VERSAflux System

Operating Instructions
Original instructions
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 Table of Contents

Table of Contents
1 Introduction .......................................................................................................... 5
1.1 Important user information ............................................................................................................. 6
1.2 Associated documentation .............................................................................................................. 9

2 Safety instructions ............................................................................................... 10

2.1 Safety precautions ............................................................................................................................... 11
2.2 Labels ......................................................................................................................................................... 20
2.3 Emergency procedures ...................................................................................................................... 23
2.4 Recycling information ......................................................................................................................... 27
2.5 Declaration of Hazardous Substances (DoHS) ........................................................................ 28

3 System description .............................................................................................. 31

3.1 Overview ................................................................................................................................................... 32
3.2 VERSAflux systems layout ................................................................................................................ 33
3.2.1 Illustrations of VERSAflux 120 system .................................................................................. 34
3.2.2 Illustrations of VERSAflux 400 system .................................................................................. 38
3.3 Standard equipment ........................................................................................................................... 42
3.3.1 Skid and electric cabinet ............................................................................................................. 43
3.3.2 Automation ....................................................................................................................................... 45
3.3.3 Connections and drains .............................................................................................................. 46
3.3.4 Feed pump and feed line ............................................................................................................ 48
3.3.5 Retentate line ................................................................................................................................... 51
3.3.6 Permeate line ................................................................................................................................... 55
3.4 Optional equipment ............................................................................................................................. 57
3.4.1 Dummy filters .................................................................................................................................. 58
3.4.2 Hose kit ............................................................................................................................................... 59
3.5 Hollow fiber (HF) configuration ....................................................................................................... 60
3.5.1 VERSAflux 120 HF configuration ............................................................................................. 61
3.5.2 VERSAflux 400 HF configuration ............................................................................................. 62
3.5.3 HF cartridges .................................................................................................................................... 63
3.6 Meters and sensors ............................................................................................................................. 65
3.7 Flow charts .............................................................................................................................................. 66
3.7.1 External connections .................................................................................................................... 67
3.7.2 Flow diagrams ................................................................................................................................ 69
3.8 Control system ....................................................................................................................................... 72

4 Installation ............................................................................................................ 94
4.1 Site requirements .................................................................................................................................. 95
4.2 Transport .................................................................................................................................................. 97
4.3 Unpack VERSAflux ................................................................................................................................ 99
4.4 Setup ........................................................................................................................................................... 101
4.4.1 Assembly ............................................................................................................................................ 102
4.4.2 Process component connections ............................................................................................ 104
4.4.3 Power supply ................................................................................................................................... 106

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Table of Contents

5 Run preparations ................................................................................................. 109

5.1 Sample handling ................................................................................................................................... 111
5.2 Starting VERSAflux ............................................................................................................................... 114
5.3 Filter installation .................................................................................................................................... 115
5.4 Priming the rotary lobe pump ......................................................................................................... 116

6 Operation .............................................................................................................. 117

6.1 Perform the run ..................................................................................................................................... 119
6.2 PID control and feedback tuning ................................................................................................... 121
6.2.1 Introduction ...................................................................................................................................... 122
6.2.2 Using PID-control ........................................................................................................................... 124
6.2.3 More information ........................................................................................................................... 125
6.3 Procedures after use ........................................................................................................................... 127

7 Maintenance ......................................................................................................... 128

7.1 User maintenance schedule ........................................................................................................... 129
7.2 Cleaning .................................................................................................................................................... 130
7.3 Storage ...................................................................................................................................................... 132
7.4 Disassembly and assembly ............................................................................................................. 134

8 Troubleshooting ................................................................................................... 138

9 Reference information ........................................................................................ 142

9.1 Specifications ......................................................................................................................................... 143
9.2 Process wetted materials ................................................................................................................. 147
9.3 Chemical resistance ............................................................................................................................ 148
9.4 More information .................................................................................................................................. 150
Index ....................................................................................................................... 151

4 VERSAflux System Operating Instructions 29-0900-27 AA

 1 Introduction

1 Introduction

Purpose of this document

The Operating Instructions provide you with the instructions needed to install, operate
and maintain VERSAflux in a safe way.

Scope of this document

This manual is valid for all variants of standard VERSAflux systems. The system configu-
ration for your system is described in the General Specification and on the system label.
Detailed information regarding Hollow Fiber Cartridge is not covered.

About this chapter

This chapter contains important user information, description of safety notices, regulatory
information, a general description of VERSAflux and its intended use, and a list of asso-
ciated documentation.

In this chapter
This chapter contains the following sections:

Section See page

1.1 Important user information 6

1.2 Associated documentation 9

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1 Introduction
1.1 Important user information

1.1 Important user information

Read this before operating

VERSAflux

All users must read the entire Operating Instructions before installing, operating or
maintaining VERSAflux.
Always keep the Operating Instructions at hand when operating VERSAflux.
Do not operate VERSAflux in any other way than described in the user documentation.
If you do, you may be exposed to hazards that can lead to personal injury and you may
cause damage to the equipment.

Intended use of VERSAflux

VERSAflux systems are intended for pilot to production scale biological separations.
The systems are configured to operate hollow fiber cartridges suited for microfiltration
applications such as cell clarification/harvesting, or hollow fibers for ultrafiltration appli-
cations, such as protein concentration and diafiltration in downstream unit operations.
VERSAflux is not suitable for operation in a potentially explosive atmosphere or for han-
dling flammable liquids.
VERSAflux shall not be used in any clinical procedures, or for diagnostic purposes.

WARNING
Do not operate VERSAflux in any other way than described in the
Operating Instructions.

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 1 Introduction
1.1 Important user information

Prerequisites
In order to operate VERSAflux safely, and according to the intended purpose, the following
prerequisites must be met:
• You should be acquainted with the use of bioprocessing equipment and with the
handling of biological materials.
• The system must be installed according to the instructions in Chapter 4 Installation,
on page 94.

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 pro-
ceed 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.

VERSAflux System Operating Instructions 29-0900-27 AA 7

1 Introduction
1.1 Important user information

Notes and tips

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.

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 items are identified in the text by bold text (for example, Power).

8 VERSAflux System Operating Instructions 29-0900-27 AA

 1 Introduction
1.2 Associated documentation

1.2 Associated documentation

System-specific documentation
In addition to the Operating Instructions, the documentation package supplied with
VERSAflux also includes detailed specifications and traceability documents.
The most important documents in the documentation package with regard to technical
aspects of VERSAflux are:

Document Abbreviation Purpose/Contents

Piping and Instrumenta- P&ID Schematic overview of the entire process

tion Diagram flow, all components and instruments
and the control system.

General Specification GS Technical data for the system.

Assembly Drawing AD Physical layout. Provides all dimensional

data.

Spare Part List SPL List of spare parts available from GE

Healthcare.

Equipment List EQL Major components specification

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2 Safety instructions

2 Safety instructions

About this chapter

This chapter describes safety precautions and emergency shutdown procedures for
VERSAflux. The labels on the system and information regarding recycling are also de-
scribed.

Important

WARNING
Before installing, operating or maintaining VERSAflux, all users
must read and understand the entire contents of this chapter
to become aware of the hazards involved.
Failure to do this may cause human injury or death, or damage to
the equipment.

In this chapter
This chapter contains the following sections:

Section See page

2.1 Safety precautions 11

2.2 Labels 20

2.3 Emergency procedures 23

2.4 Recycling information 27

2.5 Declaration of Hazardous Substances (DoHS) 28

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 2 Safety instructions
2.1 Safety precautions

2.1 Safety precautions

Introduction
The safety precautions in this section are grouped in the following categories:
• General precautions, on page 11
• Flammable liquids and explosive environment, on page 12
• Personal protection, on page 13
• Installing and moving, on page 14
• Power supply, on page 16
• System operation, on page 16
• Maintenance, on page 18
Note: Some of the safety precautions in this chapter may concern components or
situations described in other VERSAflux product documents.

General precautions

WARNING
Perform a risk assessment for any risks due to the process or pro-
cess environment. Evaluate the effects the use of VERSAflux and
the operational processes may have on the classification of the
hazardous area. The process might cause the area to increase or
the zone classification to change. Implement the risk reduction
measures needed, including use of personal protection equipment.

WARNING
Make sure that all installation, maintenance, operation and inspec-
tion is carried out by qualified personnel who are adequately
trained, understand and adhere to local regulations and the oper-
ating instructions, and have a thorough knowledge of VERSAflux
and the entire process.

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2 Safety instructions
2.1 Safety precautions

WARNING
VERSAflux is designed for fixed installation. No main power supply
cable plug is provided. Connect the system directly to the electrical
cabinet or use other type of fixed installation.

WARNING
Do not operate VERSAflux in any other way than described in the
Operating Instructions.

WARNING
Protective earth. VERSAflux must always be connected to
protective earth when energized.

WARNING
Do not use VERSAflux if it is not working properly, or 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: EXPLOSION HAZARD

Flammable liquids. VERSAflux is not approved to handle flammable
fluids.

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 2 Safety instructions
2.1 Safety precautions

Personal protection

WARNING
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 and maintenance of
VERSAflux.

WARNING
Personal Protective Equipment (PPE). Whenever packing, unpack-
ing, transporting or moving VERSAflux, wear:
• Protective footwear, preferably with steel lining.
• Working gloves, protecting against sharp edges.
• Protective glasses.

WARNING
Only personnel authorized by GE Healthcare may open the cabinet
doors. There is high voltage inside the cabinet that can cause
human injury or death.

CAUTION
Do not touch the system while pumping fluid through the system
that has a temperature above the normal working temperature.
Do not touch the system until you are sure that this can be done
without risk and when all components in the system have reached
the normal working temperature range.

CAUTION
Avoid spillage and overflow. Make sure that the waste tubing is
inserted in an appropriate waste container and secured in place.

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2 Safety instructions
2.1 Safety precautions

CAUTION
Use ear protection whenever working close to the system in oper-
ation.

Installing and moving

WARNING
VERSAflux must be installed and prepared by GE Healthcare per-
sonnel or third party authorized by GE Healthcare.

WARNING
Move transport crates. Make sure that the forklift has capacity to
safely lift the crate weight. Make sure that the crate is properly
balanced so that it will not accidentally tip when moved.

WARNING
Heavy object. Because of the significant weight of VERSAflux, great
care must be taken not to cause squeezing or crushing injuries
during movement. At least two, but preferably three or more, per-
sons are recommended when moving the unit.

WARNING
Access to power switch and power cord. The power switch must
always be easy to access. The power cord must always be easy to
disconnect.

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 2 Safety instructions
2.1 Safety precautions

CAUTION
To prevent bacterial growth, VERSAflux may be partly filled with
denatured Ethanol (18% C2H5OH (Ethanol), 2% C3H7OH (Isopropanol)
and 80% H2O (water)) or 0.1 M NaOH (Sodium Hydroxide) at delivery.
The mixture is hazardous to humans if consumed. Flush out the
denatured Ethanol or Sodium Hydroxide before assembling, testing
or integrating VERSAflux into the intended process context.

CAUTION
The wheels of VERSAflux should be locked during normal use. The
wheels should be unlocked only when moving the unit.

CAUTION
Make sure that all tubing, hoses and cables are placed so that the
risk for tripping accidents is minimized.

CAUTION
VERSAflux is designed for indoor use only.

CAUTION
Do not use VERSAflux in a dusty atmosphere or close to spraying
water.

CAUTION
Make sure that correct air pressure is always maintained. Too high
or too low air pressure may be hazardous and may cause erroneous
results and leakage.

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2 Safety instructions
2.1 Safety precautions

Power supply

WARNING
VERSAflux must always be connected to a grounded power outlet.

WARNING
National Codes and standards (NEC, VDE, BSI, IEC, UL etc.) and local
codes outline provisions for safely installing electrical equipment.
Installation must comply with specifications regarding wire types,
conductor sizes, plug, branch circuit protection and disconnect
devices. Failure to do so may result in personal injury and/or
equipment damage.

WARNING
All electrical installations must be performed by authorized
personnel only.

System operation

WARNING
Safe distance. Always maintain a safe distance from
VERSAflux during drainage or other activities that may involve
splashing.

WARNING
Before operation, all process connections and the piping system
must be tested for leakage at maximum pressure for continued
protection against injury risks due to fluid jets, burst pipes or poten-
tially explosive atmosphere.

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 2 Safety instructions
2.1 Safety precautions

WARNING
Never exceed the operating limits stated in this document and on
the system label. Operation of VERSAflux outside these limits may
damage equipment and bodily harm or death may occur.

WARNING
Emergency stop. Pressing the EMERGENCY STOP will not shut off
mains power to the cabinet.

WARNING
Power failure. During a power failure, or if the EMERGENCY STOP
button is pressed, VERSAflux may remain pressurized. Opening a
line or vessel at this point could result in the release of potentially
hazardous process or cleaning fluid, and cause bodily harm.
When recovering from a power failure or emergency shutdown,
make sure all lines and vessels are depressurized before opening.

WARNING
Alarm signals. All alarm signals must be set within the limits
specified in the system documentation. Pressure and temperature
control must be activated while the system is in use to prevent the
piping system to leak or break.

NOTICE
Only use chemicals that have been proven not to be harmful to
the wetted parts of the unit.

NOTICE
Make sure that large particles are prevented from entering the
VERSAflux system during operation, otherwise the filters may be-
come clogged and the feed pump may malfunction.

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2 Safety instructions
2.1 Safety precautions

NOTICE
Do not start the rotary lobe pump before it is primed.

Maintenance

WARNING
The electric cabinet doors may only be opened when VERSAflux is
taken out of operation and subject to LOCK OUT / TAG OUT.

WARNING
Only personnel authorized by GE Healthcare may perform service,
installation, and maintenance of components inside the VERSAflux
cabinet.

WARNING
LOCK OUT / TAG OUT! Before any maintenance or decommission-
ing work is performed on VERSAflux, make sure that:
• it is empty and depressurized.
• it is disconnected from process feed, electrical power and
pneumatic supply.
• it is prevented from accidentally becoming re-energized during
maintenance.
• it is clearly tagged as taken out of operation.
• all process wetted areas are clean and decontaminated.

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 2 Safety instructions
2.1 Safety precautions

WARNING
For continued protection against injury risks due to fluid jets, burst
pipes or potentially explosive atmosphere, the piping system must
be tested for leakage at maximum pressure:
• After assembly or maintenance
• Before operation or CIP

CAUTION
Do not climb on any parts of VERSAflux except where clearly al-
lowed. Follow local regulations and make sure that equipment is
properly secured when inspecting VERSAflux at high level.

NOTICE
Although system filter type reconfiguration can be performed by
a properly skilled user, GE Healthcare recommends that a GE
Healthcare service engineer is assigned for this work.
Contact your GE Healthcare representative for more information
on changing filter configurations if required.

VERSAflux System Operating Instructions 29-0900-27 AA 19

2 Safety instructions
2.2 Labels

2.2 Labels

Introduction
This section describes the various labels on VERSAflux and their meaning.

System label illustration

The illustration below shows an example of a system label.
Note: Actual data is specific for each individual system and may vary from system
to system.

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 2 Safety instructions
2.2 Labels

System label description

Label text Description

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 Electronics.

Serial number System serial number.

Year of manufacture Manufacturing year.

Max. system Max. system pressure at temperature.

pressure/temperature

Pneumatic supply Pneumatic supply pressure requirement.

Overall protection class Overall protection class, ingress protection according to

IEC 60529. This cover all components of the system except
the electric cabinet.

Supply voltage system Supply voltage system.

Supply voltage pump Supply voltage pump.

Frequency Supply voltage frequency.

Max. current Max. current consumption system.

consumption system

Max. current Max. current consumption pump.

consumption pump

Protection class Protection class.

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2 Safety instructions
2.2 Labels

Safety labels
The table below describes the various safety labels that may be found on VERSAflux.

Symbol/text 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.

WARNING! High Voltage. Always make sure that the

system is disconnected from electric power before
opening the cabinet doors or disconnecting any electric
device.

EMERGENCY STOP label, yellow with black text.

(emergency stop button is red).
Refer to Section 2.3 Emergency procedures, on page 23
for further information regarding the emergency stop.

WARNING! WARNING! High voltage inside cabinet! Authorized

High voltage inside cabinet!
Authorised personnel only!
personnel only! For continued protection against fire,
For continued protection
against fire replace only with
only replace fuses with the same type and rating.
same type and rating of fuse

CAUTION! Hot surface. Risk of burning injuries.

CAUTION! Use ear protection whenever working close

to the system in operation.

CAUTION! Do not use water jets directly on the system.

CAUTION! CAUTION! Pressure control valve shall be set to 5.5 –

Pressure control valve 7 bar g for instrument air supply.
shall be set to
5.5 – 7 bar g
for instrument air
supply

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 2 Safety instructions
2.3 Emergency procedures

2.3 Emergency procedures

Introduction
This section describes how to perform an emergency shutdown of VERSAflux, and the
result in the event of power failure.

Precautions

WARNING
Emergency stop. Pressing the EMERGENCY STOP will not shut off
mains power to the cabinet.

WARNING
Power failure. During a power failure, or if the EMERGENCY STOP
button is pressed, VERSAflux may remain pressurized. Opening a
line or vessel at this point could result in the release of potentially
hazardous process or cleaning fluid, and cause bodily harm.
When recovering from a power failure or emergency shutdown,
make sure all lines and vessels are depressurized before opening.

VERSAflux System Operating Instructions 29-0900-27 AA 23

2 Safety instructions
2.3 Emergency procedures

Emergency stop button and main

power switch
VERSAflux 120 - front

VERSAflux 120 - rear

B A

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 2 Safety instructions
2.3 Emergency procedures

VERSAflux 400

Part Function

A EMERGENCY STOP button

B MAIN SWITCH, power

Emergency shutdown
Step Action Result

1 Press the EMERGENCY STOP • Pumps stop immediately.

button (A).
• The built-in computer (HMI) and PLC
remain powered.
• Red indicator lamp is lit.

• Buzzer is activated.

• No data is lost.

2 If required, also switch off the • The entire system, including the HMI
mains power supply using the and PLC, becomes powerless.
MAIN SWITCH, power (B), dis-
connect the power cord or • Data and run status may be lost.
switch off the fixed power sup-
ply circuit breaker.

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2 Safety instructions
2.3 Emergency procedures

Power failure
The system power is lost if the MAIN SWITCH on the cabinet is turned off or the mains
cable is disconnected or the power supply is lost.
Pump stops if the electrical power to the system is lost. All valves will immediately revert
to default positions. Any data that has not been saved at that time may be lost.

Restart after emergency

shutdown or power failure
Follow the instruction below to restart VERSAflux after emergency shut down or power
failure.

Step Action

1 Make sure that the condition that caused the power failure or emergency
stop is corrected.

Reset the EMERGENCY STOP button by twisting it clock-wise.

3 Press the Start button on the HMI.

NOTICE
If the system does not restart as expected, contact your local GE
Healthcare representative for assistance.

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 2 Safety instructions
2.4 Recycling information

2.4 Recycling information

Introduction
This section contains information about the decommissioning of VERSAflux.

Decontamination
VERSAflux shall be decontaminated before decommissioning and all local regulations
shall be followed with regard to scrapping of the equipment.

Disposal, general instructions

When taking VERSAflux out of service, the different materials must be separated and
recycled according to national and local environmental regulations.

Recycling of hazardous
substances
VERSAflux contains hazardous substances.

Disposal of electrical
components
Waste electrical and electronic equipment must not be disposed as unsorted municipal
waste and must be collected separately. Please contact an authorized representative
of the manufacturer for information concerning the decommissioning of equipment.

VERSAflux System Operating Instructions 29-0900-27 AA 27

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/T11364-
2006 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 ex-

cess of the limits established by the Chinese standard SJ/T11363-2006
Requirements for Concentration Limits for Certain Hazardous Sub-
stances 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 decom-
missioning.

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 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/T11363-
2006 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

VERSAflux System Operating Instructions 29-0900-27 AA 29

2 Safety instructions
2.5 Declaration of Hazardous Substances (DoHS)

List of hazardous substances

Component Hazardous substance

name 有毒有害物质或元素
部件名称

Pb Hg Cd Cr6+ PBB PBDE

铅 汞 镉 六价铬 多溴联苯 多溴二苯醚

VERSAflux X 0 0 0 0 0

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 3 System description

3 System description

About this chapter

This chapter provides an overview of the technical properties of VERSAflux.

In this chapter
This chapter contains the following sections:

Section See page

3.1 Overview 32

3.2 VERSAflux systems layout 33

3.3 Standard equipment 42

3.4 Optional equipment 57

3.5 Hollow fiber (HF) configuration 60

3.6 Meters and sensors 65

3.7 Flow charts 66

3.8 Control system 72

VERSAflux System Operating Instructions 29-0900-27 AA 31

3 System description
3.1 Overview

3.1 Overview

General
These Operating Instructions cover the VERSAflux 120 and 400 systems.
VERSAflux is a series of cross flow filtration (CFF) systems that utilize WinCC™ Advanced
(TIA Portal) V11 software for semi automation, with data logging capabilities over the
entire cross flow process.
VERSAflux systems are intended for pilot to production scale biological separations.
The systems are configured to operate hollow fiber cartridges suited for microfiltration
applications such as cell clarification/harvesting, or hollow fibers for ultrafiltration appli-
cations, such as protein concentration and diafiltration in downstream unit operations.

Material compliance
All plastic and polymer materials that come in contact with buffers and samples are
compliant with FDA CFR 21 part 177, or USP Class VI.
Used materials are traceable back to their production batches.
You can find information about the design and materials used in your system in the
System-specific documentation, on page 9.

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 3 System description
3.2 VERSAflux systems layout

3.2 VERSAflux systems layout

In this section
This section contains the following subsections:

Section See page

3.2.1 Illustrations of VERSAflux 120 system 34

3.2.2 Illustrations of VERSAflux 400 system 38

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3 System description
3.2 VERSAflux systems layout
3.2.1 Illustrations of VERSAflux 120 system

3.2.1 Illustrations of VERSAflux 120 system

VERSAflux 120: Front view

8 1 2

7
3

6 4

Part Function

1 EMERGENCY STOP buttons

2 Human machine interface (HMI)

3 Indicator lamps

4 Electrical connectors

5 Cartridge drain outlet connection

6 Feed inlet connection

7 Permeate outlet connection

8 Retentate outlet connection

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 3 System description
3.2 VERSAflux systems layout
3.2.1 Illustrations of VERSAflux 120 system

VERSAflux 120: Rear view

15

14
9

13

12

10
11

Part Function

9 Retentate drain connection

10 Swivelling caster with brake (4 pcs)

11 Adjustable floor supports

12 Electric cabinet

13 System label

14 MAIN SWITCH, power

15 Connectors on top

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3 System description
3.2 VERSAflux systems layout
3.2.1 Illustrations of VERSAflux 120 system

VERSAflux 120: External

connectors
Electrical connectors

7 8 9 10 11

1 2 3 4 5 6 12

Connector Function

1 Weight Signal Input

2 Compressed air to PCV-341

3 PT-113

4 TT-161

5 FIT-142 Signal

6 FIT-142 Power

7 Emergency stop HS3

8 PT-111

9 PT-112

10 FIT-141 Signal

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 3 System description
3.2 VERSAflux systems layout
3.2.1 Illustrations of VERSAflux 120 system

Connector Function

11 FIT-141 Power

12 USB connector

Top connectors

1 2 3

Connector Function

1 Compressed air inlet

2 Main power supply

3 Power supply for P-201

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3 System description
3.2 VERSAflux systems layout
3.2.2 Illustrations of VERSAflux 400 system

3.2.2 Illustrations of VERSAflux 400 system

VERSAflux 400: Front view

6 2

3
5

Part Function

1 EMERGENCY STOP buttons

2 Human machine interface (HMI)

3 Indicator lamps

4 MAIN SWITCH, power

5 Feed inlet connection

6 Permeate outlet connection

7 Retentate outlet connection

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 3 System description
3.2 VERSAflux systems layout
3.2.2 Illustrations of VERSAflux 400 system

VERSAflux 400: Rear view

11 12

10

Part Function

8 Adjustable floor support (2 pcs)

9 Swivelling caster with brake (4 pcs)

10 System label

11 Connectors on top

12 Retentate drain connection

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3 System description
3.2 VERSAflux systems layout
3.2.2 Illustrations of VERSAflux 400 system

VERSAflux 400: External

connectors
Side panel connectors

13

8 9 10 11 12

1 2 3 4 5 6 7

Connector Function

1 Power Converter to Motor

2 Load cell Signal Input

3 Compressed air to PCV-341

4 PT-113

5 TT-161

6 FIT-142 Signal

7 FIT-142 Power

8 Emergency stop HS3

9 PT-111

10 PT-112

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 3 System description
3.2 VERSAflux systems layout
3.2.2 Illustrations of VERSAflux 400 system

Connector Function

11 FIT-141 Signal

12 FIT-141 Power

13 USB connector

Top connectors

1 2 3

Connector Function

1 Compressed air inlet

2 Main power supply

3 Power supply for P-201

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3 System description
3.3 Standard equipment

3.3 Standard equipment

About this section

This chapter provides an overview of the technical properties of VERSAflux.

In this section
This section contains the following subsections:

Section See page

3.3.1 Skid and electric cabinet 43

3.3.2 Automation 45

3.3.3 Connections and drains 46

3.3.4 Feed pump and feed line 48

3.3.5 Retentate line 51

3.3.6 Permeate line 55

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 3 System description
3.3 Standard equipment
3.3.1 Skid and electric cabinet

3.3.1 Skid and electric cabinet

Skid

The rigid stainless steel structure supports and protects all process components and
the electric cabinet. The structure is designed for handling in a production environment
and is easy to move and keep clean.
The structure occupies a small box-shaped space that makes it easy to fit into any loca-
tion in the production facility.

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3 System description
3.3 Standard equipment
3.3.1 Skid and electric cabinet

Electric cabinet

The electric cabinet contains all electrical and pneumatic equipment. When the door is
closed, the entire cabinet is ingress protected according to IP54.

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 3 System description
3.3 Standard equipment
3.3.2 Automation

3.3.2 Automation

Control system

The VERSAflux System is automated by means of the WinCC Advanced (TIA Portal) V11C
control platform. Once the required control mode is selected and parameters entered,
a user can safely operate the system.

HMI

The HMI is built in to the cabinet and has high IP protection from the environment.
The HMI automatically starts when the system power is turned on, no specific starting
procedure is required for the HMI.
For HMI specifications, refer to the product documentation package.

User interface
The display and input devices are ergonomically designed for use in a clean production
environment.

Communications
All communication with controlled components mounted outside the cabinet uses the
HART™ industry standard communication protocol and hardware.

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3 System description
3.3 Standard equipment
3.3.3 Connections and drains

3.3.3 Connections and drains

Description
A standard VERSAflux system is provided with the following process connections:
• Feed inlet
• Filter inlet, outlet and drain connections
• Retentate outlet
• Permeate outlet
• Pump outlet located before filters and meters.

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 3 System description
3.3 Standard equipment
3.3.3 Connections and drains

Illustration
VERSAflux 120 VERSAflux 400

P1

P5

P2

B1

P4

P3

Part Label on system Function

B1 FEED Feed inlet to system

P1 RETENTATE Retentate outlet

P2 PERMEATE Permeate outlet

P3 FEED DRAIN Feed drain point

P4 CARTRIDGE DRAIN Cartridge drain point

P5 RETENTATE DRAIN Retentate drain point

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3 System description
3.3 Standard equipment
3.3.4 Feed pump and feed line

3.3.4 Feed pump and feed line

Description
The main purposes of the feed line is to transfer product (or feed) from the recirculation
tank, to the filter, FILTER and to raise the pressure of the feed so that correct trans
membrane pressure (TMP), filter pressure and feed flow is achieved. This is done by the
feed pump, P-201.
To protect the system against over pressure, one pressure sensor, PT-111 is installed
after the pump. If the system pressure rises over pre-set value, an alarm will be triggered
in HMI and the pump will stop, to make sure that the system is not subject to over pres-
sure. The feed line for VERSAflux 120 has a temperature sensor, TT-161 (optional), installed
before the pressure sensor.
The feed line can be drained through the HV-301 valve.
The internal diameter of the feed line is selected to keep the flow velocity of the product
within a favorable range with regard to the flow range for each system.

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 3 System description
3.3 Standard equipment
3.3.4 Feed pump and feed line

Feed: VERSAflux 120

ME1

B1
F

P-201

PT-111
HV-301

TT-161
P3

Part Label on system Function

B1 FEED Feed inlet

ME1 ME1 Spare port on feed line

P-201 P-201 Feed pump

HV-301 HV-301 Feed drain valve

P3 FEED DRAIN Feed drain

TT-161 TT-161 Temperature sensor

PT-111 PT-111 Pressure sensor

F FILTER Hollow fiber

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3 System description
3.3 Standard equipment
3.3.4 Feed pump and feed line

Feed: VERSAflux 400

ME1

B1

P-201

PT-111 HV-301

P3

Part Label on system Function

B1 FEED Feed inlet

ME1 ME1 Spare port on feed line

P-201 P-201 Feed pump

HV-301 HV-301 Feed drain valve

P3 FEED DRAIN Feed drain

PT-111 PT-111 Pressure sensor

F FILTER Hollow fiber

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 3 System description
3.3 Standard equipment
3.3.5 Retentate line

3.3.5 Retentate line

Description
Particles / molecules too large to pass through the filter pores are retained by the filter
as retentate.
Retentate is led out from the filter (FILTER) through the retentate connection and then
guided to the retentate outlet.
A sensor for pressure, PT-112 is located on the retentate outlet line. For VERSAflux 400
System, a sensor for temperature, TT-161 (optional), is located on the retentate line.
TMP is controlled by the pressure control valve PCV-341 (optional) regulated by control
software, or is controlled by the manual diaphragm valve PCV-331 in alternative option.
The entire retentate line can be shut off by closing the retentate valve HV-302 (optional)
combined with PCV-341 (optional), or by closing PCV-331 in alternative option.
The retentate line is drained through the drain valve HV-306.
All retentate drain valves on VERSAflux 120 and 400 use uniformed tag, HV-303.

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3 System description
3.3 Standard equipment
3.3.5 Retentate line

Retentate: VERSAflux 120

F PT-112 FIT-141 PCV-341 HV-302

HV-303 P5 P1

F PT-112 FIT-141

HV-303 P5 PCV-331 P1

Part Label on system Function

P1 RETENTATE Retentate outlet

P5 RETENTATE DRAIN Retentate drain

F FILTER Hollow fiber

PT-112 PT-112 Pressure sensor

HV-303 HV-303 Retentate drain valve

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 3 System description
3.3 Standard equipment
3.3.5 Retentate line

Part Label on system Function

FIT-141 FIT-141 Flow sensor

PCV-331 PCV-331 Manual diaphragm valve

PCV-341 PCV-341 Pressure control valve

HV-302 HV-302 Manual butterfly valve

Retentate: VERSAflux 400

F PT-112 FIT-141 PCV-341 HV-302

HV-303 P5 TT-161 P1

F PT-112 FIT-141 PCV-331

HV-303 P5 TT-161 P1

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3 System description
3.3 Standard equipment
3.3.5 Retentate line

Part Label on system Function

P1 RETENTATE Retentate outlet

P5 RETENTATE DRAIN Retentate drain

F FILTER Hollow fiber

PT-112 PT-112 Pressure sensor

HV-303 HV-303 Retentate drain valve

FIT-141 FIT-141 Flow sensor

TT-161 TT-161 Temperature sensor

PCV-331 PCV-331 Manual diaphragm valve

PCV-341 PCV-341 Pressure control valve

HV-302 HV-302 Manual butterfly valve

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 3 System description
3.3 Standard equipment
3.3.6 Permeate line

3.3.6 Permeate line

Description
Particles / molecules small enough to pass through the filter pores are collected as
permeate.
Permeate is led out from the filter through the permeate connection (FILTER) and guided
to the permeate outlet through valve HV-304.
Sensors for pressure, PT-113 (optional), and flow, FIT-142 (optional) are located on the
permeate outlet line. The temperature sensor, TT-161, for VERSAflux 120 is located on
the Feed line.

Permeate: VERSAflux 120

P2 HV-304 FIT-142 PT-113 F

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3 System description
3.3 Standard equipment
3.3.6 Permeate line

Permeate: VERSAflux 400

P2 HV-304 FIT-142 PT-113 F

Part Label on system Function

F FILTER Hollow fiber

PT-113 PT-113 Pressure sensor

FIT-142 FIT-142 Permeate flow meter

HV-304 HV-304 Manual diaphragm valve

P2 PERMEATE Permeate outlet

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 3 System description
3.4 Optional equipment

3.4 Optional equipment

About options
The VERSAflux suite of filtration systems comes in a basic setup, as described in previous
sections.
Additionally, a selection of options are available to extend the functionality of the instru-
ment.

In this section
This section contains the following subsections:

Section See page

3.4.1 Dummy filters 58

3.4.2 Hose kit 59

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3 System description
3.4 Optional equipment
3.4.1 Dummy filters

3.4.1 Dummy filters

Description
Dummy filters allow the system to operate with liquid but without filtering capability.
These can be either purpose made dummies or decommissioned filters.
Usage can be for tests and set-up where running the system is required but actual filtra-
tion is not.
Contact your local GE Healthcare representative for more information regarding dummy
filters.

Illustration: Dummy filters

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 3 System description
3.4 Optional equipment
3.4.2 Hose kit

3.4.2 Hose kit

Description
To connect the feed tank to a corresponding VERSAflux 120 or 400 system, a set of hoses
is required. Hose kits are available as an option from GE Healthcare. The hoses are made
of reinforced PT-cured silicone and are designed to meet the tank and system specifica-
tions.

Illustration: Hose kit

Basic hose kit

The basic kit contain the following hoses:
• Cartridge permeate port to permeate line;
• Cartridge drain port to cartridge drain line.

Optional hose kits

Optionally, depending on the tank and VERSAflux system configuration, the following
hoses can be included if requested:
• Feed from transfer pump to tank
• Feed from tank to system
• Retentate from system to tank
• Permeate recycle from system to tank

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3 System description
3.5 Hollow fiber (HF) configuration

3.5 Hollow fiber (HF) configuration

Overview
When the VERSAflux systems are operated with hollow fiber cartridges, required compo-
nents of the piping system must be installed.
The retentate line must be in the upper position.

In this section
This section contains the following subsections:

Section See page

3.5.1 VERSAflux 120 HF configuration 61

3.5.2 VERSAflux 400 HF configuration 62

3.5.3 HF cartridges 63

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 3 System description
3.5 Hollow fiber (HF) configuration
3.5.1 VERSAflux 120 HF configuration

3.5.1 VERSAflux 120 HF configuration

Illustration: Hollow fiber sizes 75,

55 and 35
1 2 2 2

4 3 4 3 4
75 55 35
An optional spool piece kit is needed to mount size 55 and 35 hollow fibers to the system,
see feed line extension pipes in the next table.

Description of HF components

Part Function

1 Retentate line

2 Hollow fiber cartridges

3 Feed line extension pipe

4 HF cartridge drain hose

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3 System description
3.5 Hollow fiber (HF) configuration
3.5.2 VERSAflux 400 HF configuration

3.5.2 VERSAflux 400 HF configuration

Illustration: Hollow fiber sizes 85,

65 and 45
1 2 2 2

4 3 4 3 4
85 65 45
An optional spool piece kit is needed to mount sizes 65 and 45 hollow fibers to the system,
see feed line extension pipes in the Description of HF components, on page 61.

Description of HF components

Part Function

1 Retentate line

2 Hollow fiber cartridges

3 Feed line extension pipe

4 HF cartridge drain hose

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 3 System description
3.5 Hollow fiber (HF) configuration
3.5.3 HF cartridges

3.5.3 HF cartridges

Illustration: HF cartridge

Description of HF cartridges
Hollow fiber (HF) cartridges contain numerous very thin hollow fibers glued together at
the ends.
Each fiber is open at the ends and the feed flows inside the fibers and out the other end.
The size of the pores determines the filtering characteristics of the cartridge, that is, the
cut-off size for particles that either will be retained or filtered out with the permeate.
The permeate flows outside the fibers and is collected through one of the side connectors.

Available types of HF cartridges

VERSAflux is designed to adopt hollow fiber cartridges of different sizes. These cartridges
are described in the Ambio hollow fiber filter user guide, GE Healthcare article no.
18-1165-30, and in the Hollow fiber selection guide , GE Healthcare article no. 18-1165-29.

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3 System description
3.5 Hollow fiber (HF) configuration
3.5.3 HF cartridges

HF cartridge draining

VERSAflux 120 VERSAflux 400

Hollow fibre cartridges are provided with two connections to the permeate compartment,
one at each end.
When mounted vertically, which is the case for all VERSAflux systems, the bottom con-
nection serves as a drain for the permeate. This allows for more complete recovery of
the permeate.

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 3 System description
3.6 Meters and sensors

3.6 Meters and sensors

Pressure sensors
Three pressure sensors are provided. The pressure sensor, PT-111, provides pressure
data for the feed pump outlet and filter feed inlet pressure, PT-112, measures retentate
pressure and PT-113 (optional) measures permeate pressure.
The pressure drop (delta P) is calculated by the control software by subtracting the re-
tentate pressure from the feed pressure.
The transmembrane pressure (TMP) is calculated by the control software by subtracting
the permeate pressure from the average of the feed and retentate pressure.
The pump outlet pressure sensors also provide overpressure protection for the feed
pump and system.

Flow sensors
Two flow sensors are provided. A magnetic flow meter for the retentate, and a magnetic
flow meter for the permeate flow.
FIT-141 (optional) measures the retentate flow and FIT-142 (optional) measures the
permeate flow.
The feed flow is calculated by adding the permeate flow to the retentate flow.

Temperature
On VERSAflux 120 system, temperature is measured in the feed line by sensor TT-161
(optional).
On VERSAflux 400 system, temperature is measured in the retentate line by sensor
TT-161 (optional) .

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3 System description
3.7 Flow charts

3.7 Flow charts

In this section
This section contains the following subsections:

Section See page

3.7.1 External connections 67

3.7.2 Flow diagrams 69

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 3 System description
3.7 Flow charts
3.7.1 External connections

3.7.1 External connections

Introduction
This section describes the external connections between VERSAflux 120 and 400 and
the optional tank.

Connection diagram

P1
P5

P2

B1 ME1

P4
P3

Legend

Symbol Color Description

Blue Outlets

Orange Inlets

Green Interface points

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3 System description
3.7 Flow charts
3.7.1 External connections

Battery limits
"Battery limits" represent all interface points between the VERSAflux and the customer
process plant.
System battery limits require hose connections not provided by GE Healthcare.
Normally, the user provides hoses for these connections. Refer to Section9.1 Specifications,
on page 143 for details of hose and connection types and sizes.

Tag Location Description

B1 System Feed inlet

P1 System Retentate outlet

P2 System Permeate outlet

P3 System Feed drain

P4 System Cartridge drain

P5 System Retentate drain

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 3 System description
3.7 Flow charts
3.7.2 Flow diagrams

3.7.2 Flow diagrams

VERSAflux 120: Flow diagram

P2
HV-304

P4
FIT-142
P F

PT-113
HV-305.3 HV-305.4

HV-305.1
FILTER
HV-306

HV-304.4

HV-304.3
HV-304.1
FILTER
HV-305

PT-111
P

HV-301

PT-112 TT-161
P

P3
P5

HV-303
FIT-141
F

P-201
PCV-341

ME1
PCV-331

HV-302

B1
P1

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3 System description
3.7 Flow charts
3.7.2 Flow diagrams

VERSAflux 400: Flow diagram

P2
HV-304

P4
FIT-142

P F
PT-113
HV-307.3 HV-307.4

HV-307.1
FILTER
HV-308

HV-306.3 HV-306.4

HV-306.1
FILTER
HV-307

HV-305.3 HV-305.4
HV-305.1
FILTER
HV-306

HV-304.4
HV-304.1

HV-304.3
FILTER
HV-305

PT-111
P

HV-301

PT-112
P

P3
P5

FIT-141
T F

HV-303

TT-161
P-201
HV-302 PCV-341
PCV-331

ME1
B1
P1

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3.7 Flow charts
3.7.2 Flow diagrams

Component description

Tag Description

B1 Feed

P1 Retentate

P2 Permeate

P3 Feed drain

P4 Cartridge drain

P5 Retentate drain

P-201 System pump

PT-111 Feed pump outlet pressure meter

PT-112 Retentate pressure meter

PT-113 Permeate pressure meter (optional)

TT-161 Temperature meter, VERSAflux 120 on Feed, VERSAflux 400 on

Retentate (optional)

FIT-141 Retentate flow meter (optional)

FIT-142 Permeate flow meter (optional)

HV-302 Manual butterfly valve HV-302 used together with PCV-341, on

Retentate (alternative option PCV-331)

PCV-341 Pneumatic pressure control valve PCV-341 together with HV-302,

on Retentate (alternative option PCV-331)

PCV-331 Manual pressure control valve, on Retentate (alternative option

PCV-341 together with HV-302)

TANK Not included in the system

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3 System description
3.8 Control system

3.8 Control system

Introduction
VERSAflux is operated and monitored using the HMI (Human machine interface) that is
displayed on the screen. The screens and the structure of the HMI are described below.
All set range and data in this chapter are for VERSAflux 400 system.

Cabinet indicators

1 2 3

Part Label Color Function

1 Power Green Power on

2 Run Yellow Pump on

3 Alarm Red Alarming

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3.8 Control system

Structure of the HMI

Welcome screen

Step Action

1 Start the VERSAflux

Result: The welcome screen appears.

2 Wait until the system is ready, as shown by the System Starting countdown
and appearance of the Logon button.

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3 System description
3.8 Control system

Step Action

3 Click on the Logon button.

Result:

4 Enter the correct information for User and Password, then press OK.
Result:

5 Confirm that USB memory stick is installed on the cabinet, then click YES.
Result: The system moves on to the Home screen.

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3.8 Control system

Home screen
The Home screen provides an overview and is the main control screen for system
operation.

Part Area/Indicator Displays ...

1 Head display area Important parameters that always display on

screen

2 Piping & Flow diagram Flow Scheme

Instrument Reading

3 Live trend Instrument live data trend

4 Instance Alarm and Alarm information

Acknowledge area

5 Acknowledge and Reset Instance Alarm

area Warning and System events
Acknowledge and reset

6 Control mode area Pump Control mode selection

PCV Control parameters

7 On and Off buttons Start and stop for the pump

8 Foot display area Switch between different screens

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3 System description
3.8 Control system

Head display area

The Head display area shows up on all screens. It only displays the selected important
parameters.

Name Description Range Deci-

mal

Pump Set Pump actual speed set point 0.0~100.0% 1

Feed Pressure PT-111 actual value 0.00~6.00 bar 2

TMP Trans-membrane pressure 0.00~4.00 bar 2

Delta P Delta P = Feed pressure - Permeate 0.00~4.00 bar 2

pressure

Acc. VOL1: Accumulated retentate flow volume, this - 0

Retentate value can only be reset manually.

Acc. VOL2: Accumulated permeate flow volume, this - 0

Permeate value can only be reset manually.

Acc. Time Batch running time. It starts from pump - -

running, can be paused by alarm signals,
and reset manually.

System time Time reading from the system HMI. - -

User Display logged on user name. - -

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3.8 Control system

Piping and Flow Diagram area

The flow scheme area displays as Piping & Flow Diagram (PFD), as shown in the following
example:

All instruments with corresponding settings can be found in this area, as shown in the
following table (Range data for VERSAflux 400 system):

Name Installation Range Decimal Unit

PT-111 Default 0.00~6.00 2 Bar in default

PT-112 Default 0.00~6.00 2 Bar in default

PT-113 Optional 0.00~4.00 2 Bar in default

TT-161 Optional 0.0~150.0 1 Degree Celsius

FIT-141 Optional 0.0~600.0 1 l/min

FIT-142 Optional 0.0~95.0 1 l/min

PCV-341 Optional 10~100 0 %

P-201 Default 0.0~100.0 1 %

WIT-176 Optional 0.0~1200.0 1 kg

Note: If an optional instrument is not selected, it will disappear from the PFD area
together with its corresponding settings and related processes.

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3.8 Control system

Optional instrument Related processes

PT-113 PT-113 reading

•

• PT-113 alarm setting

• TMP value

• TMP control

• TMP alarm setting

TT-161 TT-161 reading

•

• TT-161 alarm setting

FIT-141 FIT-141 reading

•

• FIT-141 alarm setting

• Constant retentate flow control

• Constant retentate flow control alarm setting

• Acc. VOL1

FIT-142 FIT-142 reading

•

• FIT-142 alarm setting

• Acc. VOL2

PCV-341 PCV-341 setting

•

• Delta P control

• Delta P control alarm setting

WIT-176 WIT-176 reading

•

• WIT-176 alarm setting

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3.8 Control system

Live trend display area

The Live Trend area displays instance values for the following:

Name Displayed live trend of ...

FIT-141 Retentate flow meter (FIT-141) reading

PT-111 Feed pressure meter reading

Delta P Pressure difference between Feed and Retentate

TT-161 Temperature reading

Instance Alarm and Acknowledge area

The Instance Alarm & Acknowledge area indicates instance alarm, warnings and system
events. The alarm background will become yellow when acknowledged.

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3.8 Control system

Acknowledge and Reset area

The Acknowledge & Reset area comprises the buttons that are used to acknowledge
and reset information, as shown in the following table.

Button Function

Reset Acc. VOL 1 Reset retentate accumulated flow

Reset Acc. VOL 2 Reset permeate accumulated flow

Reset Acc. Time Reset accumulated batch time

Reset Fault Restore system after alarm has disappeared

Alarm Ack. Alarms acknowledged by operator, after which the alarm dis-
appears from the window

Control mode area

The Control mode area displays the different control modes that can be selected.

Clicking the icon allows selection of the control mode to be used.

The parameter table below allows the user to choose the proper control parameters,
control modes and settings:

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Control group 1:

Pump Control Description Set Range Deci-

Group mal

Pump Set Manual pump speed control set point. 0.0~100.0% 1

Delta P Set Delta P control set point, 0.00~4.00 bar 2

Delta P = P_feed – P_retentate.

Flow Set Retentate flow control set point, 0.0~400.0 1

Constant flow control. l/min

Control group 2:

PCV Control Description Range Deci-

Group mal

PCV Set Manual PCV valve opening control set 10.0~100.0% 1

point.

TMP Set TMP control set point, 0.00~4.00 Bar 2

TMP = (P_feed + P_retentate)/2 – P_per-
meate.

Start and Stop Buttons

The Start and Stop Buttons area allows the user to start and stop the pump.

Name Function

On button (green) Start pump if the system is OK.

Off button (red) Stop pump

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3.8 Control system

Foot display area

The Foot Display area shows up on all screens. It displays the different screen selection
possibilities for the system.

Name Description Function

Home Page Button Switch to Home page.

Setting1 Page Button Switch to instrument alarm/warning settings

page.

Setting2 Page Button Switch to miscellaneous settings including PID,

dry run protection, etc.

Trend Page Button Switch to history trend page.

AlarmLog Page Button Switch to alarm log page.

UserAdmin Page Button Switch to user administration page.

Language Function Button Switch between English and Chinese.

Log Off Function Button Log off the current user.

Exit Function Button Exit current runtime with admin authority.

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Setting1 screen
The Setting1 screen includes the Alarm and Warning settings range and enable/disable
functions for the installed in-line instruments.
Click the Setting1 button in the Foot display area to go to the Setting1 screen.

Posi- Area / Indicator Description Remark

tion

1 Alarm disable switches Corresponding alarm Red: Disabled

will be disabled Green: Enabled

2 Alarm parameter set- User settings for each Need Admin account to
tings instrument modify; data will be re-
Alarm/Warning tained during power
off.

The detailed information for instrument Alarm/Warning settings are shown in the following
table:

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3.8 Control system

Tag Range Decimal Unit

PT-111 HA 0.00~6.00 2 bar

PT-111 LA 0.00~6.00 2 bar

PT-111 HW 0.00~6.00 2 bar

PT-111 LW 0.00~6.00 2 bar

PT-112 HA 0.00~6.00 2 bar

PT-112 LA 0.00~6.00 2 bar

PT-112 HW 0.00~6.00 2 bar

PT-112 LW 0.00~6.00 2 bar

PT-113 HA 0.00~4.00 2 bar

PT-113 LA 0.00~4.00 2 bar

PT-113 HW 0.00~4.00 2 bar

PT-113 LW 0.00~4.00 2 bar

TT-161 HA 0.0~150.0 1 Degree Celsius

TT-161 LA 0.0~150.0 1 Degree Celsius

TT-161 HW 0.0~150.0 1 Degree Celsius

TT-161 LW 0.0~150.0 1 Degree Celsius

FIT-141 HA 0.0~600.0 1 l/min

FIT-141 LA 0.0~600.0 1 l/min

FIT-141 HW 0.0~600.0 1 l/min

FIT-141 LW 0.0~600.0 1 l/min

FIT-142 HA 0.0~95.0 1 l/min

FIT-142 LA 0.0~95.0 1 l/min

FIT-142 HW 0.0~95.0 1 l/min

FIT-142 LW 0.0~95.0 1 l/min

WIT-176 1 HA 0.0~1200.0 1 kg

WIT-176 LA 0.0~1200.0 1 kg

WIT-176 HW 0.0~1200.0 1 kg

WIT-176 LW 0.0~1200.0 1 kg

1 WIT-176 is the load cell signal from a tank. It is valid only when the system is connected to a specific tank and the Enable
Tank button is enabled on the Setting2 page.

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3.8 Control system

Setting2 screen
The Setting2 screen includes the Alarm and Warning settings range, the enable/disable
functions and the PID settings for the different control modes together with the Misc
function settings (such as unit switch from bar to PSI, tank load cell enable/disable
function, Buzzer enable/disable function, Compress air alarm enable/disable function,
and the Abnormal flow alarm enable/disable function).
Click the Setting2 button in the Foot display area to go to the Setting2 screen.

Posi- Area/ Description Remark

tion Indicator

1 Alarm Corresponding alarm will be disabled for Red: Disabled

disable different control modes: Green: Enabled
switches
• Delta P

• TMP Alarm

• Retentate Flow Control (RFC Alarm )

2 Alarm User settings for corresponding Alarm/ Need Admin ac-

parameter Warning for different control modes: count to modify;
settings data will be kept
• Delta P
during power
• TMP off.

• Retentate Flow Control (RFC)

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3 System description
3.8 Control system

Posi- Area/ Description Remark

tion Indicator

3 PID PID parameter settings for different con- Detailed PID

Parameter trol modes: tuning refers to
settings Section 6.2 PID
• Delta P
control and
• TMP feedback tuning,
on page 121.
• Retentate Flow Control (RFC)

4 Misc. Different kinds of functions enable/dis- Red: Disabled

switches able switches: Green: Enabled
• Unit switch: bar-PSI

• Enable Tank

• Buzzer enable/disable

• Compress air alarm enable/disable

(Pneumatic)
• Abnormal flow alarm enable/disable
(Flow Abnormal)

Note: Once the Enable Tank button has been enabled, a Tank will appear on the
PFD on the Home page. Otherwise the Tank is hidden.

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3.8 Control system

Detailed information for instrument Alarm/Warning settings is shown in the following

table:

Tag Range Decimal Unit

Delta P HA 0.0~4.0 1 bar in default

Delta P LA 0.0~4.0 1 bar in default

Delta P HW 0.0~4.0 1 bar in default

Delta P LW 0.0~4.0 1 bar in default

TMP HA 0.0~4.0 1 bar in default

TMP LA 0.0~4.0 1 bar in default

TMP HW 0.0~4.0 1 bar in default

TMP LW 0.0~4.0 1 bar in default

RFC HA 0.0~400.0 1 l/min

RFC LA 0.0~400.0 1 l/min

RFC HW 0.0~400.0 1 l/min

RFC LW 0.0~400.0 1 l/min

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3.8 Control system

Trend screen
All the installed instruments´ historical data trend can be found on the Trend page.
Click the Trend button in the Foot display area to go to the Trend screen.

In the trend diagram area, the Y axis to the left shows the measurement for flowrate
and temperature (FIT-141, FIT-142, TT-161), and the Y axis to the right shows the mea-
surement for pressure (PT-111, PT-112, PT-113, TMP, Delta P).
The user can drag the marker over the trend curve to read the process data from the
data table below the trend curve area.

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3.8 Control system

AlarmLog screen
The AlarmLog screen records all the warnings and alarms that ocur.
Click the AlarmLog button in the Foot display area to go to the AlarmLog screen.

All warnings will display with a white background. When an alarm occurs, the background
will turn yellow. It will remain yellow when the user acknowledges the alarm and will
turn blue when the fault is corrected and the system is reset.

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3.8 Control system

The UserAdmin screen

The UserAdmin screen provides tools to edit specific user and administrator information
as shown in detail below.
Click the UserAdmin button in the Foot display area to go to the UserAdmin screen:

Important information for all users:

Admin (adminnistrator) OP (operator)

Functions • Create new user account • Change own password

• Add/Remove/Edit all user informa- • Modify own logoff time

tion (e.g. change own and others
password)
• Modify logoff time for all users

• Change alarm and warning set-

tings

Restric- None • Change alarm range set-

tions ting
• Create new account

• Exit the program

Remark Default Password: 123456 Default Password: 000000

Default logout: 5 minutes Default logout: 60 minutes

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3.8 Control system

Create new user account

Step Action

1 Click the User pane.

Result: the User pane is activated and a keyboard pops up:

2 Enter the new user name.

3 Click the Password pane.

Result: The Change password window appears:

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3.8 Control system

Step Action

4 Enter the new password and confirm it.

5 Click the Group pane.

Result: the Group pane is activated:

6 Choose the correct acount level for the new user.

7 Click the Logoff time pane.

Result: the Logoff time pane is activated and a keyboard pops up:

8 Enter the automatic Logoff time for the new user in minutes (default).

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3.8 Control system

Functional Buttons
The Language, Log Off and Exit buttons in the Foot display area are all functional buttons.

Language
By clicking the Language button in the Foot display area the user can switch between
English and Chinese language display.

Log Off
By clicking the Log Off button in the Foot display area, the current user will be logged
off from the system and the user information in the Head display area will disappear,
although the system will keep the current working condition.
When the operation of the system software is resumed, the user will be asked to log on
to the system.

Exit
Only the administrator can exit the current filtration software interface and go back to
the Window CE interface by clicking the Exit button.

Data recording
The system operation data will be recorded on the USB memory stick in *.csv file format.
All the instrument readings will be recorded as Process Data[X].csv, where X stands for
a number, starting from 0, 1, 2, etc.
All the warnings and alarms will be recorded as Alarm Log[X].csv, where X stands for a
number, starting from 0, 1, 2, etc.
The *.csv files can be opened and edited by the Microsoft® Excel® software on any
other computer.

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4 Installation

4 Installation

About this chapter

This chapter provides information required to enable users and service personnel to
unpack, install, move and transport VERSAflux.

Precautions

WARNING
Before attempting to perform any of the procedures described in
this chapter, you must read and understand all contents of the
corresponding section(s) in the Section 2.1 Safety precautions, on
page 11 as listed below:

• General precautions, on page 11

• Personal protection, on page 13
• Installing and moving, on page 14
• Power supply, on page 16

In this chapter
This chapter contains the following sections:

Section See page

4.1 Site requirements 95

4.2 Transport 97

4.3 Unpack VERSAflux 99

4.4 Setup 101

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 4 Installation
4.1 Site requirements

4.1 Site requirements

Space and floor load

For space and floor requirement, see external dimensions and weights in Section 9.1
Specifications, on page 143.
• Make sure that the floor can handle the VERSAflux weight at fully loaded conditions.
Please observe that for the weight to be equally distributed over all wheels, the floor
must be level and without irregularities.
• In order to allow convenient working conditions for the operator, sufficient space
should be provided at all sides of the combined VERSAflux system and VERSAflux
tank when installed at the intended production location.

Ambient environment
Avoid:
• Direct sunlight.
• Strong magnetic or electric fields.
• Vibrations.
• Corrosive gas.
• Dust.

Electrical power
Refer to Section4.4.3 Power supply, on page106 and Section9.1 Specifications, on page143
for power, voltage and phase requirements.

Compressed air
• Dry and particle free air for system supply.
• Refer to Section 9.1 Specifications, on page 143 regarding capacity requirements.
• Refer to Connect compressed air supply, on page 102 regarding connections to the
instrument.

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4 Installation
4.1 Site requirements

Media supply
Refer to Section 9.1 Specifications, on page 143 regarding requirements for media supply
and delivery.
Supply must be arranged so that piping dimensions, piping lengths, valves and height
differences do not obstruct processing.

Computer
VERSAflux 120 and 400 has an industrial built-in HMI installed.

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 4 Installation
4.2 Transport

4.2 Transport

In the transport crate

WARNING
Move transport crates. Make sure that the forklift has capacity to
safely lift the crate weight. Make sure that the crate is properly
balanced so that it will not accidentally tip when moved.

WARNING
Personal Protective Equipment (PPE). Whenever packing, unpack-
ing, transporting or moving VERSAflux, wear:
• Protective footwear, preferably with steel lining.
• Working gloves, protecting against sharp edges.
• Protective glasses.

Use a pallet jack or fork-lift with a minimum capacity to match the empty weight of the
system plus the transport crate. Refer to Section 9.1 Specifications, on page 143 regarding
system weight.
Note: Make sure that intended openings and apertures are large enough to allow
passage of the crate when lifted from the floor for transport.

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4 Installation
4.2 Transport

Unpacked

WARNING
Heavy object. Because of the significant weight of VERSAflux, great
care must be taken not to cause squeezing or crushing injuries
during movement. At least two, but preferably three or more, per-
sons are recommended when moving the unit.

• VERSAflux can be rolled by hand on hard and level surface with wheel brakes released.
• If the floor quality does no allow rolling the VERSAflux on its own wheels, it can be
moved with a pallet jack or fork-lift.
• For minimum door aperture size, refer to Section 9.1 Specifications, on page 143.

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 4 Installation
4.3 Unpack VERSAflux

4.3 Unpack VERSAflux

Tools required
• Suitable lifting device, forklift or similar. Refer to Section 9.1 Specifications, on page 143
for dimensions and weight to be handled.
• 13 mm wrench (or ratchet with 13 mm socket).
• Electrical screwdriver no. 2 bit.
• Knife.
• Lever.

Visual inspection
Check:
• that all equipment is enclosed in the crate according to the packing list.
• the equipment for any apparent damage and document carefully if found.
If any equipment is missing or damages are found, contact your GE Healthcare repre-
sentative immediately.

Precautions

CAUTION
To prevent bacterial growth, VERSAflux may be partly filled with
denatured Ethanol (18% C2H5OH (Ethanol), 2% C3H7OH (Isopropanol)
and 80% H2O (water)) or 0.1 M NaOH (Sodium Hydroxide) at delivery.
The mixture is hazardous to humans if consumed. Flush out the
denatured Ethanol or Sodium Hydroxide before assembling, testing
or integrating VERSAflux into the intended process context.

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4 Installation
4.3 Unpack VERSAflux

General unpacking instructions

Note: Refer to the unpacking instructions attached to the outside of the crate when
unpacking the crate. In absence of the unpacking instructions, follow the
general unpacking instructions below.

Step Action

1 Remove the front, side and back panels by loosening the bolts.

2 Remove the accessories and documentation package.

3 Use a forklift or similar lifting equipment to move the system out from the
crate.

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 4 Installation
4.4 Setup

4.4 Setup

In this section
This section contains the following subsections:

Section See page

4.4.1 Assembly 102

4.4.2 Process component connections 104

4.4.3 Power supply 106

Precautions

CAUTION
To prevent bacterial growth, VERSAflux may be partly filled with
denatured Ethanol (18% C2H5OH (Ethanol), 2% C3H7OH (Isopropanol)
and 80% H2O (water)) or 0.1 M NaOH (Sodium Hydroxide) at delivery.
The mixture is hazardous to humans if consumed. Flush out the
denatured Ethanol or Sodium Hydroxide before assembling, testing
or integrating VERSAflux into the intended process context.

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4 Installation
4.4 Setup
4.4.1 Assembly

4.4.1 Assembly

Lock the wheels

The VERSAflux system is delivered fully assembled. No further specific assembly proce-
dures are required.
After positioning the system at its designated location, lock the wheels (figure).

Connect compressed air supply

Locate your air inlet as in the previous figure, and connect to the compressed air supply.
For air supply requirements, refer to Compressed air, on page 95.

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4.4 Setup
4.4.1 Assembly

Control system

VERSAflux 120 and 400 are delivered with the WinCC Advanced (TIA Portal) V11 system
control software.
WinCC Advanced (TIA Portal) V11 is pre-installed and configured on the built-in HMI with
no additional specifications required.
For more information see Section 3.3.2 Automation, on page 45.

Filter setup
If the system is configured for the intended filter type, there is no need for further config-
uration upon arrival at the process site or inbetween processing runs.
If the system needs to be reconfigured for different size of HF cartridges, refer to Sec-
tion 7.4 Disassembly and assembly, on page 134.

Feed pump and CFF filter

protection
To protect the system from feed containing particles that may clogg the CFF-filter or
damage the pump, use upstream normal flow filtering as described in Section 5.1 Sample
handling, on page 111.

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4 Installation
4.4 Setup
4.4.2 Process component connections

4.4.2 Process component connections

Introduction
This section provides guidelines for the connection of process components to VERSAflux.

Recommended hoses and

connections

Use hoses delivered with the tank to connect the tank and the system to each other.
Use customer supplied hoses to connect the combined tank and system assembly battery
limits to the plant interface points.
Refer to Section 9.1 Specifications, on page 143 for information regarding connection type
and size.

General guidelines for

connections
• Use piping or tubing that has an internal diameter sufficient for the flow rate specified.
The inner diameter of the tubing and its connections should be greater than or equal
to the corresponding diameter of the system.
• Inlet and outlet containers shall be located and arranged so that back pressure and
suction height remains within system specification limits, refer to Section 9.1 Specifi-
cations, on page 143 or the Section 1.2 Associated documentation, on page 9 (GS).
• Keep the tubing lengths as short as possible to minimize hold-up volume in the sys-
tem.
• Route the tubing to minimize the risk of tripping when operating the instrument and
connected device.
• If the hoses should be violently pulled, for example caused by an accidental tripping,
they should be checked for damage, leakage and mechanical rigidity before contin-
uing operation.

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4.4 Setup
4.4.2 Process component connections

• The chemical properties of the tubing used shall meet or exceed the properties
specified in Section 9.3 Chemical resistance, on page 148.

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4 Installation
4.4 Setup
4.4.3 Power supply

4.4.3 Power supply

Power requirements
The power supply requirements are specified in Section 9.1 Specifications, on page 143.

Installation
Connect the system power cord to either:
• A fixed power supply by means of a permanent connection which can be detached
only by the use of a tool.
• An EN 60309-2 compliant connector.

Grounding and protective earth

• The protective earth wire must be connected to system ground.
• Ground impedance must conform to the requirements of national and local industrial
safety regulations and/or electrical codes.
• If the leak current exceeds 10 mA, a high leakage current earth connection must be
provided and confirmed before connecting power supply. Refer to the product doc-
umentation package for information regarding the leak current for your system.
• The integrity of all ground connections must be periodically checked.

Circuit breaker
A circuit breaker must be present in the fixed power supply.
Breaking the power supply to the VERSAflux system by using this breaker must be
equivalent to disconnecting the power cord for a non-fixed connected instrument.

Power supply cable

The mains power supply cable is shielded ÖLFLEX™ of type: 150 CY (3G x 2.5 mm2);
The pump power supply cable is shielded ÖLFLEX of type: 191 CY (5G x 4.0 mm2).
If the cable needs to be replaced due to damage, the same type of cable or equivalent
must be used.

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4.4 Setup
4.4.3 Power supply

WARNING
Only personnel authorized by GE Healthcare may perform service,
installation, and maintenance of components inside the VERSAflux
cabinet.

Wire colors and tags

All instrument power cord wires must be connected to the fixed power supply wires with
orresponding colors and tags.

Function Color Marking

Neutral Black N

Live Black L

Protective Yellow-green PE = GND

ground (earth)

Live and neutral wire cross

section area
All live- and neutral wiring must have a cross section area equal to or more than the
specification in this table:

Mains current Mains and neutral conductor

up to minimum area

10 A 1 mm2

16 A 1.5 mm2

25 A 2.5 mm2

32 A 4 mm2

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4.4 Setup
4.4.3 Power supply

Protective earth wire cross

section area
All protective earth wiring must have a cross section area equal to or more than the
specification in this table:

Leak current PE conductor minimum area

> 10 mA 10 mm2 copper or 16 mm2 aluminium

≤ 10 mA Equal to or larger than the L and N-wire

Ground fault breaker

VERSAflux is not equipped with a general Ground Fault Circuit Breaker and it is not an
option that is available from GE Healthcare.
However, if ground fault protection for the system is desired,
• a Ground Fault Circuit Breaker may be installed or
• the system may be connected to an outlet that is protected by a permanently installed
Ground Fault Circuit Breaker.
The tripping current for such an interrupter must be higher than the leak current as
stated in the test protocol in the product documentation package.

Built-in circuit breakers

The mains power supply to VERSAflux and the pumps are equipped with circuit breakers
inside the cabinet. Refer to the product documentation package for the specific types
used in your system.

More information
Voltage, power, fuse requirements and the tripping current for the fixed power supply
ground fault protector can be found in the General Specification provided in the product
documentation package.

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 5 Run preparations

5 Run preparations

About this chapter

This chapter provides the information required to safely prepare VERSAflux for operation.
Before VERSAflux is taken into operation, make sure that all procedures in these chapters
and sections have been performed:
• Chapter 4 Installation, on page 94 and
• actions before operation in Section 7.1 User maintenance schedule, on page 129.

In this chapter
This chapter contains the following sections:

Section See page

5.1 Sample handling 111

5.2 Starting VERSAflux 114

5.3 Filter installation 115

5.4 Priming the rotary lobe pump 116

Precautions

WARNING
Before attempting to perform any of the procedures described in
this chapter, you must read and understand all contents of the
corresponding section(s) in the Section 2.1 Safety precautions, on
page 11 as listed below:

• General precautions, on page 11

• Personal protection, on page 13

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5 Run preparations

• System operation, on page 16

NOTICE
Only use chemicals that have been proven not to be harmful to
the wetted parts of the unit.

Refer to Section 9.3 Chemical resistance, on page 148 for more information.

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 5 Run preparations
5.1 Sample handling

5.1 Sample handling

Reasons for Normal flow

filtration (NFF)
NFF before CFF
If it can be suspected that large particles may be present in the sample, for instance
because of settling during sample hold, a Normal Flow Filter (NFF) can be used to prevent
these particles from entering the VERSAflux during operation.

NOTICE
Make sure that large particles are prevented from entering the
VERSAflux system during operation, otherwise the filters may be-
come clogged and the feed pump may malfunction.

NFF after CFF

If there is a need to prevent residual particles, larger than the CFF cut-off size, from being
recovered from the completed run, a NFF can be used when recovering the processed
product from the system.

Recommendations

The table below describes the situations where the GE Healthcare range of ULTA™ NFF
capsules can be used.

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5 Run preparations
5.1 Sample handling

If... Then use the following NFF... Placement...

Large particles are • ULTA Prime CG capsule Between the

present in the sample container
sample container and the system
feed inlet

Large particles are • ULTA Prime CG 0,2 µm Between the

present in the recovery outlet
product • ULTA Pure HC 0,2 µm sterile grade and the product
ULTA Pure SG 0.2 µm sterile grade container
•

Illustration of sample handling

Part Function

A Container for starting material

B Starting material feed to ULTA NFF filter

C Filtered material to VERSAflux feed inlet

D Feed from tank to system

E Retentate from system to tank

F Permeate out

G Recovered material from VERSAflux after completed CFF-run.

H ULTA NFF-filtered recovered material

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 5 Run preparations
5.1 Sample handling

Part Function

I Container for recovered material, preferably a ReadyCircuit™ bag (part of

the ReadyToProcess™ portfolio) or equal.

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5 Run preparations
5.2 Starting VERSAflux

5.2 Starting VERSAflux

Starting VERSAflux

Step Action

1 Make sure that the air supply to the system is turned on.

2 Turn on the UPS if used.

3 Make sure that the USB stick has been plugged in.

4 Make sure that the cabinet doors are closed and locked.

5 Switch on power to VERSAflux by turning the MAIN SWITCH, power, to the

"I" position. See Section 3.2 VERSAflux systems layout, on page 33 for loca-
tion.

6 Wait until the HMI has started up and the Logon button is displayed.

7 Click the Logon button, then enter the correct user name (User) and
password (Password).

8 Click Yes when the USB Memory Installed window pops up.

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 5 Run preparations
5.3 Filter installation

5.3 Filter installation

Installing hollow fiber (HF)

cartridges
Follow the intruction below to install the HF cartridges.

Step Action

1 Make sure that the system is configured for using HF cartridges and car-
tridges of the intended size, refer to Section 7.4 Disassembly and assembly,
on page 134 if required.

2 Prepare the HF cartridge(s) according to the manufacturer's instructions.

3 Install the cartridge into the system, refer to illustrations in Section 3.5
Hollow fiber (HF) configuration, on page 60.

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5 Run preparations
5.4 Priming the rotary lobe pump

5.4 Priming the rotary lobe pump

Introduction
Before using your VERSAflux system and cartridge to process product, you should prime
the rotary lobe pump as follows.
Priming is done for VERSAflux 120 and 400.

NOTICE
Do not start the rotary lobe pump before it is primed.

Prepare connection
Step Action

1 Close the retentate valve, permeate valve, retentate drain valve, permeate
drain valve and cartridge drain valve.

2 Connect the feed drain port with a hose to a container.

3 Open the feed drain valve.

4 Connect the feed inlet with a hose to a container full of pure water.

5 Open the feed supply to let feed flow into the pump slowly.

Run priming
Step Action

1 Run the pump while watching the flow through the membrane cartridge.

2 Check that the inlet hose is full of water.

3 Stop the pump and close the feed drain valve.

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 6 Operation

6 Operation

About this chapter

This chapter provides the information required to safely prepare the VERSAflux for oper-
ation.

In this chapter
This chapter contains the following sections:

Section See page

6.1 Perform the run 119

6.2 PID control and feedback tuning 121

6.3 Procedures after use 127

Precautions

WARNING
Before attempting to perform any of the procedures described in
this chapter, you must read and understand all contents of the
corresponding section(s) in the Section 2.1 Safety precautions, on
page 11 as listed below:

• General precautions, on page 11

• Personal protection, on page 13
• System operation, on page 16

VERSAflux System Operating Instructions 29-0900-27 AA 117

6 Operation

NOTICE
Only use chemicals that have been proven not to be harmful to
the wetted parts of the unit.

Refer to Section 9.3 Chemical resistance, on page 148 for more information.

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 6 Operation
6.1 Perform the run

6.1 Perform the run

Final checks before start

NOTICE
Make sure that the actions listed below are completed before
VERSAflux is started.

• Check that the pump is filled with correct lubricant oil before start, refer to the pump
supplier documentation found in the document package for details.
• Check that all inlets and outlets to the system are connected, closed or in the state
that they are supposed to be before the system is started.
- Inlets that are not in use shall be closed.
- Outlets that are not in use shall be fitted with tubing and directed to waste.
• Check the condition of all connections and gaskets.
• Check that no chemicals that may be harmful to the system will be used.

Start VERSAflux
Step Action

1 Make sure that the cabinet doors are closed and locked.

2 Make sure that the Emergency Stop button has been reset.

3 Make sure that the USB stick was plugged in.

4 Switch on power to VERSAflux by turning the Main power switch to the ON

position

5 Wait until the HMI has started up and the Logon button is displayed.

6 Click the Logon button, then enter the correct user name (User) and password
(Password).

7 Click Yes when the USB Memory Installed window pops up.

8 Check that the standby state of the HMI has no error message.

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6 Operation
6.1 Perform the run

Prime VERSAflux
Perform the priming as described in Section 5.4 Priming the rotary lobe pump, on page 116.

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 6 Operation
6.2 PID control and feedback tuning

6.2 PID control and feedback tuning

About this chapter

This chapter provides information to enable users to set up a satisfying control behaviour
of the VERSAflux by being able to understand and use the PID-control functions provided
by WinCC Advanced (TIA Portal) V11.

In this chapter
This chapter contains the following sections:

Section See page

6.2.1 Introduction 122

6.2.2 Using PID-control 124

6.2.3 More information 125

VERSAflux System Operating Instructions 29-0900-27 AA 121

6 Operation
6.2 PID control and feedback tuning
6.2.1 Introduction

6.2.1 Introduction

PID process control regulator

Process

vp

sp

I
P
D
te Time

This illustration shows the behaviour of the P, I and D components of a typical PID process
control regulator.
• Process is the process to be controlled.
• Time is elapsed time.
• sp is the "set point" where the process should operate.
• te is a point in time where the process is disturbed and the regulator will act.
• vp is the process value.
• P (orange) is the proportional component of the regulator.
• I (cyan) is the integral component of the regulator.
• D (purple) is the derivate component of the regulator.

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 6 Operation
6.2 PID control and feedback tuning
6.2.1 Introduction

PID parameter description

Parameter Meaning Behaviour Usage

P Proportional Guides the process to Reduces the effect of an error but does not
its setpoint with an completely eliminate it. A simple P-regulator
input that varies results in a stable stationary error between
proportinally to the actual and requested flow or pressure.
error.
• Too large P-component will make the
system unstable.
• Too small P-component will make the
regulator slow and prevent it from
eliminating the error entirely.

I Integrating Samples the error over The I parameter eliminates the stationary
time and reinforces error, but results in a slight instability leading
the regulator output to oscillations in the actual flow or pressure.
as long as the error is The I parameter can have values between 0
not eliminated. and infinity.

• Too large I-component will cause the

system to oscillate after the error has been
eliminated.
• Too small I-componet will prevent the
regulator from eliminating the entire error.

D Derivating Delivers an inital "kick" The D parameter can reduce the oscillations
to the regulator with introduced by a PI-regulator. D can have
an amplitude that is values between 0 and infinity.
proportional to the
• Too large D-component may cause the
error change rate.
system to overshoot initally and make the
system sensitive to noise.
• Too small D-component may cause for
the system to respond slowly to errors and
possiblly oscillate.

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6 Operation
6.2 PID control and feedback tuning
6.2.2 Using PID-control

6.2.2 Using PID-control

Using WinCC Advanced (TIA

Portal) V11 for VERSAflux
Whenever an automated process step requires the control of pressure (feed, retentate
and permeate pressure), the WinCC Advanced (TIA Portal) V11 control software of VER-
SAflux employs PID-type controllers to control the pressure to its setpoint.
The controllers for the feed pump and the trans membrane pressure (TMP) may require
adjustment depending on the type and behaviour of the filter.
The I parameter can have values between 0 and infinity. Smaller values have a greater
effect and a value of infinity has no effect.
Note: The value infinity is set as 9999 in WinCC Advanced (TIA Portal) V11.
Most often, a simple PI-regulator is preferable for pressure control, and VERSAflux is
therefore configured by default with the D parameter set to zero.

Setting up feedback tuning

WinCC Advanced (TIA Portal) V11 uses so-called PI feedback tuning, where P and I are
parameters that determine the tuning characteristics.
There is one way to apply the feedback tuning instructions, in the Setting2 module.

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 6 Operation
6.2 PID control and feedback tuning
6.2.3 More information

6.2.3 More information

Tuning and adjustments

Tuning the PID parameters
If tuning of the PID control is required, it is most likely that the control settings for the
feed pump need to be adjusted.
Common methods for PID optimization (e.g. Ziegler-Nichols method) can be applied.
Faster and slower response

If Then...

Slower (more stable) control is required Increase I

Decrease P

Faster (less stable) control is required Decrease I

Increase P

The system tends to overshoot intially Decrease D

The system tends to keep on oscillating after the Decrease I

error has been eliminated Decrease P
Increase D

Adjustment rate
No drastic changes should be applied.
An appropriate measure is to change the I parameter by a factor of 0.5 or 2, respectively,
while initially keeping the P parameter constant.
Faster regulation required
When optimizing the parameters to obtain a faster regulation, a recommended start
may be to:
• Decrease I parameter by dividing by 2.
• Increase P parameter by multiplying by 1.2.
More stable regulation required
When the regulation is too fast, for example noisy curves, it may be necessary to optimize
the parameters in the opposite way, i.e., increase I parameter and decrease P parameter.

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6 Operation
6.2 PID control and feedback tuning
6.2.3 More information

Troubleshooting

If the Is too... Consequence

parameter...

P Large The system will become unstable.

Small The system will respond slow to errors and possibly be

unable to eliminate errors completely.

I Large The system will oscillate after the error has been elimi-
nated.

Small The system will be unable to eliminate errors completely.

D Large The system will overshoot initally when regulating for

errors.

Small The system will be prevented from increasing the P-

component enough to achieve fast response without
resulting oscillations.

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 6 Operation
6.3 Procedures after use

6.3 Procedures after use

Shut down the system

Step Action

1 Click the green OFF button on the Home screen in WinCC Advanced (TIA
Portal) V11.

2 Confirm that the pump has stopped.

3 Turn off the MAIN SWITCH.

Cleaning the filters

The filters can be cleaned in place if the method is set within the specified ranges for
solutions, temperature and pressure. The filters should be cleaned as described in Filters
, on page 130.

Preparing for storage

Clean the system as described in Section 7.2 Cleaning, on page 130 and then prepare the
system for storage as described in Section 7.3 Storage, on page 132 as required.

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7 Maintenance

7 Maintenance

About this chapter

This chapter provides required information to enable users and service personnel to
clean, maintain, calibrate and store VERSAflux.

In this chapter
This chapter contains the following sections:

Section See page

7.1 User maintenance schedule 129

7.2 Cleaning 130

7.3 Storage 132

7.4 Disassembly and assembly 134

Precautions

WARNING
Before attempting to perform any of the procedures described in
this chapter, you must read and understand all contents of the
corresponding section(s) in the Section 2.1 Safety precautions, on
page 11 as listed below:

• General precautions, on page 11

• Personal protection, on page 13
• Power supply, on page 16
• Maintenance, on page 18

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 7 Maintenance
7.1 User maintenance schedule

7.1 User maintenance schedule

Before each run or weekly

This section covers maintenance actions required before each run or weekly (depending
on which happens first).

Component Action

Complete system Clean/sanitize the system according to the procedure described

in Cleaning-in-place (CIP), on page 130.

Protective earth Make sure that the protective earth wiring is not disconnected
or damaged.

Monthly or as needed

Component Action

Connection and Check for leakage. Replace seals if needed. Do a leakage test
seals at maximum operating pressure.

Emergency stop Check that the Emergency stop button functions correctly.

Annually or as needed
This section covers maintenance actions required annually or as needed.

Component Action

Complete system A preventive maintenance test procedure on all instruments,

sensors, pumps and valves should be performed annually by
trained and certified personnel. Contact your local GE
Healthcare representative. Replace all gaskets, o-rings and
valve diaphragms.

Complete stainless Inspect stainless steel systems for rust. If needed, passivate
steel system the steel by recirculating a solution of 5% phosphoric acid in
the system overnight at room temperature and then rinse with
purified water until the pH of the outlet liquid is neutral.

Pump Replace all wear and tear parts. Replace drive element lubricant.
Refer to the System Documentation for details.

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7 Maintenance
7.2 Cleaning

7.2 Cleaning

General
A suitable frequency of routine cleaning is determined by the nature of the starting
material and the type of process. However, routine cleaning shall be performed at
intervals aimed at prevention rather than cleaning VERSAflux (and connected equipment)
from microbial growth or contamination.

Cleaning-in-place (CIP)
It is possible to run CIP manually on the VERSAflux system.
After completed CIP, rinse the VERSAflux interior and all cleaned components thoroughly
with water of desired quality, for example Water For Injection (WFI), to remove all traces
of the cleaning agent.

Recommended cleaning agents

All components can be cleaned with the most commonly used agents, such as detergents,
Ethanol, weak acids, Sodium Hydroxide and salt solutions.
Refer to Section 9.3 Chemical resistance, on page 148.

Filters
• GE Healthcare Hollow fiber cartridges cleaning procedures are provided in the Hollow
fiber cartridges for membrane separations Operating Handbook, GE Healthcare article
no 18-1165-30.
• Filter units provided by other manufacturers shall be cleaned according to the in-
structions from the respective manufacturer.

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 7 Maintenance
7.2 Cleaning

External surfaces
The VERSAflux is designed to be operated in a clean environment and the external sur-
faces should not normally accumulate any substantial amount of dust or dirt.
Regularly, wipe the outside of the VERSAflux with a clean cloth. Use a mild cleaning agent
such as water, followed by 20% Ethanol. Regular wiping and care of the equipment will
help keep the surfaces uncorroded.
It is not recommended to spray or splash liquids towards external surfaces.
Do not spray or splash liquids towards filters or the fan on the electric cabinet.

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7 Maintenance
7.3 Storage

7.3 Storage

Short term storage

This procedure works for storage duration up to one month.

Step Action

1 Perform cleaning as described in Section 7.2 Cleaning, on page 130.

2 Fill the VERSAflux with 20% Ethanol to prevent microbial growth.

Make sure that the filter cartridges are at least partially wetted during stor-
age.

3 Seal off VERSAflux to prevent contamination caused by the surrounding

environment.

Long term storage

This procedure is applicable for storage duration longer than one month.

Step Action

1 Perform the actions described for Short term storage above.

2 Replace the filter cartridges with filter cartridge dummies.

3 Place VERSAflux in a dust free environment with well-controlled climate.

The temperature should be stable and in the range 4ºC to 25ºC.
The air humidity and air temperature differences should be kept as low as
possible to prevent condensation and corrosion.

4 Remove TC connector rubber gaskets in good condition suitable for

processing and place them in dark and cold storage while VERSAflux is out
of operation. This prevents them from aging and drying out.
Use other sealings, not in processing condition, as replacements during the
storage period.

To prevent microbial growth, the storage solution shall be replaced regularly if VERSAflux
is stored for long periods of time.

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 7 Maintenance
7.3 Storage

Filters
• GE Healthcare Hollow fiber cartridges storage procedures are provided in the Hollow
fiber cartridges for membrane separations Operating Handbook, GE Healthcare article
no 18-1165-30.
• Filter units provided by other manufacturers shall be stored according to the
instructions from the respective manufacturer.

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7 Maintenance
7.4 Disassembly and assembly

7.4 Disassembly and assembly

User-allowed actions
This section covers all disassembly and assembly procedures that the end user is allowed
to perform without support from GE Healthcare.

WARNING
Only personnel authorized by GE Healthcare may open the cabinet
doors. There is high voltage inside the cabinet that can cause
human injury or death.

WARNING
The electric cabinet doors may only be opened when VERSAflux is
taken out of operation and subject to LOCK OUT / TAG OUT.

WARNING
LOCK OUT / TAG OUT! Before any maintenance or decommission-
ing work is performed on VERSAflux, make sure that:
• it is empty and depressurized.
• it is disconnected from process feed, electrical power and
pneumatic supply.
• it is prevented from accidentally becoming re-energized during
maintenance.
• it is clearly tagged as taken out of operation.
• all process wetted areas are clean and decontaminated.

WARNING
For continued protection against injury risks due to fluid jets, burst
pipes or potentially explosive atmosphere, the piping system must
be tested for leakage at maximum pressure:
• After assembly or maintenance
• Before operation or CIP

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 7 Maintenance
7.4 Disassembly and assembly

About filter configuration change

The VERSAflux suite of filtration systems can be operated with different size of HF car-
tridges. While systems in general, including the entire automation software, supports
both configurations, some components must be exchanged to allow running the systems
with each filter type.
This chapter describes the procedures and components required to switch between
different size HF operation.

NOTICE
While system filter type reconfiguration can be performed by a
properly skilled user Technician, GE Healthcare recommends that
a GE Healthcare service engineer is assigned for this work.
Contact your GE Healthcare representative for more information
on changing filter configurations if required.

Changing from HF75 to HF55 or

HF35 for VERSAflux 120

Hollow fiber Action

type

HF size 75 Install it directly by connecting to the permeate hose and the car-
tridge drain hose.

Switch to HF 1 Connect the HF55 supporting tube with the HF55 filter on the
size 55 top.
2 Install the filter on the system with a tri-clamp tighten.

3 Connect the filter to the permeate hose (same as for HF75) and
the HF55 permeate port.
4 Install the unique HF55 drain hose on the cartridge drain mani-
fold and connect to the HF55 drain port.

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7 Maintenance
7.4 Disassembly and assembly

Hollow fiber Action

type

Switch to HF 1 Connect the HF35 supporting tube with the HF35 filter on the
size 35 top.
2 Install the filter on the system with a tri-clamp tighten.

3 Connect the filter to the permeate hose (same as for HF75) and
the HF35 permeate port.
4 Install the unique HF35 drain hose on the cartridge drain mani-
fold and connect to the HF35 drain port.

Changing from HF85 to HF65 or

HF45 for VERSAflux 400

Hollow fiber Action

type

HF size 85 Install it directly by connecting to the permeate hose and the car-
tridge drain hose.

Switch to HF 1 Connect the HF65 supporting tube with the HF65 filter on the
size 65 top.
2 Install the filter on the system with a tri-clamp tighten.

3 Connect the filter to the permeate hose (same as for HF85) and
the HF65 permeate port.
4 Install the unique HF65 drain hose on the cartridge drain mani-
fold and connect to the HF65 drain port.

Switch to HF 1 Connect the HF45 supporting tube with the HF65 filter on the
size 45 top.
2 Install the filter on the system with a tri-clamp tighten.

3 Connect the filter to the permeate hose (same as for HF85) and
the HF45 permeate port.
4 Install the unique HF45 drain hose on the cartridge drain mani-
fold and connect to the HF45 drain port.

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 7 Maintenance
7.4 Disassembly and assembly

Other components
Other than described in this chapter, the VERSAflux is not designed to be disassembled
or assembled by the user.
If the need for further disassembly should arise, always contact your GE Healthcare
representative for advice before attempting any actions not described by this document.

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8 Troubleshooting

8 Troubleshooting

About this chapter

This chapter provides required information to enable users and service personnel to
identify and correct problems that may occur when operating VERSAflux.
If the suggested actions in this guide do not solve the problem, or if the problem is not
covered by this guide, contact your GE Healthcare representative for advice.

Precautions

WARNING
Before attempting to perform any of the procedures described in
this chapter, you must read and understand all contents of the
corresponding section(s) in the Section 2.1 Safety precautions, on
page 11 as listed below:

• General precautions, on page 11

• Personal protection, on page 13
• Power supply, on page 16
• Maintenance, on page 18

System

Component Possible cause Corrective action

Computer No system found • Make sure the system is switched on.

(HMI) when starting up
WinCC Advanced • Check communication cable and connec-
(TIA Portal) V11. tors.
• Switch off the system power switch, wait
at least 5 sec, restart system.

Power Power failure during Check circuit breaker, both in system and for
a run. external supply, as applicable.

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 8 Troubleshooting

Component Possible cause Corrective action

Compressed Compressed air fail- Insufficient air pressure caused by, for in-
air ure during a run. The stance, malfunctioning air supply equipment
alarm “No air supply or a leaking air hose.
to the system” is dis- a) Rectify the air supply problem.
played and the sys- b) Restart the run by pressing the green ON
tem is stopped. button on the Home screen.

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8 Troubleshooting

Component Possible cause Corrective action

Pump Pump not working. • Emergency button has been pressed.

• No inlet or outlet valve open. Check the

valves.
• Incorrect parameter setting. Check by
entering Pump Set (%).
• The alarm has been triggered and not
been acknowledged and reset. Click
Alarm Ack. and Reset Fault until the
alarm message disappears.
• If none of the above, contact GE
Healthcare service personnel.

Little or no flow. • Check that connected inlet is actually

used.
• Inlet containers are placed too low rela-
tive to the pump. Check inlet containers.
• No liquid is supplied to the pump. Check
inlet containers.
• Tubing from inlet container causes pres-
sure or flow loss. Reasons may be too
long tubing, too small internal diameter,
tube may have a narrow section or is
partly plugged.
• Malfunctioning valve at container battery
limit.

Too high outlet pres- • Check that connected outlet is actually

sure. used.
• Outlet containers are placed too high
relative to the pump.
• Tubing to outlet container causes pres-
sure or flow loss. Reasons may be too
long tubing, to small internal diameter,
tube may have a narrow section or is
partly plugged. Check also for non-func-
tioning valve(s).
• Malfunctioning valve at container battery
limit.

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 8 Troubleshooting

Pressure curve

Error symptom Possible cause Corrective action

Erratic flow, noisy base- Gas bubbles passing Check that there is sufficient
line signal, irregular through or trapped in supply of liquid.
pressure trace. the pump.
Check all connections for leaks.

Blockage or partial Flush through to clear block-

blockage of flow path. age.

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9 Reference information

9 Reference information

About this chapter

This chapter provides reference information that may become useful when installing,
operating, maintaining and troubleshooting VERSAflux. It also contains ordering informa-
tion.
The VERSAflux is a modular built instrument that can be configured in many different
ways.
To understand the specific configuration that applies to your VERSAflux, please refer to
the system documentation supplied with the instrument.

In this chapter
This chapter contains the following sections:

Section See page

9.1 Specifications 143

9.2 Process wetted materials 147

9.3 Chemical resistance 148

9.4 More information 150

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 9 Reference information
9.1 Specifications

9.1 Specifications

Dimensions
Note: All dimensions are presented in cm where nothing else is noted.
VERSAflux 120

205
144 80

VERSAflux 400
235

197 95

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9 Reference information
9.1 Specifications

Technical specifications

Parameter for VERSAflux 120 400

Main power Voltage, frequency L-N-PE, 110/230 VAC, 50-60 Hz

supply
Min. fuse rating 16 A (110 VAC) / 10 A (230 VAC) SB

System pump Voltage, frequency L1-L2-L3-N-PE, 400/480 VAC, 50-60 Hz

power
supply Min. fuse rating 10 A SB 30 A SB

Electrical inputs System Shielded cable 5 m 2.5 mm2 /

CE approved

Pump Shielded cable 5 m 4.0 mm2 /

CE approved

Overvoltage category II

Pollution degree 2

System weight with feed pump approx 400 kg approx 600 kg

without filters (P-201)

without feed pump approx 250 kg approx 400 kg

(P-201)

Operating limits

Property Value

Feed pump pressure at 20ºC, max. 4 bar g

Battery limits back pressure Min. 0

Max. 0.2 bar (3 psi)

Process temperature Min. 2ºC (36ºF)

Max. 60ºC (140ºF)

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 9 Reference information
9.1 Specifications

Environmental limits

Parameter Value

Altitude Max. 2000 m

Relative Humidity Max. 80% for temperatures up to 31ºC, decreasing

linearly to 50% relative humidity at 40ºC

Ambient temperature 2 to 30°C

Ingress protection IP 54

Battery limits
Process
The indicated dimensions represent the TriClamp flange size and the minimum inner
diameter for used hoses required to match battery limit connections.

Battery limit Label Tag VERSAflux VERSAflux

120 400

Feed inlet FEED B1 2" TC64 3" TC91

Retentate RETENTATE P1 1 1/2" TC50 2" TC64

outlet

Permeate PERMEATE P2 3/4" TC25 1 1/2" TC50

outlet

Feed drain FEED DRAIN P3 1 1/2" TC50 1 1/2" TC50

HF cartridge CARTRIDGE DRAIN P4 3/4" TC25 1 1/2" TC50

drain

Retentate RETENTATE DRAIN P5 1 1/2" TC50 1 1/2" TC50

drain

Pneumatic

Battery limit Label Tag Size and connector type

Air inlet AIR INLET PN1 Quickfit, female, hose 10 x 1 mm

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9 Reference information
9.1 Specifications

Electrical

Battery limit Label Tag Size and connector type

Main power - EL1 Shielded cable 5 m 2.5 mm2 / CE

supply approved

Power supply - EL2 Shielded cable 5 m 4.0 mm2 / CE

pump P-201 approved

USB on operator - EL3 USB connection

console

Passive signal - EL4 Analog weight sensor input

from tank

Power consumption

VERSAflux 1-phase 110/230 VAC 3-phase 400/480 VAC

120 3A 5A

400 3A 18 A

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 9 Reference information
9.2 Process wetted materials

9.2 Process wetted materials

For a complete list of wetted materials, refer to the Bill of Material in the product docu-
mentation kit.

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9 Reference information
9.3 Chemical resistance

9.3 Chemical resistance

Introduction
The table below gives allowed exposure concentrations and times for various chemicals
that may be used in GE Healthcare BioProcess instruments in general. For information
regarding hollow fiber chemical resistance, please refer to Hollow fiber cartridges for
membrane separations Operating Handbook, GE Healthcare article no 18-1165-30.
Some of the chemicals listed may not be applicable for your instrument.

WARNING
Flammable liquids. VERSAflux is not approved to handle flammable
liquids.

WARNING
Some of the chemicals used with VERSAflux may be flammable
under certain conditions. Make sure to use chemicals only under
conditions where they are not flammable. Refer to local and/or
national classifications of flammable liquids.

List of chemicals allowed

Chemical Concentration Max. time / cycle Max. acc. ex- Usage

pos.

Acetic acid 25% 3h 3000 h CIP

Acetone 10% 1h Unlimited UV cell test

Citric acid pH 2 to 2.5 1 h at temp ≤ 60°C 1000 h CIP

Ethanol 20% 12 months Unlimited Storage

Ethanol / Acetic 20% 3h 3000 h CIP

acid

Guanidine 6M 5h 5000 h CIP

hydrochloride

Hydrochloric 0.1 M at pH=1 1h 1000 h CIP

acid

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 9 Reference information
9.3 Chemical resistance

Chemical Concentration Max. time / cycle Max. acc. ex- Usage

pos.

Phosphoric acid 5% Overnight Unlimited For SS passiva-

tion

2-propanol 30% 1h 1000 h CIP

Sodium chloride 0 to 3 M 3h 3000 h Purification, CIP

Sodium hydrox- 1 M at pH=14 24 h at temp ≤40°C 1000 days CIP

ide 0.5 M 3 h at temp ≤ 60°C 3000 h CIP
0.01 M at pH=12 12 months Unlimited Storage

Sodium 300 ppm 3 h at temp ≤ 60°C 3000 h CIP

hypochlorite

Sodium 1 M / 20% 3h 3000 h CIP

hydroxide
/Ethanol

Urea 8M 5h 5000 h Purification, CIP

Cleaning 1% to 6% Steris CIP 3 h at temp ≤ 60°C 3000 h CIP

solutions 100™, 0.5% Henkel
P3™-11, 0.2% Micro,
0.2% Terg-A-Zyme™,
0.1% Tween™ 80

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9 Reference information
9.4 More information

9.4 More information

Spare parts and accessories

Additional information regarding spare parts and acccessories can be found in the system
documentation.
Your local GE Healthcare representative will also be able to suggest recommended spare
parts and accessories.

Remaining aspects
Regarding
• Training
• Service
• Method optimization
• Ordering information
• Other issues not covered by this manual
Please contact your local GE Healthcare representative for advice.
Contact information is found on the back cover of this manual.

150 VERSAflux System Operating Instructions 29-0900-27 AA

 Index

Index
A Method optimization, 150
More information, 150
Accessories, 150
Ambient environment, 95 N
C NFF, reasons for , 111
NFF, recommendations, 111
Checks, final before start, 119 NFF, sample handling, 112
Chemical resistance, 148 Notes and tips, 8
Cleaning
Cleaning agents, 130 O
External surfaces, 131
Operating limits, 144
General, 130
Ordering information, 150
Compressed air, 95

D P
Personal protection, 13
Decontamination, 27
PID, faster regulation, 125
Disassembly, other compo-
PID, more stable regula-
nents, 137
tion, 125
Disposal, general instruc-
PID, parameters descrip-
tions, 27
tion, 123
Disposal of electrical compo-
PID, trouble shooting, 126
nents, 27
PID, tuning and adjust-
E ments, 125
Power failure, 26
Electrical power, 95 Prerequisites, 7
Emergency Purpose of this document, 5
Procedures, 23
Restarting the system, 26 R
Shutdown, 25
Recycling of hazardous sub-
Stop, 25
stances, 27
H Reference information, 142
Restart after emergency, 26
Hollow fiber cartridges, installa- Rinsing, after CIP, 130
tion, 115
S
I
Safety
Installing and moving, precau- notices, 7
tions, 14 Safety labels, 22
L Safety precautions, 11
Service , 150
Labels Space and floor load, 95
Safety labels, 22 Spare parts, 150
Starting, VERSAflux, 114
M Storage
Maintenance schedule, 129 Long term, 132
Media supply, 96

VERSAflux System Operating Instructions 29-0900-27 AA 151

Index

Short term, 132 Typographical conventions, 8

System
Description, 31, 42 U
System operation, precau- Unpacking, procedure, , 100
tions, 16 Unpacking, tools required, , 99
Unpacking, visual inspec-
T tion, 99
Training , 150 Use, intended, 32
Transport, in the crate, 97 User allowed actions, 134
Transport, unpacked, 98 User information, important, 6
Troubleshooting, 138

152 VERSAflux System Operating Instructions 29-0900-27 AA

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29-0900-27 AA 01/2014