

The table below lists the primary system specifications of the CBCU.

Parameter

Gas flow control range

Total gas flow accuracy (reference flow

- setpoint)

Fast fill flow

CO

2 control range

CO

2 measurement accuracy at 5% CO

2

CO

2 control accuracy (versus setpoint)

O

2 control range

Data

50 to 1000 mL/min

±(10 + 3% of read value) mL/min

~3 L/min

0% to 15% CO

2

±0.5% CO

2 when mixed only with air/N

2

±0.4% CO

2

0% to 50% O

2

21% to 50% O

2 when mixed with N

2 when mixed with air

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8 Reference information

8.2 Component specifications

Parameter

O

2 measurement accuracy

O

2 control accuracy (versus setpoint) pH measurement range pH control range pH measurement accuracy pH control accuracy (versus setpoint)

DO measurement range

DO measurement accuracy

DO control range

Data

±(0.6 + 1% of read value) within 0% to

50% O

2

, when mixed only with air/N

2

±0.6% O

2 pH 4.5 to 8.5

pH 6.0 to 8.0

±0.05 pH within ±0.25 pH from offset calibration pH

±0.1 pH within 0.25 to 0.5 pH from offset calibration pH

±0.05 pH

0% to 250% air saturation

±5% air saturation, excluding atmospheric pressure variations

0% to 100% air saturation

ReadyToProcess Pump 25 specifications

The table below lists the system specifications of ReadyToProcess Pump 25.

Note:

Different tubing dimensions are required to cover the full flow rate range of

the pump (see Pump tubing sizes, on page 164). Pump tubing is not supplied

with the system and must be purchased separately.

Parameter

Pump flow rate range

Pump flow rate accuracy

Accumulated pumped volume accuracy

Supported tubing dimensions

Data

0.1 to 144 L /day (0.07 to 100 mL/min)

±(0.1 + 5% of read value) mL/min after calibration

±10% of measured volume

Inner diameter: 0.5 to 4.8 mm (1/50" to

3/16")

Wall thickness: 1.6 mm (1/16")

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 245

8 Reference information

8.3 Client computer specifications

8.3

Client computer specifications

The table below lists client computer specifications for a UNICORN system for use with

ReadyToProcess WAVE 25. In the table, "Windows 7" refers to Windows Professional x86 and x64 with SP1 installed.

ReadyToProcess WAVE 25 is supplied with UNICORN 7, which requires Windows 7. If you wish to use ReadyToProcess WAVE 25 with an earlier version of UNICORN, contact GE for assistance.

Min. free disc space

Min. available RAM

Disc format

Processor and operating system

1

OS language

UNICORN Client

6 GB

3 GB

NTFS

Intel™ Dual Core

(or better)

Windows XP

Windows 7

English (U.S.)

Code 1033

Database Server

6 GB

3 GB

NTFS

Intel™ Dual Core

(or better)

Intel™ Dual Core

(or better)

Windows XP

Windows 7

Windows Server®

2003/2003 R2

Windows Server

2008/2008 R2

English (U.S.)

Code 1033

Workstation installation

12 GB

3 GB

NTFS

Intel™ Dual Core

(or better)

Windows XP

Windows 7

English (U.S.)

Code 1033

E-License Server

500 MB

2 GB

NTFS

Intel™ Dual Core

(or better)

Windows XP

Windows 7

Windows Server

2003 x86/2003 R2 x86, x64

Windows Server

2008 x86/2008 R2 x64

Common Components

500 MB

2 GB

NTFS

Intel™ Dual Core

(or better)

Windows XP

Windows 7

Windows Server

2003 x86/2003 R2 x86, x64

Windows Server

2008 x86/2008 R2 x64

English (U.S.)

Code 1033

English (U.S.)

Code 1033

1

UNICORN version 7 has been verified for Windows 7. Windows XP may be used only with UNICORN version 6.3.

Note:

• UNICORN is tested using an English operating system version. Using other language versions of the operating system may cause errors.

A screen resolution of 1280x1024 or higher is recommended. Parts of the

UNICORN user interface may not be displayed properly using a lower resolution.

• Changing the default font and font size in Windows may cause problems in the UNICORN user interface.

The Windows basic color scheme is recommended (UNICORN must be restarted when the color scheme is changed).

Using the Windows 7 Aero color scheme is not recommended.

Windows power save features should be turned off to avoid conflicts with system operations.

246 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

8 Reference information

8.3 Client computer specifications

UNICORN is not compatible with the Windows 7 feature High DPI Awareness, which allows the graphic user interface to be scaled. The interface scale must remain at 100% to avoid issues with clipping and misaligning of parts of the UNICORN user interface. Normally, the scale is set at 100% by default.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 247

8 Reference information

8.4 Chemical resistance

8.4

Chemical resistance

The chemicals listed below have been approved for use with the bioreactor system.

Chemical

Alconox

DesiDos

Ethanol

Hydrochloric acid

Isopropanol

Klercide

PBS solution

Sodium bicarbonate

Sodium carbonate

Sodium chloride

Sodium hydroxide

Sodium hypochlorite

Virkon

5 M

1 M

1%

1%

1 M

70%

N/A

10×

Concentration

N/A

N/A

70%

7.5%

1 M

Use

Cleaning/Disinfection

Cleaning/Disinfection

Cleaning/Disinfection pH control

Cleaning/Disinfection

Cleaning/Disinfection

Testing pH control pH control

Testing pH control

Cleaning/Disinfection

Cleaning/Disinfection

CAS no./EC no.

N/A

N/A

75-08-1/200-837-3

7647-01-0/231-595-7

67-63-0/200-661-7

N/A

N/A

144-55-8/205-633-8

497-19-8/207-838-8

7647-14-5/231-598-3

1310-73-2/215-185-5

7681-52-9/231-668-3

N/A

248 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

8 Reference information

8.5 Control settings

8.5

Control settings

In this section

This section lists the different control settings that can be made in UNICORN.

This section contains the following subsections:

Section

8.5.1 Rocking control

8.5.2 Heating control

8.5.3 Gas flow control

8.5.4 CO

2 mix control

8.5.5 O

2 mix control

8.5.6 Pump control

8.5.7 pH measurement

8.5.8 pH control

8.5.9 DO measurement

8.5.10 DO control

8.5.11 Media control

See page

250

253

254

256

257

258

261

263

269

271

275

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 249

8 Reference information

8.5 Control settings

8.5.1 Rocking control

8.5.1

Rocking control

Rocking control settings

The following table shows general settings used for rocking control.

Setting Description

Settings:

Rocking

Settings:

Rocking

PP

Speed setpoint

Angle setpoint

Stop angle

Sampling mode duration

Cellbag size (total volume)

Digital output

Rocking motion

Auto start mode

Prepare for tilt at

END

The number of rocking cycles per minute.

The maximum angle between the tray and the horizontal plane during a rocking cycle.

The angle between tray and horizontal plane the tray will settle at when the rocking is stopped. At a positive stop angle, the tray will lean towards the front side of the rocker and vice versa.

The number of minutes the rocker will stay in sampling mode, before it automatically starts to rock again. See help text for En-

ter sampling mode instruction to learn more about sampling mode.

The Cellbag size defined in total volume

(liquid and head space).

Sets the outputs of the digital output ports.

Defines the share of the rocking cycle where the speed curve is sinusoid. The lowest value (15%) provides a rocking motion similar to the Wave 20/50 system.

The highest value (100%) will give a completely sinusoidal speed curve.

By setting this parameter to Not resume

activity, rocking or heating will not start automatically at startup of the system at any time. When the parameter is set to

Resume activity, rocking and heating will start automatically at startup, if it was on when the system was shut down without given an END command.

If No the rocking platform will not prepare for tilt at system END, if Yes, the rocking platform will prepare for tilt at system

END.

Settings:

Rocking

Settings:

Rocking

Settings:

Cellbag

-

-

-

-

Set from

Rocker:

Rocking

Rocker:

Rocking

MI

Rocker:

Rocking

Rocker:

Rocking

Rocker:

Cellbag size

Rocker:

Digital output

Rocker:

Set rocking motion

System settings:

Auto start:Rocker

-

System settings:

Rocker

Y

PP

View from

RD CD

-

Y

Y

Y

Y

-

-

-

-

-

-

-

Y

Y

-

-

Y

-

-

-

-

-

-

-

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8 Reference information

8.5 Control settings

8.5.1 Rocking control

Setting Description

PP

Set from

MI

System settings:

Rocker

-

PP

View from

RD

-

CD

Analog input 1 input mode

Analog input 2 input mode

Defines how signals from the analog 1 input port shall be interpreted. The input signal will be converted to a percentage

[0 to 100]. To be able to select the two

‘mA’ options, the input port hardware must be reconfigured by Service.

Defines how signals from the analog 2 input port shall be interpreted. The input signal will be converted to a percentage

[0 to 100]. To be able to select the two

‘mA’ options, the input port hardware must be reconfigured by Service.

Note:

System settings:

Rocker

-

The following abbreviations are used in the table: PP = Process Picture; MI =

Manual instruction; RD = Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

Rocking control output data

Data Description

Rocking speed measurement

Time left in sampling mode

Weight

Weight L

Weight R

Detected tray type

Weight share front left

Weight share front right

Weight share rear left

Weight share rear right

Digital input 1

The actual rocking speed, measured by the rocker.

The time left until the rocker starts to rock when in sampling mode. Unit [s].

The weight measured by the rocker. If tared correctly, it should correspond to the weight of the content of the Cellbag.

Shows the weight of the left Cellbag content in dual mode. The bags must be centered on each half of the tray and a tare must be performed to ensure accuracy of this measurement.

Shows the weight of the right Cellbag content in dual mode. The bags must be centered on each half of the tray and a tare must be performed to ensure accuracy of this measurement.

Shows the tray type detected by the rocker.

Percentage of the weight load on the front left load cell.

Percentage of the weight load on the front right load cell.

Percentage of the weight load on the rear left load cell.

Percentage of the weight load on the rear right load cell.

Shows if the digital input 1 is 0 or 1.

PP

Y

-

Y

View from

RD

-

Y

Y

CD

Y

-

Y

Y

Y

Y

Y

-

-

Y

Y

Y

Y

Y

Y

-

-

-

-

-

-

-

-

Y

Y

-

-

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8 Reference information

8.5 Control settings

8.5.1 Rocking control

Digital input 2

Digital input 3

Digital input 4

Analog input 1

Analog input 2

Data

Note:

Description

Shows if the digital input 2 is 0 or 1.

Shows if the digital input 3 is 0 or 1.

Shows if the digital input 4 is 0 or 1.

Shows the analog input 1 in percent.

Shows the analog input 2 in percent.

-

-

-

-

PP

-

View from

Y

Y

Y

Y

RD

Y

Y

Y

-

-

CD

-

The following abbreviations are used in the table: PP = Process Picture; RD =

Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

252 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

8 Reference information

8.5 Control settings

8.5.2 Heating control

8.5.2

Heating control

Heating control settings

The following table shows general settings used for heating control.

Temperature setpoint

Deviation alarm

Deviation alarm delay

Setting

Allowed deviation up

Allowed deviation down

Heat enabling

Description

The temperature setpoint of the liquid in the Cellbag.

Enables or disables the deviation alarm.

PP

Settings:

Temp

Settings:

Temp

Settings:

Temp

Sets the extent to which the temperature can vary above the setpoint without triggering the deviation alarm.

Sets the extent to which the temperature can vary below the setpoint without triggering the deviation alarm.

Sets the time for which the temperature must be outside the defined alarm limits before the deviation alarm is triggered.

The timer is reset if the temperature falls back within the limits before the alarm is triggered.

When set to Enabled, the heating will be on when the rocking is on. When set to

Disabled, the heating will be off.

Settings:

Temp

-

-

Note:

Set from

MI

Heating:

Heating

Heating:

Heating

Heating:

Heating

Heating:

Heating

Heating:

Heating

System settings:

Heating:Heater enabling

PP

View from

RD CD

Y Y

Y

Y

Y

-

-

-

-

-

Y

-

-

-

-

-

-

The following abbreviations are used in the table: PP = Process Picture; MI =

Manual instruction; RD = Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

Heating control output data

Data Description

PP

Y

View from

RD

-

CD

Y

Temperature measurement

The measured Cellbag temperature.

Note:

The following abbreviations are used in the table: PP = Process Picture; RD =

Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 253

8 Reference information

8.5 Control settings

8.5.3 Gas flow control

8.5.3

Gas flow control

Gas flow control settings

The following table shows general settings used for gas flow control.

Setting

Gas flow setpoint

Deviation alarm

The gas flow controller setpoint to the

Cellbag.

Description

Enables or disables the deviation alarm.

Allowed deviation up

Allowed deviation down

Deviation alarm delay

Air source

Auto start mode

Sets the extent to which the gas flow can vary above the setpoint without triggering the deviation alarm.

Sets the extent to which the gas flow can vary below the setpoint without triggering the deviation alarm.

Sets the time for which the gas flow must be outside the defined alarm limits before the deviation alarm is triggered. The timer is reset if the gas flow falls back within the limits before the alarm is triggered.

If set to Compressed air, compressed air shall be connected to the inlet on the back of the CBCU. If set to N2, pressurized nitrogen shall be connected to the inlet on the back of the CBCU.

By setting this parameter to Not resume

activity gas mixing will not start automatically at startup of the system at any time.

When the parameter is set to Resume

activity, the gas mixing will start automatically at start-up, if it was on when the system was shut down (without first going to END).

-

-

PP

Settings:

Gas control:

Gas flow

Settings:

Gas control:

Gas flow

Settings:

Gas control:

Gas flow

Settings:

Gas control:

Gas flow

-

Set from

MI

Gas flow:

Gas flow

Gas flow:

Gas flow

Gas flow:

Gas flow

Gas flow:

Gas flow

Gas flow:

Gas flow

Gas flow:

Air source

System settings:

Auto start:CBCU

Note:

Y

PP

View from

RD CD

Y

Y

Y

Y

-

Y

-

-

-

-

Y

-

-

-

-

-

-

-

-

The following abbreviations are used in the table: PP = Process Picture; MI =

Manual instruction; RD = Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

254 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

8 Reference information

8.5 Control settings

8.5.3 Gas flow control

Gas flow control output data

Data Description

PP

Y

View from

RD

-

CD

Y

Gas flow measurement

The measured gas flow from the CBCU.

Note:

The following abbreviations are used in the table: PP = Process Picture; RD =

Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 255

8 Reference information

8.5 Control settings

8.5.4 CO

2 mix control

8.5.4

CO

2

mix control

CO

2

mix control settings

The following table shows general settings used for CO

2 mix control.

Deviation alarm delay

Setting

CO2 Mix setpoint

Deviation alarm

Allowed deviation up

Allowed deviation down

Description

The gas mixer target CO

2 setpoint.

concentration

Enables or disables the deviation alarm.

PP

Settings:Gas control:CO2

Settings:Gas control:CO2

Settings:Gas control:CO2

Sets the extent to which the CO

2 concentration delivered to the Cellbag can vary above the setpoint without triggering the deviation alarm.

Sets the extent to which the CO

2 concentration delivered to the Cellbag can vary below the setpoint without triggering the deviation alarm.

Sets the time for which the CO

2 concentration must be outside the defined alarm limits before the deviation alarm is triggered. The timer is reset if the CO

2 concentration falls back within the limits before the alarm is triggered.

Settings:Gas control:CO2

-

Set from

MI

CO2 mix:

CO2 mix

CO2 mix:

CO2 mix

CO2 mix:

CO2 mix

CO2 mix:

CO2 mix

CO2 mix:

CO2 mix

Y

PP

View from

-

RD CD

Y

Y

Y

Y

-

-

-

-

Y

-

-

-

-

Note:

The following abbreviations are used in the table: PP = Process Picture; MI =

Manual instruction; RD = Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

CO

2

mix control output data

Data

CO2 measurement

Description

PP

Y

View from

RD

-

CD

Y

Note:

The measured CO

2 concentration from the CBCU.

The following abbreviations are used in the table: PP = Process Picture; RD =

Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

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8 Reference information

8.5 Control settings

8.5.5 O

2 mix control

8.5.5

O

2

mix control

O

2

mix control settings

The following table shows general settings used for O

2 mix control.

Deviation alarm delay

Setting

O2 Mix setpoint

Deviation alarm

Allowed deviation up

Allowed deviation down

Description

The gas mixer target O

2 setpoint.

concentration

Enables or disables the deviation alarm.

Sets the extent to which the O

2 concentration delivered to the Cellbag can vary above the setpoint without triggering the deviation alarm.

Sets the extent to which the O

2 concentration delivered to the Cellbag can vary below the setpoint without triggering the deviation alarm.

Sets the time for which the O

2 concentration must be outside the defined alarm limits before the deviation alarm is triggered. The timer is reset if the O

2 concentration falls back within the limits before the alarm is triggered.

-

Set from

PP

Settings:Gas control:O2

Settings:Gas control:O2

Settings:Gas control:O2

O2 mix:

O2 mix

O2 mix:

O2 mix

O2 mix:

O2 mix

MI

Settings:Gas control:O2

O2 mix:

O2 mix

O2 mix:

O2 mix

Note:

PP

Y

View from

RD

-

CD

Y

Y

Y

Y

-

-

-

-

Y

-

-

-

-

The following abbreviations are used in the table: PP = Process Picture; MI =

Manual instruction; RD = Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

O

2

mix control output data

Data

O2 measurement

Description

PP

Y

View from

RD

-

CD

Y

Note:

The measured O

2 concentration from the CBCU.

The following abbreviations are used in the table: PP = Process Picture; RD =

Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

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8 Reference information

8.5 Control settings

8.5.6 Pump control

8.5.6

Pump control

General pump settings

The following table shows general settings used for pump control.

Setting

Pump 25:1A role

Pump 25:1B role

Pump 25:2A role

Pump 25:2B role

Pump 25:3A role

Pump 25:3B role

Note:

Note:

Description

Assigns pump head 1A to desired role

Assigns pump head 1B to desired role

Assigns pump head 2A to desired role

Assigns pump head 2B to desired role

Assigns pumphead 3A to desired role

Assigns pump head 3B to desired role

-

PP

-

-

-

-

-

Set from

MI

System settings: Set Pump 25:1A role

System settings: Set Pump 25:1B role

System settings: Set Pump 25:2A role

System settings: Set Pump 25:2B role

System settings: Set Pump 25:3A role

System settings: Set Pump 25:3B role

Y

PP

View from

RD CD

-

Y

Y

Y

Y

Y

-

-

-

-

-

-

-

-

-

-

The following abbreviations are used in the table: PP = Process Picture; MI =

Manual instruction; RD = Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

All system settings are sent when any setting is sent. Therefore, check the role assigned to all pump heads before sending a 'role' command, to ensure that conflicting roles are not assigned to the different pump heads.

Settings for manually running the pumps

The pump settings in this section (except the tubing inner diameter) are only valid when the pumps are started manually. When the pumps are used by pH or media control, these settings have no effect. Setting apply individually to each pump head.

Setting

Time mode

Description

If Limited is selected the pump will run as long as given by Duration. If Continuous is selected, the pump will run until stopped.

PP

Always Continu-

ous when started from PP.

Set from

MI

Pump control:

Start pump

-

PP

View from

-

RD

-

CD

258 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

8 Reference information

8.5 Control settings

8.5.6 Pump control

Setting

Duration

Rate mode

Pump RPM

Pump flow

Tube inner diameter

Description

PP

The time for which the pump will run, if

Time mode is set to Limited. Otherwise this parameter has no effect.

Sets whether the flow or RPM setpoint will be used when the pump is started manually.

The RPM at which the pump will run if started manually in RPM mode.

The flow rate at which the pump will run if started manually in flow mode.

The inner diameter of the tubing fitted to the pump.

-

Settings:

Cellbag pumps

Settings:

Cellbag pumps

Settings:

Cellbag pumps

Settings:

Cellbag pumps

Set from

MI

Pump control:

Start pump

Pump control:

Rate mode

Pump control:

Pump RPM

Pump control:

Pump flow

Pump control:

Pump flow

-

PP

View from

RD

-

CD

Y

Y

1

Y

2

Y

-

-

-

-

-

-

-

-

1

2

Not shown in process picture when pump is used by pH or Media control, or in flow mode.

Not shown in process picture when pump is used by pH or Media control, or in RPM mode.

Note:

The following abbreviations are used in the table: PP = Process Picture; MI =

Manual instruction; RD = Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

Pump control output data

Output data is available separately for each pump head.

Data Description

Actual flow

Actual speed

Accumulated volume

Time left of actual shot

Max possible flow

Min possible flow

Calibration factor

The estimated flow rate of the pump.

The pump rpm, obtained from the pump itself.

The estimated total volume since last reset.

This counter shows the remaining running time when the pump is running for a limited time. This is the case when the pump is started manually for a limited time, during calibration or when used as acid/base pump by pH control.

The maximum flow rate obtainable with the currently installed tubing.

The minimum flow rate obtainable with the currently installed tubing.

The current calibration factor for the pump.

1

2

3

Only shown in process picture when pump is running manually in RPM mode.

Only shown in process picture when pump is used by pH or Media control, or is running manually in flow mode.

Shown as tool-tip when entering flow.

-

-

3

-

3

Y

Y

PP

Y

1

Y

2

View from

RD

-

-

CD

-

-

-

-

-

-

-

-

-

-

-

Y

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8 Reference information

8.5 Control settings

8.5.6 Pump control

Note:

The following abbreviations are used in the table: PP = Process Picture; RD =

Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

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8 Reference information

8.5 Control settings

8.5.7 pH measurement

8.5.7

pH measurement

pHOPT calibration values

The pH surrounding the pH sensor is calculated from a measured variable called “the phase angle”. The calculation is based on a transfer equation programmed in the pHOPT monitor. This transfer equation is defined by a set of constants, or, more correctly, a set of values that are specific for the mixture of the substances forming the luminophoric dye. This means that the dye properties, and consequently the transfer equation, may differ between different dye batches.

The constants for each batch (after gamma irradiation) are determined at the factory and are printed on the pHOPT label of the Cellbag as calibration values: cmin, cmax,

cpH0, and cdpH.

The interpretation of the calibration values on the transfer equation is illustrated in the graph below:

A fifth calibration value, ctemp, is also necessary. It is not directly included in the transfer equation, but since the sensor is temperature dependent, the ctemp value is used for fine tuning the pH against the actual temperature.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 261

8 Reference information

8.5 Control settings

8.5.7 pH measurement

Settings

The following table shows pH measurement related settings.

Setting

cmin cmax cpH0 cdpH ctemp

Reading cycle time

Reset calibration values at

END

Calibration value, high pH end of the sensor range.

Calibration value, low pH end of the sensor range.

Calibration value, related to offset calibration.

Calibration value, related to resolution.

Calibration value, calibration temperature.

The reading cycle when pH control is off.

Description

A System setting that defines if the pH calibration values shall be reset or not when the system goes to END.

-

PP

Settings:

Cellbag

Settings:

Cellbag

Settings:

Cellbag

Settings:

Cellbag

Settings:

Cellbag

Settings:pH

Set from

MI

pH sensor calibration values pH sensor calibration values pH sensor calibration values pH sensor calibration values pH sensor calibration values

Set pH reading cycle time

System settings:pH sensor:Reset calibration values at END

Y

PP

View from

RD

-

CD

-

Y

Y

Y

Y

Viewed when pH control is off

-

-

-

-

-

-

-

-

-

-

-

-

-

Note:

The following abbreviations are used in the table: PP = Process Picture; MI =

Manual instruction; RD = Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

Output data

Data

pH measurement timer pH measurement cycle time pH measurement pH amplitude

Description

The time left to next pH measurement.

The actual measurement cycle time. This value is set by the user when pH control is off, and by pH control when the pH control is on.

The latest measured pH value.

A measure of the strength of the responsive pH signal received by the pH monitor.

Y

-

PP

-

Y

View from

RD

Y

-

CD

-

-

-

-

Y

Y

Note:

The following abbreviations are used in the table: PP = Process Picture; RD =

Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

262 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

8 Reference information

8.5 Control settings

8.5.8 pH control

8.5.8

pH control

Introduction

The following tables describe settings and parameters that can be used for pH control.

General settings

The following table shows general settings used for pH control.

Deviation alarm delay

Setting

Control scheme pH setpoint

Deviation alarm

Allowed deviation up

Allowed deviation down

Description

PP

Settings:pH

Select CO2/Base for a combination of CO

2 and base as actuators, where the control always starts in CO2 mode. Select

Acid/Base for a combination of acid and base as actuators. Select CO2 for using only CO

2 as actuator.

The pH target value.

Settings:pH

Set from

MI

pH control

(general)

Enables or disables the deviation alarm.

Settings:pH

Settings:pH

pH control

(general) pH control

(general) pH control

(general)

Sets the extent to which the pH can vary above the setpoint without triggering the deviation alarm.

Sets the extent to which the temperature can vary below the setpoint without triggering the deviation alarm.

Sets the time for which the pH must be outside the defined alarm limits before the deviation alarm is triggered. The timer is reset if the pH falls back within the limits before the alarm is triggered.

Settings:pH

pH control

(general) pH control

(general)

Note:

PP

View from

RD CD

Y -

Y

Y

Y

Y

-

-

-

-

-

Y

Y

-

-

-

-

The following abbreviations are used in the table: PP = Process Picture; MI =

Manual instruction; RD = Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

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8 Reference information

8.5 Control settings

8.5.8 pH control

CO2 control mode settings

The following table shows CO

2 control mode settings used for pH control.

time

Setting

Manual cycle

to Manual.

Description

Max CO2 concentration

Min CO2 concentration

PID parameter mode

Manual P

Manual I

Manual D

Cycle time mode

The maximum CO

2 concentration setpoint allowed for the pH control.

The minimum CO

2 concentration setpoint allowed for the pH control.

When Auto is selected, the system will automatically set the PID parameters. When Manual is selected, the system will use the manual PID parameters set by this instruction.

The P-parameter used if PID parameter mode is set to Manual.

The I-parameter used if PID parameter mode is set to Manual. Note, that increasing the Iparameter will reduce the integrating effect and vice versa.

The D-parameter used if PID parameter mode is set to Manual.

When Auto is selected, the system will automatically set the cycle time. When Manual is selected, the system will use Manual cycle time.

-

-

-

-

-

-

The cycle time used if Cycle time mode is set

PP

-

Set from

MI

pH control (CO2)

pH control (CO2) pH control

(advanced CO2)

-

pH control (advanced

CO2) pH control

(advanced CO2)

pH control

(advanced CO2) pH control

(advanced CO2) pH control

(advanced CO2)

A hand symbol is shown if set to Man-

ual

-

-

A hand symbol is shown if set to Man-

ual

-

PP

View from

RD

Y

Y

Y

Y

Y

Y

Y

Y

CD

-

-

-

-

-

-

-

-

Note:

The following abbreviations are used in the table: PP = Process Picture; MI =

Manual instruction; RD = Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

CO2 control mode output data

Data

Auto pH CO2 P

Auto pH CO2 I

Auto pH CO2 D

Description

The P-parameter used if PID parameter mode is set to Auto.

The I-parameter used if PID parameter mode is set to Auto.

The D-parameter used if PID parameter mode is set to Auto.

-

-

PP

-

View from

Y

Y

RD

Y

-

-

CD

-

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8 Reference information

8.5 Control settings

8.5.8 pH control

Data Description

PP

-

View from

RD

Y

CD

-

Auto pH CO2 Cycle time

The cycle time used if Cycle time mode is set to Auto.

Note:

The following abbreviations are used in the table: PP = Process Picture; RD =

Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

Acid/Base control mode settings

The following table shows Acid/Base control mode settings used for pH control.

Setting

Acid molarity

Base molarity

PID parameter mode

Manual P

Description

The molarity of the acid used expressed as equivalent HCl concentration (mol/L). If the strength (pK a

) of the selected acid differs from that of HCl, estimate the equivalent molarity. Entering lower molarity will result in addition of larger volumes by the pH control, and vice versa.

The molarity of the base used expressed as equivalent NaOH concentration

(mol/L). If the strength (pK b

) of the selected acid differs from that of NaOH, estimate the equivalent molarity. Entering lower molarity will result in addition of larger volumes by the pH control, and vice versa.

When Auto is selected, the system will automatically set the PID parameters. When

Manual is selected, the system will use the manual PID parameters set by this instruction.

The P-parameter used if PID

parameter mode is set to

Manual.

PP

Settings:

Cellbag pumps

Settings:

Cellbag pumps

-

-

Set from

MI

pH control

(acid) pH control

(base)

Y

Y pH control (advanced acid/base)

-

PP

View from

pH control (advanced acid/base)

A hand symbol is shown if set to Manu-

al

RD

-

-

X

Y

CD

-

-

-

-

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8 Reference information

8.5 Control settings

8.5.8 pH control

Setting Description

Manual I

Cycle time mode

Manual cycle time

The I-parameter used if PID

parameter mode is set to

Manual.

When Auto is selected, the system will automatically set the cycle time. When Manu-

al is selected, the system will use Manual cycle time.

The cycle time used if Cycle

time mode is set to Manual.

-

-

-

Flow mode

Manual acid flow

When Auto is selected, the system will automatically set the acid/base flow. The automatically computed acid/base can be displayed as run data. When Manual is selected, the system will use the manual acid/base flow set by this instruction.

The acid flow used if Flow

mode is set to Manual.

-

-

Manual base flow

The base flow used if Flow

mode is set to Manual.

-

Acid dead band

The pH control output when using acid or base is a percentage of the cycle time, telling how much of the cycle time the acid or base pump shall run. The acid dead band defines the percentage interval in which the acid pump will not run. E.g., if the acid dead band is

2.0%, the output from the pH control needs to be above

2.0% for the acid pump to start.

-

PP

Set from

PP

View from

MI

pH control (advanced acid/base) pH control (advanced acid/base)

-

A hand symbol is shown if set to Manu-

al

RD

Y

X

CD

-

pH control (advanced acid/base) pH control (advanced acid/base) pH control (advanced acid/base) pH control (advanced acid/base) pH control (advanced acid/base)

-

A hand symbol is shown if set to Manu-

al

-

-

-

Y

Y

Y

Y

Y

-

-

-

-

-

266 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

Setting

Base dead band

8 Reference information

8.5 Control settings

8.5.8 pH control

Description

The pH control output when using acid or base, is a percentage of the cycle time, telling how much of the cycle time the acid or base pump shall run. The base dead band defines the percentage interval in which the base pump will not run. E.g., if the base dead band is

2.0%, the output from the pH control needs to be above

2.0% for the base pump to start.

-

Note:

PP

Set from

MI

pH control (advanced acid/base)

-

PP

View from

RD

Y

CD

-

The following abbreviations are used in the table: PP = Process Picture; MI =

Manual instruction; RD = Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

Acid/Base control mode output data

Data Description

Auto Acid/Base P

Auto Acid/Base I

Auto pH acid/base cycle time pH acid/base regulator output

The P-parameter used if PID parameter mode is set to Auto.

The I-parameter used if PID parameter mode is set to Auto.

The cycle time used if Cycle time mode is set to Auto.

The output of the acid/base control, expressed as pump run time in % of the cycle time. Negative values shall be interpreted as acid, positive values as base.

-

-

-

PP

View from

RD CD

Y

Y

Y

-

-

-

Y Y

Note:

The following abbreviations are used in the table: PP = Process Picture; RD =

Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 267

8 Reference information

8.5 Control settings

8.5.8 pH control

Transition delay settings

The following table shows the transition delay settings used for pH control.

Setting Description

CO2/Base transition delay mode

Manual CO2 to base delay

Manual base to

CO2 delay

When Auto is selected, the system will automatically set the transition delay time. The automatically computed transition delay times can be displayed as run data.

When Manual is selected, the system will use the manual transition delay times set by this instruction.

The transition delay time from CO

2 to base control used if CO2/Base

transition delay mode is set to

Manual.

The transition delay time from base to CO

2 control used if

CO2/Base transition delay mode

is set to Manual.

-

-

-

PP

Set from

MI

pH control (transition delays) pH control (transition delays) pH control (transition delays)

PP

A hand symbol is shown if set to Man-

ual

View from

RD

Y -

CD

-

-

Y

Y

-

-

Transition delay output data

Data Description

Auto CO2 to base transition delay

Auto base to CO2 transition delay

The CO

2 to base transition delay time used if pH CO2/base transition delay mode is set to Auto.

The base to CO

2 is set to Auto.

transition delay time used if pH CO2/base transition delay mode

PP

-

View from

RD

Y

CD

-

Y -

Note:

The following abbreviations are used in the table: PP = Process Picture; RD =

Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

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8 Reference information

8.5 Control settings

8.5.9 DO measurement

8.5.9

DO measurement

DOOPT calibration values

The DO surrounding the DO sensor is calculated from a measured variable called “the phase angle”. The calculation is based on a transfer equation programmed in the DOOPT monitor. This transfer equation is defined by a set of constants, or, more correctly, a set of values that are specific for the mixture of the substances forming the luminophoric dye. This means that the dye properties, and consequently the transfer equation, may differ between different dye batches.

The constants for each batch (after gamma irradiation) are determined at the factory and are printed on the DOOPT label of the Cellbag as calibration values: clhp, and clzp.

The interpretation of the calibration values on the transfer equation is illustrated in the graph below:

The calibration values clht and clzt are temperatures recorded during the factory calibration. They are used by the DO monitor for temperature compensation.

The calibration value calp is the atmospheric pressure during the factory calibration. It is not used by the DO monitor, but is kept for informative purpose.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 269

8 Reference information

8.5 Control settings

8.5.9 DO measurement

Settings

The following table shows DO measurement related settings.

clhp clht clzp clzt

Setting

calp

Reading cycle time

Calibration value, temperature when determining clzp.

Calibration value, atmospheric pressure during calibration.

The reading cycle when DO control is off.

Description

Calibration value, 100% air saturation.

Calibration value, temperature when determining clhp.

Calibration value, 0% air saturation.

PP

Settings:

Cellbag

Settings:

Cellbag

Settings:

Cellbag

Settings:

Cellbag

Settings:

Cellbag

Settings:

DO

Set from

MI

DO sensor calibration values

DO sensor calibration values

DO sensor calibration values

DO sensor calibration values

DO sensor calibration values

Set DO reading cycle time

Reset calibration values at

END

A System setting that defines if the DO calibration values shall be reset or not when the system goes to END.

-

Y

Y

Y

Y

Y

PP

View from

RD

-

-

-

-

-

System settings:DO sensor:Reset calibration values at END

Viewed when DO control is off

-

-

-

CD

-

-

-

-

-

-

-

Note:

The following abbreviations are used in the table: PP = Process Picture; MI =

Manual instruction; RD = Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

Output data

Data

DO measurement timer

DO measurement cycle time

DO measurement

DO amplitude

Description

The time left to next DO measurement.

The actual measurement cycle time. This value is set by the user when DO control is off, and by DO control when the DO control is on.

The latest measured DO value.

A measure of the strength of the responsive DO signal received by the DO monitor.

Y

-

PP

-

Y

View from

RD

Y

-

CD

-

-

-

-

Y

Y

Note:

The following abbreviations are used in the table: PP = Process Picture; RD =

Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

270 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

8 Reference information

8.5 Control settings

8.5.10 DO control

8.5.10

DO control

Introduction

The following tables describe settings and parameters that can be used for DO control.

General settings

The following table shows general settings used for DO control.

Deviation alarm delay

Setting

Control scheme

DO setpoint

Deviation alarm

Allowed deviation up

Allowed deviation down

Description

PP

Settings:DO

Select Speed for using only rocking speed as actuator. Select O2 for using only O

2 as actuator. Select O2/Speed for a combination of O

2 and rocking speed as actuators, where the control always starts in

O

2 mode. Only the O2 scheme is available in dual mode.

The DO target value.

Settings:DO

Set from

MI

DO control

(general)

Enables or disables the deviation alarm.

Settings:DO

Settings:DO

DO control

(general)

DO control

(general)

DO control

(general)

Sets the extent to which the DO reading can vary above the setpoint without triggering the deviation alarm.

Sets the extent to which the DO reading can vary below the setpoint without triggering the deviation alarm.

Sets the time for which the DO reading must be outside the defined alarm limits before the deviation alarm is triggered.

The timer is reset if the DO reading falls back within the limits before the alarm is triggered.

Settings:DO

-

DO control

(general)

DO control

(general)

Note:

PP

View from

RD CD

Y -

Y

Y

Y

Y

-

-

-

-

-

Y

Y

-

-

-

-

The following abbreviations are used in the table: PP = Process Picture; MI =

Manual instruction; RD = Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

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8 Reference information

8.5 Control settings

8.5.10 DO control

O2 control mode settings

The following table shows O2 control mode settings used for DO control.

Setting

Max O2 concentration

Min O2 concentration

PID parameter mode

Manual P

Manual I

Manual D

Cycle time mode

Manual cycle time

Description

The maximum O

2

DO control.

concentration allowed for the

The minimum O

2 control.

concentration allowed for the DO

When Auto is selected, the system will automatically set the PID parameters. When Manual is selected, the system will use the manual PID parameters set by this instruction.

The P-parameter used if PID parameter mode is set to Manual.

The I-parameter used if PID parameter mode is set to Manual. Note, that increasing the I-parameter will reduce the integrating effect and vice versa.

The D-parameter used if PID parameter mode is set to Manual.

When Auto is selected, the system will automatically set the cycle time. When Manual is selected, the system will use Manual cycle time.

The cycle time used if Cycle time mode is set to

Manual.

-

-

-

-

-

PP

-

-

-

Set from

MI

DO control

(O2)

DO control

(O2)

DO control

(advanced O2)

DO control

(advanced O2)

DO control

(advanced O2)

DO control

(advanced O2)

DO control

(advanced O2)

DO control

(advanced O2)

-

-

PP

View from

Y

A hand symbol is shown if set to Manual

Y

-

-

-

Y

Y

Y

A hand symbol is shown if set to Manual

-

Y

Y

RD

Y

CD

-

-

-

-

-

-

-

-

Note:

The following abbreviations are used in the table: PP = Process Picture; MI =

Manual instruction; RD = Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

O2 control mode output data

Data Description

Auto DO O2 P

Auto DO O2 I

Auto DO O2 D

Auto DO O2 Cycle time

The P-parameter used if PID parameter mode is set to Auto.

The I-parameter used if PID parameter mode is set to Auto.

The D-parameter used if PID parameter mode is set to Auto.

The cycle time used if Cycle time mode is set to Auto.

-

-

-

-

PP

View from

RD CD

Y

Y

Y

Y

-

-

-

-

272 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

Note:

8 Reference information

8.5 Control settings

8.5.10 DO control

The following abbreviations are used in the table: PP = Process Picture; RD =

Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

Speed control mode settings

The following table shows Speed control mode settings used for DO control. Speed control settings are not available in dual mode.

Setting Description

PP

Set from

DO control

(speed)

DO control

(speed)

DO control

(speed)

MI PP

Y

View from

RD

-

CD

Max speed

Min speed

Speed step

Control cycle

Upper dead band

Lower dead band

The maximum rocking speed setpoint allowed for the DO control.

The minimum rocking speed setpoint allowed for the DO control.

The change of rocking speed setpoint at each control action when DO reading is outside dead band.

The cycle time of the DO speed control, i.e., the time between each control action.

When DO reading is between DO setpoint and DO setpoint + upper dead band, there will be no control actions.

When DO reading is between DO setpoint and DO setpoint – lower dead band, there will be no control actions.

-

-

-

-

-

-

Note:

DO control

(speed)

DO control

(speed)

DO control

(speed)

Y

Y

Y

-

-

-

-

-

Y

Y

-

-

-

-

-

The following abbreviations are used in the table: PP = Process Picture; MI =

Manual instruction; RD = Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 273

8 Reference information

8.5 Control settings

8.5.10 DO control

Transition delay settings

The following table shows the transition delay settings used for DO control. Transition delay settings are not available in dual mode.

Setting

O2/Speed transition delay mode

Manual O2 to speed delay

Manual speed to

O2 delay

Description

When Auto is selected, the system will automatically set the transition delay time. The automatically computed transition delay times can be displayed as run data. When Manual is selected, the system will use the manual transition delay times set by this instruction.

The transition delay time from O

2 to speed control used if O2/Speed transition delay mode is set to Manual.

The transition delay time from speed to O

2 control used if O2/Speed transition delay mode is set to Manual.

-

-

PP

-

Set from

MI

DO control (transition delays)

DO control (transition delays)

DO control (transition delays)

-

-

PP

View from

RD

A hand symbol is shown if set to

Manual

Y

CD

-

Y

Y

-

-

Transition delay output data

Transition delay output data is not available in dual mode.

Data Description

PP

-

View from

RD

Y

CD

-

Auto O2 to speed transition delay

Auto speed to O2 transition delay

The O

2 to speed transition delay time used if O2/speed transition delay mode is set to Auto.

The speed to O

2 set to Auto.

transition delay time used if O2/speed transition delay mode is

Note:

Y -

The following abbreviations are used in the table: PP = Process Picture; RD =

Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

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8 Reference information

8.5 Control settings

8.5.11 Media control

8.5.11

Media control

Media control settings

The following table shows general settings used for media control.

Media control mode

Deviation alarm delay

Setting

Weight setpoint

Weight deviation alarm

Allowed deviation up

Allowed deviation down

Flow rate

Description

If Media addition is selected, the feed pump will run with the flow given by parameter Flow rate, until the weight setpoint is reached. If Perfusion is selected, the feed or harvest pump will run with the flow given by parameter Flow rate, until the weight setpoint is reached. Then both feed and harvest pumps will run together, keeping the weight setpoint.

The weight target value.

Enables or disables the deviation alarm.

Sets the extent to which the weight can vary above the setpoint without triggering the deviation alarm.

Sets the extent to which the weight can vary above the setpoint without triggering the deviation alarm.

Sets the time for which the weight must be outside the defined alarm limits before the deviation alarm is triggered. The timer is reset if the weight falls back within the limits before the alarm is triggered.

The flow of the feed pump when media control is on. In perfusion, the harvest pump will also start at this flow rate, and then do minor flow adjustments to keep the weight setpoint.

PP

Settings:

Media control

Settings:

Media control

Settings:

Media control

Settings:

Media control

Settings:

Media control

-

Settings:

Media control

Set from

MI

Media control

(general)

Media control

(general)

Media control

(general)

Media control

(general)

Media control

(general)

Media control

(general)

Media control

(general)

PP

View from

RD CD

Y -

Y

Y

Y

Y

-

Y

-

-

-

-

Y

-

Y

-

-

-

-

-

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8 Reference information

8.5 Control settings

8.5.11 Media control

Setting

Auto calibration

Auto calibration cycle

Description

Select On to activate the auto calibration, and Off to deactivate it. Media control

mode also needs to be set to Perfusion, since no auto calibration will take place in Media addition. When auto calibration is on, the feed and harvest pumps will be calibrated automatically by the system when the weight SP is reached, then with the time interval given by Auto calibra-

tion cycle. If an extra auto calibration is wanted, select Off, and then On again.

If auto calibration is on, this parameter defines the time interval between the auto calibrations.

-

PP

Settings:

Media control

Set from

MI

Media control

(general)

Media control

(general)

Note:

Y

PP

View from

-

RD

-

CD

Y -

The following abbreviations are used in the table: PP = Process Picture; MI =

Manual instruction; RD = Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

Media control output data

Data

Momentary/instant weight setpoint

Auto calibration cycle timer

Note:

Description

In Media addition mode, the weight setpoint is ramped towards the user set weight setpoint. This output data shows the current value of the ramped setpoint.

The time left to start of next auto calibration (hours).

-

PP

View from

RD CD

Y Y

Y -

The following abbreviations are used in the table: PP = Process Picture; RD =

Run data; CD = Curve data; Y = Yes; - = No or Not applicable.

276 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

8 Reference information

8.6 Digital and analog I/O connections

8.6

Digital and analog I/O connections

The rear panel of the rocker has a 15-pin male D-SUB connector, providing four digital inputs, four digital outputs and two analog inputs for connection to external equipment.

This section describes the pinout specifications of this connector and details of the signals.

Contact GE if you require further details of the I/O specifications.

Pinout specifications

The illustration below shows the pin arrangement for the male D-SUB connector.

Signal

AIN1_P

AIN1_N

AIN2_P

AIN2_N

DIN1

DIN2

DIN3

DIN4

DIN_COM

6

7

12

15

8

14

Pin

1

9

11

Function

Analog In 1 Positive,

0 to 10 V/1 to 20 mA

(optional)

Analog In 1 Negative

Analog In 2 Positive,

0 to 10 V/

1 to 20 mA (optional)

Analog In 2 Negative

Digital In 1

Digital In 2

Digital In 3

Digital In 4

Digital In Common/negative

Normal operation

-0.5 to 11 V

-0.5 to 1.0 V

-0.5 to 11 V

-0.5 to 1.0 V

< 0.8 V = Off

> 2 V = On relative to

DIN_COM

-0.5 to 32 V

Comments

Accuracy ±(0.5% reading + 1 digit)

R in

~50 kΩ (0 to 10 V)

R in

~500 Ω (0 to 20 mA)

R in

~1 kΩ

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8 Reference information

8.6 Digital and analog I/O connections

Signal

DOUT1

DOUT2

DOUT3

DOUT4

DOUT_COM

2

3

5

10

4

NC

Pin

13

Function Normal operation

-0.5 to 32 V Digital Out 1

Digital Out 2

Digital Out 3

Digital Out 4

Digital Out Common/ negative or positive

Not connected N/A

Comments

Solid state relay outputs supporting max 100 mA.

Can sink or source.

Signal specifications and handling

All signals

Maximum ratings for all signals and pins are -0.5 to 35 V realtive to ground or chassis.

To avoid ground loops, signals are allowed to float a little relative to ground chassis: -0.5

to 1.0 V for analog in, and -0.5 to 32 V for digital in/out.

Digital signals

Digital inputs consist of optocouplers. A high level/on state corresponds to a voltage in the range 2 to 32 V DC.

Digital outputs consist of solid state optical relays, voltage range 0 to 32 V DC. The outputs are protected against overcurrent by 0.1 A fuses that reset automatically when the overcurrent condition is removed. Connect the Digital Out common pin as follows:

• For sourcing output, connect common to a positive voltage.

For sinking output, connect common to the user equipment common.

The status of the digital inputs can be read by a Watch instruction in a method, allowing appropriate action to be programmed.

Analog signals

The analog input signal voltage range is 0 to 10 V DC, presented in UNICORN as 0% to

100%. One or both inputs can be changed by GE Service to measure 0 to 20 mA/4 to 20 mA DC. There are currently no procedures for GE Service to calibrate either of the analog inputs if one or both of them is changed to measure current, but the specified accuracy still applies.

Accuracy is ±(0.5% reading + 1 digit).

278 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

Examples

Analog In 1

Digital In 1 and 2

Digital Out 1 and 2: example 1

8 Reference information

8.6 Digital and analog I/O connections

Digital Out 1 and 2: example 2

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 279

8 Reference information

8.7 Ordering information

8.7

Ordering information

Systems and accessories

Product

ReadyToProcess WAVE 25

ReadyToProcess CBCU pH

ReadyToProcess CBCU DO

ReadyToProcess CBCU Full

ReadyToProcess Pump 25

UNICORN 7.0 WrkStn-pure-BP

UNICORN 7.0 Remote

UNICORN 7.0 Dry

UNICORN 7.0 DVD pack, no license

UNICORN 7.0 Manual package

Tray 10

Tray 20

Tray 50

Lid 10

Lid 20

Lid 50

Filter heater

Bag sensor adaptor assembly 2.5 m

Description

Rocker

Gas flow/mix and pH

Gas flow/mix and DO

Gas flow/mix, pH, and DO

Pump

License

License

License

Media only

Printed copies of UNICORN manuals

Fiber cable for pH and DO control

Code no.

28-9880-00

29-0442-13

29-0442-16

29-0440-81

29-0320-03

29-1281-16

29-1154-26

29-1154-27

29-1280-20

29-1277-95

29-0444-72

29-0444-73

29-0444-74

29-0444-75

29-0444-76

29-0444-77

29-0444-71

28-9841-89

280 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

8 Reference information

8.7 Ordering information

Spare parts

Product

UniNet cable 0.3 m

UniNet cable 1 m (CAN cable)

UniNet cable 2 m (for external modules)

Mains cable (UK)

Mains cable, 120 V

Mains cable, 220 V

O-ring 5.1 × 1.6 mm, EPDM INDEX 100

Rubber feet kit

Tray handle, Cellbag locking handle

Jumper 1 IEC 1394

Adjustable foot wrench

Tubing kit CBCU

Ethernet cable

Code no.

18-1109-73

29-0288-07

29-0113-66

18-1100-13

19-2447-01

19-2448-01

18-1107-67

29-0528-58

29-0919-66

29-9564-89

29-1125-25

29-1121-87

28-4001-23

For ordering information for Cellbag bioreactors and accessories, see the Cellbag data file, code number 28-9511-36.

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC 281

Index

Index

A

Acid/Base control mode

Dead band, 128

Flow rate, 127

Adjustable foot

Description, 19

Administration module

description, 41 icons, 41

Alarm

Deviation, 120, 143

Assign pump roles, 179

Auto calibration

Criteria, 142

Pumps, 140

B

Bioreactor system

Description, 13

Illustration, 14

Troubleshooting, 212

C

CAN ID

CBCU

Description, 28

Pump

Description, 31

CBCU

Description, 26

Status LED, 27

Troubleshooting, 217

CBCU specifications, 244

Cellbag bioreactor

Description, 32

Illustration, 33

Size selection guide, 155

Troubleshooting, 232

Cell cultivation

Tips, 145

Chromatograms

Insert a marker for measure-

ments, 91

Measure using marker refer-

ences, 92

282

CO

2

Function verification, 151

CO

2

mix control settings, 256

Component specification

CBCU specifications, 244

equipment dimensions, 243 equipment weight, 243

Pump 25 specifications, 245

Rocker specifications, 243

Control cycle, 119

Control mode, 123, 131

Control parameters, 16

Control scheme, 123, 131

Curves

Highlight in a chro-

matogram, 91

Measure using a marker

reference, 92

Cycle time

Acid/base control, 126

CO2 control, 124

O2 control, 132

Speed control, 134

Tuning, 124, 132

D

Dead band, 134

Deviation alarm, 120

DO

Control mode

Control scheme, 131

Reading cycle, 119

DO control

O2 control mode, 132

Speed control mode, 134

Transition delays, 135

DO control settings

general, 271

O2 control mode, 272

Speed control mode, 273

transition delay, 274

Documentation, 11

DO measurement

principles, 117

DO mesurement settings, 270

DO sensor

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

Connect, 159

Description, 34

Dual mode, 10

E

Edit

Method notes, 63

Variables, 69

Emergency stop

Pumps, 142

Equipment dimensions, 243

Equipment weight, 243

Evaluation module

description, 88 icons, 88

F

Fast fill

Function verification, 152

Feed pump

Auto calibration, 140

Foaming

Reduction, 147

G

Gas flow

Function verification, 150

Operating conditions, 146

Gas flow control settings, 254

Gas mix

Connect, 170

Description, 169

H

Harvest pump

Auto calibration, 140

Heating control settings, 253

Help

Text instructions, 65

Help utility, 38

I

Instrument

Components, 235

Instrument configura-

tion, 235

L

Lid

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

Index

Size, 20

Load cells, 17

Log on

UNICORN, 174

M

Manual instructions, 48

Media addition mode

Principles, 138

Media control

Media addition mode, 138

Perfusion mode, 139

Media control settings, 275

Method Editor

Saving a method, 73

Saving a phase, 75

Method Editor module

description, 51

icons, 52

Method notes

Add to method, 63

Edit, 63

Method queues, 83

Create, 83

Mulitple systems, 84

Methods

Add notes, 63

Create empty method, 56

Create new method, 54

Edit notes, 63

Open a method, 58

Saving, 73

Saving a phase, 75

Start protocol, setup, 62

Syntax errors in, 235

unable to create predefined

method, 236

unable to export mehod to

network drive, 236

N

Notes

Method notes, 63

Notes and tips, 9

O

O

2

Function verification, 151

O

2

mix control settings, 257

Operating conditions, 145

283

Index

284

Output data

CO

2

mix control, 256

DO control, O2 mode, 272

DO control, transition de-

lay, 274

DO measurement, 270

Gas flow control, 255

Heating control, 253

Media control, 276

O

2

mix control, 257

pH control, Acid/Base

mode, 267

pH control, CO2 mode, 264

pH control, transition de-

lay, 268

pH measurement, 262

Pump control, 259

Rocking control, 251

P

Perfusion mode

Principles, 139

pH

Control mode

Control scheme, 123

Reading cycle, 119

Phases

Syntax errors in, 235

pH control

Acid/Base control

mode, 126

CO2 control mode, 124

Transition delays, 129

pH control settings

Acid/base control

mode, 265

CO2 control mode, 264

general, 263

transition delay, 268

pH measurement

principles, 117

pH mesurement settings, 262

pH sensor

Connect, 159

Description, 34

PID parameters

CO2 control, 124

O2 control, 132

Tuning, 124, 132

PI parameters

Acid/Base control, 126

Tuning, 126

Power switch, 18

Prepare for tilt, 23

Prepare the system

Start UNICORN, 174

Process picture, 198

Pump

Description, 29

Status LEDs, 30

Troubleshooting, 231

Pump 25 specifications, 245

Pump control

general settings, 258 manual run settings, 258

Pump roles, 179

Pumps

Emergency stop, 142

R

Reading cycle, 119

Reports

Add objects to a report, 107

Alignment toolbar icons in

Customize Report, 109

Change the page setup, 105

Create a new report for-

mat, 101

Customize Report - general

toolbar icon functions, 103,

106

Customize Report toolbar

command buttons, 102

Edit an existing report for-

mat, 111

Generate and print a prede-

fined format, 99

Save a new report for-

mat, 110

Save a report in PDF for-

mat, 100

Result files

Open a result, 90

Rocker

Description, 17

Filter heater, 25

Front view, 18

Function verification, 148

Rear view, 19

Rocking parameters, 17

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

Troubleshooting, 213

Rocker specifications, 243

Rocking angle

Operating conditions, 145

Rocking control settings, 250

Rocking motion

Operating conditions, 146

Rocking speed

Operating conditions, 145

Run

start, 181

Run documentation

Documentation tabs, de-

scription, 95

Print, 94

Save the used method as a

new method, 98

Search for log entry text, 97

View, 94

S

Safety

notices, 9

Scouting

Change variable values, 80

Overview, 77

Scouting scheme, 77

Single mode, 10

Snapshots

Take a Snapshot of curve

values in a result, 93

Software overview, 36

software modules, 37

Speed step, 134

Start protocol

Set up start protocol, 62

Status LED

CBCU, 27

Status LEDs

Pump, 30

Syntax errors

In methods, 235

In phases, 235

In text instructions, 235

System

Components, 235

Instrument configura-

tion, 235

System Control module

curves, 46

ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

Index

description, 42

icons, 46

manual instructions, 48

process picture, 198

run data, 49

system settings, 47

System properties

edit a definition, 177

System recommendations computer specifica-

tions, 246

System settings, 47, 179

System specifications, 242

T

Temperature control

Function verification, 149

Text editing

Help texts, 65

Text instructions, 65

Text instructions

Add a new instruction, 65

Help, 65

Syntax errors in, 235

Text editing a method, 65

Tilt position, 23

Transition delays, 129, 135

Tray

Attach, 156

Detach, 158

Size, 20

Troubleshooting access to UNICORN func-

tions, 238

export of archived re-

sult, 240

maximum number of curves

exceeded, 240

system or computer connec-

tions, 239

user access, 237

Tubing

Load tubing, 167

Tubing holder position, 164

U

UNICORN, 36

Administration module, 41

connect to system, 175

Evaluation module, 88

285

Index

Log on, 174

Method Editor module, 51

Start, 174

System Control module, 42

V

Variables

Breakpoints or gradient

lengths, 68

Defining, 67

Identification in text instruc-

tions, 68

W

Wave motion

Illustration, 15

286 ReadyToProcess WAVE 25 System Handbook 29-0095-98 AC

Page intentionally left blank

For local office contact information, visit www.gelifesciences.com/contact

GE Healthcare Bio-Sciences AB

Björkgatan 30

751 84 Uppsala

Sweden www.gelifesciences.com/wave

GE, imagination at work and GE monogram are trademarks of General Electric

Company.

Cellbag, ReadyToProcess, ReadyToProcess WAVE and UNICORN are trademarks of General Electric Company or one of its subsidiaries.

This product or portions thereof is sold under a sub-license from Sartorius Stedim

Biotech under US 6,673,532, US 7,041,493 and/or its foreign equivalents.

Clave is a trademark of ICU medical Inc.

Tygon is a trademark of Saint-Gobain Performance Plastics.

Virkon is a trademark of E. I. du Pont de Nemours and Company or its affiliates.

Microsoft, Windows and Windows Server are registered trademarks of Microsoft

Corporation.

All other third party trademarks are the property of their respective owner.

Any use of UNICORN is subject to GE Healthcare Standard Software End-User

License Agreement for Life Sciences Software Products. A copy of this Standard

Software End-User License Agreement is available on request.

UNICORN 7 © 2009-2014 General Electric Company.

© 2014 General Electric Company – All rights reserved.

First published Jun. 2013

All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them. A copy of these terms and conditions is available on request. Contact your local GE Healthcare representative for the most current information.

GE Healthcare Europe GmbH

Munzinger Strasse 5, D-79111 Freiburg, Germany

GE Healthcare UK Limited

Amersham Place, Little Chalfont, Buckinghamshire, HP7 9NA, UK

GE Healthcare Bio-Sciences Corp.

800 Centennial Avenue, P.O. Box 1327, Piscataway, NJ 08855-1327, USA

GE Healthcare Japan Corporation

Sanken Bldg. 3-25-1, Hyakunincho Shinjuku-ku, Tokyo 169-0073, Japan

29-0095-98 AC 10/2014 a2001

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