KMPi TFF System Instructions for Use

KMPi TFF System

KrosFlo

®

MiniKros

®

Pilot i TFF System

Product Information and Operating Instructions

advancing the science of separation

™

TRADEMARKS AND WARRANTY

KMPi

SpectrumLabs.com’s KMPi meets strict quality control standards and is warranted against defects in material and workmanship for a period of two (2) years from date of shipment.

The information contained herein is believed to be accurate and is offered in good faith for the convenience of the user. PRODUCTS ARE FURNISHED UPON THE CONDITION THAT THE USER ASSUMES ALL RISKS

AND LIABILITIES AND THAT NEITHER THE SELLER NOR MANUFACTURER SHALL BE LIABLE FOR ANY

LOSS OR DAMAGE, DIRECT OR CONSEQUENTIAL, ARISING FROM THE USE OF THESE PRODUCTS.

Spectrum

®

, KrosFlo

®

, MicroKros

®

, MidiKros

® and MiniKros

® are registered trademarks of Spectrum Laboratories,

Inc. Microsoft

®

, Windows

® and Excel

® are registered trademarks of Microsoft Corporation. C-Flex

® and

Pharmapure

® are registered trademarks of Saint-Gobain. MasterFlex

® is a registered trademark of Cole-Parmer.

Trademarks bearing the

® symbol in this publication are registered in the U.S. and in other countries.

This document copyright © 2015 by Spectrum Laboratories, Inc. All rights reserved. Reproduction prohibited except by permission of the copyright owner.

ii

KMPi TFF System • PRODUCT INFORMATION AND OPERATING INSTRUCTIONS

TABLE OF CONTENTS

KMPi

Table of Contents

System Overview and Operation

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

2. Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

3. Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

4. System Configuration and Major Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

4.1. KMPi Pump Drive, Pump Head, & Integrated Pressure Monitor . . . . . . . . . . . . . . . 6

4.2. KMPi Mounting Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

4.3. KMPi Octopus Cables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

5. System Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

6. Materials of Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

7. KMPi Setup and Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

7.1. Basic Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

7.2. Manual Mode Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

7.3. C Mode Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

7.4. C/D, C/D/C, CFC Mode Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

7.5. C/D/D/C Mode Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

7.6. Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

7.6.1. Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

7.6.2. Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

7.6.3. System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

7.6.4. Hardware Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

7.7. Pressure Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

7.8. Pressure Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

7.9. Tubing Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

7.10. Firmware Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

8. Pump Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

8.1. Running the KMPi System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

8.2. Pump Mode Status Timeout Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

9. KMPi Pump Head Setup and Operational . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

9.1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

9.2. Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

9.3. Installation and Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

9.4. Tubing Loading and Unloading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

9.5. Occlusion Adjustment on Easy-Load Pump Head . . . . . . . . . . . . . . . . . . . . . . .25

9.6. Multi-Channel Mounting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

iii


TABLE OF CONTENTS

KMPi

9.7. Maintenance and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

10. Auxiliary Component Setup and Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

10.1. Auxiliary Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

10.1.1. Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

10.1.2. Controls, Indicators and Connectors. . . . . . . . . . . . . . . . . . . . . . . . . . . 27

10.2. Auxiliary Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

10.2.1. Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

10.2.2. Controls, Indicators and Connectors. . . . . . . . . . . . . . . . . . . . . . . . . . . 29

10.2.3. Auxiliary Pump Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

10.2.4. Auxiliary Pump Control Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30

10.3. Automatic Backpressure Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

10.3.1. Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

10.3.2. Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

10.3.3. Updating Automatic Backpressure Valve . . . . . . . . . . . . . . . . . . . . . . . 32

11. KFComm Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

11.1. KFComm License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

11.2. Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

11.2.1. KFComm Software Suite . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

11.2.2. USB Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

11.3. Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

11.3.1. Opening and Configuring the KFComm Workbook Template . . . . . . . . 36

11.3.2. Data Collection Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

11.3.3. Pump Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

11.3.4. Worksheets Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

11.3.5. Shear Lookup Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

12. Basic Concepts of Tangential Flow Filtration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

12.1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

12.2. Concentration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

12.3. Diafiltration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

12.4. Sample Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

12.4.1. Equations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

12.4.2. Concentration Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

iv


TABLE OF CONTENTS

KMPi

12.4.3. Concentration/Diafiltration Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

12.4.4. Concentration 1/Diafiltration/Concentration 2 Mode . . . . . . . . . . . . . 47

12.4.5. Concentration 1/Diafiltration 1/Diafiltration 2/Concentration 2 Mode . 47

12.4.6. Constant Feed Concentration Mode . . . . . . . . . . . . . . . . . . . . . . . . . 47

13. Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48

Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49

v


INTRODUCTION

KMPi

1. Introduction

The KMPi [KrosFlo

®

MiniKros

®

Pilot i] Tangential Flow Filtration (TFF) System is the ideal system for processes ranging from 10-1000L. The system consists of a digital peristaltic pump, multi-language man/machine interface with graphical LCD display, KMPi Easy-Load Pump Head, digital readouts of pressure values with automated shut-off controls, module stand, and real time data collection software KFComm. With the pump drive and Easy-Load Pump Head, the KMPi provides flow rates from

0.01-13.0 LPM. The KMPi can also mount up to two 13 LPM KMPi Easy-Load Pump Heads or one

17 LPM High-Performance Pump Head.

When equipped with optional auxiliary components, the KMPi's automated functions are extended further. Through the combination of specific set-points measured through the KMPi's auxiliary pumps, scales, and backpressure valves, the KMPi is able to carry out complicated TFF processes with improved accuracy and efficiency.

The peristaltic pump handles abrasive slurries, corrosive fluids and highly viscous fluids with minimal wear. The pump also allows only the tubing and other tube material to come in contact with the fluid, has no valves to clog, and has smooth and easy-to-clean inner surfaces. Its performance has proven that the bidirectional and self-priming KMPi has low shear, is capable of running dry and pumping fluids with high quantities of entrained air, has high volumetric efficiency, and a motor speed repeatability of 0.1 percent to maximize productivity in precision liquid dosing, batch dispensing, and filling applications.

The KMPi has been designed to be used with SpectrumLabs.com’s Disposable KrosFlo

®

Bag-Tubing (MBT

®

KMPi and MBT

®

Module-

) sets, which are fully-assembled and disposable process flowpaths for TFF. The sets are ideal for upstream TFF microfiltration and downstream TFF ultrafiltration.

The disposable flowpath—including the filter, pressure transducers, tubing and fittings—eliminates the possibility of cross contamination.

TFF systems offer many conveniences over traditional cross-flow membrane systems. The hollow fiber (HF) membrane modules and cross-flow filtration system provides faster and gentler separation that helps avoid membrane fouling and maximizes product recovery. The disposability of the modules eliminates not only the potential for cross-contamination and costs associated with cleaning and rinsing, but also the difficulties associated with validating reusable membranes. Used in conjunction with

HF membrane modules, the KMPi offers the following advantages:

•

•

•

•

•

Faster processing times

Superior filtration dynamics

Module disposability

Lower costs

Direct and easy scale-up for production volumes

1


SAFETY PRECAUTIONS

KMPi

2. Safety Precautions

DANGER:

WARNING:

High voltages exist and are accessible. Use extreme caution when servicing internal components.

Remove power from the pump before any cleaning operation is started.

Remove power from the pump before attempting any maintenance.

WARNINGS:

CAUTIONS:

CAUTION:

CAUTION:

Tubing breakage may result in fluid being sprayed from pump. Use appropriate measures to protect operator and equipment.

Turn drive off before removing or installing tubes. Fingers or loose clothing could get caught in drive mechanism.

Power must be turned off before connecting the external remote control cable to prevent damage to the drive.

Do not contaminate the lubricant in the container, on the shaft or on the seal with foreign material. Failure to observe this precaution may result in damage to the seal and premature failure of the seal.

No foreign matter should be allowed under the gasket on the back of the front plate or under the heads of the screws. Failure to observe this precaution may result in leakage during washdown of the drive.

To avoid electrical shock, the power cord protective grounding conductor must be connected to ground. Not for operation in wet locations as defined by EN61010-1.

Keep fingers away from rotor while pump is in operation. Stop pump before loading or unloading tubing.

Explanation of Symbols:

CAUTION: Risk of Danger. Consult Operating Instructions for nature of hazard and corrective actions.

CAUTION:

CAUTION:

Risk of crushing. Keep fingers away from rotor while pump is in operation.

Stop pump before loading or unloading tubing.

Hot surface. Do not touch.

CAUTION: Risk of electric shock. Consult Operating Instructions for nature of hazard and corrective actions.

2


SAFETY PRECAUTIONS

KMPi

WARNING: Product Use Limitation

Risk of Danger. Consult Operating Instructions for nature of hazard and corrective actions.

This product is not designed for, nor intended for use in patient connected applications;

including, but not limited to, medical and dental use, and accordingly has not been

submitted for FDA approval.

This product is not designed for, nor intended for use in hazardous duty areas as defined

by ATEX or the NEC (National Electrical Code); including, but not limited to use with

flammable liquids. Consult the factory for products suitable for these types of applications.

3


SPECIFICATIONS

3. Specifications

Output

Speed:

All models

Torque output, max.

All models

0.1 to 650 rpm

520 oz-in (37.4 kg • cm)

1560 oz-in Starting

Speed regulation:

All models

Display:

All models

Remote outputs:

All models

All models

All models

All models

Input

Supply voltage limits:

All models

Current, max.:

All models

Remote Inputs:

All models

All models

All models

Line ±0.1% F.S.

Load ±0.1% F.S.

Drift ±0.1% F.S.

128 x 64 LCD w/ LED Backlight

Voltage speed output

(0-10V DC @ 1 kΩ min)

Current speed output

(0-10 mA @ 0-600Ω)

Tach output

(100 to 6500 Hz, 50% duty cycle, 10 Hz/rpm)

Motor running output

(N.O. & N.C. contact closure, 1A @ 28V DC)

90 to 260 Vrms @ 50/60 Hz

(Universal Input)

4.5A @ 115 Vrms, or 2.6A @ 230 Vrms

START/STOP, CW/CCW, PRIME

(Contact closure)

Voltage input (0-10V DC @ 10 kΩ),

±50V common mode range

Current input

(0-20 mA or 4-20 mA @ 250 Ω),

±50V common mode range

Construction

Dimensions (L x W x H):

All models

Weight:

All models

Enclosure Rating:

All models

17.5 in x 11 in x 13 in

(445 mm x 280 mm x 330 mm)

40 lbs (18 kg)

NEMA 4X per IEC 60529 - indoor use

4


KMPi

SPECIFICATIONS

Environment

Temperature, Operating:

All models

Temperature, Storage:

All models

Humidity (non-condensing):

All models

0° to 40°C (32° to 104°F)

-25° to 65°C (-13° to 149°F)

10% to 100%

Altitude:

All models

Noise Level:

Pollution Degree:

All models

Less than 2000 m

<70dBa @ 1 meter

Pollution Degree 3

(Indoor use — Sheltered locations)

Chemical Resistance:

Models with stainless steel Exposed material is 316 stainless steel enclosure and hard coat anodized aluminum

Models with powder coated Exposed material is polyester coated steel enclosure steel and hard coat anodized aluminum

Compliance:

Conforms to ANSI/UL Std 61010-1

Certified to CAN/CSA Std C22.2 No. 61010-1

This product has been tested to the requirements of CAN/CSA-C22.2 No. 61010-1 second edition, including Amendment 1, or a later version of the same standard incorporating the same level of testing requirements.

(For CE Mark):

EN61010-1: (EU Low Voltage Directive) and

EN61326: (EU EMC Directive)

KMPi

5


SYSTEM CONFIGURATION AND MAJOR COMPONENTS

KMPi

4. System Configuration and Major Components

4.1.

KMPi Pump Drive, Pump Head, & Integrated Pressure Monitor

The KMP

i

TFF System comes with the Digital Pressure Monitor integrated into the Pump Drive as one unit. The Programable Logic Controller (PLC) runs both the Pump and Pressure monitor functions.

The Easy-Load Pump Head can accommodate tubing sizes I/P #26 (¼” HB), #73 (⅜” HB), and #82

(½” HB). The High-Performance Pump Head can accommodate tubing sizes I/P #70 (⅜” HB), I/P#

88 (½” HB), and I/P #89 (⅝” HB).

4.2.

KMPi Mounting Hardware

The KMPi TFF system comes with an attached mounting plate for the KMPi Easy-Load Pump Head.

4.3.

KMPi Octopus Cables

The KMPi comes with two Octopus Cables—one with more pins for the Auxiliary Components, and one with less pins for the Pressure Transducers. On the back of the KMPi are two Interface ports for the Octopus Cables. Simply plug the Auxiliary Component Octopus Cable into the left-hand Interface port, then plug in the Pressure Transducer Octopus Cable into the right-hand Interface port.

6


SYSTEM PARTS LIST

5. System Parts List

The complete KMPi TFF system with corresponding catalog number is listed below:

KMPi TFF System Selection Guide

Part Number Pump Description

SYM3-U20 Complete

KMPi

System

SYM3-U10

KMPi

Pump Drive and Head Only

System Parts List:

Part Description

KMP i Pump Drive w/ Integrated Pressure Monitor

Auxiliary Component Octopus Cable

Pressure Transducer Octopus Cable

Power Supply Cable

KMPi 13LPM Easy-Load Pump Head

KMPi Stainless Steel Stand

KMPi Fittings Kit

KrosFlo Module Accessory Kit

Arlyn SAW Scale 12" x 12" 60kg x 1g

10L Process Reservoir

PharmaPure #26 Tubing Pack

PharmaPure #73 Tubing Pack

Automatic Backpressure Valve, 3/16"-5/8" OD Tubing

Process System Computer

KrosFlo KFComm Software Suite (on USB)

Quantity

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

KMPi

7


MATERIALS OF CONSTRUCTION

KMPi

6. Materials of Construction

Part Description Material

KMP

i

TFF System (Product Contact Surfaces)

Tubing / Reservoir Closures C-Flex

®

/ Pharmapure

®

Reservoirs Polypropylene

Disposable Pressure Transducers Polysulfone

Plastic Fittings Polypropylene / Polycarbonate

Hollow Fiber Module (Module Sold Separately)

Membrane ME, mPES, PES or PS

Housing Pigmented and Non-pigmented Polysulfone

Potting Polyurethane / Epoxy

End-caps Pigmented Polysulfone

8


KMPi SETUP AND OPERATION

KMPi

7. KMPi Setup and Operation

7.1.

Basic Setup

NOTE:

See Section 12.4 for Sample Applications.

1. Mount KMPi on a flat, horizontal surface with no more than two Pump Heads attached

(see Section 9 for

Pump Head Setup details).

2. Connect both Octopus Cables to the back of the KMPi.

3. Connect up to three pressure transducers to the Pressure Transducer Octopus Cable ports as suitable for application.

4. Connect up to two Automatic Backpressure Valves (ABV’s) to the Auxiliary Component Octopus Cable’s

“Valve 1” and/or “Valve 2” ports, then connect ABV power cable(s)

(see Section 10.4 for ABV Setup

details).

5. Connect power cable to the KMPi.

6. Follow guidelines and diagrams below to determine which Auxiliary Components are required to operate specific Pump Modes for manual, semi-automated, and automated processes

(see Section 8 for Pump

Mode Setup details).

i.

If using Auxiliary Pump, configure Auxiliary Pump before starting application

(see Section 10.2

for Pump Setup details).

ii. After connecting Auxiliary Components, power on KMPi first before powering on Auxiliary

Components.

7. Connect TFF flowpath to KMPi.

8. Input Concentration Factor/Diafiltration Volume (CF/DV) set-points into KMPi’s Pump Mode settings to start application.

Pump Mode

Auxiliary Components Required for Pump Modes Tubing

Feed Scale Permeate Scale Diafiltration Pump

(see Section 10.1 for Scale

Setup details)

(see Section 10.1 for

Scale Setup details)

(see Section 10.2 for Pump

Setup details)

Permeate Pump

(see Section 10.2 for Pump

Setup details)

M Mode

C Mode

X*

C/D Mode

X X X X**

C/D/C Mode

C/D/D/C Mode

X

X

X

X

X

X

X**

X

* The Feed Scale is only required in applications using C Mode if user does not want to input starting

Feed Scale values

** The Permeate Pump is only required in applications that necessitate it, such as MF applications

9


MANUAL MODE SETUP

7.2. Manual Mode Setup

NOTE:

Valves are intentionally left out of the diagrams below for visual clarity.

Diafiltration Buffer Reservoir

Module

Feed Reservoir

KMPi

Permeate Reservoir

Diafiltration Pump Feed Scale KMPi Pump Permeate Pump Permeate Scale

1.

Any combination of Auxiliary Components is possible in Manual Mode—the only required component is the KMPi pump itself. Diagram above is a full setup with all Auxiliary Components.

2.

Auxiliary Pumps

a.

Connect up to two KrosFlo Research I (KRI) auxiliary pumps to the Auxiliary Component Octopus

Cable’s “Diafiltration Pump” and/or “Permeate Pump” ports.

b.

Connect auxiliary pump power cable(s).

3.

Auxiliary Scales

a.

Connect up to two Arlyn SAW scales to the Auxiliary Component Cable’s “Feed Scale” and/or

“Permeate Scale” ports.

7.3. C Mode Setup

Module

Permeate Reservoir

Feed Reservoir KMPi Pump Permeate Scale

10


C MODE SETUP

KMPi

1.

Auxiliary Pumps

a.

Connect KRI to the Auxiliary Component Octopus Cable’s “Diafiltration Pump” port

b.

Connect Diafiltration Pump’s power cable.

2.

Auxiliary Scales

a.

Connect Arlyn SAW scale to the Auxiliary Component Cable’s “Permeate Scale” port.

7.4. C/D, C/D/C, CFC Mode Setup

NOTE:

Permeate Pump is optional and shown in the diagram as an example for applications that require permeate control.


Module

Feed Reservoir

Permeate Reservoir

Diafiltration Pump Feed Scale

1.

Auxiliary Pumps

KMPi Pump Permeate Pump Permeate Scale

a.

Connect KRI to the Auxiliary Component Octopus Cable’s “Diafiltration Pump” port.

b.

Connect Diafiltration Pump’s power cable.

2.

Auxiliary Scales

a.

Connect first Arlyn SAW scale to the Auxiliary Component Cable’s “Feed Scale” port and second

Arlyn SAW scale to the Auxiliary Component Cable’s “Permeate Scale” port.

11


C/D/D/C Mode Setup

7.5. C/D/D/C Mode Setup

Diafiltration Buffer Reservoir 1

Feed Reservoir

KMPi

Module

Diafiltration Buffer

Reservoir 2

Permeate Reservoir

Diafiltration Pump 1 Feed Scale KMPi Pump Diafiltration Pump 2

(Permeate Pump)

Permeate Scale

1.

Auxiliary Pumps

a.

Connect first KRI to the Auxiliary Component Octopus Cable’s “Diafiltration Pump” port and second KRI to the Auxiliary Component Octopus Cable’s “Permeate Pump” port.

b.

Connect auxiliary power cables.

c.

The Diafiltration Pump will function as Diafiltration Pump 1, and the Permeate Pump will function as Diafiltration Pump 2.

2.

Auxiliary Scales

a.

Connect first Arlyn SAW scale to the Auxiliary Component Cable’s “Feed Scale” port and second

Arlyn SAW scale to the Auxiliary Component Cable’s “Permeate Scale” port.

7.6. Home Screen

The

KMPi

’s easy-to-use keypad allows the user to navigate through the LCD Home Screen to utilize the many convenient functionalities it offers.

12


KEYPAD

KMPi

7.6.1. Keypad

a.

LCD Screen – Digital, high-contrast LCD screen that allows user to interface with KMPi

b.

Directional Arrows – Navigate throughout menu items by highlighting with directional arrows

c.

Enter – Select highlighted menu items and input information

d.

Start/Pause – Start/Pause main KMPi pump from any menu

e.

Tare/Alarm Acknowledgement – When held down, will tare pressure transducer values—during an alarm, will acknowledge alarm

7.6.2. Main Screen

a.

Current Pump Mode – Formatted as “Spectrum: (Pump Mode),” allows user to see the current

Pump Mode the KMPi is in.

b.

Pressure Readings – The current values read by any connected Pressure Transducers.

Preferred unit of measurement can be selected in Hardware Setup.

i. Feed Pressure – Symbolized as P f ii. Permeate Pressure – Symbolized as P p iii. Retentate Pressure – Symbolized as P r iv. TMP (Transmembrane Pressure) – Calculated measurement of the average of the

Feed and Retentate pressures subtracted by the Permeate pressure

c.

Settings Menu – Symbolized as a wrench icon; entering this menu allows the user to change the KMPi’s settings.

d.

Pump Direction – Represented by an arrow that denotes whether the pump turns Clockwise

(CW) or Counterclockwise (CCW)—pressing Enter on this icon will change the pump direction.

e.

Tubing Selection Menu – Represented by a number (the current selected tubing size) and a small “c” (only when current selected tubing size has been calibrated); entering this menu allows the user to change the tubing selection (#26, #73, #82, #70, #88, #89) or set pump to RPM mode (can not be calibrated).

f.

Feed Flow Rate – KMPi’s main drive’s flow rate.

g.

Pump Mode Resume Icon – When a Pump Mode other than Manual Mode is paused with the

Start/Pause key, the Pump Mode can be resumed by pressing the Enter key while highlighting the Pump Mode Resume icon. If the user wishes to restart the Pump Mode instead, the user can press the Start/Pause key.

h.

Auxiliary Pump Control Icons – When Auxiliary Pumps are connected, powered on, and configured correctly, the user will be able to access the Auxiliary Pump Control Icons to release, capture, start, pause, and change the flow rate of Auxiliary Pumps

(see Section 10.2 Auxiliary

Pumps for details).

13


SYSTEM SETTINGS

KMPi

i.

Pump Mode Status Timeout Display – When Auxiliary Scales are connected and powered on, the user will be able to view the Pump Mode Status Timeout Display. The Timeout Display will show current weight information related to the current Pump Mode if the user highlights the double arrow button and does not touch the pump for seven seconds

(see Section 8.2 for

Timeout Display details).

Spectrum: C

Pf:

Pp:

Pr:

0.0 Psi

0.0 Psi

0.0 Psi

TMP: 0.0 Psi

Feed: 585 ml/min

D

F

Pump Mode Resume Icon

Diafiltration Pump Control Icon

Permeate Pump Control Icon

7.6.3. System Settings

a.

Pump Mode – Depending on user’s Auxiliary Components, user may select one of many Pump

Modes for KMPi to operate in that allow for manual, semi-automated, and automated processes

b.

Pressure Calibrate – Using a calibrated pressure source, the user can calibrate pressure transducer readings

Spectrum: CDDC

F:1.00

Pf:

Pp:

0.0 Psi

0.0 Psi

Pr: 0.0 Psi

2.00

TMP: 0.0 Psi

Conc

Feed: 585 ml/min

c.

Alarm and Stops – Safety pressure alarm and stops

d.

Tubing Calibrate – After running the tubing in the pump for ten minutes, the user may calibrate the tubing to ensure accurate fluid dispensing

e.

Aux Pumps – KMPi’s Aux Pump settings must be configured prior to using the Auxiliary Pumps to ensure the KMPi sends the correct commands to each pump

f.

Hardware Setup – Time, date, unit of measure, and some Pump Mode options may be set from the Hardware Setup menu

g.

Diagnostics – Diagnostics are for the factory use only, but may viewed by the user

14


HARDWARE SETUP

KMPi

7.6.4. Hardware Setup

a.

Auto Tare – When “On,” KMPi will tare pressure transducer readings

b.

Pressure Units – User is able to choose “psi” or “bar” (selected unit of measure is also displayed in KFComm software)

c.

Time – Change system time

d.

Date – Change system date

e.

Key Beep – When “On,” KMPi will make an audible noise when a soft button is pressed

f.

Display Contrast – Raise or lower the screen contrast

g.

PSI Decimals – For PSI unit of measure only—select preferred number of PSI decimals (range of 0, 1, and 2)

h.

Bar Decimals – For BAR unit of measure only—select preferred number of BAR decimals

(range of 1, 2, and 3)

i.

Key Timeout – When “On,” if KMPi’s soft buttons are untouched for ten minutes while on any screen other than the Main Screen, the KMPi will automatically switch back to the Main Screen

j.

Running Change – When “On,” the tubing size and pump direction can be changed while the pump is running

k.

No. of Heads – Input number of attached KMPi heads

l.

Perm Stop First - Permeate Pump motor stops before KMPi pump motor stops

m.

Check Weight - Pump Mode will not start if Feed Scale Weight is less than Initial Concentration

Weight, or if the Permeate Scale Weight is more than the Initial Diafiltration Weight

n.

Scale Req 4 Man - Manual Mode will not start unless both Feed and Permeate Scales are present

o.

Slow for Valve - If Automatic Backpressure Valve is unable to control pressure, then KMPi pump will slow down gradually until control is regained

p.

Ramp Seconds - Determines rate at which KMPi will increase feed flow rate linearly over desired amount of time

q.

Minus Modes – Enables KMPi to use weight set-points instead of CF/DV set-points

r.

USB Resets – If the USB cable is connected and disconnected from the KMPi repeatedly, then the USB interface chip may go into an invalid state that results in no communication. When set to “on,” the KMPi will reset the USB chip when turned on and off

15


PRESSURE CALIBRATE

7.7.

Pressure Calibrate

Pressure Cal

Feed

Pf: 4.84 Psi

Set: 0 5 .00 Psi

Clear

Cal

Quit

KMPi

1.

Ensure proper connection between pressure transducers and Octopus Cable ports, then tare pressure readings on KMPi

2.

Turn on positive air source from a calibrated pressure source and adjust to dispense 5 psi / 0.35

bar of pressure, then turn positive air source off

3.

Connect Feed pressure transducer to be in-line with positive air source—cap the remaining open end of the pressure transducer

4.

Turn on positive air source

5.

Wait for Feed pressure reading to stabilize

6.

If Feed pressure reading differs from calibrated source measurement, select Pressure Calibrate from Settings Menu

7.

Select source of pressure (in this case, “Feed”), then adjust “Set:” pressure reading to reflect that of calibrated source

8.

Save changes by selecting “Cal”

9.

Repeat steps 3 to 8 with the Retentate and Permeate ports

16


PRESSURE ALARM SETTINGS

KMPi

7.8.

Pressure Alarm Settings

The KMPi has a number of safety pressure alarms and stops that may be set in the Alarm Settings menu.

a.

P f

Hi Stop – When P f value ≥ P f

Hi Stop value, the KMPi pump will stop running

b.

P f

Hi Alarm – When P ning f value ≥ P f

Hi Alarm value, the KMPi pump will alarm but continue run-

c.

P f

Lo Alarm – When P ning f value ≤ P f

Lo Alarm value, the KMPi pump will alarm but continue run-

d.

P p

Lo Alarm – When P ning p value ≤ P p

Lo Alarm value, the KMPi pump will alarm but continue run-

e.

P p

Lo Stop – When P p value ≤ P p

Lo Stop value, the KMPi pump will stop running

f.

Silent Alarm – Set to “On” to silence alarms, set to “Off” to play alarm sound

1.

To enable an alarm, highlight the alarm value and press Enter.

2.

Use the directional keys to set the desired alarm value, then press Enter to save the setting.

3.

To disable an alarm, change the value to 0 and KMPi will read the alarm as “OFF.”

7.9. Tubing Calibration

NOTE:

Condition tubing by running at ½ of maximum flow rate of tubing being calibrated for at least 10-15 minutes before conducting tubing calibration.

1.

Select tubing size in Calibration menu.

2.

Press CAL, the system set calibration volume will appear.

3.

Press START / STOP, the pump will use its stored memory to dispense the specified calibration sample quantity. The pump will stop automatically.

4.

Weigh/measure the sample.

5.

Use directional keys to correct the volume on the flashing display.

6.

Press the Enter key to save the calibration setting. Once calibrated, a lower case "c" appears next to the tubing (e.g. 73c).

7.

To confirm tubing calibration, press CHECK to dispense calibration volume using calibrated tubing and weigh dispensed volume.

NOTE:

If the adjusted calibration is high, "Err" will appear in the display. If this occurs, press the CAL control and repeat the calibration procedure. The microprocessor will retain one special calibration value per tubing size, even when power is turned off. The next calibration will replace the existing value.

17


FIRMWARE UPDATE

KMPi

7.10. Firmware Update

Contact SpectrumLabs.com to obtain a copy of the latest firmware if necessary.

1.

Power on KMPi and connect it via the USB cable on Auxiliary Component Octopus Cable to a computer

2.

Confirm with Device Manager that computer properly reads the connection as a COMM port

3.

Launch firmware updater in firmware folder with Program KMPi.exe file

4.

Press “Start” and make sure both “Update Display” and “Update Interface” checkboxes are checked

5.

Click “Proceed” and then use “Find Comm” module to allow updater to test COMM connection to verify correct COMM port has been selected

6.

Click “Go” and wait ~15 minutes for KMPi to complete firmware update. KMPi LCD screen will go dark until firmware update is completed

7.

Firmware update acknowledgment dialogue box will appear—press “OK” to close it

18


PUMP MODES

KMPi

8.

Pump Modes

The KMPi alternates through different functions based on user-defined set-points suitable for the user’s application—these combinations of functions are Pump Modes. All Pump Modes are composed of different sequences of Concentration and Diafiltration functions.

NOTE:

To see a detailed explanation of Pump Mode set-points and options, see Section 11.3.3 Pump Control. To see detailed examples to better understand how set-points are used for automated processes, see Section

12.4 Sample Applications.

a.

Concentration: Reduce volume of process solution

b.

Diafiltration: Wash permeable molecules out of the process solution

Auxiliary Components are associated with the following automated functions and actions:

c.

Feed Scale: Weighs feed reservoir to monitor Concentration and Diafiltration functions

d.

Permeate Scale: Weighs permeate reservoir to monitor Concentration and Diafiltration functions

e.

Diafiltration Pump: Replenishes loss feed reservoir volume during diafiltration function

f.

Permeate Pump: Controls permeation rate for MF applications

g.

Valve 1: Control TMP

h.

Valve 2: Control Permeate Pressure

19


RUNNING THE KMPi SYSTEM

KMPi

8.1.

Running the KMPi System

1.

Prior to running application, set KMPi's Hardware

(see Section 7.6.4 for Hardware Setup

details) and Auxiliary Pump (see Section 10.2.3 for Auxiliary Pump Settings) configurations through either the KMPi or KFComm Pump Control

(see Section 11.3.3 for Pump Control)

2.

Set the flow rate of the KMPi in the Main Screen

3.

Select a Pump Mode suitable for application

(see Section 12.4 for Sample Applications)

a.

M Mode: Manual Mode b.

C Mode: Concentration Mode c.

C/D Mode: Concentration/Diafiltration Mode d.

C/D/C Mode: Concentration 1/Diafiltration/Concentration 2 Mode e.

C/D/D/C Mode: Concentration 1/Diafiltration 1/Diafiltration 2/ Concentration 2 Mode f.

CFC Mode: Constant Feed Concentration Mode

3.

Input set-points required for the Pump Mode

4.

Press the Start/Pause soft button on the KMPi to start Pump Mode

When each set-point is reached during functions, Pump Mode will seamlessly continue to next function until the

Pump Mode’s set of functions are completed. Pump Mode will then end automatically.

8.2.

Pump Mode Status Timeout Display

Use the Pump Mode Status Timeout display to monitor Pump Mode progress. Depending on the Pump Mode, the

Timeout display will either show scale weight values or Concentration Factor/Diafiltration Volumes (CF/DV). Manual

Mode will always show scale weight values.

a.

Manual Mode/Before Running Pump Mode: i.

First Line: Current Feed Scale weight (preceded by “F:”) ii.

Second Line: Current Permeate Scale weight (preceded by “P:”)

b.

After Running Pump Mode: i.

First Line: Current CF/DV; during Concentration function, will be Current CF (measured from starting weight on Feed Scale and increasing weight on Permeate Scale, then denoted with “F:”) during Diafiltration function, will be Current Number of DV’s

(measured from increasing weight value on Permeate Scale, then denoted with “P:”) ii.

Second Line: Target CF/DV; during Concentration function, will be Target CF; during

Diafiltration function, will be Target DV’s iii.

Fourth Line: Current function (e.g. Conc 2, Dia 2)

20


KMP i PUMP HEAD SETUP AND OPERATION

KMPi

9.

KMPi Pump Head Setup and Operation

9.1.

Introduction

The KMPi Easy-Load and High-Performance Pump Heads are designed to be used with the KMPi as a simple peristaltic pump system. The Pump Heads accept 3 different tubing sizes for a wide range of flow rates, and the unique designs and automatic tubing retention allow for quick tubing changes.

9.2.

Specifications

Easy-Load Pump Head

Pump tubing size mL per rev

I/P 26

I/P 73

I/P 82

6.2

12.3

20.0

100

0.6

(0.2)

1.2

(0.3)

2.0

(0.5)

Flow rates in LPM (GPM) at indicated rpm

540 1 to 650

3.3

(0.9)

6.6

(1.7)

10.8

(2.9)

0.01 to 4.0

(0.002 to 1.1)

0.01 to 8.0

(0.002 to 2.1)

0.02 to 13.0

(0.005 to 3.5)

Maximum System pressure psi (bar)

40 (2.7)

20 (1.4)

I/P ® 26, I/P 73 I/P ® 82

Maximum continuous

discharge pressure—psi (bar): 25 (1.7)* 10 (0.7)*

Maximum intermittent

discharge pressure—psi (bar): 40 (2.7)* 20 (1.4)*

Maximum vacuum: 660 mm (26) in Hg* 660 mm (24) in Hg*

Maximum suction lift: 8.8 m (29 ft) H

2

0* 8.2 m (27 ft) H

2

0*

Number of rollers: 3

Occlusion: Adjustable (with Knob on top of Pump Head)

Maximum pump speed (rpm): 650

Normal torque load-Starting: up to 13 kg-cm (180 oz-in)

Normal torque load-Running: up to 9 kg-cm (120 oz-in)

Housing materials: Polysulfone (PSF) or Polyphenylene sulfide (PPS),

Polyester, Aluminum, Nylon

Roller/rotor materials: Cold-rolled steel (CRS) or Stainless steel (SS)

Operating temperature

‡

: 0 to 40°C (32 to 104°F)

* As tested with NORPRENE

®

, PHARMED

®

, and TYGON

® tubing. Values will be less with silicone and C-FLEX.

‡ Use in this temperature range for continuous duty operation with no decrease in performance or life.

Pump heads will work outside this range with some possible reductions in performance or product life.

21


HIGH-PERFORMANCE PUMP HEAD

KMPi

High-Performance Pump Head

I/P

Tubing

Flow rate

@ 20 rpm

L/min

@ 650 rpm

L/min

I/P 70

.26

8

I/P 88

.40

13

I/P 89

.52

17

Discharge Pressure*

Continuous psig (bar)

Intermittent psig (bar)

25 (1.7) 40 (2.7)

20 (1.4) 35 (2.4)

15 (1.0) 20 (1.4)

Vacuum*

@ 650 rpm in (mm) Hg

26 (660)

26 (660)

24 (610)

Suction Lift*

@650 rpm ft (m) H

2

O

29 (8.8)

29 (8.8)

27 (8.3)

Number of rollers:

Occlusion:

Maximum pump speed (rpm):

Nominal torque load-running:

Housing materials:

Roller/bearing materials:

Rotor materials:

Operating Temperature

‡

:

Storage Temperature:

Humidity:

Dimensions (W x H x D):

Operating:

Open:

Weight:

3

Fixed

650 up to 600 oz-in (43 kg-cm)

Stainless Steel (SS), polyester (PE) body and tubing bed, polypropylene (PP) knob

Stainless Steel (SS)/Sealed Stainless Steel

Stainless Steel (SS)

32°F to 104°F (0°C to 40°C)

-40°F to 149°F (-40°C to 65°C)

5% to 95% (non-condensing)

7.5 in x 7.0 in x 6.0 in (191 mm x 178 mm x 152 mm)

8.7 in x 7.0 in x 10.0 in (221 mm x 178 mm x 254 mm)

8 lb (3.63 kg)

* As tested with NORPRENE

®

, PHARMED

®

, and TYGON

® tubing.

Values will be less with silicone and C-FLEX.

‡

Use in this temperature range for continuous duty operation with no decrease in performance or life. Pump heads will work outside this range with some possible reductions in performance or product life.

9.3.

Installation and Removal

A flat-bladed screwdriver is required to complete installation.

a.

Check that tang boot has plastic dampening to prevent damage to the pump shaft.

b.

Raise occlusion bed to expose mounting holes for top two short screws of Easy-Load

Pump Head.

22


TUBING LOADING AND UNLOADING

KMPi

c.

Aim back of Pump Head towards mounting plate to align pump shaft tang and five screw holes

(for Easy-Load Pump Head) or four screw holes (for High-Performance Pump Head).

NOTE:

Inspect the tang boot after 1,000 hours of operation and replace if necessary.

d.

Insert mounting bolts into the mounting holes through the pump head and into the KMPi’s mounting plate. On High-Performance Pump Head, use round mounting holes for left side tubing entry and exit, or hexagonal mounting holes for top tubing entry and exit.

e.

Secure Pump Head to mounting plate and KMPi by tightening mounting bolt screws with flatbladed screwdriver.

Pump Shaft Tang

Motor

Shaft

Mounting

Holes

Mounting Bolt

Figure 1:

Components of the Easy-Load Pump Head

Latch

Occlusion Bed

Cover

Tachometer Opening

Tube Retainer Knob

Figure 2:

Components of the High-Performance Pump Head

23


TUBING LOADING AND UNLOADING

KMPi

9.4.

Tubing Loading and Unloading

a.

Ensure that KMPi is turned off.

b.

For Easy-Load Pump Head, move KMPi Easy-Load Pump Head lever to the left to open the pump occlusion bed. For High-Performance Pump Head, rotate tubing retainer knob counterclockwise to release retainer, then pull open the cover and lift latch to open occlusion bed.

c.

Load the correct tubing into tubing retainers.

d.

For Easy-Load Pump Head, move the lever to the right to close the occlusion bed. For High-

Performance Pump Head, press occlusion bed against the tubing, snap the latch close, close cover, and pull tubing snugly around rotor assembly. Finish by tightening tubing retainer by rotating tubing retainer knob clockwise to prevent tubing from moving, and run the drive for at least one revolution to break in tubing. Unlatch the bed from Slot 1 and then relatch using Slot 2.

Figure 3:

Loading tubing into opened occlusion bed of Easy-Load Pump Head

Latch Slot 2

Latch Slot 1

Tubing Guide

Tubing Retainer

Figure 4:

Loading tubing into opened occlusion bed of High-Performance Pump Head

24


OCCLUSION ADJUSTMENT ON EASY-LOAD PUMP HEAD

easy-load

KMPi

Figure 5:

Closing occlusion bed of Easy-Load Pump Head

9.5.

Occlusion Adjustment on Easy-Load Pump Head

Use knob on top of KMPi Easy-Load Pump Head to adjust occlusion to suit application. Occlusion usually does not need to be readjusted when altering tubing. After operation for some time, the retainer teeth of the Pump

Head may scratch or mark the surface of the tubing—this is expected and does not reduce the tubing quality or life.

a.

“3” for minimal performance

b.

“4” or “5” for increased pressure/vacuum with reduced tubing life

c.

“1” or “2” for longer life with less pressure and vacuum

d.

For optimum performance, turn occlusion knob to “1” after loading—then start drive and adjust knob until pump primes and fluid begins to flow

Figure 6:

Occlusion knob on top of Easy-Load Pump Head

25


MULTI-CHANNEL MOUNTING

KMPi

9.6.

Multi-Channel Mounting

NOTE:

Do not overtighten screws or wing nuts

To mount two KMPi Easy-Load Pump Heads, use the additional mounting hardware that comes with the purchase of a second set of KMPi Easy-Load Pump Heads. The High-Performance Pump Head is incompatible with Multi-Channel Mounting.

a.

Aim the three mounting holes and pump shaft tang on the back of the second Easy-Load Pump

Head towards the front three mounting holes and exposed motor shaft on the front of the original

Easy-Load Pump Head.

b.

Insert threaded rods into three mounting holes through second and original Easy-load Pump

Heads, then secure with wing nuts.

Figure 7:

Easy-Load Pump Head mounting holes on bottom half of Pump Heads for multi-channel mounting

9.7.

Maintenance and Cleaning

Use mild detergent with water to clean the pump and rotor assembly for both Easy-Load and High-Performance

Pump Heads. Do not immerse or use excessive fluid.

26


AUXILIARY COMPONENT SETUP AND OPERATION

KMPi

10.

Auxiliary Component Setup and Operation

10.1. Auxiliary Scales

The KMPi interfaces with digital Ultra Precision Surface Acoustic Wave (SAW) auxiliary scales. These SAW scales are sensitive, accurate, stable, rugged, and versatile—which makes it a dynamic instrument suitable for the varied application environments of TFF processes.

10.1.1. Installation

Place auxiliary scale on a level surface that is not prone to vibrations, and ensure that weighing area is clean and dry. Do not install the auxiliary scale near heaters, air condition vents, and drafts. Do not operate the auxiliary scale in close proximity with RF transmitters, such as cell phones and walkie-talkies.

Auxiliary scales are powered through the KMPi’s auxiliary component octopus cables—simply connect the scale’s serial cable to the proper auxiliary scale cable port ("Feed" or "Permeate") when the pump is off and then power on the pump. The scale will start up and load its Ready Mode screen—press “On/Off” to change to

Operating Mode. Allow scale to warm-up for five minutes in either Ready or Operating Mode prior to use so that scale can yield stable and accurate results.

10.1.2. Controls, Indicators and Connectors

a.

Main Display Screen

The scale is equipped with 128x64 LCD Graphics Display with a wide viewing angle and variable contrast. For normal operations, the user has a choice of viewing weight information from two main screens. The user may switch screens by pressing the MENU key and then press ENTER to accept the “Next Screen” menu choice.

0.000

net lb

Weight Display

Units

Net Indicator

Status/Zero Indicator

i.

Weight Display: Shows the weight on the platform in the current units setting ii.

Units: Shows the active conversion units iii.

Net Indicator: Shows “Net” if the indicator is in net weighing mode iv.

Status/Zero Indicator: Shows either “zr” if the platform is at zero, a bar graph showing how close the scale is to maximum capacity, or “Ouch” if the platform is overloaded

27


AUXILIARY SCALE

b.

Keypad

[ ]

1.8785

net kg

ARLYN

SCALES

Tare

Net

Gross

Menu/

Back

Print Units

On/Off Zero

Enter

KMPi

i.

On/Off: Press once on Ready Mode to move to Operating Mode. Pressing and holding the key during Operating Mode will move back to Ready Mode.

ii.

Tare: Press once to tare any weight on the platform. Pressing and holding the key will clear any active tare weight.

iii.

Net/Gross: Toggles the indicator between net and gross mode. Net mode will show the weight on the platform subtracted by any tared weight.

iv.

Units: Press the key to step through various conversions. More conversions are available in the setup menu.

v.

Zero: Zeroes the indicator.

vi.

Menu/Back: Enter the setup menu from Operating Mode. When in the setup menu, this key is used to back out of any other menus or to complete operations.

vii.

Enter: Select items and complete operations.

viii.

Arrows: Navigate and highlight menu items.

10.2. Auxiliary Pumps

The KrosFlo

®

Research I (KRI) peristaltic pump has both internal and external control modes, making it the perfect auxiliary pump for the KMPi System. The 600 rpm drive can run two KrosFlo

®

Research I Pump

Heads.

28


AUXILIARY PUMP

KMPi

10.2.1 Installation

Up to two auxiliary pumps can be connected to the KMPi Auxiliary Component Octopus Cable. The DB9 port on the back of the unit can be used to connect the KRI to the KMPi using the KMPi Auxiliary

Component Octopus Cable. Once this connection has been made and the KMPi has been powered on, the KRI can then be powered on and used in its internal or external modes depending on the TFF process.

NOTE:

The controls below are only accessible when the auxiliary pumps are in Internal control mode. When in External control mode, the auxiliary pumps are controlled by input from the KMPi.

10.2.2 Controls, Indicators and Connectors

Front Panel Rear Panel

Controls, Indicators and Connectors

A.

Power (On/Off) Switch: Turns the unit On or Off.

B.

Speed Keys: Sets the speed of the pump. The higher the number, the faster the speed of the pump. When the speed key is depressed, the smallest speed units change first followed by an increasing rate of change.

C.

Flow Direction Key: Sets the direction of pump rotation Clockwise/Counterclockwise. An LED annunciator indicates the active direction. The motor is brought to a controlled stop before reversing direction.

D.

Internal/External Key: Changes the drive operation mode. Internal (Local) operation from the front panel keypad is designated by INT, external (Remote) operation is designated by EXT. In INT mode, Start/Stop, Flow Direction, and Speed keys on the front panel determine operating state.

Depression and release of keys enables toggling between the two operating states.

E.

Start/Stop Key: Press once to start the pump and again to stop the pump. If the pump is in EXT mode, then pressing this won’t start the pump. If the pump is already running, pressing this will stop it.

F.

External/Remote Connector: Utilized to connect wiring for the KMPi's remote control operation with a DB9 connector.

G.

IEC Power Entry Module/Line Cord: Utilized to connect the line cord to the drive.

29


AUXILIARY PUMP

KMPi

10.2.3. Auxiliary Pump Settings

Auxiliary Pumps do not communicate back to the KMPi, so the KMPi is unable to determine the presence/absence and settings of Auxiliary Pumps automatically.

In order for the KMPi to control the Auxiliary Pumps properly, input the tubing size being loaded into the

Auxiliary Pump Pumpheads.

10.2.4. Auxiliary Pump Control Icons

When on the lower half of the main screen’s side bar and both Auxiliary Pumps connected, there are two arrow icons with the letters “D” and “P” under each of them. These arrow icons are the Auxiliary Pump

Control Icons. The “D” arrow controls the Diafiltration Pump, while the “P” arrow controls the Permeate

Pump.

1.

Press the Enter key on a highlighted Control Icon to set the flow rate of the selected pump in ml/min using the Directional Arrow soft buttons.

2.

Press Enter again to exit the Auxiliary Pump flow rate screen.

3.

When a Pump Mode is not running, the user may release and capture control of the Auxiliary

Pumps.

a. Highlight the Captured Pump (represented by a solid line arrow graphic) and press the left soft button.

b. The arrow icon will then change to a disjointed arrow graphic, signifying that the

Captured Pump is now a Released Pump.

c. When released, the KMPi will stop sending signals to the Released Pump. The

Auxiliary Pump can then be switched from External to Internal mode and used as a standalone pump, instead of being controlled by the KMPi system.

NOTE:

While Auxiliary Pump is in Internal mode, the Flow Direction of the Auxiliary Pump can be changed. However, once switched back to External Mode and recaptured, the Auxiliary Pump will only pump in a Clockwise Flow

Direction. Auxiliary Pump Flow Direction is always Clockwise when part of the KMPi system.

4.

A Released Pump can also be re-captured.

a. First, stop any running Pump Modes b. Highlight the target Released Pump and press the left soft button c. The arrow icon will then change back to a solid line arrow graphic b. Highlight the target Released Pump and press the left soft button

30


AUTOMATIC BACKPRESSURE VALVE

KMPi

5.

When an Auxiliary Pump is running due to a Pump Mode, the solid line arrow graphic will become an animated arrow graphic.

a. To start or stop the Permeate Pump during a Pump Mode using the Auxiliary Pump

Control Icon, highlight the Permeate Pump Control Icon and then press the right soft button.

NOTE:

The Permeate Pump cannot be started or stopped during C/D/D/C Mode, because it is functioning as

Diafiltration Pump 2. Similarly, the Diafiltration Pump cannot be started or stopped in the same manner as the

Permeate Pump during any running Pump Modes other than Manual Mode.

10.3. Automatic Backpressure Valve

The KrosFlo

®

Automatic Backpressure Valve controls TMP or permeate pressure during tangential flow filtration processes when used in conjunction with the KMPi TFF System. The valve is designed to pinch flexible tubing on the retentate or permeate line based on digital pressure readings to maintain the userset pressure. Up to two Automatic Backpressure Valves can be connected to the KMPi Auxiliary

Component Octopus Cable.

31



KMPi

10.3.1 Installation

1.

The cable on the KrosFlo

®

Automatic Backpressure Valve has both an RS232 port and a power supply. Connect the RS232 port to the terminal labeled “Valve 1” on the Octopus cable at the back of the KMPi.

2.

Plug in the transformer and connect to the power supply on the Automatic Backpressure Valve.

3.

Optional: If using a second ABV, follow steps 1 through 2 again but connect the second ABV's

RS232 port to the terminal labeled "Valve 2" instead.

Power Requirements

ACPC-F16-01N, ¼” (max) OD tubing valve 0.5A @ 12V

ACPC-F17-01N, ⅝” (max) OD tubing valve 1.0A @ 12V

ACPC-F82-01N, 1” (max) OD tubing valve 1.0A @ 12V

10.3.2 Operation

Automatic TMP Pressure Control

1.

To operate the backpressure valve in the auto TMP mode, switch the toggle on the top of the valve to the “TMP” setting. Press the OPEN button to load the tubing and reset the pressure controls.

2.

Set the desired TMP using the INC and DEC buttons.

3.

After starting the main pump, press GO. The valve will incrementally pinch until the desired TMP pressure is reached. This may take a few minutes to equilibrate.

4.

To pause the valve, press the GO button (the light will turn off). To resume, press the GO button

(the light will turn back on).

32



KMPi

a.

If the KMPi Pump is turned to off or to 1/2 the rpm when the GO button is pressed, the valve will pause and will maintain the same pinch distance. The valve will flash “SLO” while in this paused state. The valve will resume the normal pinch control when the pump is turned on or recovers at least 1/2 the original rpm.

!

Automatic Permeate Pressure Control

1.

To operate the backpressure valve in the auto PERMEATE mode, switch the toggle on the top of the valve to the “Permeate” setting. Press the OPEN button to load the tubing and reset the pressure controls.

2.

Set the desired Permeate pressure using the INC and DEC buttons.

3.

After starting the main pump, press GO. The valve will incrementally pinch until the desired

Permeate pressure is reached. This may take a few minutes to equilibrate.

4.

To pause the valve, press the GO button (the light will turn off). To resume, press the GO button

(the light will turn back on).

Manual

To control the valve manually, hold down the GO button for >3 seconds. The light will begin to flash and then the INC and DEC buttons can be used to adjust the pinch.

33



KMPi

10.3.3. Updating Automatic Backpressure Valve

1.

Connect the KrosFlo

®

Automatic Backpressure Valve to the computer via the RS232 port

2.

Turn on the valve and wait 60 seconds

3.

Ensure the appropriate update for the specific valve has been obtained

4.

Press and hold the Open button on the valve for 6 seconds, blanking the display

5.

Start the .exe file by double-clicking on it

6.

Click on the Start button to begin the process

7.

Either click the Find Comm button, or select the Comm port used by the valve

8.

Click on the OK button and the valve display will go dark — the valve will begin to update

9.

To verify a successful update, toggle the TMP/Permeate to restart the valve. The valve should now display the most current version

11. KFComm Software

11.1. KFComm License

Copyright © 2015 Spectrum Laboratories, Inc., Rancho Dominguez, USA. All rights reserved.

Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:

•

•

Redistribution of source code must retain the above copyright notice, this list of conditions and the following disclaimer.

Redistribution in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution.

34


KFCOMM SOFTWARE

KMPi

• Neither the name of Spectrum Laboratories, Inc. nor the names of its contributors may be used to endorse or promote products derived from this software without specific prior written permission.

THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS “AS IS” AND

ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WAR-

RANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN

NO EVENT SHALL THE COPYRIGHT OWNER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDI-

RECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT

LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROF-

ITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY,

WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE)

ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY

OF SUCH DAMAGE.

11.2. Installation

The KrosFlo

®

Windows

®

Excel

®

KMPi TFF System is accompanied with the KFComm Software Suite that can be used on

PCs. The software requires Microsoft

®

Windows XP (32-bit or 64-bit) or newer and Microsoft

®

2007 (32-bit or 64-bit) or newer. The software also does not run on any version of Windows CE and RT.

For increased ease of use, the KMPi can also be controlled using the KMPi PC Control that runs when

KMPi-specific templates are launched. The KMPi system and auxiliary components are connected to the computer with a USB connection that is read as a virtual serial (COM) port.

11.2.1. KFComm Software Suite

1.

Launch “Installer.exe” file from KFComm folder contents

2.

The Spectrum KFComm Installer will check the system settings—press Proceed to continue

3.

Ensure that all relevant components are selected, then press OK

35


KFCOMM SOFTWARE

KMPi

4.

Individual installation screens specific to what was selected will load—after each individual installation is completed, the next installation screen will automatically load

5.

Complete and confirm installation of all selected components from software suite

11.2.2. USB Connection

1.

Power on KMPi

2.

Power on computer

3.

Launch Device Manager on computer to monitor installation progress

4.

Connect USB cable from Auxiliary Component Octopus Cable to computer

5.

Device Manager will automatically refresh to indicate recognition of a hardware change

6.

Through Device Manager, user can monitor the installation of the USB drivers a. The KMPi connection will be read through multiple drivers in a sequence of three before it is completely installed b. The entire process may take up to ten minutes or more depending on computer

7.

Computer should load the correct drivers installed from KFComm Software Suite—when it has, the computer will read the KMPi connection as a single virtual serial (COM) port a. If computer loads a compatible but incorrect driver, a dialog that says the device driver was installed incorrectly will appear b. If that happens, disconnect the USB, restart both the KMPi and computer, then connect the USB cable to a different port c. If problem persists, update the driver software through its properties and manually select the KFComm Software Suite’s installation folder and allow console to search through subfolders

11.3. Instructions for Use

11.3.1. Opening and Configuring the KFComm Workbook Template

1.

Before opening the KMPi template, ensure that user has Administrator or similar access to both the computer and Excel

2.

To open the KMPi template, the user may

36


OPENING AND CONFIGURING THE KFCOMM WORKBOOK TEMPLATE

KMPi

a. Open the Spectrum Labs folder with shortcuts on the desktop, then select the KMPi

Data Collection shortcut link b. Click on the Start Menu and type in “KMPi Data Collection,” then click on the retrieved file c. Hit the Windows key on their keyboard and type in “KMPi Data Collection,” then click on the retrieved file

3.

If asked, enable macros in KFComm workbook

4.

After opening the template, an expected KMPi com port selection error will appear—this is normal, as the default COM port that KFComm will use is usually not the actual COM port the KMPi was read as by the computer

5.

The About KMPi Control dialog will appear—press OK to confirm

6.

The Pump Control window will load automatically

7.

Navigate to Add-ins tab and open Configure Collection menu

8.

From the Configure Collection menu, the user may a. Reopen the About KMPi Control dialog b. Retrieve KMPi Interface License dialog c. Use the Control button to retrieve the Pump Control window d. Check “Always Show Control” checkbox to enable KFComm to always load Control window e. Set Collection Intervals f. Use the “Find Comm” tool to automatically detect and select the KMPi port g. Open the Hardware settings menu to access Hardware, Auxiliary Pump, and Pressure

Alarms options h. Apply all changes

9.

After selecting the proper KMPi port and applying the changes, the workbook template will start to blink and show live data retrieved from the KMPi and auxiliary components

10. The KMPi can now be controlled through the Pump Control and data can now be collected

11.3.2. Data Collection Tools

Data Collection Tools may be found in the “Add-ins” tab on the Excel ribbon. Different versions of Excel may also display graphical icons to represent the tools.

37


DATA COLLECTION TOOLS

KMPi

a.

End Control: Used to end data collection. Certain functions in Excel need to be disabled for the data in the TFF Trial Template to be accessible. Clicking this will stop the spreadsheet from receiving live data, stop collection, and disable other controls. The data can then be saved and accessed for analysis like a normal Excel workbook. If the End Collection button is clicked once, the saved data can still be used for further data collection. If the End Collection button is clicked twice, the saved data cannot be used for further data collection.

b.

Configure Collection: Allows the user to open the Setup menu to configure basic KFComm settings.

c.

Stop Collection: After starting collection, the user may use the Stop Collection function to suspend data collection.

d.

One More Data Point: Allows the user to take a data point that was not part of the data collection intervals.

e.

Start Collection: Starts collecting data.

f.

Hardware Settings: Access and change the KMPi’s basic hardware settings.

g.

Workbook License: Calls up a dialog with licensing information.

h.

About KFComm: Calls up a dialog with basic KFComm information.

11.3.3. Pump Control

38



KMPi

a.

Main Pump: Set and display KMPi’s flow rate, pump direction, current Pump Mode, and Ramp

Rate.

i.

Feed Status: If set to "Full," KMPi will calculate set-points as if Feed Holdup volume is suspended in Feed flowpath loop. If set to “Empty,” KMPi will calculate set-points as if Feed Holdup volume is not suspended in Feed flowpath loop.

ii.

Permeate Status: If set to “Full,” KMPi wil calculate set-points as if Permeate

Holdup volume is suspended in Permeate flowpath loop. If set to “Empty,” KMPi will calculate set-points as if Permeate Holdup volume is not suspended in Permeate flowpath loop.

iii.

Feed Hold-up: The amount of liquid in L suspended in the Feed flowpath loop.

iv.

Permeate Void: The amount of void in L suspended in the Permeate flowpath loop.

v.

Feed Weight: Only available if no Feed Scale connected to KMPi. User must input starting Feed Weight.

b.

Set-points: Input set-points for application. Contents will vary based on Pump Mode.

c.

Diafiltration Pump: Display Diafiltration Pump flow rate. Only available on Manual mode.

d.

Permeate Pump: Set and display Permeate Pump flow rate. Can not be set in C/D/D/C Mode, as the Permeate Pump operates as a second Diafiltration Pump in C/D/D/C Mode.

e.

Automatic Backpressure Valve: Set and display target psi/bar. Dialog box also displays current pressure readings from pressure transducers.

f.

Auxiliary Scale Alarms and Stops: Set and display auxiliary alarms and stops. Dialog box also displays current weight readings from scales.

g.

Safe Checkboxes: Checking the “safe” checkbox disables changing values.

h.

Process Calculator: Clicking on the small black arrow on the right-hand side of the Pump

Control window will open a Process Calculator that is for reference only. The Process Calculator does not auto-populate with information from the application.

11.3.4. Worksheets Overview

a.

Integrity Test: Collect data with this worksheet during integrity testing to ensure membrane integrity

b.

Module Characteristics: Collect data with this worksheet when analyzing initial water flux

c.

Header: Contains information that is used to populate the Header of the Trial Data worksheet; fill out information in either the Header worksheet or the Header section of the Trial Data worksheet

d.

Trial Data: Collect data with this worksheet when running application

e.

Graph Worksheets: There are a number of other worksheets in the workbook template that are automatically populated with information from the three data collection worksheets. These graphs are:

i. NWP

39



KMPi ii. CF and Pressure vs Time iii. CF and Pressure vs VT iv. Flux Rate vs Time v. Flux vs CF iv. Feed Flow Rate vs Time

11.3.5. Shear Lookup Tool

The Shear Lookup Tool is a worksheet for the user’s reference only. By inputting the part number of the module being used for the application, the user may retrieve a Retentate Flow Rate Range

Recommendation chart to better plan their process.

12.

Basic Concepts of Tangential Flow Filtration

12.1. Introduction

Membranes use the principle of barrier separations to differentiate components based on size.

Components larger than the membrane pore are quantitatively held back by the membrane while smaller components pass through the membrane structure along with the permeate. Although there are other methods for driving the separation process, SpectrumLabs.com’s HF TFF modules are designed for pressure-driven applications.

Tangential Flow Filtration is an efficient way to separate streams that would quickly become plugged if processed by dead-end filtration techniques. Most of the process fluid flows along the membrane surface, rather than passing through the membrane structure. Fluid is pumped at a relatively high velocity parallel to the membrane surface.

Except for water treatment applications, only a small percentage of the tangential flow along the membrane surface ends up as permeate. In most cell and particle separations, only 1-5% of the inlet flow to the membrane device becomes permeate. The remaining 95-99% exits the membrane device as retentate. The retentate is recirculated back to the process reservoir and the module inlet so that another 1-

5% can be removed as permeate. This recirculation process continues in rapid succession, generating a significant and continuous permeation rate.

Filtrate flow results in a build up of retained components on the membrane’s inner lumen surface—these may occasionally accumulate into a cake layer instead of being carried away by the sweeping action of the recirculation fluid. This cake layer becomes a membrane barrier, reducing the functional size of the membrane pore and affecting module performance.

Caking is influenced by fluid variables: degree of solvation, concentration and nature of the solids and solutes, fluid temperature, along with operating variables—such as the solution’s velocity along the membrane—and TMP. Controlling this phenomenon by ensuring adequate fluid velocity at the liquid-membrane wall interface will maximize flux, solute passage, and optimize process parameters.

Fluid velocity is controlled by the pumping rate. Pumping rate depends on the quantity of fibers in the module and shear rate considerations. Typically, a shear rate of 12000s

-1 is used for filtration applications and up to 4000s

-1 is used for perfusion applications. However, some certain applications work well at reduced rates while others may require rates that are significantly higher. These are the considerations that the user usually investigates during Research and Development prior to moving to Pilot phase for their applications.

40



KMPi

12.2. Concentration

Concentration is the reduction of the initial sample volume to a lower, final sample volume. The opposite would be a dilution—where the initial sample volume is lower than the final sample volume through the addition of buffer or other medium. If the process volume is 10L and needs to be concentrated to 10X, then the final sample volume will be 1L. By removing 1-5% of each sweep of recirculated process volume,

SpectrumLabs.com’s HF TFF modules will gradually reduce the initial sample volume’s weight. When using Feed and Permeate Scales, this weight loss is communicated to the KMPi so that the KMPi knows when the process volume has been reduced to its desired concentration factor. As the weight decreases on the Feed Scale and increases on the Permeate Scale, the KMPi knows that the process volume is being concentrated. If the weight stays constant on the Feed Scale while increasing on the Permeate

Scale, the KMPi knows that the volume is undergoing a fed-batch concentration.

12.3. Diafiltration

Diafiltration is the washing of cells, cell debris, virus, precipates, proteins, and other materials. For instance, this is often done as an efficient method of buffer exchange, for instance. Diafiltration is measured by how many washes the process volume has undergone. If the process volume is 10L and needs to be washed 5 times, then 50L of diafiltration buffer must wash through the process volume.

The KMPi’s Diafiltration function relies upon feedback from both the Feed and Permeate Scales. The KMPi will add buffer to maintain the concentrated weight on the Feed scale. Once a set amount of weight is reached on the Permeate Scale—which would indicate that a set amount of Diafiltration Volumes have washed through the process volume—the KMPi will know that the process volume has been washed a desired number of times.

12.4. Sample Applications

The following examples are used to familiarize the user with the calculations and terminology used with the KMPi to use as set-points for automating their TFF process. These examples are simplified for easy comprehension and are not representative of real-life applications.

For specific module preparation procedures, see Hollow Fiber Module Preparation & Instruction Guide

(400-12058-000).

12.4.1. Equations

a.

Key and Definitions

1.

Feed Wt After C1: Feed Weight After Concentration 1

2.

Perm Wt After C1: Permeate Weight After Concentration 1

3.

Perm Wt After D1: Permeate Weight After Diafiltration 1

4.

Perm Wt After D2: Permeate Weight After Diafiltration 2

5.

Feed Wt After C2: Feed Weight After Concentration 2

6.

Perm Wt After C2: Permeate Weight After Concentration 2

41


EQUATIONS

7.

Conc Factor 1: Initial Concentration Factor

8.

Conc Factor 2: Final Concentration Factor

9.

Diaf Volumes 1: Diafiltration Volumes 1

10.

Diaf Volumes 2: Diafiltration Volumes 2

11.

Diaf Wt 1: Diafiltration Weight 1

12.

Diaf Wt 2: Diafiltration Weight 2

13.

SW: Starting Weight

14.

Feed Wt: Feed Holdup Weight

15.

Perm Wt: Permeate Holdup Weight b.

Concentration Weight Initial:

c.

Concentration 1 + Diafiltration 1 Permeate Weight:

SW – Perm Wt – Feed Wt After C1 + [Diaf Volumes 1 x (Feed Wt After C1 + Feed Wt)]

d.

Permeate 1 Weight:

SW – Feed Wt After C1

e.

Permeate 2 Weight:

Perm Wt After D1 + [Diaf Volumes 2 *(Feed Wt After C1 + Feed Wt]

f.

Concentration Weight Final:

KMPi

42


EQUATIONS

g.

Initial Concentration Factor:

SW

Feed Wt After C1

h.

Final Concentration Factor:

SW

Feed Wt After C2

KMPi

i.

Diafiltration Volumes 1:

(Perm Wt After D1) - (Perm Wt After C1)

Feed Wt After C1

j.

Diafiltration Volumes 2:

(Perm Wt After C2) - (Perm Wt After D1)

Feed Wt After C1

k.

Diafiltration Weight 1:

Feed Wt After C1 * Diaf Volumes 1

l.

Diafiltration Weight 2:

Feed Wt After C1 * Diaf Volumes 2

NOTE:

Feed and Permeate Holdup Volumes and Weights are determined by the user’s flowpath (such as tubing length, module size, and fiber diameter).

43


C MODE

KMPi

12.4.2. Concentration Mode

Concentration Mode may be used to flush the module to prepare it for use. Modules must be flushed with

2 ml of water for every cm

2 of its surface area. The module in the example below has a Surface Area of

~0.80 m

2

, which means the module must be flushed with ~16L of water.

To automate flushing the module on the KMPi while only using a Permeate Scale, the user can simply start with 32 kg of water in the Feed Reservoir, input the value into the KMPi as 32L of Feed Hold-up and set

Feed Status Empty. Then the user must set the Conc Factor setpoint to 2X. Once 16 kg of water has been moved from the Feed scale to the Permeate Scale, C Mode will end.


Module

Feed Reservoir

Permeate Reservoir

Diafiltration Pump Feed Scale

Conc Factor 1

KMPi Pump Permeate Pump Permeate Scale

2X

SW

Feed Wt After C1

32 kg

Perm Wt After C1

16 kg

Feed Scale *

16 kg

Permeate Scale

* Feed Scale is optional in this example to demonstrate how to use Feed Hold-up and Feed Fill options.

44


C/D MODE

KMPi

12.4.3. Concentration/Diafiltration Mode

C/D Mode may be used for a Fed-Batch concentration, followed by a Diafiltration. On the Feed Reservoir with four ports, set-up the ports as described below to create a vacuum that will draw excess feed into the Feed Reservoir from the Extra Feed Reservoir:

1.

Inlet: Connect to Module’s Outlet port

2.

Outlet: Connect through KMPi to Module’s Inlet port

3.

Buffer: Connect through Diafiltration Pump to Diafiltration Buffer Reservoir

4.

Vent: Connect to Extra Feed Reservoir

On both the Extra Feed Reservoir and Diafiltration Buffer Reservoir, install a vent. Ensure that the

Diafiltration Pump’s head is closed on the tubing between the Diafiltration Buffer and Feed Reservoir.

The result of the setup is that the vacuum will pull the entirety of the Extra Feed Reservoir’s contents as volume is depleted from the Process Reservoir the C function of C/D Mode. Once the contents of the

Extra Feed Reservoir are depleted, the vacuum will pull air. After the Concentration set-point is reached

(Conc Wt Ini), the KMPi will then switch to D mode until the Diafiltration set-point (Perm Wt After D1) is reached.

The KMPi will be able to properly calculate the Concentration Factor because it will know that a Fed-Batch

Concentration is taking place when the Permeate Scale increases while the Feed Scale weight stays constant.


Extra Feed Reservoir

Module

Feed Reservoir

Permeate Reservoir

Diafiltration Pump Feed Scale KMPi Pump Permeate Pump Permeate Scale

45


C/D/C MODE

KMPi

Conc Factor 1

Diaf Volumes 1

10X

7

SW


20 kg


2 kg

Diaf Wt 1

Perm Wt After D1

Feed Scale

18 kg

14 kg

30 kg

Permeate Scale

12.4.4. Concentration 1/Diafiltration/Concentration 2 Mode

C/D/C Mode may be used to further concentrate the process solution after Diafiltration.


Module

Feed Reservoir

Permeate Reservoir

Diafiltration Pump

Conc Factor 1

Diaf Volumes 1

Conc Factor 2

Feed Scale

10X

7

20X

KMPi Pump

SW



Permeate Pump Permeate Scale

20 kg


2 kg

Diaf Wt 1


1 kg

Feed Scale

18 kg

14 kg

30 kg

Permeate Scale

46


C/D/D/C MODE

KMPi

12.4.5. Concentration 1/Diafiltration 1/Diafiltration 2/Concentration 1 Mode

C/D/D/C Mode may be used to wash the solution with two different buffers.

Diafiltration Buffer Reservoir 1 Module Diafiltration Buffer Reservoir 1

Feed Reservoir

Permeate Reservoir

Diafiltration Pump 1 Feed Scale KMPi Pump Diafiltration Pump 2

(Permeate Pump)

Permeate Scale

NOTE:

In C/D/D/C Mode only, the Permeate Pump functions as Diafiltration Pump 2. For this functionality test, prepare two buffer reservoirs that both lead into the Feed Reservoir, and have one line go through the

Diafiltration Pump and the other line go through the Permeate Pump.

SW

Conc Factor 1

Diaf Volumes 1

Diaf Volumes 2

Conc Factor 2

10X

7

8

20X



20 kg


2 kg

Diaf Wt 1


Diaf Wt 2


1 kg

Feed Scale

18 kg

14 kg

30 kg

16 kg

46 kg

Permeate Scale

12.4.6. Constant Feed Concentration Mode

Set-up CFC mode exactly like C/D Mode

(see Section 12.4.5.)

47


ORDERING INFORMATION

KMPi

13. Ordering Information

KMPi TFF System (KrosFlo

®

MiniKros

®

Pilot i)

Part Number Description

SYM3-U20 Complete

KMPi

System

SYM3-U10

KMPi

Pump Drive and Head Only

ACM3-IQOQ-PW IQ/OQ Paperwork

ACM3-IQOQ-SR IQ/OQ Sales Rep Service

System Components & Accessories

Part Number Description

ACPX-N-01N MiniKros Fittings Kit

ACPX-K-01N KrosFlo Fittings Kit

ACPX-KE-01N KrosFlo Essentials Fittings Kit

ACM3-H3S-01N 13 LPM Easy-Load Pump Head with mounting hardware

ACM3-PHP-01N 17 LPM High-Performance Pump Head with mounting hardware

ACPC-F17-01N KrosFlo Automatic Backpressure Valve for use with 3/16” to 5/8” OD Tubing,

110V (L/S #25, 17, 18, 15, 24, 35, 36 and IP # 26, 73)

ACPC-F82-01N KrosFlo Automatic Backpressure Valve for use with 1/4” to 1” OD Tubing, 110V

(L/S #73 and 82)

ACSC-60K-1212 Surface Acoustic Wave Auxiliary Scale, 60kg Capacity, Universal Voltage


ACSC-200k-2023 Surface Acoustic Wave Auxiliary Scale, 200kg Capacity, Universal Voltage


ACBT-4TC-01N Process Reservoir - Bottle, 4 L, 3/4” TC

ACBT-10TC-01N Process Reservoir - Carboy, 10 L, 3/4” TC

ACBT-20TC-01N Process Reservoir - Carboy, 20 L, 3/4” TC

ACBT-50TC-01N Process Reservoir - Carboy, 50 L, 3/4”

ACBT-1-D Process Reservoir - Disposable Bottle, 1 L, 2 1/8” HB and 2 1/4” HB

ACBT-2-D Process Reservoir - Disposable Bottle, 2 L, 2 1/8” HB and 2 1/4” HB

ACTU-P26-25N PharmaPure Tubing Size 26, 0.25” ID, 1/4” Hose Barb



NOTE:

Contact SpectrumLabs.com for assistance selecting the appropriate HF Module, Flowpath,

Reservoir Bottles and Customized Sterile Flowpaths (MBT's) for user’s application.

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CONTACT INFORMATION

Contact Information:

SpectrumLabs.com America

World-wide Headquarters

voice 310-885-4600 (world-wide) • 800-634-3300 (toll-free US and Canada)

fax 310-885-4666 (world-wide) • 800-445-7330 (toll-free US and Canada)

e-mail [email protected]

web www.spectrumlabs.com

SpectrumLabs.com Europe

European Headquarters

voice +31 (0) 76 5719 419

fax +31 (0) 76 5719 772


web www.spectrumlabs.eu

Southern Europe


web www.spectrumlabs.fr

Central Europe


web www.spectrumlabs.de

UK and Ireland


web www.spectrumlabs.co.uk

Scandinavia



SpectrumLabs.com China

voice (+86) 21 68810228

400-6284448 (toll-free Mainland China)

fax (+86) 21 60919246


web www.spectrumlabs.cn

SpectrumLabs.com Japan

voice +81-77-552-7820

fax +81-77-552-7826


web www.spectrumlabs.jp

Benelux



KMPi

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400-12355-000 Rev. 01 • 152010

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