The Operating instructions provide you with the instructions needed to install, operate and maintain Xuri Cell Expansion System W25 in a safe way. Xuri Cell Expansion System W25 is intended for cell cultivation. The system, composed of the rocker, CBCU and pump, enables measurement and control of pH, DO, weight and media distribution, and provides different gas flow and gas mixing possibilities.

The Operating instructions provide you with the instructions needed to install, operate and maintain Xuri Cell Expansion System W25 in a safe way. Xuri Cell Expansion System W25 is intended for cell cultivation. The system, composed of the rocker, CBCU and pump, enables measurement and control of pH, DO, weight and media distribution, and provides different gas flow and gas mixing possibilities.
Xuri™ Cell Expansion System W25
Operating Instructions
Original instructions
Page intentionally left blank
Table of Contents
Table of Contents
1
Introduction ..........................................................................................................
1.1
1.2
1.3
1.4
1.5
2
6
7
9
13
14
Safety instructions ...............................................................................................
15
2.1
2.2
16
23
Safety precautions ...............................................................................................................................
Labels .........................................................................................................................................................
2.2.1
2.2.2
2.2.3
Instrument labels ...........................................................................................................................
Safety labels .....................................................................................................................................
Additional labels .............................................................................................................................
24
27
29
Emergency procedures ......................................................................................................................
Recycling information .........................................................................................................................
Declaration of Hazardous Substances (DoHS) ........................................................................
31
33
34
System description ..............................................................................................
37
3.1
3.2
3.3
3.4
3.5
3.6
38
40
49
52
55
58
2.3
2.4
2.5
3
System overview ...................................................................................................................................
Xuri Cell Expansion System W25, rocker ...................................................................................
Xuri Cell Expansion W25 CBCU .......................................................................................................
Xuri Cell Expansion W25 Pump ......................................................................................................
Cellbag bioreactor ................................................................................................................................
UNICORN software overview ..........................................................................................................
3.6.1
3.6.2
3.6.3
3.6.4
4
General UNICORN operation .....................................................................................................
System control ................................................................................................................................
Evaluation .........................................................................................................................................
Administration .................................................................................................................................
59
62
67
68
Installation ............................................................................................................
69
4.1
70
Site preparation .....................................................................................................................................
4.1.1
4.1.2
4.2
Delivery and storage ....................................................................................................................
Site requirements ...........................................................................................................................
71
73
Hardware installation .........................................................................................................................
76
4.2.1
4.2.2
4.3
Unpack the system units ............................................................................................................
Connect the system units ...........................................................................................................
77
79
Software installation ...........................................................................................................................
85
4.3.1
4.3.2
4.3.3
5
5
About this manual ................................................................................................................................
Important user information .............................................................................................................
Regulatory information ......................................................................................................................
Important concepts .............................................................................................................................
User documentation ...........................................................................................................................
Install UNICORN ..............................................................................................................................
Configure an e-license .................................................................................................................
Define a system ..............................................................................................................................
86
96
104
Operation ..............................................................................................................
106
5.1
107
Prepare the system ..............................................................................................................................
5.1.1
5.1.2
Select tray and Cellbag bioreactor .........................................................................................
Prepare pH and DO sensors ......................................................................................................
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
108
112
3
Table of Contents
5.1.3
5.1.4
5.1.5
5.2
5.3
5.4
Attach the Cellbag bioreactor ...................................................................................................
Prepare the pump ..........................................................................................................................
Connect gas to system ................................................................................................................
115
117
122
Start the system ....................................................................................................................................
Edit system properties ........................................................................................................................
Prepare cultivation ...............................................................................................................................
126
130
132
5.4.1
5.4.2
5.4.3
5.4.4
5.5
Start a run .........................................................................................................................................
Pre-culture preparation ...............................................................................................................
Addition of culture medium .......................................................................................................
Equilibrate the culture medium ...............................................................................................
133
137
139
142
Perform cultivation ..............................................................................................................................
145
5.5.1
5.5.2
5.5.3
6
7
8
4
Inoculation ........................................................................................................................................
Monitor a run ...................................................................................................................................
End cultivation .................................................................................................................................
146
147
148
Maintenance .........................................................................................................
150
6.1
6.2
Calibrations .............................................................................................................................................
Cleaning ....................................................................................................................................................
151
153
Troubleshooting ...................................................................................................
154
7.1
7.2
7.3
7.4
7.5
Xuri Cell Expansion System W25 ..................................................................................................
Xuri Cell Expansion System W25, rocker ...................................................................................
Xuri Cell Expansion W25 CBCU .......................................................................................................
Xuri Cell Expansion W25 Pump ......................................................................................................
UNICORN System Control .................................................................................................................
155
156
160
161
162
Reference information ........................................................................................
164
8.1
8.2
8.3
8.4
8.5
8.6
System specifications .........................................................................................................................
Component specifications ................................................................................................................
Client computer specifications .......................................................................................................
Xuri Cell Expansion W25 CBCU semi-wetted materials ......................................................
Chemical resistance ............................................................................................................................
Tubing and connectors ......................................................................................................................
165
166
170
172
173
174
Index .......................................................................................................................
175
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
1 Introduction
1
Introduction
In this chapter
This chapter includes important user information, description of safety notices, regulatory information, intended use of the system, and lists of important concepts and user
documentation.
This chapter contains the following sections:
Section
See page
1.1 About this manual
6
1.2 Important user information
7
1.3 Regulatory information
9
1.4 Important concepts
13
1.5 User documentation
14
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
5
1 Introduction
1.1 About this manual
1.1
About this manual
Purpose of the Operating
Instructions
The Operating Instructions provide you with the instructions needed to install, operate
and maintain Xuri Cell Expansion System W25 in a safe way.
Scope of this document
This manual covers Xuri Cell Expansion System W25, including the rocker, CBCU, pump,
UNICORN™ software and accessories.
Typographical conventions
Software items are identified in the text by bold italic text. A colon separates menu levels,
thus File:Open refers to the Open command in the File menu.
Hardware controls, indicators and connections are identified in the text by bold text (e.g.,
Power switch).
Text entries that UNICORN generates or that the user must type are represented by a
monotype typeface (e.g., \Program Files\GE Healthcare\UNICORN\).
6
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
1 Introduction
1.2 Important user information
1.2
Important user information
Read this before operating Xuri
Cell Expansion System W25
All users must read the entire Xuri Cell Expansion System W25 Operating Instructions
before installing, operating, or maintaining the instrument. Always keep the Operating
Instructions at hand when operating Xuri Cell Expansion System W25.
Do not operate Xuri Cell Expansion System W25 in any other way than described in the
Operating Instructions. Otherwise, you may be exposed to hazards that can lead to personal injury and you may cause damage to the equipment.
Intended use
Xuri Cell Expansion System W25 is intended to be used as laboratory and manufacturing
equipment for cell cultivation.
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® Windows® operating systems work.
•
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 these Operating
Instructions.
•
the system is installed according to the instructions in these Operating Instructions.
•
a user account has been created according to UNICORN Administration and Technical
manual.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
7
1 Introduction
1.2 Important user information
Safety notices
This user documentation contains WARNINGS, CAUTIONS and NOTICES concerning the
safe use of the product. See definitions below.
Warnings
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.
Cautions
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.
Notices
NOTICE
NOTICE indicates instructions that must be followed to avoid
damage to the product or other equipment.
Notes and tips
8
Note:
A note is used to indicate information that is important for trouble-free and
optimal use of the product.
Tip:
A tip contains useful information that can improve or optimize your procedures.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
1 Introduction
1.3 Regulatory information
1.3
Regulatory information
Manufacturing information
The table below summarizes the required manufacturing information. For further information, see the EC Declaration of Conformity document.
Requirement
Content
Name and address of manufacturer
GE Healthcare Bio-Sciences AB,
Björkgatan 30, SE 751 84 Uppsala,
Sweden
CE conformity
This product complies with the European directives listed in the table below, by fulfilling
the corresponding harmonized standards. For further information, see the EC Declaration
of Conformity document.
Directive
Title
2006/42/EC
Machinery Directive (MD)
2006/95/EC
Low Voltage Directive (LVD)
2004/108/EC
ElectroMagnetic Compatibility (EMC) Directive
CE marking
The CE marking and the corresponding EC Declaration of Conformity is valid for the instrument when it is:
•
used as a stand-alone unit, or
•
connected to other products recommended or described in the user documentation,
and
•
used in the same state as it was delivered from GE Healthcare, except for alterations
described in the user documentation.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
9
1 Introduction
1.3 Regulatory information
International standards
The standard requirements fulfilled by this product are summarized in the table below.
Standard
Description
Notes
EN ISO 12100
Safety of machinery. General
principles for design. Risk assessment and risk reduction.
EN ISO standard is harmonized with EU directive 2006/42/EC
EN 61010-1,
IEC 61010-1,
UL 61010-1,
CAN/CSA-C22.2
No. 61010-1
Safety requirements for electrical
equipment for measurement,
control and laboratory use.
EN standard is harmonized with EU directive
2006/95/EC
EN 61010-2-010,
IEC 61010-2-010
Safety requirements for electrical
equipment for measurement,
control and laboratory use. Part
2-010: Particular requirements for
laboratory equipment for the
heating of materials.
EN standard is harmonized with EU directive
2006/95/EC
EN 61326-1,
IEC 61326-1
(Emission according
to CISPR 11, Group 1,
class A)
Electrical equipment for measurement, control, and laboratory use
- EMC requirements.
EN standard is harmonized with EU directive
2004/108/EC
Other regulations
The table below lists additional regulatory requirements that are fulfilled by Xuri Cell
Expansion System W25.
10
Regulation
Description
FCC 47 CFR Part 15
Federal Communications Commission (FCC) title 47 of the Code
of Federal Regulations (CFR), Part 15, Radio Frequency Devices
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
1 Introduction
1.3 Regulatory information
FCC statement
Xuri Cell Expansion System W25 complies with FCC 47 CFR Part 15b.
Note:
This equipment has been tested and found to comply with the limits for a Class
A digital device, pursuant to part 15 of the FCC Rules. These limits are designed
to provide reasonable protection against harmful interference when the
equipment is operated in a commercial environment. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instruction manual, may cause harmful interference to
radio communications. Operation of this equipment in a residential area is
likely to cause harmful interference in which case the user will be required to
correct the interference at his own expense.
Software declaration of
conformity
UNICORN 6.3 is technically compatible with all relevant sections of FDA 21 CFR Part 11.
A part 11-system assessment checklist is available on request from your local GE
Healthcare representative.
Regulatory compliance of
connected equipment
Any equipment connected to Xuri Cell Expansion System W25 should meet the safety
requirements of EN 61010-1/IEC 61010-1 or other relevant harmonized standards.
Within EU, connected equipment must be CE marked.
Environmental conformity
The environmental requirements fulfilled by this product are listed in the table below.
Requirement
Title
2011/65/EU
Restriction of Hazardous Substances (RoHS) Directive
2012/19/EU
Waste Electrical and Electronic Equipment (WEEE) Directive
2006/66/EC
Battery directive
Regulation (EC) No
1907/2006
Registration, Evaluation, Authorization and restriction of
CHemicals (REACH)
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
11
1 Introduction
1.3 Regulatory information
12
Requirement
Title
ACPEIP
Administration on the Control of Pollution Caused by Electronic Information Products, China Restriction of Hazardous
Substances (RoHS)
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
1 Introduction
1.4 Important concepts
1.4
Important concepts
The concepts and abbreviations used in this manual are explained in the table below.
Concept/
abbreviation
Explanation
Cellbag™ bioreactor
The disposable container in which the cells are cultured.
DO
Dissolved oxygen.
DO sensor
Optical sensor for measurement of dissolved oxygen. Attached on DO configured Cellbag bioreactors.
pH sensor
Optical sensor for pH measurement. Attached on pH configured Cellbag bioreactors.
CBCU
Xuri™ Cell Expansion System W25 Cellbag Control Unit
Refers to instrument labeled Xuri Cell Expansion W25 CBCU.
Control unit for gas mixing, pH and DO control.
Pump
Xuri™ Cell Expansion System W25 Pump
Refers to instrument labeled Xuri Cell Expansion W25 Pump.
Rocker
Xuri™ Cell Expansion System W25
Refers to instrument labeled Xuri Cell Expansion System W25
Bioreactor system
The entire system, including rocker, CBCU, and pump, together
with Cellbag bioreactor and filter heater.
UNICORN
The software used for controlling and monitoring the system.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
13
1 Introduction
1.5 User documentation
1.5
User documentation
The table below describes the user documentation for Xuri Cell Expansion System W25,
which is available from the Help menu in UNICORN or on the user documentation CD.
14
Document
Main contents
Xuri Cell Expansion System
W25 Operating Instructions
Instructions needed to install, operate and maintain
Xuri Cell Expansion System W25 in a safe way. Includes basic UNICORN system control functions.
Xuri Cell Expansion System
W25 User Manual
Detailed system descriptions and instructions on
how to run, maintain and troubleshoot Xuri Cell
Expansion System W25. Includes UNICORN system
control functions, method creation and handling,
together with evaluation and presentation of data.
Xuri Cell Expansion System
W25 Cue Card
Brief instructions providing an overview of how to
run the system.
UNICORN Administration and
Technical manual
Overview and detailed description of network setup
and complete software installation. Administration
of UNICORN and the UNICORN database.
UNICORN Online Help
Dialog descriptions for UNICORN.
User Documentation CD
CD containing the listed manuals and translated
versions of Xuri Cell Expansion System W25
Operating Instructions.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
2 Safety instructions
2
Safety instructions
In this chapter
This chapter describes safety precautions, safety labels and emergency shutdown procedures for Xuri Cell Expansion System W25. Decommissioning information is also described.
This chapter contains the following sections:
Section
See page
2.1 Safety precautions
16
2.2 Labels
23
2.3 Emergency procedures
31
2.4 Recycling information
33
2.5 Declaration of Hazardous Substances (DoHS)
34
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
15
2 Safety instructions
2.1 Safety precautions
2.1
Safety precautions
Introduction
Before installing, operating or maintaining the system, you must be aware of the hazards
described in this manual. Follow the instructions provided to avoid personal injury or
damage to the equipment.
The safety precautions in this section are grouped into the following categories:
•
General precautions
•
Flammable liquids and explosive environment
•
Personal protection
•
Installing and moving the equipment
•
Power supply
•
System operation
•
Maintenance
Some of the safety precautions in this chapter concern situations that are described in
other manuals.
General precautions
WARNING
Do not operate Xuri Cell Expansion System W25 in any other way
than described in the user documentation.
WARNING
Operation and user maintenance of Xuri Cell Expansion System
W25 should be performed by properly trained personnel only.
WARNING
Do not use any accessories not supplied or recommended by
GE Healthcare.
16
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
2 Safety instructions
2.1 Safety precautions
WARNING
Do not use Xuri Cell Expansion System W25 if it is not working
properly, nor if it has suffered any damage, for example:
•
damage to the power cord or its plug.
•
damage caused by dropping the equipment.
•
damage caused by splashing liquid onto it.
Flammable liquids and explosive
environment
WARNING
Xuri Cell Expansion System W25 is not designed to handle
flammable liquids.
WARNING
Xuri Cell Expansion System W25 is not approved for work in a potentially explosive atmosphere.
Personal protection
CAUTION
Always use appropriate personal protective equipment during
operation, maintenance and decommissioning of Xuri Cell
Expansion System W25.
CAUTION
Hazardous substances. When using hazardous chemical and
biological agents, take all suitable protective measures, such as
wearing protective glasses and gloves resistant to the substances
used. Follow local and/or national regulations for safe operation,
maintenance and decommissioning of the system.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
17
2 Safety instructions
2.1 Safety precautions
CAUTION
Spread of biological agents. The operator has to take all necessary
actions to avoid spreading hazardous biological agents in the
vicinity of the system equipment. The facility should comply with
the national code of practice for biosafety.
Installing and moving the
equipment
CAUTION
Heavy object. Because of the significant weight of Xuri Cell
Expansion System W25, rocker, assistance from another person is
highly recommended when lifting or moving the equipment. Use
the handles on the sides of the rocker when possible, and do not
lift Xuri Cell Expansion System W25, rocker with tray attached.
CAUTION
Falling equipment. Do not stack more than one Xuri Cell Expansion
W25 CBCU and/or Xuri Cell Expansion W25 Pump unit on top of
each other.
Power supply
WARNING
Protective ground. Xuri Cell Expansion System W25, rocker must
always be connected to a grounded power outlet.
WARNING
Only use grounded power cords delivered or approved by GE
Healthcare.
18
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
2 Safety instructions
2.1 Safety precautions
WARNING
Do not block access to the power switch and power cord. The
power switch must always be easy to access. The power cord with
plug must always be easy to disconnect.
WARNING
Disconnect power. Always disconnect power from the equipment
before connecting the Xuri Cell Expansion System W25 units to any
other instrument.
System operation
WARNING
Suffocation hazard. Xuri Cell Expansion System W25 equipment
must only be used in locations with forced ventilation. When N2
and/or CO2 are connected, make sure that:
•
the pressure over the gas connections does not exceed 1.5 bar.
•
the gas connections are tightly secured and visually inspect
the inlet tubing regularly.
Exceeding pressure or loose connections may cause the gas tubing
to disconnect, resulting in dangerous leakages.
WARNING
Prevent gas leakage. To prevent any gas leakage, always switch
off all gas supplies when the system is not in use.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
19
2 Safety instructions
2.1 Safety precautions
CAUTION
Fire hazard. O2 leakage in combination with heat may cause ignition. To avoid O2 leakages, make sure that:
•
the pressure over the gas connections does not exceed 1.5 bar.
•
the gas connections are tightly secured and visually inspect
the inlet tubing regularly.
CAUTION
Only Cellbag bioreactors approved by GE Healthcare for Xuri Cell
Expansion System W25 may be used together with the equipment.
CAUTION
Heavy object. The filled Cellbag bioreactor have a considerable
weight and heavy lifting must be done with care. This is also the
case for optional equipment such as calibration weights.
CAUTION
Leakage risk of biological substances. Before every use, check
the integrity of all tubing and connections.
CAUTION
Leakage risk of biological substances. Always enter the correct
Cellbag bioreactor size in the UNICORN system settings. Failure to
do this may cause overpressure and subsequent rupture of the
Cellbag bioreactor.
CAUTION
Pinch hazard. Body parts may be caught between the rocker base
and tray.
20
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
2 Safety instructions
2.1 Safety precautions
CAUTION
Pinch hazard. Be careful not to pinch any fingers between the
rocker platform and tray when repositioning Tray 10 from tilt position. Fold down tray by firmly gripping both sides of the tray.
CAUTION
Pinch hazard. Moving parts in Xuri Cell Expansion W25 Pump. Do
not open any pumphead flip tops during operation.
CAUTION
Falling equipment. To prevent the different bioreactor system units
from accidently being pulled from the bench, make sure that all
tubing are located inside the bench area.
Maintenance
WARNING
Electrical shock hazard. All repairs should be done by service
personnel authorized by GE Healthcare. Do not open any covers
or replace parts unless specifically stated in the user documentation.
WARNING
Disconnect power. Always disconnect power before performing
any maintenance on the equipment.
WARNING
Always clean the equipment in a well ventilated area. Never
immerse any part of the equipment in liquid or spray liquid on the
equipment. Always make sure that the equipment is completely
dry before plugging it in. Make sure to follow all environmental,
health, and safety guidelines pertaining to the materials used.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
21
2 Safety instructions
2.1 Safety precautions
WARNING
Only spare parts that are approved or supplied by GE Healthcare
may be used for maintaining or servicing the system.
CAUTION
Falling equipment. Due to pinch and crush hazards, calibration
weights should not be stacked on top of each other. Remove calibration weights before the power is turned off.
CAUTION
Hazardous substances. Before maintenance, service and decommissioning, clean Xuri Cell Expansion System W25 with an appropriate cleaning agent to remove any hazardous substances.
CAUTION
Always use appropriate personal protective equipment, like protective gloves, shoes and lab coat, during maintenance and decommissioning of the equipment.
22
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
2 Safety instructions
2.2 Labels
2.2
Labels
This section describes instrument, safety and additional labels that are attached to the
bioreactor system units. For information about marking of the client computer equipment,
refer to the manufacturer's instructions.
Section
See page
2.2.1 Instrument labels
24
2.2.2 Safety labels
27
2.2.3 Additional labels
29
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
23
2 Safety instructions
2.2 Labels
2.2.1 Instrument labels
2.2.1
Instrument labels
Xuri Cell Expansion System W25,
rocker label
The instrument label on the rocker is located on the back of the rocker platform.
Filter heater label
The following label is attached to the filter heater.
Tray and lid labels
The following labels are examples of the labels found on the different sizes of trays and
lids.
Tray label
24
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
2 Safety instructions
2.2 Labels
2.2.1 Instrument labels
Lid label
Xuri Cell Expansion W25 CBCU
label
The instrument label on the CBCU is located on the underside of the unit. The illustration
below is an example of the label attached to a CBCU with full configuration. Corresponding
labels are attached to the CBCU units with alternative configurations.
Xuri Cell Expansion W25 Pump
label
The instrument label on the pump is located on the rear panel of the unit.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
25
2 Safety instructions
2.2 Labels
2.2.1 Instrument labels
Symbol description
The following symbols are used in the labels.
Label
Description
Warning! Read the user documentation before using the system. Do not
open any covers or replace parts unless specifically stated in the user
documentation.
The system complies with applicable European directives.
The system complies with applicable requirements for Australia and New
Zealand.
This symbol indicates that the system has been certified by a Nationally
Recognized Testing Laboratory (NTRL). An NRTL is an organization that
the Occupational Safety and Health Administration (OSHA) has recognized
as meeting the legal requirements in USA title 29 of the Code of Federal
Regulations (29 CFR) Part 1910.7.
This symbol indicates that electrical and electronic equipment must not
be disposed of as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer
for information concerning the decommissioning of equipment.
This symbol indicates that the product contains hazardous materials in
excess of the limits established by the Chinese standard SJ/T11363-2006
Requirements for Concentration Limits for Certain Hazardous Substances
in Electronic Information Products.
26
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
2 Safety instructions
2.2 Labels
2.2.2 Safety labels
2.2.2
Safety labels
Safety labels on Xuri Cell
Expansion System W25, rocker
The following symbols can be found on the rocker.
Label
Description
Warning! Read the user documentation before using the system. Do not open any covers or replace parts unless specifically
stated in the user documentation.
Indicates a risk for body parts getting caught between two
parts of the system and that care must be taken to avoid injury.
Safety labels on Xuri Cell
Expansion W25 Pump
The following symbols can be found on the pump.
Label
Description
Warning! Indicates a risk for fingers getting caught between
moving parts in the pump and that care must be taken to avoid
injury.
Safety labels on filter heater
The following symbols can be found on the filter heater.
Label
Description
Warning! Indicates a hot surface and that care must be exercised to prevent injury.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
27
2 Safety instructions
2.2 Labels
2.2.2 Safety labels
Safety labels on tray
The following symbols can be found on the tray.
Label
Description
Warning! Indicates a hot surface and that care must be exercised to prevent injury.
LEFT indicates the left side of the tray.
Warning! Indicates a hot surface and that care must be exercised to prevent injury.
RIGHT indicates the right side of the tray.
28
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
2 Safety instructions
2.2 Labels
2.2.3 Additional labels
2.2.3
Additional labels
Illustration of Cellbag label
The following image is an example of the label attached to the cellbag.
Illustration of DO sensor label
The following image shows the DO sensor label attached to the cellbag next to the DO
sensor.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
29
2 Safety instructions
2.2 Labels
2.2.3 Additional labels
Illustration of pH sensor label
The following image shows the pH sensor label attached to the cellbag next to the pH
sensor.
Illustrations of fiber cable labels
The following image shows the label to be attached to the optical fiber cable of the DO
sensor.
The following image shows the label to be attached to the optical fiber cable of the pH
sensor.
Illustration of pumphead label
The following image shows the label attached to the pumphead. The label indicates the
pumping direction of the pump.
30
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
2 Safety instructions
2.3 Emergency procedures
2.3
Emergency procedures
Introduction
This section describes how to perform an emergency shutdown of Xuri Cell Expansion
System W25. This section also describes the result in the event of power failure or network
interruption.
Emergency shutdown
In an emergency situation, stop the run in one of the following ways:
•
Stop the run from System Control by clicking the Stop icon, if UNICORN is in control
of the system.
.
or
•
Switch off power by pressing the Power switch on the rocker front panel. The run is
interrupted immediately.
Note:
If the button is pressed once, a normal shut down is performed. If it is kept
pressed in, a forced shut down is performed.
Xuri™ Cell Expansion System W25
Xuri™ Cell Expansion System W25
The power is off when the indicator
shows no light.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
The power is on when the indicator
light is green.
31
2 Safety instructions
2.3 Emergency procedures
Power failure
The result of a power failure or emergency shutdown depends on which unit is affected.
Power failure to...
will result in...
Xuri Cell Expansion
System W25
The system is inactive during power failure.
If System Settings:Auto start:Rocker and System Settings:Auto
start:CBCU is set to Resume activity, the rocker and the CBCU
will restart using the same values as prior to the power failure
when the system is reenergized.
Note:
Data collection, media control, and regulation of pH and DO
must be reinitiated manually by reconnecting to the system and
starting a new run.
Client computer
No interruption of the cell cultivation run. The operator will not,
however, be able to view system status, change settings or
send manual instructions during power failure of client computer.
Uninterruptible power supply
(UPS)
A UPS can postpone power failure, which allows time for a controlled shut-down of the
bioreactor system and prevents data loss.
For UPS power requirements, see the system specifications in Xuri Cell Expansion System
W25 User Manual. Take the specifications for the client computer and monitor into account. Refer to the manufacturers' documentation.
32
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
2 Safety instructions
2.4 Recycling information
2.4
Recycling information
Introduction
This section describes the procedures for disposal and recycling of Xuri Cell Expansion
System W25.
Decommissioning of the
equipment
The bioreactor system units must be decontaminated before decommissioning. Follow
local regulations for scrapping of the equipment.
Disposal, general instructions
When taking Xuri Cell Expansion System W25 out of service, the different materials must
be separated and recycled according to national and local environmental regulations.
Disposal of electrical
components
Waste comprising electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately. Please contact an authorized
GE Healthcare representative for information concerning the decommissioning of your
equipment.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
33
2 Safety instructions
2.5 Declaration of Hazardous Substances (DoHS)
2.5
Declaration of Hazardous Substances (DoHS)
Introduction
The following product pollution control information is provided according to SJ/T113642006 Marking for Control of Pollution caused by Electronic Information Products.
根据SJ/T11364-2006《电子信息产品污染控制标识要求》特提供如下有关污染 控制
方面的信息
Symbols used in pollution control
label
电子信息产品污染控制标志说明
Label
Meaning
This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese standard SJ/T11363-2006
Requirements for Concentration Limits for Certain Hazardous Substances in Electronic Information Products. The number in the symbol
is the Environment-friendly Use Period (EFUP), which indicates the period
during which the toxic or hazardous substances or elements contained
in electronic information products will not leak or mutate under normal
operating conditions so that the use of such electronic information
products will not result in any severe environmental pollution, any
bodily injury or damage to any assets. The unit of the period is “Year”.
In order to maintain the declared EFUP, the product shall be operated
normally according to the instructions and environmental conditions
as defined in the product manual, and periodic maintenance schedules
specified in Product Maintenance Procedures shall be followed strictly.
Consumables or certain parts may have their own label with an EFUP
value less than the product. Periodic replacement of those consumables
or parts to maintain the declared EFUP shall be done in accordance
with the Product Maintenance Procedures.
This product must not be disposed of as unsorted municipal waste,
and must be collected separately and handled properly after decommissioning.
34
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
2 Safety instructions
2.5 Declaration of Hazardous Substances (DoHS)
Label
Meaning
该标志表明本产品含有超过SJ/T11363-2006《电子信息产品中有毒
有害物质的限 量要求》中限量的有毒有害物质。标志中的数字为本
产品的环保使用期,表明本 产品在正常使用的条件下,有毒有害物
质不会发生外泄或突变,用户使用本产品 不会对环境造成严重污染
或对其人身、财产造成严重损害的期限。单位为年。
为保证所申明的环保使用期限,应按产品手册中所规定的环境条件
和方法进行正 常使用,并严格遵守产品维修手册中规定的期维修和
保养要求。
产品中的消耗件和某些零部件可能有其单独的环保使用期限标志,
并且其环保使 用期限有可能比整个产品本身的环保使用期限短。应
到期按产品维修程序更换那 些消耗件和零部件,以保证所申明的整
个产品的环保使用期限。
本产品在使用寿命结束时不可作为普通生活垃圾处理,应被单独收
集妥善处理
List of hazardous substances and
their concentrations
产品中有毒有害物质或元素的名称及含量
Indication for each major part if substance exceeds limit
Value
Meaning
O
Indicates that this toxic or hazardous substance contained in all of the
homogeneous materials for this part is below the limit requirement in
SJ/T11363-2006.
表示该有毒有害物质在该部件所有均质材料中的含量均在SJ/T113632006 标准规定的限量要 求以下
X
Indicates that this toxic or hazardous substance contained in at least
one of the homogeneous materials used for this part is above the limit
requirement in SJ/T11363-2006.
•
Data listed in the table represents best information available at the
time of publication
表示该有毒有害物质至少在该部件的某一均质材料中的含量超出
SJ/T11363-2006 标准规定的
限量要求
•
此表所列数据为发布时所能获得的最佳信息
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
35
2 Safety instructions
2.5 Declaration of Hazardous Substances (DoHS)
List of hazardous substances
Component name
Hazardous substance
部件名称
有毒有害物质或元素
Pb
Hg
Cd
Cr6+
PBB
PBDE
铅
汞
镉
六价铬
多溴联苯
多溴二苯醚
29-0645-68 1
X
O
O
O
O
O
29-0645-71 1
X
O
O
O
O
O
29-0646-00 1
X
O
O
O
O
O
29-0645-99 1
X
O
O
O
O
O
29-0646-02 1
X
O
O
O
O
O
1
36
The product has not been tested as per the Chinese standard SJ/T11363-2006 Requirements for Concentration
Limits for Certain Hazardous Substances in Electronic Information Product.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
3 System description
3
System description
In this chapter
This chapter gives a brief overview of Xuri Cell Expansion System W25. For more detailed
information, refer to Xuri Cell Expansion System W25 User Manual.
This chapter contains the following sections:
Section
See page
3.1 System overview
38
3.2 Xuri Cell Expansion System W25, rocker
40
3.3 Xuri Cell Expansion W25 CBCU
49
3.4 Xuri Cell Expansion W25 Pump
52
3.5 Cellbag bioreactor
55
3.6 UNICORN software overview
58
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
37
3 System description
3.1 System overview
3.1
System overview
Introduction
Xuri Cell Expansion System W25 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.
The cell culture volume range is 0.3 L to 25 L, and working volume may be expanded up
to 10 times during one cultivation. Gas transfer and mixing of culture is accomplished
by wave-induced agitation, performed by a rocker unit.
The system, composed of the rocker, CBCU and pump, enables measurement and control
of pH, DO, weight and media distribution, and provides different gas flow and gas mixing
possibilities.
Illustration of the system
The illustration below shows the main bioreactor system units.
38
Part
Description
1
Hatch
2
Filter heater
3
Cellbag bioreactor
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
3 System description
3.1 System overview
Part
Description
4
Xuri Cell Expansion W25 Pump
5
Xuri Cell Expansion W25 CBCU
6
Xuri Cell Expansion System W25, rocker
7
Tray
8
Lid
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
39
3 System description
3.2 Xuri Cell Expansion System W25, rocker
3.2
Xuri Cell Expansion System W25, 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 an embedded computer, which allows running the system independently
of the performance of the connected network and client computer.
The dimensions and weight of the rocker are listed in Section8.2 Component specifications,
on page 166.
Front view of the rocker
The illustration below shows the front view of the rocker.
Xuri TM Cell
40
Expansio
n System
W25
Part
Description
1
Rocker platform
2
Temperature sensors
3
Rocker base
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
3 System description
3.2 Xuri Cell Expansion System W25, rocker
Part
Description
4
Power switch
5
Location of adjustable foot
Power switch
The power switch indicates the status of the rocker according to the list below.
Light indicator
Description
No light
The power is off.
Green blinking light
The rocker is starting up.
Green steady light
The power is on and the rocker is operational.
Red blinking light
The rocker failed to connect to the system.
Red steady light
Indicates an error of the rocker.
Adjustable foot
The adjustable foot is placed in the front right corner of the rocker when viewed from
the front. It is used to evenly distribute weight over the four rocker feet.
To adjust the foot, remove the side plate, carefully lift the front right corner of the rocker
and turn the foot by hand.
In the image below, the rocker is shown without a side plate in order to display the adjustable foot.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
41
3 System description
3.2 Xuri Cell Expansion System W25, rocker
Rear view of the rocker
The illustration below shows the rear panel of the rocker.
1
42
2
Part
Description
1
15-pin D-sub connector
2
Filter heater connectors
3
UniNet-9 ports
4
USB ports
5
Ethernet connector
6
Power connector
3
4 5
6
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
3 System description
3.2 Xuri Cell Expansion System W25, rocker
Tray and lid sizes
Trays and lids are available in the different sizes listed below:
Trays
Lids
Tray 10
Lid 10
Tray 20
Lid 20
Tray 50
Lid 50
Illustrations of tray and lid
The illustration below shows the rocker with Tray 50 attached.
1
Xu
ri™
Ce
ll Exp
an
2
sio
n Sys
tem
W2
5
4
3
Part
Description
1
Bag clamp (upper)
2
Bag clamp opener (one in each upper corner)
3
Bag clamp opener (one in each lower corner)
4
Bag clamp (lower)
The illustration below shows the rocker with Tray 50 and Lid 50 mounted.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
43
3 System description
3.2 Xuri Cell Expansion System W25, rocker
4
5
3
2
Xuri™
Cel
l Ex
pans
ion
Syste
mW
25
1
44
Part
Description
1
Rocker base
2
Lid
3
Tray
4
Tubing exit
5
Hatch
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
3 System description
3.2 Xuri Cell Expansion System W25, rocker
The illustration below shows the rocker with Tray 10 and Lid 10 mounted.
Xuri™
Cel
l Ex
pans
ion
Syste
mW
25
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
45
3 System description
3.2 Xuri Cell Expansion System W25, rocker
Prepare for tilt
When the system enters END mode, the tray prepares for tilt by default. It can be changed
in System Settings:Rocker:Prepare for tilt at END. This position is the mechanical end
position of the rocker, which is 14 degrees. This position can also be set by executing
the manual instruction Rocker:Prepare for tilt. See illustration below.
Xuri™
Cell Expan
sion Syste
m W25
Tilt position
In order to facilitate sampling and harvest, it is possible to position the tray with the attached Cellbag bioreactor into an upright position called tilt position.
For visibility purposes the tray is shown without the Cellbag bioreactor attached in the
images below.
46
Step
Action
1
Select the largest possible angle in UNICORN, i.e., 12 degrees, or prepare for
tilt as described above.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
3 System description
3.2 Xuri Cell Expansion System W25, rocker
Step
Action
2
Grab the textured grip area on each side of the tray and pull the tray towards
you.
Xuri™
Cell Expansi
on System
W25
The illustration below shows the tilt position:
Xuri™
Cell
Expa
nsion
Syste
m W25
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
47
3 System description
3.2 Xuri Cell Expansion System W25, rocker
Illustration of filter heater
The filter heater prevents occurrence of condensation and clogging of the outlet gas
filter of the Cellbag bioreactor.
2
1
3
48
Part
Description
1
Filter heater
2
Connector for connection to the rocker
3
Filter heater stand
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
3 System description
3.3 Xuri Cell Expansion W25 CBCU
3.3
Xuri Cell Expansion W25 CBCU
Introduction
The control unit, Xuri Cell Expansion W25 CBCU, is connected to the rocker via a UniNet9 connector. The full configuration mixes air/N2, O2, and CO2 gas, and contains O2 and
CO2 sensors, a mass flow controller, an optical pH sensor reader, and an optical DO
sensor reader. Three configurations are available:
•
CO2, O2 and pH.
•
CO2, O2 and DO.
•
CO2, O2, pH and DO, full configuration.
The dimensions and weight of the CBCU are listed in Section 8.2 Component specifications,
on page 166.
Front view of Xuri Cell Expansion
W25 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.
Xuri™ Cell Expansion W25 CBCU
1
2
3
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
4
49
3 System description
3.3 Xuri Cell Expansion W25 CBCU
Part
Component
Description
1
pH port
Connector for pH sensor fiber cable.
2
GAS MIX OUT
Gas outlet for connection to Cellbag bioreactor.
3
Status LED
Indicates the CBCU operating status.
4
DO port
Connector for DO sensor fiber cable.
Status LED
The status LED indicates the CBCU operating status according to the following table.
Light indicator
Description
Steady green light
The CBCU is ready for operation.
Green blinking light
The CBCU is operating.
Red blinking light
Indicates an internal error, but the CBCU is still operating.
Steady red light
Indicates an internal error, and the CBCU is not operating.
Rear view of Xuri Cell Expansion
W25 CBCU
The illustration below shows the rear panel of a fully configured CBCU.
50
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
3 System description
3.3 Xuri Cell Expansion W25 CBCU
Part
Component
Description
1
UniNet-9 port
Power connection to the rocker.
2
CAN indicator LED
Indicates system connection status.
3
CAN ID switch
Switch for setting the CBCU unit number for system
recognition.
4
O2 IN
Inlet connection for O2 supply.
5
CO2 IN
Inlet connection for CO2 supply.
6
AIR/N2
Inlet connection for air or N2 supply.
CAN ID
The CAN ID is a unit number used by UNICORN to recognize that the CBCU is connected
to the system.
The CAN ID is set by turning a switch on the CBCU rear panel (see illustration above).
Two possible CAN ID positions are available on the switch, marked 1 and 2, respectively.
The CAN ID should always be set to position 1.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
51
3 System description
3.4 Xuri Cell Expansion W25 Pump
3.4
Xuri Cell Expansion W25 Pump
Introduction
Xuri Cell Expansion W25 Pump is a peristaltic pump unit that includes two roller pumps.
It pumps fluid for feed, harvest/waste, and pH control with acid and base.
The dimensions and weight of the pump are listed in Section8.2 Component specifications,
on page 166.
Front view of the pump
The illustration below shows the front panel of the pump.
XuriTM Cell Expansion W25 Pump
ACID
BASE
FEED
HARVEST
WASTE
52
Part
Description
1
Pumphead flip top
2
Pumphead
3
Status LEDs for pumping function per pumphead
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
3 System description
3.4 Xuri Cell Expansion W25 Pump
Status LEDs
The status LEDs indicate the pumping function status according to the following table.
Light indicator
Description
Steady green light
The pumping function is ready for operation.
Green blinking light
Pumping is ongoing.
Red blinking light
Indicates an internal error, but the pump is still operating.
Steady red light
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.
Part
Component
Description
1
UniNet-9 port
Power connection to the rocker.
2
CAN indicator LED
Indicates system connection status.
3
CAN ID switch
Shows the unit number of the pump for recognition
by the system.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
53
3 System description
3.4 Xuri Cell Expansion W25 Pump
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).
Four possible CAN ID positions are available on the switch, marked 1, 2, 3, and 4, respectively. The CAN ID should be set to position 1 for the first pump and to position 2 for the
second pump.
54
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
3 System description
3.5 Cellbag bioreactor
3.5
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 must
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 Xuri Cell Expansion System W25:
•
2L
•
10 L
•
20 L
•
22 L
•
50 L
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
55
3 System description
3.5 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
9
56
4
8
5
7
6
Part
Description
1
pH bag sensor port, located on the underside of the bag.
2
Outlet gas filter with pressure control valve
3
Inlet gas filter
4
Addition port
5
DO bag sensor port, located on the underside of the bag.
6
Cellbag rod
7
CLAVE™ sampling port
8
Addition port
9
Addition/harvest port
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
3 System description
3.5 Cellbag bioreactor
pH and DO sensors
The Cellbag bioreactor may be equipped with optical sensors for monitoring of pH and
dissolved oxygen (DO). The sensors are light sensitive and should therefore 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
Description
Bag sensor
port
The sensor port is located on the underside of the Cellbag bioreactor.
The actual sensor (white 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
Sensor
adapter
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.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
57
3 System description
3.6 UNICORN software overview
3.6
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.
This section contains the following subsections:
Section
58
See page
3.6.1 General UNICORN operation
59
3.6.2 System control
62
3.6.3 Evaluation
67
3.6.4 Administration
68
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
3 System description
3.6 UNICORN software overview
3.6.1 General UNICORN operation
3.6.1
General UNICORN operation
UNICORN modules overview
UNICORN consists of four modules: System Control, Evaluation, Administration and
Method Editor.
The main functions of three of the modules are described in the table below.
Module
Main functions
System Control
Start, view and control runs.
Evaluation
Open results, evaluate runs and create reports.
Administration
Perform user and system setup, system log and database
administration.
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.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
59
3 System description
3.6 UNICORN software overview
3.6.1 General UNICORN operation
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...
then...
find information about
a UNICORN module
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)
•
•
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
•
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
•
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
search for a specific
term in the online help
access manuals in PDF
format
60
press the F1 key with the item of interest selected and
in focus
or
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
3 System description
3.6 UNICORN software overview
3.6.1 General UNICORN operation
If you want to...
then...
find information about
an instruction
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
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
61
3 System description
3.6 UNICORN software overview
3.6.2 System control
3.6.2
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. Data is illustrated as curves in the Chart tab during the
entire run.
Refer to Section 5.5 Perform cultivation, on page 145 for information on how to perform
a run and to Section 5.5.2 Monitor a run, on page 147 for information on how to work with
the Process Picture.
Tip:
62
To get more information than what is shown in the Process Picture, select
View:Run Data to open the Run Data pane which presents current data in
numerical values.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
3 System description
3.6 UNICORN software overview
3.6.2 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...
then...
activate or deactivate a
function
click on the right-hand side of the button.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
63
3 System description
3.6 UNICORN software overview
3.6.2 System control
If you want to...
then...
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
64
enter appropriate values in the Settings dialog and click
OK or press enter.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
3 System description
3.6 UNICORN software overview
3.6.2 System control
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.
Step
Action
1
In the System Control module, select System:Settings.
Result: The System Settings dialog opens with the Instructions displayed.
See examples of different menus below.
2
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.
3
Select settings and choose parameter values for the selected instruction.
Click OK.
4
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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3 System description
3.6 UNICORN software overview
3.6.2 System control
Step
Action
1
In the System Control module:
•
select Manual:Execute Manual Instructions
or
•
use the shortcut Ctrl +M.
Result: The Manual instructions dialog opens.
2
In the Manual instructions dialog:
3
•
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.
4
To perform the instructions, click Execute.
Run data
The Run Data pane shows the current values of for example rocking motion, pH measurement and accumulated time. Since there are many Run Data the view can be customized. To see more information, select View:Run Data and:
•
right-click in the Run Data pane and select Run Data Groups:Detailed
or
•
66
right-click and select Customize to customize the appearance of the Run Data pane.
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3.6 UNICORN software overview
3.6.3 Evaluation
3.6.3
Evaluation
Introduction
The Evaluation module is used to evaluate the results from bioreactor runs.
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 Xuri Cell Expansion System W25 User Manual for more information about
result evaluation.
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3 System description
3.6 UNICORN software overview
3.6.4 Administration
3.6.4
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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4
Installation
In this chapter
This chapter provides instructions to enable users and service personnel to:
•
unpack the bioreactor system delivered from the factory
•
install the system units
•
install UNICORN software
•
edit system properties
Read the entire installation chapter before starting to install Xuri Cell Expansion System
W25.
NOTICE
The rocker has a scale function (load cells) and should therefore
be handled with extra care. The rocker shall not be placed on any
parts that may move. Avoid exposing the load cells to lateral forces,
such as pushing it sideways on the bench, which may cause disturbances in the measurement, or damage the load cells.
This chapter contains the following sections:
Section
See page
4.1 Site preparation
70
4.2 Hardware installation
76
4.3 Software installation
85
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4.1 Site preparation
4.1
Site preparation
In this section
This section describes the site planning and the preparations necessary before installation
of Xuri Cell Expansion System W25. The purpose is to provide planners and technical
staff with the data needed to prepare the laboratory for the installation.
This section contains the following subsections:
Section
70
See page
4.1.1 Delivery and storage
71
4.1.2 Site requirements
73
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4.1.1 Delivery and storage
4.1.1
Delivery and storage
When you receive the delivery
boxes
•
Record on the packing slip if there is any apparent damage on the delivery boxes.
Inform your GE Healthcare representative of any such damage.
•
Move the delivery boxes to a protected location indoors.
Delivery boxes
The system units are shipped in delivery boxes with the following dimensions and weight.
Contents
Dimensions (mm)
Weight (kg)
Xuri Cell Expansion
System W25,
rocker
685 x 540 x 390 (including pallet)
32
Xuri Cell Expansion
W25 CBCU
370 x 405 x 160
7
Xuri Cell Expansion
W25 Pump
370 x 345 x 160
5
Tray 10
655 x 545 x 170
7
Tray 20
880 x 685 x 150
11
Tray 50
940 x 815 x 150
13
Lid 10
585 x 540 x 275
4
Lid 20
850 x 590 x 285
6
Lid 50
910 x 720 x 305
7
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4.1.1 Delivery and storage
Storage requirements
The delivery boxes should be stored in a protected location indoors. The following storage
requirements must be fulfilled for the unopened boxes.
72
Parameter
Allowed range
Ambient temperature, storage
-25°C to 50°C
Humidity
5% to 95% humidity, non-condensing
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4.1 Site preparation
4.1.2 Site requirements
4.1.2
Site requirements
Laboratory bench
•
The bench is recommended to be at least 80 cm deep and 180 cm wide.
•
The bench must be clean, level, flat and stable, and able to withstand vibration from
the rocking.
•
Do not place any other vibrating equipment on the same bench, since vibrations
might affect the weight reading.
•
The bench must be able to support the total weight of the system, including the filled
Cellbag bioreactor. See Equipment weight, on page 166. If other optional instruments
are installed, their weights must also be included.
•
Do not place soft material, paper sheets or similar under the system, as this may
block the ventilation inlet.
Illustration of system setup
The illustration below shows the recommended setup of the bioreactor system on the
laboratory bench.
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4 Installation
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4.1.2 Site requirements
Power requirements
The table below specifies the power requirements.
Parameter
Requirement
Supply voltage
100-120/200-240 V ~ ±10%
Frequency
50-60 Hz
Transient level
Overvoltage category II
Maximum power consumption
of the system
1500 VA
Type of sockets
EU or US plugs. Grounded main sockets, fused or
protected by equivalent circuit breaker.
Location of sockets
Maximum 2 m from the instrument (due to length
of mains cable). Extension cables can be used if
necessary.
Environment requirements
The bioreactor system is intended for indoor use only. The following requirements must
be fulfilled:
•
The room must have forced ventilation, adapted for usage of CO2, O2 and N2.
•
The system units should not be exposed to direct sunlight.
Allowed ranges for environmental parameters are specified in the table below.
Parameter
Allowed range
Ambient temperature, operating
15°C to 32°C
Relative humidity, operating
Maximum relative humidity 80%
Altitude
Maximum 2000 m
Atmospheric pressure
800 mbar to 1060 mbar
Pollution degree
2
Note:
74
For satisfactory temperature control, the ambient temperature must be at
least 5°C lower than the desired culture growth temperature.
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4.1.2 Site requirements
Noise level
•
The noise level of the operating bioreactor system is below 65 dBA.
•
Audio warning signals have a higher noise level than the operating system.
Heat output
The heat output data is listed in the table below.
Component
Heat output
Bioreactor system, including the rocker
unit, CBCU and pump.
Maximum 1500 W
Gas supply
The table below lists the gas supplies that may be required.
Gas
Pressure (bar)
Compressed
air/N2, CO2 and O2.
1.2 (1.0 to 1.5)
Gas flow
The table below lists the gas flow required.
Gas
Flow (l/min)
Normal use
Flow (l/min)
Fast fill
Compressed air/N2
1.3
3.5
CO2
0.2
0.5
O2
0.7
1.7
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4.2 Hardware installation
4.2
Hardware installation
In this section
This section describes the installation procedure for Xuri Cell Expansion System W25.
This section contains the following subsections:
Section
76
See page
4.2.1 Unpack the system units
77
4.2.2 Connect the system units
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4.2 Hardware installation
4.2.1 Unpack the system units
4.2.1
Unpack the system units
Unpacking instruction
Follow the instructions below to unpack each box and to lift the system units onto the
bench.
Step
Action
1
Place the box on a smooth and flat surface with the correct side facing upwards.
2
Open the packaging with a knife and remove the pieces of foam from around
the system unit.
3
Lift up the system unit and place it on the bench.
Note:
When lifting the rocker, use the handles placed on each long side
Note:
Keep each unit in an upright position during unpacking. Protect units from
bumping into other objects.
NOTICE
The rocker has a scale function (load cells) and should therefore
be handled with extra care. The rocker shall not be placed on any
parts that may move. Avoid exposing the load cells to lateral forces,
such as pushing it sideways on the bench, which may cause disturbances in the measurement, or damage the load cells.
CAUTION
Heavy object. Because of the significant weight of Xuri Cell
Expansion System W25, rocker, assistance from another person is
highly recommended when lifting or moving the equipment. Use
the handles on the sides of the rocker when possible, and do not
lift Xuri Cell Expansion System W25, rocker with tray attached.
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4.2 Hardware installation
4.2.1 Unpack the system units
Install the client computer
equipment
Install the client computer equipment according to the manufacturer's instructions. The
computer is either:
•
Supplied as a part of the bioreactor system delivery
•
Supplied locally
IP settings for standalone installation
For a standalone installation, the client computer's network card that is connected to
the rocker should have the static IP 192.168.1.3. Refer to UNICORN Administration and
Technical manual, Appendix D for instructions on how to change these settings.
NOTICE
Any computer used with the equipment shall comply with IEC 60950
and be installed and used according to the manufacturer's instructions.
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4.2.2 Connect the system units
4.2.2
Connect the system units
Connect power to the rocker and
computer
Step
Action
1
Connect the supplied power cord between the power inlet on the rear panel
of the rocker and a grounded power outlet.
1
2
3 4
5
Part
Description
1
Filter heater connector no. 1
2
Filter heater connector no. 2
3
UniNet-9 port no. 1
4
UniNet-9 port no. 2
5
UniNet-9 port no. 3
6
Ethernet connector
7
Power connector
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7
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4 Installation
4.2 Hardware installation
4.2.2 Connect the system units
Step
Action
2
Follow the manufacturer's instruction to connect power to computer, monitor
and local printer (if used).
Connect system units to the
rocker
Follow the instructions below to connect system units to the rocker.
Step
Action
1
Connect the supplied UniNet cable between the UniNet-9 port on the CBCU
rear panel (see image below) and UniNet-9 port no. 1 on the rocker rear
panel.
1
2
80
Part
Description
1
UniNet-9 port
2
CAN ID switch
2
Make sure that the CBCU CAN ID is in position 1.
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4.2 Hardware installation
4.2.2 Connect the system units
Step
Action
3
Connect the supplied UniNet cable from the UniNet-9 port on the rear panel
of the first pump (see image below) to UniNet-9 port no. 2 on the rocker rear
panel. If an additional pump is used, it should be connected to UniNet-9 port
no. 3.
4
Part
Description
1
UniNet-9 port
2
CAN ID switch
Make sure that the pump CAN ID is in position 1. If an additional pump is
connected, it should have CAN ID 2.
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4.2 Hardware installation
4.2.2 Connect the system units
Step
Action
5
Connect the supplied cable, with the flat part facing up, from the port on
the filter heater (see image below) to the filter heater connector no. 1 on the
rocker rear panel.
Note:
When connected, the filter heater connector is locked to prevent it from being
disconnected by a sudden pull. It has a spring effect in the sleeve and by
pulling the connector backwards, the spring effect releases the lock.
Prepare gas tubing
For gas distribution with full gas mixing functionality (N2/Air, CO2 and O2), four pieces of
gas tubing are needed. Three pieces are used to connect the gas sources to the inlets
on the rear panel of the CBCU, and one piece is used to connect the gas mix outlet on
the front panel of the CBCU with the Cellbag bioreactor.
Follow the instructions below to prepare tubing for gas distribution.
Step
Action
1
Cut the Tygon™ tubing in four pieces of appropriate length.
2
Insert the CPC tubing connectors to one end of each piece.
Note:
Up to three of the pieces may be used for gas distribution from the gas sources
of choice to the CBCU inlets.
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4.2.2 Connect the system units
Step
Action
3
On the fourth piece of tubing: connect the end without the CPC connector
to the silicone tubing using a reducer connector.
Note:
This piece of tubing shall be used for gas distribution from the CBCU gas mix
outlet to the Cellbag bioreactor.
Jumpers
Since the rocker UniNet-9 ports are connected in series, there should not be any unused
UniNet-9 ports when the rocker has been connected to other system units.
Special jumpers that should be used to plug unused ports are delivered with the rocker,
see image below.
Connect to network or computer
Connect a network cable between the Ethernet connector on the rocker rear panel and
your network. In case of a stand-alone installation, the network cable should be directly
connected to the client computer. See Section 4.3 Software installation, on page 85 for
more information about stand-alone installations.
The illustration below shows the symbol of the Ethernet connector.
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4 Installation
4.2 Hardware installation
4.2.2 Connect the system units
If you want to connect to a wireless network, you can connect a WiFi USB adapter to
the USB port. Contact your GE Healthcare representative for support on how to make
network installations.
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4.3 Software installation
4.3
Software installation
In this section
This section describes how to perform a complete UNICORN installation on a stand-alone
workstation (Full installation). Instructions on how to configure an e-license, define a
system, and set up a system printer are also included.
Note:
For other types of installations, contact your GE Healthcare representative for
support. This includes network installations when you want to access Xuri Cell
Expansion System W25 from several client computers, or if you want an installation for control from external software.
Additional information about software installation and configuration is available in the
UNICORN Administration and Technical manual.
This section contains the following subsections:
Section
See page
4.3.1 Install UNICORN
86
4.3.2 Configure an e-license
96
4.3.3 Define a system
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85
4 Installation
4.3 Software installation
4.3.1 Install UNICORN
4.3.1
Install UNICORN
Introduction
The full UNICORN installation includes all software component parts, including the
UNICORN database, necessary to operate UNICORN and a connected local system.
The installation includes the components described in the table below.
Software component
Characteristics
UNICORN software
The UNICORN software includes the four modules; Administration, Method Editor, System Control and Evaluation.
Database server
The server software necessary to operate the database
where all UNICORN data is stored. Microsoft SQL Server®
Express Edition is used for this.
License server
The license server software is used to authorize that the
UNICORN software installation is properly licensed.
Note:
86
For general technical specifications for UNICORN computers, refer to Section8.3
Client computer specifications, on page 170.
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4.3 Software installation
4.3.1 Install UNICORN
Step 1 - Insert the installation
DVD
Step
Action
1
Insert the installation DVD in your DVD drive.
Result: The UNICORN Installation wizard opens with a welcome dialog.
Tip:
If the DVD drive is not set up to allow automatic start, browse the DVD contents
and doubleclick the file Setup.exe to initiate the installation.
2
Click the Next button.
3
The UNICORN Installation Program is launched. Continue the installation
below.
Tip:
You can exit the installation by clicking the Cancel button. However, if you do
this the installation will be incomplete and the software cannot be used. You
may also click the Back button in some installation steps, to return to a previous
step to change selections.
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4 Installation
4.3 Software installation
4.3.1 Install UNICORN
Step 2 - License agreement
The next installation step shows the UNICORN License Agreement text.
88
Step
Action
1
Read the license agreement carefully.
2
Select the I accept the terms option.
3
Click the Next button to proceed.
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4.3 Software installation
4.3.1 Install UNICORN
Step 3 - Select type of installation
In the third step of the installation you decide what kind of installation you want to make.
Step
Action
1
Click the Full installation button. The Full installation includes all the
UNICORN software necessary for stand-alone operation.
2
Click the Next button to proceed.
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4 Installation
4.3 Software installation
4.3.1 Install UNICORN
Step 4 - Select type of system
Specify what kind of system that UNICORN mainly will be used for.
90
Step
Action
1
Click the Cell Cultivation button.
2
Click the Next button to proceed.
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4.3 Software installation
4.3.1 Install UNICORN
Step 5 - Select installation folder
Select the installation folder for UNICORN.
Step
Action
1
By default, UNICORN will suggest the following installation folder:
C:\Program Files\GE Healthcare\UNICORN\.
Either
•
accept this installation folder
or
•
click Change ... and locate the folder you want to install in.
Note:
UNICORN will calculate the available diskspace for the selected installation
folder. The space required for the installation is also shown.
Note:
UNICORN 6 cannot be installed on a compressed disk.
2
Click the Next button to proceed.
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4 Installation
4.3 Software installation
4.3.1 Install UNICORN
Note:
The general UNICORN installation folder structure will be saved in the folder
selected in this step. However, the SQL Server software and e-license server
software will be installed on the C drive by default. If the available space for
this is insufficient, the installation may fail. The required space will vary depending on what is previously installed on the computer but at least 2 GB should
be available to ensure that the installation will be completed correctly.
Step 6 - Specify data storage
Specify storage folders for database backups and for archived database items.
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4.3.1 Install UNICORN
Step
Action
1
Click the Browse button adjacent to the Backup files folder field and navigate
to a suitable folder where the database backups should be saved.
Note:
By default UNICORN will suggest a Backup folder in the selected installation
folder. However, if possible it is recommended that the backups are saved on
another physical drive than where the active database is stored. This physical
drive must be installed on the same computer as where the database is installed, for example a D drive as illustrated above. Network folders cannot be
used for this purpose.
2
Click the Browse button adjacent to the Archive files folder field and navigate
to a suitable folder where the data should be archived.
Note:
By default UNICORN will suggest an Archive folder in the selected installation
folder. However, if possible it is recommended that the archives are saved on
another physical drive than where the active database is stored. This physical
drive must be installed on the same computer as where the database is installed. Network folders cannot be used for this purpose.
3
Click the Next button to proceed.
Note:
To ensure data safety, it is recommended that the backup and the archive
folders are copied or moved at regular intervals to another server computer
or some other storage media.
Tip:
Under the Windows Start menu Programs:GE Healthcare:UNICORN
6.3:Configuration Tools you will find UNICORN Configuration Manager. This
dialog can be used to edit the backup and archive information after the installation.
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4 Installation
4.3 Software installation
4.3.1 Install UNICORN
Step 7 - Password settings
Choose the password settings you wish to apply for UNICORN.
Step
Action
1
By default, the Require passwords option is selected.
•
2
Tip:
94
If you do not want to use passwords at log on or for electronic signatures,
de-select this option.
Click the Next button to proceed.
Under the Windows Start menu Programs:GE Healthcare:UNICORN
6.3:Configuration Tools you will find UNICORN Configuration Manager. This
dialog can be used to edit the password settings after the installation.
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4.3 Software installation
4.3.1 Install UNICORN
Step 8 - Installation completed
The final wizard dialog shown below opens when the installation is complete and the
UNICORN database, e-license server and software are all installed on the workstation
computer.
At this point you may select to
•
click Configure eLicense...
Result: The Configure eLicense... dialog opens.
•
click Define System... to define a system
Result: The Define System dialog opens.
and/or
•
view an installation summary report.
These dialogs are described in subsequent sections in this chapter
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4 Installation
4.3 Software installation
4.3.2 Configure an e-license
4.3.2
Configure an e-license
Introduction
This section describes how to configure an e-license as part of a UNICORN installation.
You can access the configuration dialog at a later time to perform the steps described
below. The dialog is available from the Windows Start:All programs menu under the
heading GE Healthcare. Choose Windows Start menu Programs:GE Healthcare:UNICORN
6.3:Configuration Tools:Configure e-License.
Before you start
Access Code
Before you can retrieve an e-license from the GE Healthcare software e-licensing web
site, you must have received an Access Code with your software or via courier mail.
Without this code you will not be able to configure the e-license. Contact your GE
Healthcare representative if you have not received the code.
Internet connection
To activate the e-license, you must have access to the Internet. If you are configuring
the e-license for a stand-alone workstation with no external network access, retrieve
the e-license file using another computer and then move the file to the workstation
computer using, for example, a USB memory stick.
Computer Ethernet address
You will need the Ethernet address for the computer when you follow the instructions
in this section. This address is shown in the Configure e-License dialog.
Note:
96
The displayed address should be the Ethernet address for the Network Interface
Card (NIC) which is used for the communication with the instrument, and not
the address for a second interface card used for external network communication. If the computer is equipped with two interface cards you may need to
verify the Ethernet address.
This is described below.
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4.3 Software installation
4.3.2 Configure an e-license
Step
Action
1
•
Open a Command Prompt window 1
and
•
enter the command ipconfig/all to display the Ethernet addresses.
2
Locate the Network Interface Card (also called Ethernet adapter) with the
IP address used to connect to the instrument. This is the Network Interface
Card which is used for instrument communication.
3
The Ethernet address for this card is listed as the Physical Address. Verify
that this is address shown in the Configure e-License dialog.
Different types of e-licenses
The table below provides an overview of some of the types of e-licenses available for
UNICORN. A floating license can be used on any workstation in a network, but there can
only be as many simultaneous users as there are valid licenses. UNICORN can be installed
on more workstations than the number of valid licenses, but all these workstations
cannot be used simultaneously. A node locked license can be used on one workstation
only.
1
Type
Description
Workstation license
The workstation license is a node locked license that is used
for one client computer only.
Remote license
The remote license is a floating license that can be used on
any workstation in a network.
Dry license
The dry license is a floating license that can be used for all
functionality except connecting to an instrument.
In Windows XP, click the Start button and choose Programs:Accessories:Command Prompt.
In Windows 7, click the Windows icon and choose All Programs:Accessories:Command Prompt.
You can also press and hold the Windows key and then press the letter R. Type 'cmd' in the
input field and click OK or press Enter.
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4.3 Software installation
4.3.2 Configure an e-license
Initiate the e-license
configuration
After completing a UNICORN installation, you can choose to proceed to configure e-licenses for the installation. The table below describes how to perform the final installation
step and initiate the e-license configuration.
Step
Action
1
In the Configure e-License dialog:
•
Click the Copy to Clipboard button to copy the Ethernet address.
If the Network Interface Card name has been changed, the Configure
E-License program will not find the address. If this is the case:
•
change the name of the Network Interface Card so that it starts with
Local Area Connection
or
•
2
Note:
98
find the MAC address as described in Computer Ethernet address, on
page 96. Copy the address into the Configure E-License dialog.
Click the hyperlink in the dialog to proceed to access the e-licensing web
site.
When activating additional licenses, it is essential to always use the Ethernet
address for the computer where the license server software is installed. You
should not use the Ethernet addresses for the additional client computers.
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4.3 Software installation
4.3.2 Configure an e-license
Access the e-licensing web site
You must retrieve the e-license from the GE Healthcare e-licensing web site. The table
below describes how to access the site from the configuration dialog.
Step
Action
1
Click the Copy to Clipboard button in the e-License Configuration dialog.
•
2
This will copy the Ethernet address from the computer (shown in the
adjacent field), which will be used in subsequent steps.
Click the hyperlink in the configuration dialog.
Result: The GE Healthcare software elicensing web site opens in your web
browser.
3
Type the Access Code and click the Login button.
Result: The Operations Portal opens.
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4 Installation
4.3 Software installation
4.3.2 Configure an e-license
Retrieve the e-license
The table below describes how to retrieve the e-license from the web site. For help on
how to collect an e-license file, see instructions in Help & FAQ:How do I collect an e-license file?
Step
Action
1
Click the Collect License hyperlink.
Result: The manage entitlements page opens.
2
Select the checkbox for your license and click the Activate button.
Result: A manage entitlements data input page opens.
100
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4 Installation
4.3 Software installation
4.3.2 Configure an e-license
Step
Action
3
Enter the data below:
•
Start date, if requested by the GE Healthcare software e-licensing web
site.
•
Customer data:
-
Name
-
Department
-
Organization
-
Order Email
You must also note if you want software updates and information about
related products or not. All items marked with red dots are mandatory.
•
Click the Next button to proceed to the next page.
Note:
The options Ship to Email or Ship to Address can be selected if, for some
reason, the e-license cannot be saved to a file during the configuration. Normally, this will not be necessary.
4
Under the heading Nodelocked Hosts, click the Add New Host button.
Result: The create license host dialog opens.
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101
4 Installation
4.3 Software installation
4.3.2 Configure an e-license
Step
Action
5
Click in the empty Nodelocked Hosts field and press the Ctrl and V keys simultaneously to paste your Ethernet address from the clipboard into this
field.
Note:
If you use another computer to retrieve the e-license, you must write down
the Ethernet address from the computer you are installing UNICORN on and
type this address in the Nodelocked Hosts field.
Also, if UNICORN identified the wrong Ethernet address (e.g. from a second
network interface card) in the Configure e-License dialog, you must find the
correct address and type it in manually.
Click the OK button to proceed.
Result: Your computer address is added to the Nodelocked Hosts list.
6
If the displayed information in the displayed manage entitlements page is
correct, click the Generate button.
Result: The License summary page opens.
7
Select the checkbox for your license and click the Save to File button.
Result: A download dialog opens. Save the license file in a temporary folder
or on your Windows desktop.
8
102
Click the Complete button and Logout to close the GE Healthcare software
e-licensing web site.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
4 Installation
4.3 Software installation
4.3.2 Configure an e-license
Locate and connect the e-license
The table below describes how to connect and confirm the e-license in the UNICORN
e-License Configuration dialog.
Step
Action
1
•
Click the Browse button to locate the license file
and
•
2
click the Open button to add the search path to the file in the e-License
Configuration dialog.
Click the Configure e-License button.
Result: A confirmation dialog opens, showing that the configuration has
been successful.
3
Click OK in the confirmation dialog, and Close in the configuration dialog to
complete the process.
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103
4 Installation
4.3 Software installation
4.3.3 Define a system
4.3.3
Define a system
Instruction
At the last page in the UNICORN installation program, you can choose to proceed to
define a system. To be able to monitor and control the system from the UNICORN client
you need to define the system in the UNICORN database. This is described in the table
below.
Note:
To enable connection tests, the instrument should be turned on during the
system definition.
Step
Action
1
In the Define System dialog:
Enter a name in the System name field.
Note:
The system name cannot be changed or edited after the system has been
defined.
2
Enter the serial number for the instrument in the Instrument serial no field.
This number is written on a label on the back of the rocker platform. Pull the
platform into tilt position to make the label visible.
The InstrumentServer is by default EPC-<serial number> for bioreactor.
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4.3 Software installation
4.3.3 Define a system
Step
Action
3
Select the appropriate instrument configuration from the Instrument Configuration droplist menu.
Tip:
The list includes all instrument configurations currently in the UNICORN
database. To select a new instrument configuration:
•
Insert the instrument configuration DVD in your CD-ROM drive.
•
Click the Browse button and navigate to the configuration zip-file on the
CD.
•
Select the appropriate configuration file.
The Define System dialog changes and the Connect by option differs depending on the chosen Instrument Configuration.
4
Select to connect by Fixed IP address..
Enter the IP address for the instrument control unit, 10.1.1.69.
5
1
Make sure that the rocker is powered on, and connected via Ethernet to
the client computer.
2
Click the Connection Test button.
Result: The connection between the instrument server station and the instrument is verified.
6
Click the Define System button.
Result: The system definition settings are saved and the new system is added
in the System Properties dialog as an active system. It is recommended to
restart the rocker before the system is used.
Note:
Before the UNICORN client can connect to the system, the rocker LED must
show a steady green light.
7
Select the components connected to the rocker in the System Properties
dialog, as described in Section 5.3 Edit system properties, on page 130.
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5 Operation
5
Operation
In this chapter
This chapter describes how to operate Xuri Cell Expansion System W25.
This chapter contains the following sections:
Section
106
See page
5.1 Prepare the system
107
5.2 Start the system
126
5.3 Edit system properties
130
5.4 Prepare cultivation
132
5.5 Perform cultivation
145
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
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5.1 Prepare the system
5.1
Prepare the system
In this section
This section describes how to prepare the bioreactor system for cell cultivation. For illustrations and descriptions of the system, refer to Chapter 3 System description, on page 37.
This section contains the following subsections:
Section
See page
5.1.1 Select tray and Cellbag bioreactor
108
5.1.2 Prepare pH and DO sensors
112
5.1.3 Attach the Cellbag bioreactor
115
5.1.4 Prepare the pump
117
5.1.5 Connect gas to system
122
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107
5 Operation
5.1 Prepare the system
5.1.1 Select tray and Cellbag bioreactor
5.1.1
Select tray and Cellbag bioreactor
Size selection guide
Select Cellbag bioreactor size and corresponding tray depending on experiment demands
and system configuration, see table below.
108
Cell culture volumes (L)
Cellbag bioreactor size (L)
Tray
0.3 to 1
2
Tray 10, Tray 20
0.5 to 5
10
Tray 10, Tray 20
1 to 10
20
Tray 20
1 to 10
22
Tray 50
5 to 25
50
Tray 50
Note:
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.
Tip:
To achieve good temperature control at low liquid volumes it is critical to keep
the lowest angle possible that is sufficient to attain adequate mixing and aeration.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
5 Operation
5.1 Prepare the system
5.1.1 Select tray and Cellbag bioreactor
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 ledge towards you.
2
Lift the tray into the same angle as the rocker platform.
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109
5 Operation
5.1 Prepare the system
5.1.1 Select tray and Cellbag bioreactor
Step
Action
3
Attach the upper part of the tray onto the upper part of the rocker platform
and slide the tray downwards into place.
Note:
Make sure that the hole(s) in the tray are aligned with the hole(s) in the rocker
platform.
Xuri™
4
Cel Ex
pansio
n Sy
stem W25
Plug the tray connector into the rocker platform connector.
Xuri™
Cel Ex
pansio
n Syst
em W25
110
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5 Operation
5.1 Prepare the system
5.1.1 Select tray and Cellbag bioreactor
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
Xur
i™ Cell
Exp
ans
ion
Sys
tem
W2
5
Grab the textured grip area on each side of the tray and slide it upwards.
2
Pull the tray towards you, and make sure that the temperature sensors exit
the holes of the rocker platform.
Note:
If the tray is detached in normal position, you need to lift up the tray in the
upper edge, before pushing it away from you.
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111
5 Operation
5.1 Prepare the system
5.1.2 Prepare pH and DO sensors
5.1.2
Prepare pH and DO sensors
Instructions
Follow the instructions below to connect the sensor adapters to the pH and DO bag
sensor ports.
Step
Action
1
Remove the Cellbag bioreactor from its protective cover bag.
NOTICE
Intense light will deteriorate the optical sensors on the
Cellbag bioreactor. To avoid unnecessary light exposure, remove the protective black 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 and the spot on the DO sensor port is pink/black. If both
pH and DO sensors are used, one fiber cable is needed for each sensor.
3
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.
Note:
The sensor adapter can be fastened in any of four orthogonal directions. Select
the most convenient direction.
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5.1 Prepare the system
5.1.2 Prepare pH and DO sensors
Step
Action
4
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.
Note:
When rotating the sensor adapter, make sure not to place any force on the
fiber cable.
5
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
To keep track of the optical fiber cables, mark the cables with the supplied
stickers.
7
Bundle the optical fiber cables and place them in the tubing exit. See Illustrations of tray and lid, on page 43.
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113
5 Operation
5.1 Prepare the system
5.1.2 Prepare pH and DO sensors
114
Step
Action
8
Connect the pH sensor cable to the pH port on the CBCU front panel (see
below).
9
Connect the DO sensor cable to the DO port on the CBCU front panel (see
below).
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
5 Operation
5.1 Prepare the system
5.1.3 Attach the Cellbag bioreactor
5.1.3
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, such as a
10 L bag on Tray 20, make sure to position the bag on the left side of the tray.
Step
Action
1
Push the bag clamp opener in one upper corner of the tray downwards. This
opens the upper bag clamp.
2
Insert the upper Cellbag rod into the opened bag clamp.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
115
5 Operation
5.1 Prepare the system
5.1.3 Attach the Cellbag bioreactor
Step
Action
3
Push the bag clamp opener upwards to secure the upper end of the Cellbag
bioreactor. Gently pull the Cellbag to make sure it is attached.
4
Repeat the above steps to attach the lower Cellbag rod to completely secure
the Cellbag bioreactor on the tray.
5
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.
116
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5 Operation
5.1 Prepare the system
5.1.4 Prepare the pump
5.1.4
Prepare the pump
Tubing holder positions
The pumphead 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.
The image below shows the inner position for small tubing.
Image below shows the outer position for large tubing.
The wall thickness of the tubing should be 1.6 mm (1/16"). The table below specifies the
appropriate tubing inner diameters for the two positions.
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117
5 Operation
5.1 Prepare the system
5.1.4 Prepare the pump
Tubing inner diameter
(mm)
Tubing inner diameter (")
Tubing holder position
0.5
1/50
Inner
0.8
1/32
Inner
1.6
1/16
Inner
2.4
3/32
Inner
3.2
1/8
Inner
4.0
5/32
Outer
4.8
3/16
Outer
NOTICE
If the tubing holder is in its inner position when larger tubing is
used, flow and tubing life will decrease.
If the tubing holder is in its outer position when smaller tubing is
used, there is a risk for rupture and wandering of the tubing.
Adjust tubing holder position
Use a pointed device such as a ball pen to adjust the tubing holder positions on both
sides of the pumphead. Follow the instructions below to change from outer to inner
position.
118
Step
Action
1
Make sure that the pump is not running.
2
Open the flip top of the pumphead completely.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
5 Operation
5.1 Prepare the system
5.1.4 Prepare the pump
Step
Action
3
Place the pointed device in the small depression on one side of the pumphead.
4
Press down and towards the back of the pumphead.
5
Keep pressing to the back until the jaw clicks.
6
Release the pressure and the jaw rises into the new position.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
119
5 Operation
5.1 Prepare the system
5.1.4 Prepare the pump
Step
Action
7
Repeat the above steps to adjust the tubing holder on the other side of the
pumphead.
To change the tubing holder position from inner to outer position, carry out the same
procedure, but press towards the front of the pumphead.
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.
Load tubing
Follow the instructions below to load tubing in the pumphead.
120
Step
Action
1
Make sure that the pump is switched off.
2
Open the flip top of the pumphead completely.
3
Adjust the tubing holder to the correct position for your size of tubing. See
instructions above.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
5 Operation
5.1 Prepare the system
5.1.4 Prepare the pump
Step
Action
4
Place the tubing between the rotor rollers and the track, pressed against
the pumphead inner wall.
5
Lower the flip top until it clicks into its fully closed position.
Note:
The pumping direction is clockwise.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
121
5 Operation
5.1 Prepare the system
5.1.5 Connect gas to system
5.1.5
Connect gas to 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 N2 can be mixed with
CO2 and/or O2 to obtain the desired gas mix.
Compressed air or N2 is connected to AIR/N2 on the CBCU. CO2 and O2 are connected
to CO2 IN and O2 IN, respectively, on the CBCU rear panel.
122
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5 Operation
5.1 Prepare the system
5.1.5 Connect gas to system
Set up the gas system
Follow the instructions below to connect gas to the bioreactor system.
Step
Action
1
Attach the filter heater to the outlet gas filter of the Cellbag bioreactor.
The image below shows the filter heater mounted on the stand on the Cellbag
bioreactor.
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123
5 Operation
5.1 Prepare the system
5.1.5 Connect gas to system
124
Step
Action
2
Connect tubing from the GAS MIX OUT on the CBCU front panel to the inlet
gas filter of the Cellbag bioreactor.
3
Connect the desired gas source, air or N2, at 1.2 bar (1.0 to 1.5 bar) to AIR/N2
on the CBCU rear panel.
4
If applicable, connect the CO2 gas source at 1.2 bar (1.0 to 1.5 bar) to CO2
IN on the CBCU rear panel.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
5 Operation
5.1 Prepare the system
5.1.5 Connect gas to system
Step
Action
5
If applicable, connect the O2 gas source at 1.2 bar (1.0 to 1.5 bar) to O2 IN
on the CBCU rear panel.
NOTICE
Make sure to keep the inlet pressures within the stated limits (1.0
to 1.5 bar). Too high pressure may cause internal tubing to loosen.
NOTICE
An unsteady inlet pressure will affect the speed of the gas flow
control and also the gas mix.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
125
5 Operation
5.2 Start the system
5.2
Start the system
Introduction
This section describes how to start the system, log on to UNICORN and connect the
system to UNICORN.
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.
See Section 4.3.2 Configure an e-license, on page 96 for more information about e-licenses.
Step
Action
1
Turn on the client computer.
2
Double-click the UNICORN icon on the desktop.
Result: The Log On dialog opens.
126
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5 Operation
5.2 Start the system
Step
Action
3
In the Log On dialog:
•
select User Name
and
•
enter Password
Note:
It is also possible to select the Use Windows Authentication checkbox
and enter a network ID in the User Name field.
•
click OK
Result: The UNICORN modules the user has chosen under Options are
opened.
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127
5 Operation
5.2 Start the system
Step
Action
4
Switch on the rocker. It is blinking green while starting up.
Xuri™ Cell Expansion System W25
Note:
Pressing the power button while the rocker is on will shut down the system
and stop any ongoing run.
Connect to 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.
128
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
5 Operation
5.2 Start the system
Step
Action
2
In the Connect to Systems dialog:
•
Select the system.
•
Select Control mode.
•
Click OK.
Result: The Process Picture appears.
Tip:
If UNICORN is unable to connect to the selected system, see Section 7.5
UNICORN System Control, on page 162.
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129
5 Operation
5.3 Edit system properties
5.3
Edit system properties
Introduction
The system properties of a system can be edited. For example if you want to:
•
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, delivered on
a DVD or possible to download from the GE Healthcare homepage..
Instruction
The table below describes how to edit the properties of a system:
Step
Action
1
In the Tools menu, open the Administration module.
Click System Properties.
130
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5 Operation
5.3 Edit system properties
Step
Action
2
•
Select your system in the System Properties dialog.
Note:
Only active systems can be edited.
•
Click the Edit button.
Result: The Edit dialog is displayed.
3
4
5
1
Select the desired instrument configuration from the Instrument configuration droplist menu.
2
Select the instrument server named EPC-<serial number> from the Instrument server droplist menu.
3
Choose the connection type Instrument serial no.
All possible components are shown in the Component selection list.
•
Click the checkboxes to select or de-select components.
•
Make sure the components selected match the units connected to the
system.
Click the OK button to apply the changes.
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131
5 Operation
5.4 Prepare cultivation
5.4
Prepare cultivation
In this section
This section describes the procedures before starting the cell cultivation. For illustrations
and descriptions of the system, refer to Chapter 3 System description, on page 37.
This section contains the following subsections:
Section
132
See page
5.4.1 Start a run
133
5.4.2 Pre-culture preparation
137
5.4.3 Addition of culture medium
139
5.4.4 Equilibrate the culture medium
142
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
5 Operation
5.4 Prepare cultivation
5.4.1 Start a run
5.4.1
Start a run
Introduction
This section describes how to start a manual run or to start a run using a previously
defined method. The data collection begins when a run starts.
For further information on method creation, refer to Xuri Cell Expansion System W25
User Manual.
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133
5 Operation
5.4 Prepare cultivation
5.4.1 Start a run
Start a manual run
The instruction below describes how to start a manual run.
Step
Action
1
Acknowledge a change of any settings, for example:
1
Click the Cellbag icon.
2
Enter pH and DO calibration data.
3
Click OK.
Result: The Start Protocol dialog for the manual run opens.
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5 Operation
5.4 Prepare cultivation
5.4.1 Start a run
Step
Action
2
On the displayed page in the Start Protocol:
1
Type the Result name and change the Location of where the result is
saved if necessary.
2
Select the correct Bag size.
3
Click OK.
Result: The manual run starts.
Start a method run
The instruction below describes how to start a method run.
Tip:
It is possible to have a method run going, for example a method based on the
predefined method WAVE 25 template, and at the same time control the
system from the Process Picture.
Step
Action
1
Open the System Control module and click the icon Open Method Navigator.
Result: The Method Navigator pane opens.
2
Select the method to run, and click the Run icon.
Result: The Start Protocol dialog for the method run opens.
3
On the displayed page in the Start Protocol, add requested input and make
appropriate changes if necessary. Click Start.
Result: The method run starts.
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135
5 Operation
5.4 Prepare cultivation
5.4.1 Start a run
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.
If you want to...
then...
temporarily hold the method
click the Hold icon.
Note:
When a method is held, the system control is maintained, but no new instructions are given.
resume a held method run
click the Continue icon.
Note:
An ended method cannot be continued.
permanently end the run
Note:
click the End icon.
When ending a method run prematurely, it is possible to save the partial result.
Actions in the Process Picture
pane
It is possible to interact with the Process Picture. Refer to Actions in the Process Picture
pane, on page 63 for more information.
136
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5 Operation
5.4 Prepare cultivation
5.4.2 Pre-culture preparation
5.4.2
Pre-culture preparation
Instructions
Follow the instructions below to prepare the bioreactor system for cell cultivation.
NOTICE
Always use aseptic technique when connecting or disconnecting
tubing to the Cellbag bioreactor.
Step
Action
1
Follow these instructions to inflate the Cellbag bioreactor.
1
Make sure that all ports on the Cellbag bioreactor are closed and that
inlet and outlet filters are open.
2
Open Settings:Gas control:Gas flow from the Process Picture in System
Control.
3
Enable Fast fill.
4
Turn on Gas flow from the Process Picture by pressing the right-hand
side of the Gas flow button.
Note:
If Fast fill is enabled, the gas flow is maximized during the first 20 minutes.
Result: The Cellbag is inflated.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
137
5 Operation
5.4 Prepare cultivation
5.4.2 Pre-culture preparation
Step
Action
2
Connect inlet and outlet tubing to the Cellbag bioreactor, for example acid,
base, feed and harvest/waste.
3
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 strength you should elaborate with the Molarity parameter to get optimal pH control.
4
If preparing a perfusion cultivation, calibrate the feed and harvest/waste
pumps to reach optimal precision.
Tip:
For perfusion, auto calibration can be enabled which makes this action unnecessary.
Click Calibrate.
Result: The Calibration dialog opens. Refer to Calibration instruction, on
page 152 for instructions on how to calibrate the pump.
5
138
Click OK.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
5 Operation
5.4 Prepare cultivation
5.4.3 Addition of culture medium
5.4.3
Addition of culture medium
Important
It is important to tare the scale with all the equipment on the tray, such as lid, Cellbag
bioreactor, and filter heater. The measured weight should for optimal control 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.
Make sure that the rocker stands on a horizontal surface and that the tray is in a horizontal position.
NOTICE
The rocker has a scale function (load cells) and should therefore
be handled with extra care. The rocker shall not be placed on any
parts that may move. Avoid exposing the load cells to lateral forces,
such as pushing it sideways on the bench, which may cause disturbances in the measurement, or damage the load cells.
Instructions
Follow the instructions below to fill the Cellbag bioreactor with culture medium.
Step
Action
1
Reduce the gas flow to avoid high pressure alarm.
Note:
Continue gas flow to the headspace to keep the Cellbag bioreactor inflated.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
139
5 Operation
5.4 Prepare cultivation
5.4.3 Addition of culture medium
Step
Action
2
Open Settings:Weight from the Process Picture in System Control.
3
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 41.
Note:
The tray must be in horizontal position.
4
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.
5
Open Rocking from the Process Picture.
Change 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 Cellbag at an angle. The angle can be adjusted to make sure that the
medium reaches all optical sensors during filling.
6
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.
7
140
Increase the gas flow to operation setpoint.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
5 Operation
5.4 Prepare cultivation
5.4.3 Addition of culture medium
Step
Action
8
If pH and/or DO control will be used, check the pH and DO sensor labels on
the Cellbag bioreactor for sensor calibration data.
Note:
Do not start pH and/or DO reading until the medium is equilibrated. The sensors do not give reliable measurements until then.
1
Open Settings:Cellbag:Left/Single.
2
Make sure the correct Bag size is selected.
3
Enter the Bag sensor calibration data.
4
Click OK.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
141
5 Operation
5.4 Prepare cultivation
5.4.4 Equilibrate the culture medium
5.4.4
Equilibrate the culture medium
Important
Equilibration of the culture medium for a minimum of 2 hours is important in order to
reach the desired operating conditions and for the optical sensors to function properly.
Standard conditions for 100% air saturation DO calibration is when the Cellbag bioreactor
is flushed with 100% air. If you perform the DO calibration with air mixed with 0%-10%
CO2 it is possible to calibrate DO down to 90% air saturation.
100% air saturation DO calibration must not be performed if N2 is used instead of air.
Note:
CO2 regulation is slow, so it takes some time before the CO2 concentration
reaches the setpoint.
NOTICE
Do not move the rocker during a run, since this could damage the
scale function and disturb the weight measurement.
Instructions
For recommendations on operating conditions, refer to Xuri Cell Expansion System W25
User Manual.
Follow the instructions below to equilibrate the culture medium.
142
Step
Action
1
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
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.
3
If applicable, turn on CO2 mixing by clicking the right-hand side of the CO2
button in the Process Picture.
4
Click the right-hand side of the Temp button to start heating.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
5 Operation
5.4 Prepare cultivation
5.4.4 Equilibrate the culture medium
Step
Action
5
When target temperature has been attained, do the following from the
Process Picture:
•
click Settings:DO and set Reading On.
•
click Settings:pH and set Reading On.
Wait until the values are stable.
6
7
Perform the DO calibration:
1
Select System:Calibrate in System Control.
2
Select the DO sensor in the Monitor to calibrate drop down menu.
3
Enter percentage of air saturation (90%-100%) depending on CO2 concentration in the Enter reference DO field.
4
Click Calibrate.
5
Close the Calibration dialog.
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:Rocking:Sampling:Pause and at an angle set in Settings:Rocking:Sampling:Stop
angle in the Process Picture.
8
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 troubleshooting in Xuri
Cell Expansion System W25 User Manual.
9
If the deviation is less than 0.5 pH units, do the following:
1
Select System:Calibrate in System Control.
2
Select the pH sensor in the Monitor to calibrate drop down menu.
3
Enter the actual pH value in the Enter reference pH field.
4
Click Calibrate.
5
Close the Calibration dialog.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
143
5 Operation
5.4 Prepare cultivation
5.4.4 Equilibrate the culture medium
144
Step
Action
10
1
Select Settings:DO in the Process Picture.
2
Enter the desired values for:
•
Control
•
Setpoint
•
Alert (deviation alarm interval).
3
Click OK.
4
Repeat step 1 to 3 for the pH parameters.
11
Turn on DO and pH control by clicking the right-hand side of the relevant
buttons in the Process Picture.
12
Make sure that the key culture parameters pH, DO and temperature are
stable before inoculation.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
5 Operation
5.5 Perform cultivation
5.5
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
See page
5.5.1 Inoculation
146
5.5.2 Monitor a run
147
5.5.3 End cultivation
148
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
145
5 Operation
5.5 Perform cultivation
5.5.1 Inoculation
5.5.1
Inoculation
Instructions
Follow the instructions below to inoculate the Cellbag bioreactor.
146
Step
Action
1
Make sure that the inlet tubing and the tubing connected to the inoculum
container is clamped.
2
Connect tubing from the inoculum container to the inlet tubing, using e.g.
tube fusing equipment or a ReadyMate connector.
3
Unclamp the inlet tubing and inoculum container tubing.
4
Transfer the desired volume of inoculum into the bag using a pump or
gravity flow.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
5 Operation
5.5 Perform cultivation
5.5.2 Monitor a run
5.5.2
Monitor a run
Introduction
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 state Ready, Manual Run or Method Run.
Process picture
The Process Picture displays the process parameters during a run. During a run, realtime data from monitors are displayed. The Process Picture is shown in the illustration
below. The buttons available depend on the system configuration.
The button, including its frame, will have a different color depending on the state of the
function. Color indication is applied as shown in the table below.
Color
Indication
White
The function is inactive.
Gray
The function is disabled due to higher level control
Green
The function is active.
Orange
The function needs attention. Click on the button to open
the related settings and to see more information.
Red
The function is not working properly. Click on the button
to open the related settings and to see an explanation of
what the problem is.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
147
5 Operation
5.5 Perform cultivation
5.5.3 End cultivation
5.5.3
End cultivation
End cultivation and harvest
To end the cultivation and harvest, follow the instructions below.
Step
Action
1
Prepare the harvest vessel.
2
Click the stop button in the toolbar in System Control to stop the run.
When asked if you want to end the run, click OK.
Note:
As a 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.
3
Grab 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.
4
Connect tubing from the Cellbag bioreactor to the harvest vessel.
5
Empty the Cellbag bioreactor using a pump or gravity flow.
6
Connect tubing from the Cellbag bioreactor to the harvest vessel.
Procedures after cultivation
Follow the instructions below when the cultivation is finished.
148
Step
Action
1
Clamp off the inlet and outlet gas filters of the Cellbag bioreactor.
2
Disconnect the tubing from the inlet gas filter on the Cellbag bioreactor.
3
Disconnect any other tubing and cables still connected to the Cellbag
bioreactor.
4
Release and remove the empty Cellbag bioreactor from the tray by pressing
down the bag clamp opener.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
5 Operation
5.5 Perform cultivation
5.5.3 End cultivation
Step
Action
5
Dispose the Cellbag bioreactor according to GE Healthcare recommendations
and local regulations.
6
Turn off all gas supplies.
Shut down the system
Follow the instructions below to shut down the system.
Step
Action
1
Disconnect from system in UNICORN.
2
Press the power button on the rocker front panel. The light is blinking 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.
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149
6 Maintenance
6
Maintenance
In this chapter
This chapter describes the required maintenance procedures for Xuri Cell Expansion
System W25. 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
150
See page
6.1 Calibrations
151
6.2 Cleaning
153
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
6 Maintenance
6.1 Calibrations
6.1
Calibrations
Calibration schedule
For the system to function properly, several calibrations may be performed. See tables
below.
Before each cultivation
Calibration
Interval
Pump
Before cultivation, see Section5.4.2 Pre-culture preparation, on page137.
DO sensor
Before cultivation, see Section 5.4.4 Equilibrate the culture medium, on
page 142.
pH sensor
Before and during cultivation if required, see Section 5.4.4 Equilibrate
the culture medium, on page 142.
When required
CO2, O2, scale and temperature are calibrated at manufacturing. It is recommended to
calibrate these parameters at least annually. Calibration of CO2 and O2 is complex and
requires expert knowledge
Calibration
Interval
Scale
When required.
Contact GE Healthcare service personnel for assistance, if needed.
Note:
It is recommended to perform scale calibration after moving the
rocker, or if working with a load that differs considerably from the
load at the last calibration. For Calibrate High point, use a weight
that is as close as possible to the load to be applied to the tray during
use.
Temperature
When required.
Contact GE Healthcare service personnel for assistance, if needed.
CO2 sensor
CO2 calibration require special competence and may impair system
performance if performed inappropriate. Contact GE Healthcare
service personnel for assistance.
O2 sensor
O2 calibration require special competence and may impair system
performance if performed inappropriate. Contact GE Healthcare
service personnel for assistance.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
151
6 Maintenance
6.1 Calibrations
Calibration instruction
Follow the instructions below to perform a calibration. The example is a scale calibration.
Step
Action
1
•
Select System:Calibrate in System Control
or
•
click Calibrate in the Process Picture Settings menu for the monitor
that you want to calibrate.
Result: The Calibration dialog opens.
152
2
Select the appropriate monitor in the Monitor to calibrate drop down menu.
3
Follow the instructions in the right-hand field and enter the correct values
in the Calibration procedure field, and click Calibrate for each value.
4
Close the Calibration dialog.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
6 Maintenance
6.2 Cleaning
6.2
Cleaning
Cleaning procedure
To prevent microbial or cross contamination, Xuri Cell Expansion System W25 should be
cleaned after each cultivation. The system must be turned off and unplugged before
cleaning begins.
•
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™ with suitable
concentrations. Refer to Section 8.5 Chemical resistance, on page 173.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
153
7 Troubleshooting
7
Troubleshooting
In this chapter
This chapter describes troubleshooting and corrective actions for Xuri Cell Expansion
System W25.
Xuri Cell Expansion System W25 User Manual contains further troubleshooting and corrective actions. If the suggested actions in this guide and Xuri Cell Expansion System
W25 User Manual do not solve the problem or if the problem is not covered by these
guides, contact your GE Healthcare representative for advice.
This chapter contains the following sections:
Section
154
See page
7.1 Xuri Cell Expansion System W25
155
7.2 Xuri Cell Expansion System W25, rocker
156
7.3 Xuri Cell Expansion W25 CBCU
160
7.4 Xuri Cell Expansion W25 Pump
161
7.5 UNICORN System Control
162
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
7 Troubleshooting
7.1 Xuri Cell Expansion System W25
7.1
Xuri Cell Expansion System W25
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
Possible cause
Corrective action
CBCU not recognized
by UNICORN.
Incorrect CBCU CAN ID.
Check and if necessary change CAN ID using the
switch on the CBCU rear panel. See CAN ID, on
page 51. The CBCU CAN ID should always be set
to position 1. The system must be switched off
before the CAN ID is changed, and then restarted.
CBCU is not selected as
a component.
Click Edit in System Properties in the Administration module and add the CBCU as a component.
Incorrect pump CAN ID.
Check and if necessary change CAN ID using the
switch on the pump rear panel. See CAN ID, on
page 54. The pump CAN ID should be set to position 1 or 2, and the pumps must have unique values. The system must be switched off before the
CAN ID is changed, and then restarted.
Pump is not selected as
a component.
Click Edit in System Properties in the Administration module and add the pump as a component.
Gap between occupied
UniNet-9 ports on the
rocker rear panel.
Reposition the connectors or insert jumpers in the
unused positions between the occupied ports.
Two pumps are connected, but only one
pump is defined in
UNICORN.
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 5.3 Edit system properties, on page 130.
Pump not recognized
by UNICORN.
CBCU and/or pump not
recognized by
UNICORN.
See Connect system units to the rocker, on page 80.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
155
7 Troubleshooting
7.2 Xuri Cell Expansion System W25, rocker
7.2
Xuri Cell Expansion System W25, rocker
Rocking
Error symptom
Possible cause
Corrective action
Rocker does not initialize properly.
Faulty safety fuses.
Try to restart the system a few times.
When starting the run,
the rocker moves too
slowly during the first
cycle.
It takes a while for the
rocker to initialize after
turning on the power.
None. This is normal.
Rocker is not rocking.
Rocker is in an error
state.
•
Check the current alarms.
•
Reset power to the unit.
•
If you still get motor alarms, contact GE
Healthcare service personnel.
•
Make sure that the tray is in normal position.
•
If this does not help, contact GE Healthcare
service personnel.
If the system still does not initialize properly, shut
it down and contact GE Healthcare service personnel.
Tray is in tilt position.
Rocker stops rocking.
Incorrect rocking angle.
Rocking speed varies.
156
Rocker is mechanically
restricted from moving.
Localize 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.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
7 Troubleshooting
7.2 Xuri Cell Expansion System W25, rocker
Error symptom
Possible cause
Corrective action
Power button is blinking red.
Rocker does not have
any network connection to the UNICORN
database.
Verify the Ethernet connection between the rocker
and the client computer.
System units such as
CBCU or pump defined
in the system setup in
UNICORN are not connected to the rocker.
Disable the missing components in UNICORN. See
Section 5.3 Edit system properties, on page 130.
An internal error has
occured in the embedded computer of the
rocker.
Read any warning message carefully and follow
the instructions. If problem persists, contact GE
Healthcare service personnel.
The embedded computer of the rocker fails to
shut down.
•
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 Healthcare
service personnel.
System does not shut
down when the power
button is pressed.
Rocking starts when
sending another command than Start rocking.
At the first command
sent to the system, the
system enters Run
state and the rocker is
initialized and makes a
few movements.
Connect the missing components to the rocker.
See Connect system units to the rocker, on page 80.
None. This is normal.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
157
7 Troubleshooting
7.2 Xuri Cell Expansion System W25, rocker
Temperature
Error symptom
Possible cause
Corrective action
No heating although
heating is enabled in
UNICORN. Frame
around the temperature button is orange.
Rocker is not rocking.
Make sure that the rocker is rocking. The heater is
automatically turned off when rocking is turned
off.
The recognition of the
tray size used does not
work.
Contact GE Healthcare service personnel.
Bag size is not set.
Set the bag size in Settings:Cellbag in the Process
Picture.
The heater is in an error
state.
Contact GE Healthcare service personnel.
Bag size setting is incorrect.
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.
•
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.
Too slow or too fast
heating.
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.
158
Calibrate the temperature sensor. See Section 6.1
Calibrations, on page 151. If needed, contactGE
Healthcare service personnel.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
7 Troubleshooting
7.2 Xuri Cell Expansion System W25, rocker
Weight
Error symptom
Possible cause
Corrective action
No weight reading.
Scale does not function
properly.
Contact GE Healthcare service personnel.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
159
7 Troubleshooting
7.3 Xuri Cell Expansion W25 CBCU
7.3
Xuri Cell Expansion W25 CBCU
General
Error symptom
Possible cause
Corrective action
Status LED is blinking
red.
An internal error has
occurred, but the CBCU
is still operating.
Check any warning message and follow the instruction. If problem persists, contact GE Healthcare
service personnel.
Status LED shows a
steady red light.
An internal error has
occurred, and the CBCU
is not operating.
Check any warning message and follow the instruction. If problem persists, contact GE Healthcare
service personnel.
CAN indicator LED is
blinking
An internal error has
occurred, and the CBCU
is not operating properly.
Contact GE Healthcare service personnel.
Note:
This is normal the first
seconds during power
up.
160
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
7 Troubleshooting
7.4 Xuri Cell Expansion W25 Pump
7.4
Xuri Cell Expansion W25 Pump
Error symptom
Possible cause
Corrective action
Status LED on the
pump rear panel is
blinking red.
An internal error has
occurred, but the pump
is still operating.
Check any warning message and follow the instruction. If problem persists, contact GE Healthcare
service personnel.
Status LED on the
pump rear panel shows
a steady red light.
An internal error has
occurred, and the
pump is not operating.
Check any warning message and follow the instruction. If problem persists, contact GE Healthcare
service personnel.
CAN indicator LED is
blinking
An internal error has
occurred, and the CBCU
is not operating properly.
Contact GE Healthcare service personnel.
Note:
This is normal the first
seconds during power
up.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
161
7 Troubleshooting
7.5 UNICORN System Control
7.5
UNICORN System Control
User Access
Problem description
Solution
Username and password not accepted.
•
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.
The log on dialog is inactive and a
password cannot be entered.
Access to UNICORN functions
Problem description
Solution
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.
•
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.
162
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
7 Troubleshooting
7.5 UNICORN System Control
System connections
Problem description
Solution
The connections are not available, i.e.
the selection checkbox is grayed out.
•
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.
•
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.
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.
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.
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.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
163
8 Reference information
8
Reference information
In this chapter
This chapter lists technical specifications and control settings for Xuri Cell Expansion
System W25. The chapter also includes a list of wetted materials and a chemical resistance guide.
This chapter contains the following sections:
Section
164
See page
8.1 System specifications
165
8.2 Component specifications
166
8.3 Client computer specifications
170
8.4 Xuri Cell Expansion W25 CBCU semi-wetted materials
172
8.5 Chemical resistance
173
8.6 Tubing and connectors
174
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
8 Reference information
8.1 System specifications
8.1
System specifications
The table below lists the system specifications of Xuri Cell Expansion System W25.
Parameter
Data
System configuration
Benchtop system, external computer
Control system
UNICORN 6.3.2 or higher version
Rocker embedded PC operating system
Windows embedded standard 7
Connection between PC and instrument
Ethernet
Power supply
100-120/200-240 V ~, 50-60 Hz
Power consumption
Maximum 1500 VA
Enclosure protective class
IP 21
External air supply
1.0 bar to 1.5 bar
Normal use: 1.3 l/min
Fast fill: 3.5 l/min
External CO2 supply
1.0 bar to 1.5 bar
Normal use: 0.2 l/min
Fast fill: 0.5 l/min
External O2 supply
1.0 bar to 1.5 bar
Normal use: 0.7 l/min
Fast fill: 1.7 l/min
Operating ambient temperature range
15°C to 32°C
Operating humidity range
20% to 80% RH (non-condensing)
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
165
8 Reference information
8.2 Component specifications
8.2
Component specifications
Equipment dimensions
The table below lists the outer dimensions of the bioreactor system units.
System unit
Dimensions, W x D x H (mm)
Rocker
404 x 560 x 205
CBCU
276 x 360 x 117
Pump
275 x 280 x 115
Tray 10
475 x 430 x 60
Tray 20
740 x 480 x 70
Tray 50
800 x 610 x 70
Lid 10
475 x 430 x 230
Lid 20
740 x 480 x 245
Lid 50
800 x 610 x 260
Equipment weight
The table below lists the weights of the bioreactor system units.
166
System unit
Weight (kg)
Rocker
24.0
CBCU
4.8
Pump
3.8
Tray 10
4.5
Tray 20
7.3
Tray 50
9.5
Lid 10
1.7
Lid 20
3.3
Lid 50
3.9
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
8 Reference information
8.2 Component specifications
Rocker specifications
The table below he table below lists the system specifications of the Rocker.
Parameter
Data
Rocking speed control range
2 to 40 rpm
1 rocking is one complete cycle
Tray 50 limited to 240 rpm x °angle
Rocking angle control range
2° to 12°
Rocking speed profile range
15% to 100%
The % unit relates to how much of the
angular displacement function that is sinusoidally shaped
15% gives an almost constant angular
velocity
100% gives a sinusoidal rocking
Media weight control range
0.5 to 25 kg
Scale, absolute accuracy
±(0.050 + 1% of load) kg
Temperature sensor
Pt100 Class A
Temperature measurement range
2°C to 50°C
Temperature control range
Ambient temperature 5°C to 40°C
Temperature control accuracy (excl.
measurement error)
±0.2°C
Xuri Cell Expansion W25 CBCU
specifications
The table below he table below lists the system specifications of the CBCU.
Parameter
Data
Gas flow control range
0 ml/min to 1000 ml/min
Gas flow total accuracy (Process value –
reference flow)
±(10 + 3% of read value) ml/min
Fast fill flow
~3 l/min
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
167
8 Reference information
8.2 Component specifications
Parameter
Data
CO2 measurement accuracy
±(0.3 + 3% of read value) when mixed
only with air/N2
CO2 control range
0% to 15% CO2
Total CO2 accuracy (Process value – reference CO2 content)
±(0.7 + 3% of read value) % CO2
O2 measurement accuracy
±(0.6 + 1% of read value) within 0% to
50% O2, when mixed only with air/N2
O2 control range
0% to 50% O2 when mixed with N2, 21%
to 50% O2 when mixed with air
Total O2 accuracy
±(1.2 + 1% of read value) % O2
pH measurement range
pH 4.5-8.5
pH measurement accuracy
±0.05 for pH 6.75-7.25
±0.1 for pH 6.5-7.5
pH control range
pH 6.0-8.0
Total pH accuracy (Process value – reference pH)
±0.1 for pH 6.75-7.25
DO measurement range
0% to 250% air saturation
DO measurement accuracy
±5% air saturation, excluding atmospheric pressure variations
DO control range
0% to 100% air saturation
Total DO accuracy (Process value – reference pH)
±10% air saturation, excluding atmospheric pressure variations
±0.15 for pH 6.5-7.5
Xuri Cell Expansion W25 Pump
specifications
The table below he table below lists the system specifications of Xuri Cell Expansion W25
Pump.
168
Parameter
Data
Pump flow rate range
100 ml - 144 l/day (0.07-100 ml/min)
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
8 Reference information
8.2 Component specifications
Parameter
Data
Pump flow accuracy
±(0.1 + 5% of read value) after calibration
Accumulated pumped volume accuracy
±10% of measured volume
Supported tubing dimensions
Inner diameter: 0.5 to 4.8 mm (1/50" to
3/16")
Wall thickness: 1.6 mm (1/16")
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
169
8 Reference information
8.3 Client computer specifications
8.3
Client computer specifications
The table below describes the recommended client computer specifications for a UNICORN system operating with the bioreactor system.
The operating systems recommended for installation are Windows XP Professional x86 with SP3 installed
and Windows 7 Professional x86 and x64 with SP1 installed. In the table below these are listed only as
Windows XP and Windows 7.
UNICORN
Client
Database Server
Workstation installation
E-License Server
Common Components
Min.
free
disc
space
6 GB
6 GB
12 GB
500 MB
500 MB
Min.
available
RAM
3 GB
3 GB
3 GB
2 GB
2 GB
Disc format
NTFS
NTFS
NTFS
NTFS
NTFS
OS
Windows
XP
Windows XP
Windows
XP
Windows XP
Windows XP
Windows 7
Windows 7
Windows 7
Windows Server
2003/2003 R2
Windows Server
2003/2003 R2
Windows Server
2008/2008 R2
Windows Server
2008/2008 R2
Windows 7
Windows 7
Windows Server®
2003/2003 R2
Windows Server
2008/2008 R2
OS language
English
(U.S.) Code
1033
English (U.S.) Code
1033
English
(U.S.) Code
1033
English (U.S.) Code
1033
English (U.S.) Code
1033
Architecture
Intel™ Dual
Core (or
better)
Intel Dual Core (or
better)
Intel Dual
Core (or better)
Intel Dual Core (or
better)
Intel Dual Core (or
better)
Windows XP
Windows XP
Windows
XP
Windows 7
Windows
XP
Windows 7
Windows 7
Windows Server
2003 x86, x64/R2
x86, x64
Windows Server
2003 x86, x64/R2
x86, x64
Windows Server
2008 x64/R2 x64
Windows Server
2008 x64/R2 x64
Windows 7
Windows XP
Windows Server
2003 x86, x64/R2
x86, x64
Windows Server
2008 x64/R2 x64
170
Windows 7
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
8 Reference information
8.3 Client computer specifications
Note:
2
•
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 2
•
Using the Windows 7 Aero color scheme is not recommended.
•
Windows power save features should be turned off to avoid conflicts with
system operations.
•
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.
UNICORN must be closed when the color scheme is changed.
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
171
8 Reference information
8.4 Xuri Cell Expansion W25 CBCU semi-wetted materials
8.4
Xuri Cell Expansion W25 CBCU semi-wetted materials
This list covers semi-wetted materials, i.e. materials that get into contact with the gas
flow from gas source to gas outlet in Xuri Cell Expansion W25 CBCU.
Those parts of the flow path that do not go to the outlet, such as connections to pressure
sensors and flow path to O2 and CO2 sensors, are not included.
For some of the materials listed, the ASTM D1418 (standard practice for rubber and
rubber lattices nomenclature) abbreviation is written in parenthesis.
172
Part
Material
Gas distribution block, pressure relief valve
Aluminum
Flow regulators, pressure relief valve
Brass
Flow restrictors, pressure relief valve, outlet connector
Stainless steel
O-rings, gaskets
Ethylene-Propylene
Terpolymer (EPDM)
Pressure relief valve
Nitrile (NBR)
Check valve
Fluoroelastomer (FKM)
Tubing
Silicone (VMQ)
Tubing connectors
Polyamide
Flow regulators
Fluoroelastomer
(FKM/FPM)
Check valve
Polypropylene
Tubing connector between Xuri Cell Expansion W25 CBCU
and gas source
Animal free polypropylene resin
Tubing connector between Xuri Cell Expansion W25 CBCU
and Cellbag bioreactor
Animal free polypropylene resin
Gas distribution tubing between Xuri Cell Expansion W25
CBCU and gas source
Tygon E3603
Gas distribution tubing between Xuri Cell Expansion W25
CBCU and Cellbag bioreactor
Tygon E3603
Tubing between gas distribution tubing and the inlet filter
of the Cellbag bioreactor
Silicone (VMQ)
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
8 Reference information
8.5 Chemical resistance
8.5
Chemical resistance
The chemicals listed below have been approved for use with the bioreactor system.
Chemical
Concentration
Use
CAS no./EC no.
Alconox
N/A
Cleaning/Disinfection
N/A
DeciDos
N/A
Cleaning/Disinfection
N/A
Ethanol
70%
Cleaning/Disinfection
75-08-1/200-837-3
Hydrochloric acid
1M
pH control
7647-01-0/231-595-7
Isopropanol
70%
Cleaning/Disinfection
67-63-0/200-661-7
Klercide
N/A
Cleaning/Disinfection
N/A
PBS solution
10×
Testing
N/A
Sodium bicarbonate
7.5%
pH control
144-55-8/205-633-8
Sodium carbonate
1M
pH control
497-19-8/207-838-8
Sodium chloride
5M
Testing
7647-14-5/231-598-3
Sodium hydroxide
1M
pH control
1310-73-2/215-185-5
Sodium hypochlorite
1%
Cleaning/Disinfection
7681-52-9/231-668-3
Virkon
1%
Cleaning/Disinfection
N/A
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
173
8 Reference information
8.6 Tubing and connectors
8.6
Tubing and connectors
The tubing and connectors listed below are delivered with the bioreactor system. The
user cuts the appropriate lengths for the tubing, and connects all connectors needed
for the application.
Tubing
Item
Inner diameter
Outer diameter
Length
Tygon E3603
1/8" (3.2 mm)
1/4" (6.4 mm)
157.5" (400 cm)
Silicone
3/16" (4.8 mm)
3/8" (9.5 mm)
7.9" (20 cm)
Connectors
174
Item
Inner diameter
Reducer connector, gas tubing
1/8" to 3/16" (3.2 mm to 4.8 mm)
Connector, CBCU
1/8" (3.2 mm)
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
Index
Index
A
Adjustable foot
Description, 41
Administration module
description, 68
icons, 68
B
Bioreactor system
Description, 38
Illustration, 38
Troubleshooting, 155
C
CAN ID
CBCU
Description, 51
Position, 80
Pump
Description, 54
Position, 80
CBCU
Description, 49
Installation, 79–80
Status LED, 50
Troubleshooting, 160
CBCU specifications, 167
Cellbag bioreactor
Description, 55
Illustration, 56
CE marking, 9
Component specification
CBCU specifications, 167
equipment dimensions, 166
equipment weight, 166
Pump 25 specifications, 168
Rocker specifications, 167
D
Define a system
At installation, 104
Documentation, 14
DO sensor
Connect, 112
Description, 57
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
E
Emergency procedures
emergency shutdown, 31
power failure, 32
Equipment dimensions, 166
Equipment weight, 166
Evaluation module
description, 67
G
Gas mix
Connect, 123
Description, 122
H
Help utility, 60
J
Jumper, 83
L
Lid
Size, 43
Log on
UNICORN, 126
M
Manual instructions, 65
Manufacturing information, 9
N
Notes and tips, 8
P
pH sensor
Connect, 112
Description, 57
Power failure, 32
Power switch, 41
Prepare for tilt, 46
Prepare the system
Start UNICORN, 126
Process picture, 147
Pump
175
Index
Description, 52
Installation, 80
Status LEDs, 53
Troubleshooting, 161
Pump 25 specifications, 168
R
Rocker
Description, 40
Filter heater, 48
Front view, 40
Jumper, 83
Rear view, 42
Troubleshooting, 156
Rocker specifications, 167
Run
start, 133
S
Safety
notices, 8
Software installation
configure e-license, 98
define a system at installation, 104
types of e-licenses, 97
Software overview, 58
software modules, 59
Status LED
CBCU, 50
Status LEDs
Pump, 53
System Control module
description, 62
manual instructions, 65
process picture, 147
run data, 66
176
system settings, 65
System properties
edit a definition, 130
System recommendations
computer specifications, 170
System settings, 65
System specifications, 165
T
Tilt position, 46
Tray
Attach, 109
Detach, 111
Size, 43
Troubleshooting
access to UNICORN functions, 162
system or computer connections, 163
user access, 162
Tubing
Connect, 82
Load tubing, 120
Tubing holder position, 117
Typographical conventions, 6
U
UNICORN, 58
Administration module, 68
connect to system, 128
Evaluation module, 67
Log on, 126
Start, 126
System Control module, 62
Uninterruptible power supply
(UPS), 32
Xuri Cell Expansion System W25 Operating Instructions 29-0646-12 AA
Page intentionally left blank
For local office contact information, visit
www.gelifesciences.com/contact
GE, imagination at work and GE monogram are trademarks of General Electric
Company.
GE Healthcare Bio-Sciences AB
Björkgatan 30
751 84 Uppsala
Sweden
Clave is a trademark of ICU medical Inc.
Microsoft, SQL server, Windows and Windows Server are registered trademarks
of Microsoft Corporation.
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.
www.gelifesciences.com/xuri
Cellbag, UNICORN and Xuri are trademarks of GE Healthcare companies.
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.
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 6 © 2009-2014 General Electric Company.
© 2014 General Electric Company – All rights reserved.
First published Feb. 2014
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
imagination at work
29-0646-12 AA 02/2014
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