Litdoc29090027 20140116215642

VERSAflux System
Operating Instructions
Original instructions
Page intentionally left blank
Table of Contents
Table of Contents
1
Introduction ..........................................................................................................
1.1
1.2
Important user information .............................................................................................................

Associated documentation ..............................................................................................................
6
9
Safety instructions ...............................................................................................
10
2.1
2.2
2.3
2.4
2.5
Safety precautions ...............................................................................................................................

Labels .........................................................................................................................................................
Emergency procedures ......................................................................................................................
Recycling information .........................................................................................................................
Declaration of Hazardous Substances (DoHS) ........................................................................
11
20
23
27
28
System description ..............................................................................................
31
3.1
3.2
32
33
Overview ...................................................................................................................................................
VERSAflux systems layout ................................................................................................................
3.2.1
3.2.2
3.3
Illustrations of VERSAflux 120 system ..................................................................................

Illustrations of VERSAflux 400 system ..................................................................................
34
38
Standard equipment ...........................................................................................................................
42
3.3.1
3.3.2
3.3.3
3.3.4
3.3.5
3.3.6
3.4
Skid and electric cabinet .............................................................................................................

Automation .......................................................................................................................................
Connections and drains ..............................................................................................................
Feed pump and feed line ............................................................................................................
Retentate line ...................................................................................................................................
Permeate line ...................................................................................................................................
43
45
46
48
51
55
Optional equipment .............................................................................................................................
57
3.4.1
3.4.2
3.5
Dummy filters ..................................................................................................................................

Hose kit ...............................................................................................................................................
58
59
Hollow fiber (HF) configuration .......................................................................................................
60
3.5.1
3.5.2
3.5.3
3.6
3.7
VERSAflux 120 HF configuration .............................................................................................

VERSAflux 400 HF configuration .............................................................................................
HF cartridges ....................................................................................................................................
61
62
63
Meters and sensors .............................................................................................................................

Flow charts ..............................................................................................................................................
65
66
3.7.1
3.7.2
External connections ....................................................................................................................

Flow diagrams ................................................................................................................................
67
69
Control system .......................................................................................................................................
72
Installation ............................................................................................................
94
3.8
4.1
4.2
4.3
4.4
Site requirements ..................................................................................................................................

Transport ..................................................................................................................................................
Unpack VERSAflux ................................................................................................................................
Setup ...........................................................................................................................................................
4.4.1
4.4.2
4.4.3
Assembly ............................................................................................................................................
Process component connections ............................................................................................
Power supply ...................................................................................................................................
VERSAflux System Operating Instructions 29-0900-27 AA
95
97
99
101
102
104
106
Table of Contents
Run preparations .................................................................................................
109
5.1
5.2
5.3
5.4
Sample handling ...................................................................................................................................

Starting VERSAflux ...............................................................................................................................
Filter installation ....................................................................................................................................
Priming the rotary lobe pump .........................................................................................................
111
114
115
116
Operation ..............................................................................................................
117
6.1
6.2
119
121
Perform the run .....................................................................................................................................

PID control and feedback tuning ...................................................................................................
6.2.1
6.2.2
6.2.3
Introduction ......................................................................................................................................
Using PID-control ...........................................................................................................................
More information ...........................................................................................................................
122
124
125
Procedures after use ...........................................................................................................................
127
Maintenance .........................................................................................................
128
7.1
7.2
7.3
7.4
User maintenance schedule ...........................................................................................................

Cleaning ....................................................................................................................................................
Storage ......................................................................................................................................................
Disassembly and assembly .............................................................................................................
129
130
132
134
Troubleshooting ...................................................................................................
138
Reference information ........................................................................................
142
9.1
9.2
9.3
9.4
Specifications .........................................................................................................................................
Process wetted materials .................................................................................................................
Chemical resistance ............................................................................................................................
More information ..................................................................................................................................
143
147
148
150
Index .......................................................................................................................
151
6.3
1 Introduction
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 configuration 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 associated documentation.
In this chapter
This chapter contains the following sections:
Section
See page
1.1 Important user information
1.2 Associated documentation
1 Introduction
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 applications, such as protein concentration and diafiltration in downstream unit operations.
VERSAflux is not suitable for operation in a potentially explosive atmosphere or for handling 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.
1 Introduction
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 proceed until all stated conditions are met and clearly understood.
Notices
NOTICE
NOTICE indicates instructions that must be followed to avoid
damage to the product or other equipment.
1 Introduction
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).
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 Instrumentation Diagram
P&ID
Schematic overview of the entire process

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
2 Safety instructions
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 described.
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
Section
10
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
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 process 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 inspection is carried out by qualified personnel who are adequately
trained, understand and adhere to local regulations and the operating instructions, and have a thorough knowledge of VERSAflux
and the entire process.
11
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.
12
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, unpacking, 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.
13
CAUTION
Use ear protection whenever working close to the system in operation.
Installing and moving

WARNING
VERSAflux must be installed and prepared by GE Healthcare personnel 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, persons 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.
14
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.
15
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 potentially explosive atmosphere.
16
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 become clogged and the feed pump may malfunction.
17
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 decommissioning work is performed on VERSAflux, make sure that:
18
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
CAUTION
Do not climb on any parts of VERSAflux except where clearly allowed. 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.
19
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:
20
Actual data is specific for each individual system and may vary from system
to system.
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
pressure/temperature
Max. system pressure at 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
consumption system
Max. current consumption system.
Max. current
consumption pump
Max. current consumption pump.
Protection class
Protection class.
21
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!
High voltage inside cabinet!
Authorised personnel only!
For continued protection
against fire replace only with
same type and rating of fuse
WARNING! High voltage inside cabinet! Authorized

personnel only! For continued protection against fire,
only replace fuses with the same type and rating.
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!
Pressure control valve
shall be set to
5.5 7 bar g
for instrument air
supply
22
CAUTION! Pressure control valve shall be set to 5.5

7 bar g for instrument air supply.
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.
23
Emergency stop button and main

power switch
VERSAflux 120 - front
A
VERSAflux 120 - rear
24
VERSAflux 400
A
Part
Function
EMERGENCY STOP button
MAIN SWITCH, power
Emergency shutdown
Step
Action
Result
Press the EMERGENCY STOP

button (A).
Pumps stop immediately.
The built-in computer (HMI) and PLC

remain powered.
Red indicator lamp is lit.
Buzzer is activated.
No data is lost.
If required, also switch off the

mains power supply using the
MAIN SWITCH, power (B), dis
connect the power cord or
switch off the fixed power supply circuit breaker.
The entire system, including the HMI

and PLC, becomes powerless.
Data and run status may be lost.
25
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
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.
26
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.
27
2.5
Declaration of Hazardous Substances (DoHS)
Introduction
The following product pollution control information is provided according to SJ/T113642006 Marking for Control of Pollution caused by Electronic Information Products.
SJ/T11364-2006
Symbols used in pollution control

label
Label
Meaning
This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese standard SJ/T11363-2006
Requirements for Concentration Limits for Certain Hazardous Substances in Electronic Information Products. The number in the symbol
is the Environment-friendly Use Period (EFUP), which indicates the period
during which the toxic or hazardous substances or elements contained
in electronic information products will not leak or mutate under normal
operating conditions so that the use of such electronic information
products will not result in any severe environmental pollution, any
bodily injury or damage to any assets. The unit of the period is Year.
In order to maintain the declared EFUP, the product shall be operated
normally according to the instructions and environmental conditions
as defined in the product manual, and periodic maintenance schedules
specified in Product Maintenance Procedures shall be followed strictly.
Consumables or certain parts may have their own label with an EFUP
value less than the product. Periodic replacement of those consumables
or parts to maintain the declared EFUP shall be done in accordance
with the Product Maintenance Procedures.
This product must not be disposed of as unsorted municipal waste,
and must be collected separately and handled properly after decommissioning.
28
Label
Meaning
SJ/T11363-2006

List of hazardous substances and

their concentrations
Indication for each major part if substance exceeds limit

Value
Meaning
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.
SJ/T113632006
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
SJ/T11363-2006
29
List of hazardous substances

Component
name
Hazardous substance
VERSAflux
30
Pb
Hg
Cd
Cr6+
PBB
PBDE
3 System description
System description
About this chapter

This chapter provides an overview of the technical properties of VERSAflux.
In this chapter
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
31
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 applications, 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.
32
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
38
33
3.2.1
Illustrations of VERSAflux 120 system
VERSAflux 120: Front view

8
34
Part
Function
EMERGENCY STOP buttons
Human machine interface (HMI)
Indicator lamps
Electrical connectors
Cartridge drain outlet connection
Feed inlet connection
Permeate outlet connection
Retentate outlet connection
VERSAflux 120: Rear view
15
14
13
12
10
11
Part
Function
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
35
VERSAflux 120: External

connectors
Electrical connectors
7 8 9 10 11
36
3 4
12
Connector
Function
Weight Signal Input
Compressed air to PCV-341
PT-113
TT-161
FIT-142 Signal
FIT-142 Power
Emergency stop HS3
PT-111
PT-112
10
FIT-141 Signal
Connector
Function
11
FIT-141 Power
12
USB connector
Top connectors
1
Connector
Function
Compressed air inlet
Main power supply
Power supply for P-201
37
3.2.2
Illustrations of VERSAflux 400 system
VERSAflux 400: Front view
7
1
6
38
Part
Function
EMERGENCY STOP buttons
Human machine interface (HMI)
Indicator lamps
MAIN SWITCH, power
Feed inlet connection
Permeate outlet connection
Retentate outlet connection
VERSAflux 400: Rear view
12
11
10
9
8
Part
Function
Adjustable floor support (2 pcs)
Swivelling caster with brake (4 pcs)
10
System label
11
Connectors on top
12
Retentate drain connection
39
VERSAflux 400: External

connectors
Side panel connectors
13
8 9 10 11 12
40
4 5
Connector
Function
Power Converter to Motor
Load cell Signal Input
Compressed air to PCV-341
PT-113
TT-161
FIT-142 Signal
FIT-142 Power
Emergency stop HS3
PT-111
10
PT-112
Connector
Function
11
FIT-141 Signal
12
FIT-141 Power
13
USB connector
Top connectors
1
Connector
Function
Compressed air inlet
Main power supply
Power supply for P-201
41
3.3
Standard equipment
About this section

This chapter provides an overview of the technical properties of VERSAflux.
In this section
Section
42
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
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 location in the production facility.
43
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.
44
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.
45
3.3.3
Connections and drains
Description
A standard VERSAflux system is provided with the following process connections:
46
Feed inlet
Filter inlet, outlet and drain connections
Retentate outlet
Permeate outlet
Pump outlet located before filters and meters.
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
47
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 pressure. 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.
48
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
FILTER
Hollow fiber
49
Feed: VERSAflux 400

ME1
B1
F
P-201
HV-301
PT-111
P3
50
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
FILTER
Hollow fiber
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.
51
Retentate: VERSAflux 120

F
PT-112
HV-303
F
PCV-341
HV-302
P1
P5
PT-112
HV-303
52
FIT-141
FIT-141
PCV-331
P5
Part
Label on system
Function
P1
RETENTATE
Retentate outlet
P5
RETENTATE DRAIN
Retentate drain
FILTER
Hollow fiber
PT-112
PT-112
Pressure sensor
HV-303
HV-303
Retentate drain valve
P1
Part
Label on system
Function
FIT-141
FIT-141
Flow sensor
PCV-331
PCV-331
Manual diaphragm valve
PCV-341
PCV-341
HV-302
HV-302
Manual butterfly valve
Retentate: VERSAflux 400

F
PT-112
FIT-141
HV-303
F
PT-112
TT-161
FIT-141
HV-303
P5
PCV-341
P5
HV-302
P1
PCV-331
TT-161
P1
53
54
Part
Label on system
Function
P1
RETENTATE
Retentate outlet
P5
RETENTATE DRAIN
Retentate drain
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
PCV-341
PCV-341
HV-302
HV-302
Manual butterfly valve
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
55
3.3.6 Permeate line
Permeate: VERSAflux 400
P2 HV-304 FIT-142
56
PT-113
Part
Label on system
Function
FILTER
Hollow fiber
PT-113
PT-113
Pressure sensor
FIT-142
FIT-142
Permeate flow meter
HV-304
HV-304
P2
PERMEATE
Permeate outlet
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 instrument.
In this section
Section
See page
3.4.1 Dummy filters
58
3.4.2 Hose kit
59
57
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 filtration is not.
Contact your local GE Healthcare representative for more information regarding dummy
filters.
Illustration: Dummy filters
58
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 specifications.
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
59
3.5
Hollow fiber (HF) configuration
Overview
When the VERSAflux systems are operated with hollow fiber cartridges, required components of the piping system must be installed.
The retentate line must be in the upper position.
In this section
Section
60
See page
3.5.1 VERSAflux 120 HF configuration
61
62
3.5.3 HF cartridges
63
3.5.1
VERSAflux 120 HF configuration
Illustration: Hollow fiber sizes 75,

55 and 35
1
4
75
3
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
Retentate line
Hollow fiber cartridges
Feed line extension pipe
HF cartridge drain hose
61
3.5.2
VERSAflux 400 HF configuration
Illustration: Hollow fiber sizes 85,

65 and 45
1
4
85
3
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
62
Part
Function
Retentate line
Hollow fiber cartridges
Feed line extension pipe
HF cartridge drain hose
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.
63
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 connection serves as a drain for the permeate. This allows for more complete recovery of
the permeate.
64
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 retentate 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) .
65
3.7 Flow charts
3.7
Flow charts
In this section
Section
66
See page
3.7.1 External connections
67
3.7.2 Flow diagrams
69
3.7 Flow charts
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
67
3.7 Flow charts
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.
68
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
3.7 Flow charts
3.7.2 Flow diagrams
3.7.2
Flow diagrams
HV-305.3
P4
HV-305.4
HV-305.1
FILTER
P2
HV-306
PT-113
P F
FIT-142
HV-304
VERSAflux 120: Flow diagram
HV-304.4
P3
TT-161
HV-301
PT-111
FILTER
HV-304.1
P5
PT-112
HV-305
HV-304.3
P-201
B1
ME1
P1
HV-302
PCV-331
PCV-341
HV-303
FIT-141
69
3.7 Flow charts
3.7.2 Flow diagrams
P4
HV-307.1
HV-306.1
HV-306.4
FILTER
HV-305.1
HV-305.4
FILTER
HV-305.3
HV-304.4
HV-304.1
HV-307
HV-306.3
HV-306
HV-307.4
FILTER
HV-308
HV-307.3
FILTER
P3
HV-301
P5
P-201
B1
ME1
P1
PCV-331
TT-161
HV-302 PCV-341
FIT-141
PT-111
HV-303
PT-112
T F
HV-305
HV-304.3
PT-113
HV-304
FIT-142
P F
P2
VERSAflux 400: Flow diagram
70
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
71
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
72
Part
Label
Color
Function
Power
Green
Power on
Run
Yellow
Pump on
Alarm
Red
Alarming
3.8 Control system
Structure of the HMI
Welcome screen
Step
Action
Start the VERSAflux

Result: The welcome screen appears.
Wait until the system is ready, as shown by the System Starting countdown
and appearance of the Logon button.
73
3.8 Control system
Step
Action
Click on the Logon button.

Result:
Enter the correct information for User and Password, then press OK.
Result:
Confirm that USB memory stick is installed on the cabinet, then click YES.
Result: The system moves on to the Home screen.
74
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 ...
Head display area
Important parameters that always display on

screen
Piping & Flow diagram
Flow Scheme
Instrument Reading
Live trend
Instrument live data trend
Instance Alarm and

Acknowledge area
Alarm information
Acknowledge and Reset

area
Instance Alarm
Warning and System events
Acknowledge and reset
Control mode area
Pump Control mode selection

PCV Control parameters
On and Off buttons
Start and stop for the pump
Foot display area
Switch between different screens
75
3.8 Control system
Head display area

The Head display area shows up on all screens. It only displays the selected important
parameters.
76
Name
Description
Range
Decimal
Pump Set
Pump actual speed set point
0.0~100.0%
Feed Pressure
PT-111 actual value
0.00~6.00 bar
TMP
Trans-membrane pressure
0.00~4.00 bar
Delta P
Delta P = Feed pressure - Permeate

pressure
0.00~4.00 bar
Acc. VOL1:
Retentate
Accumulated retentate flow volume, this

value can only be reset manually.
Acc. VOL2:
Permeate
Accumulated permeate flow volume, this

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.
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
Bar in default
PT-112
Default
0.00~6.00
Bar in default
PT-113
Optional
0.00~4.00
Bar in default
TT-161
Optional
0.0~150.0
Degree Celsius
FIT-141
Optional
0.0~600.0
l/min
FIT-142
Optional
0.0~95.0
l/min
PCV-341
Optional
10~100
P-201
Default
0.0~100.0
WIT-176
Optional
0.0~1200.0
kg
Note:
If an optional instrument is not selected, it will disappear from the PFD area
together with its corresponding settings and related processes.
77
3.8 Control system
Optional instrument
PT-113
TT-161
FIT-141
FIT-142
PCV-341
WIT-176
78
Related processes
PT-113 reading
PT-113 alarm setting
TMP value
TMP control
TMP alarm setting
TT-161 reading
TT-161 alarm setting
FIT-141 reading
FIT-141 alarm setting
Constant retentate flow control
Constant retentate flow control alarm setting
Acc. VOL1
FIT-142 reading
FIT-142 alarm setting
Acc. VOL2
PCV-341 setting
Delta P control
Delta P control alarm setting
WIT-176 reading
WIT-176 alarm setting
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.
79
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 disappears 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:
80
3.8 Control system
Control group 1:
Pump Control
Group
Description
Set Range
Decimal
Pump Set
Manual pump speed control set point.
0.0~100.0%
Delta P Set
Delta P control set point,
0.00~4.00 bar
Constant flow control.
0.0~400.0
l/min
PCV Control
Group
Description
Range
Decimal
PCV Set
Manual PCV valve opening control set

point.
10.0~100.0%
TMP Set
TMP control set point,
0.00~4.00 Bar
Delta P = P_feed P_retentate.

Flow Set
Retentate flow control set point,
Control group 2:
TMP = (P_feed + P_retentate)/2 P_permeate.
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
81
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.
82
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.
3.8 Control system
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.
Position
Area / Indicator
Description
Remark
Alarm disable switches
Corresponding alarm
will be disabled
Red: Disabled
User settings for each

instrument
Alarm/Warning
Need Admin account to

modify; data will be retained during power
off.
Alarm parameter settings
Green: Enabled
The detailed information for instrument Alarm/Warning settings are shown in the following
table:
83
3.8 Control system
84
Tag
Range
Decimal
Unit
PT-111 HA
0.00~6.00
bar
PT-111 LA
0.00~6.00
bar
PT-111 HW
0.00~6.00
bar
PT-111 LW
0.00~6.00
bar
PT-112 HA
0.00~6.00
bar
PT-112 LA
0.00~6.00
bar
PT-112 HW
0.00~6.00
bar
PT-112 LW
0.00~6.00
bar
PT-113 HA
0.00~4.00
bar
PT-113 LA
0.00~4.00
bar
PT-113 HW
0.00~4.00
bar
PT-113 LW
0.00~4.00
bar
TT-161 HA
0.0~150.0
Degree Celsius
TT-161 LA
0.0~150.0
Degree Celsius
TT-161 HW
0.0~150.0
Degree Celsius
TT-161 LW
0.0~150.0
Degree Celsius
FIT-141 HA
0.0~600.0
l/min
FIT-141 LA
0.0~600.0
l/min
FIT-141 HW
0.0~600.0
l/min
FIT-141 LW
0.0~600.0
l/min
FIT-142 HA
0.0~95.0
l/min
FIT-142 LA
0.0~95.0
l/min
FIT-142 HW
0.0~95.0
l/min
FIT-142 LW
0.0~95.0
l/min
WIT-176 1 HA
0.0~1200.0
kg
WIT-176 LA
0.0~1200.0
kg
WIT-176 HW
0.0~1200.0
kg
WIT-176 LW
0.0~1200.0
kg
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.
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.
Position
Area/
Indicator
Description
Remark
Alarm
disable
switches
Corresponding alarm will be disabled for

different control modes:
Red: Disabled
Alarm
parameter
settings
Delta P
TMP Alarm
Retentate Flow Control (RFC Alarm )
User settings for corresponding Alarm/

Warning for different control modes:
Delta P
TMP
Retentate Flow Control (RFC)
Green: Enabled
Need Admin account to modify;

data will be kept
during power
off.
85
3.8 Control system
Position
Area/
Indicator
Description
Remark
PID
Parameter
settings
PID parameter settings for different control modes:
Detailed PID
tuning refers to
Section 6.2 PID
control and
feedback tuning,
on page 121.
Note:
86
Misc.
switches
Delta P
TMP
Retentate Flow Control (RFC)
Different kinds of functions enable/disable switches:
Unit switch: bar-PSI
Enable Tank
Buzzer enable/disable
Compress air alarm enable/disable

(Pneumatic)
Abnormal flow alarm enable/disable

(Flow Abnormal)
Red: Disabled
Green: Enabled
Once the Enable Tank button has been enabled, a Tank will appear on the
PFD on the Home page. Otherwise the Tank is hidden.
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
bar in default
Delta P LA
0.0~4.0
bar in default
Delta P HW
0.0~4.0
bar in default
Delta P LW
0.0~4.0
bar in default
TMP HA
0.0~4.0
bar in default
TMP LA
0.0~4.0
bar in default
TMP HW
0.0~4.0
bar in default
TMP LW
0.0~4.0
bar in default
RFC HA
0.0~400.0
l/min
RFC LA
0.0~400.0
l/min
RFC HW
0.0~400.0
l/min
RFC LW
0.0~400.0
l/min
87
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 measurement 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.
88
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.
89
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)
Functions
Restrictions
Remark
90
OP (operator)
Create new user account
Change own password
Add/Remove/Edit all user information (e.g. change own and others

password)
Modify own logoff time
Modify logoff time for all users
Change alarm and warning settings
Change alarm range setting
Create new account
Exit the program
None
Default Password: 123456
Default Password: 000000
Default logout: 5 minutes
Default logout: 60 minutes
3.8 Control system
Create new user account

Step
Action
Click the User pane.

Result: the User pane is activated and a keyboard pops up:
Enter the new user name.
Click the Password pane.

Result: The Change password window appears:
91
3.8 Control system
Step
Action
Enter the new password and confirm it.
Click the Group pane.

Result: the Group pane is activated:
Choose the correct acount level for the new user.
Click the Logoff time pane.

Result: the Logoff time pane is activated and a keyboard pops up:
8
92
Enter the automatic Logoff time for the new user in minutes (default).
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.
93
4 Installation
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:
Installing and moving, on page 14
In this chapter
Section
4.1 Site requirements
95
4.2 Transport
97
4.3 Unpack VERSAflux
99
4.4 Setup
94
See page
101
4 Installation
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.
95
4 Installation
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.
96
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, unpacking, 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.
97
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, persons are recommended when moving the unit.
98
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.
4 Installation
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 representative immediately.
Precautions
CAUTION
99
4 Installation
General unpacking instructions

Note:
100
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
Remove the front, side and back panels by loosening the bolts.
Remove the accessories and documentation package.
Use a forklift or similar lifting equipment to move the system out from the
crate.
4 Installation
4.4 Setup
4.4
Setup
In this section
Section
See page
4.4.1 Assembly
102
4.4.2 Process component connections
104
4.4.3 Power supply
106
Precautions
CAUTION
101
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 procedures 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.
102
4 Installation
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 configuration 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 Section 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.
103
4 Installation
4.4 Setup
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
104
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 Specifications, 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 system.
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 continuing operation.
4 Installation
4.4 Setup
The chemical properties of the tubing used shall meet or exceed the properties
specified in Section 9.3 Chemical resistance, on page 148.
105
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 documentation 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 LFLEX of type: 150 CY (3G x 2.5 mm2);
The pump power supply cable is shielded LFLEX 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.
106
4 Installation
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
Live
Black
Protective
ground (earth)
Yellow-green
PE = GND
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
up to
Mains and neutral conductor

minimum area
10 A
1 mm2
16 A
1.5 mm2
25 A
2.5 mm2
32 A
4 mm2
107
4 Installation
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.
108
5 Run preparations
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
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
109
5 Run preparations
NOTICE
Refer to Section 9.3 Chemical resistance, on page 148 for more information.
110
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 become 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.
111
5 Run preparations
5.1 Sample handling
If...
Then use the following NFF...
Placement...
Large particles are

present in the
sample container
ULTA Prime CG capsule
Between the
sample container
and the system
feed inlet
Large particles are

present in the
product
ULTA Prime CG 0,2 m
ULTA Pure HC 0,2 m sterile grade
ULTA Pure SG 0.2 m sterile grade
Between the
recovery outlet
and the product
container
Illustration of sample handling
112
Part
Function
Container for starting material
Starting material feed to ULTA NFF filter
Filtered material to VERSAflux feed inlet
Feed from tank to system
Retentate from system to tank
Permeate out
Recovered material from VERSAflux after completed CFF-run.
ULTA NFF-filtered recovered material
5 Run preparations
5.1 Sample handling
Part
Function
Container for recovered material, preferably a ReadyCircuit bag (part of

the ReadyToProcess portfolio) or equal.
113
5 Run preparations
5.2 Starting VERSAflux
5.2
Starting VERSAflux
Starting VERSAflux
114
Step
Action
Make sure that the air supply to the system is turned on.
Turn on the UPS if used.
Make sure that the USB stick has been plugged in.
Make sure that the cabinet doors are closed and locked.
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 location.
Wait until the HMI has started up and the Logon button is displayed.
Click the Logon button, then enter the correct user name (User) and
password (Password).
Click Yes when the USB Memory Installed window pops up.
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
Make sure that the system is configured for using HF cartridges and cartridges of the intended size, refer to Section 7.4 Disassembly and assembly,
on page 134 if required.
Prepare the HF cartridge(s) according to the manufacturer's instructions.
Install the cartridge into the system, refer to illustrations in Section 3.5
Hollow fiber (HF) configuration, on page 60.
115
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
Close the retentate valve, permeate valve, retentate drain valve, permeate
drain valve and cartridge drain valve.
Connect the feed drain port with a hose to a container.
Open the feed drain valve.
Connect the feed inlet with a hose to a container full of pure water.
Open the feed supply to let feed flow into the pump slowly.
Step
Action
Run the pump while watching the flow through the membrane cartridge.
Check that the inlet hose is full of water.
Stop the pump and close the feed drain valve.
Run priming
116
6 Operation
Operation
About this chapter

This chapter provides the information required to safely prepare the VERSAflux for operation.
In this chapter
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
117
6 Operation
NOTICE
Refer to Section 9.3 Chemical resistance, on page 148 for more information.
118
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
Make sure that the cabinet doors are closed and locked.
Make sure that the Emergency Stop button has been reset.
Make sure that the USB stick was plugged in.
Switch on power to VERSAflux by turning the Main power switch to the ON

position
Wait until the HMI has started up and the Logon button is displayed.
Click the Logon button, then enter the correct user name (User) and password
(Password).
Click Yes when the USB Memory Installed window pops up.
Check that the standby state of the HMI has no error message.
119
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.
120
6 Operation
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
Section
See page
6.2.1 Introduction
122
6.2.2 Using PID-control
124
6.2.3 More information
125
121
6 Operation
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.
122
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.
6 Operation
6.2.1 Introduction
PID parameter description

Parameter
Meaning
Behaviour
Usage
Proportional
Guides the process to

its setpoint with an
input that varies
proportinally to the
error.
Reduces the effect of an error but does not

completely eliminate it. A simple P-regulator
results in a stable stationary error between
actual and requested flow or pressure.
Integrating
Derivating
Samples the error over

time and reinforces
the regulator output
as long as the error is
not eliminated.
Delivers an inital "kick"

to the regulator with
an amplitude that is
proportional to the
error change rate.
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.
The I parameter eliminates the stationary

error, but results in a slight instability leading
to oscillations in the actual flow or pressure.
The I parameter can have values between 0
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.
The D parameter can reduce the oscillations

introduced by a PI-regulator. D can have
values between 0 and infinity.
Too large D-component may cause the

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.
123
6 Operation
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 VERSAflux 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.
124
6 Operation
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

error has been eliminated
Decrease I
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.
125
6 Operation
Troubleshooting
If the
parameter...
Is too...
Consequence
Large
The system will become unstable.
Small
The system will respond slow to errors and possibly be

unable to eliminate errors completely.
Large
The system will oscillate after the error has been eliminated.
Small
The system will be unable to eliminate errors completely.
Large
The system will overshoot initally when regulating for

errors.
Small
The system will be prevented from increasing the Pcomponent enough to achieve fast response without
resulting oscillations.
126
6 Operation
6.3 Procedures after use
6.3
Procedures after use
Shut down the system

Step
Action
Click the green OFF button on the Home screen in WinCC Advanced (TIA
Portal) V11.
Confirm that the pump has stopped.
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.
127
7 Maintenance
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
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
128
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
seals
Check for leakage. Replace seals if needed. Do a leakage test

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
steel system
Inspect stainless steel systems for rust. If needed, passivate

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.
129
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
130
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 instructions from the respective manufacturer.
7 Maintenance
7.2 Cleaning
External surfaces
The VERSAflux is designed to be operated in a clean environment and the external surfaces 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.
131
7 Maintenance
7.3 Storage
7.3
Storage
Short term storage

This procedure works for storage duration up to one month.
Step
Action
Perform cleaning as described in Section 7.2 Cleaning, on page 130.
Fill the VERSAflux with 20% Ethanol to prevent microbial growth.

Make sure that the filter cartridges are at least partially wetted during storage.
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
Perform the actions described for Short term storage above.
Replace the filter cartridges with filter cartridge dummies.
Place VERSAflux in a dust free environment with well-controlled climate.

The temperature should be stable and in the range 4C to 25C.
The air humidity and air temperature differences should be kept as low as
possible to prevent condensation and corrosion.
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.
132
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.
133
7 Maintenance
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 decommissioning 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:
134
After assembly or maintenance
Before operation or CIP
7 Maintenance
About filter configuration change

The VERSAflux suite of filtration systems can be operated with different size of HF cartridges. 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
type
Action
HF size 75
Install it directly by connecting to the permeate hose and the cartridge drain hose.
Switch to HF
size 55
Connect the HF55 supporting tube with the HF55 filter on the
top.
Install the filter on the system with a tri-clamp tighten.
Connect the filter to the permeate hose (same as for HF75) and
the HF55 permeate port.
Install the unique HF55 drain hose on the cartridge drain manifold and connect to the HF55 drain port.
135
7 Maintenance
Hollow fiber
type
Action
Switch to HF
size 35
top.
Changing from HF85 to HF65 or

HF45 for VERSAflux 400
Hollow fiber
type
Action
HF size 85
Install it directly by connecting to the permeate hose and the cartridge drain hose.
Switch to HF
size 65
top.
top.
Switch to HF
size 45
136
7 Maintenance
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.
137
8 Troubleshooting
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
System
Component
Possible cause
Corrective action
Computer
(HMI)
No system found
when starting up
WinCC Advanced
(TIA Portal) V11.
Make sure the system is switched on.
Check communication cable and connectors.
Switch off the system power switch, wait

at least 5 sec, restart system.
Power
138
Power failure during

a run.
Check circuit breaker, both in system and for

external supply, as applicable.
8 Troubleshooting
Component
Possible cause
Corrective action
Compressed
air
Compressed air failure during a run. The

alarm No air supply
to the system is displayed and the system is stopped.
Insufficient air pressure caused by, for instance, malfunctioning air supply equipment
or a leaking air hose.
a) Rectify the air supply problem.
b) Restart the run by pressing the green ON
button on the Home screen.
139
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.
Check that connected inlet is actually

used.
Inlet containers are placed too low relative to the pump. Check inlet containers.
No liquid is supplied to the pump. Check

inlet containers.
Tubing from inlet container causes pressure 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.
Check that connected outlet is actually

used.
Outlet containers are placed too high

relative to the pump.
Tubing to outlet container causes pressure 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-functioning valve(s).
Malfunctioning valve at container battery

limit.
Little or no flow.
Too high outlet pressure.
140
8 Troubleshooting
Pressure curve
Error symptom
Possible cause
Corrective action
Erratic flow, noisy baseline signal, irregular

pressure trace.
Gas bubbles passing

through or trapped in
the pump.
Check that there is sufficient

supply of liquid.
Blockage or partial
blockage of flow path.
Flush through to clear blockage.
Check all connections for leaks.
141
9 Reference information
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 information.
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
Section
142
See page
9.1 Specifications
143
9.2 Process wetted materials
147
9.3 Chemical resistance
148
9.4 More information
150
9.1 Specifications
9.1
Specifications
Dimensions
Note:
All dimensions are presented in cm where nothing else is noted.
205
VERSAflux 120
144
80
235
VERSAflux 400
197
95
143
9.1 Specifications
Technical specifications
Parameter for VERSAflux
120
400
Main power
supply
Voltage, frequency
System pump
power
supply
Voltage, frequency
Min. fuse rating
10 A SB
Electrical inputs
System
Shielded cable 5 m 2.5 mm2 /

CE approved
Pump
Shielded cable 5 m 4.0 mm2 /

CE approved
Min. fuse rating
L-N-PE, 110/230 VAC, 50-60 Hz

16 A (110 VAC) / 10 A (230 VAC) SB
L1-L2-L3-N-PE, 400/480 VAC, 50-60 Hz
30 A SB
Overvoltage category
II
Pollution degree
System weight
without filters
with feed pump

(P-201)
approx 400 kg
approx 600 kg
without feed pump

(P-201)
approx 250 kg
approx 400 kg
Operating limits
Property
Value
Feed pump pressure at 20C, max.
4 bar g
Battery limits back pressure
Process temperature
144
Min.
Max.
0.2 bar (3 psi)
Min.
2C (36F)
Max.
60C (140F)
9.1 Specifications
Environmental limits
Parameter
Value
Altitude
Max. 2000 m
Relative Humidity
Max. 80% for temperatures up to 31C, decreasing

linearly to 50% relative humidity at 40C
Ambient temperature
2 to 30C
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
120
VERSAflux
400
Feed inlet
FEED
B1
2" TC64
3" TC91
Retentate
outlet
RETENTATE
P1
1 1/2" TC50
2" TC64
Permeate
outlet
PERMEATE
P2
3/4" TC25
1 1/2" TC50
Feed drain
FEED DRAIN
P3
1 1/2" TC50
1 1/2" TC50
HF cartridge
drain
CARTRIDGE DRAIN
P4
3/4" TC25
1 1/2" TC50
Retentate
drain
RETENTATE DRAIN
P5
1 1/2" TC50
1 1/2" TC50
Pneumatic
Battery limit
Label
Tag
Size and connector type
Air inlet
AIR INLET
PN1
Quickfit, female, hose 10 x 1 mm
145
9.1 Specifications
Electrical
Battery limit
Label
Tag
Size and connector type
Main power
supply
EL1
Shielded cable 5 m 2.5 mm2 / CE

approved
Power supply
pump P-201
EL2
Shielded cable 5 m 4.0 mm2 / CE

approved
USB on operator
console
EL3
USB connection
Passive signal
from tank
EL4
Analog weight sensor input
Power consumption
146
VERSAflux
1-phase 110/230 VAC
3-phase 400/480 VAC
120
3A
5A
400
3A
18 A
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 documentation kit.
147
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. expos.
Usage
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 60C
1000 h
CIP
Ethanol
20%
12 months
Unlimited
Storage
Ethanol / Acetic
acid
20%
3h
3000 h
CIP
Guanidine
hydrochloride
6M
5h
5000 h
CIP
Hydrochloric
acid
0.1 M at pH=1
1h
1000 h
CIP
148
Chemical
Concentration
Max. time / cycle
Max. acc. expos.
Usage
Phosphoric acid
5%
Overnight
Unlimited
For SS passivation
2-propanol
30%
1h
1000 h
CIP
Sodium chloride
0 to 3 M
3h
3000 h
Purification, CIP
Sodium hydroxide
1 M at pH=14
0.5 M
0.01 M at pH=12
24 h at temp 40C
3 h at temp 60C
12 months
1000 days
3000 h
Unlimited
CIP
CIP
Storage
Sodium
hypochlorite
300 ppm
3 h at temp 60C
3000 h
CIP
Sodium
hydroxide
/Ethanol
1 M / 20%
3h
3000 h
CIP
Urea
8M
5h
5000 h
Purification, CIP
Cleaning
solutions
1% to 6% Steris CIP
100, 0.5% Henkel
P3-11, 0.2% Micro,
0.2% Terg-A-Zyme,
0.1% Tween 80
3 h at temp 60C
3000 h
CIP
149
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
Index
Index
A
Accessories, 150
Ambient environment, 95
C
Checks, final before start, 119
Chemical resistance, 148
Cleaning
Cleaning agents, 130
External surfaces, 131
General, 130
Compressed air, 95
D
Decontamination, 27
Disassembly, other components, 137
Disposal, general instructions, 27
Disposal of electrical components, 27
E
Electrical power, 95
Emergency
Procedures, 23
Restarting the system, 26
Shutdown, 25
Stop, 25
H
Hollow fiber cartridges, installation, 115
I
Installing and moving, precautions, 14
L
Labels
Safety labels, 22
M
Maintenance schedule, 129
Media supply, 96
Method optimization, 150

More information, 150
N
NFF, reasons for , 111
NFF, recommendations, 111
NFF, sample handling, 112
Notes and tips, 8
O
Operating limits, 144
Ordering information, 150
P
Personal protection, 13
PID, faster regulation, 125
PID, more stable regulation, 125
PID, parameters description, 123
PID, trouble shooting, 126
PID, tuning and adjustments, 125
Power failure, 26
Prerequisites, 7
Purpose of this document, 5
R
Recycling of hazardous substances, 27
Reference information, 142
Restart after emergency, 26
Rinsing, after CIP, 130
S
Safety
notices, 7
Safety labels, 22
Safety precautions, 11
Service , 150
Space and floor load, 95
Spare parts, 150
Starting, VERSAflux, 114
Storage
Long term, 132
151
Index
Short term, 132

System
Description, 31, 42
System operation, precautions, 16
T
Training , 150
Transport, in the crate, 97
Transport, unpacked, 98
Troubleshooting, 138
152
Typographical conventions, 8
U
Unpacking, procedure, , 100
Unpacking, tools required, , 99
Unpacking, visual inspection, 99
Use, intended, 32
User allowed actions, 134
User information, important, 6
Page intentionally left blank
For local office contact information, visit

www.gelifesciences.com/contact
GE Healthcare Bio-Sciences AB
Bjrkgatan 30
751 84 Uppsala
Sweden
www.gelifesciences.com/filtration
GE, imagination at work and GE monogram are trademarks of General Electric

Company.
BioProcess, ReadyCircuit, ReadyToProcess and ULTA are trademarks of GE
Healthcare companies.
CIP 100 is a trademark of Steris Corporation.
HART is a trademark of HART Industrial Unions, LLC.
Microsoft and Excel are registered trademarks of Microsoft Corporation.
P3 is a trademark of Henkel.
Terg-A-Zyme is a trademark of Alconox, Inc.
Tween is a trademark of Uniqema Americas LLC.
WinCC is a trademark of Siemens.
LFLEX is a trademark of Miltronic AB
2014 General Electric Company All rights reserved.
First published Jan. 2014.
All goods and services are sold subject to the terms and conditions of sale of
the company within GE Healthcare which supplies them. A copy of these terms
and conditions is available on request. Contact your local GE Healthcare representative for the most current information.
Any use of WinCC Advanced (TIA Portal) V11 is subject to GE Healthcare Standard
Software End-User License Agreement for Life Sciences Software Products. A
copy of this Standard Software End-User License Agreement is available on request.
GE Healthcare Europe GmbH

Munzinger Strasse 5, D-79111 Freiburg, Germany
GE Healthcare UK Limited
Amersham Place, Little Chalfont, Buckinghamshire, HP7 9NA, UK
GE Healthcare Bio-Sciences Corp.
800 Centennial Avenue, P.O. Box 1327, Piscataway, NJ 08855-1327, USA
GE Healthcare Japan Corporation
Sanken Bldg. 3-25-1, Hyakunincho Shinjuku-ku, Tokyo 169-0073, Japan
imagination at work
29-0900-27 AA 01/2014

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VERSAflux System

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

Safety instructions ...............................................................................................

Safety precautions ...............................................................................................................................

System description ..............................................................................................

Illustrations of VERSAflux 120 system ..................................................................................

Standard equipment ...........................................................................................................................

Skid and electric cabinet .............................................................................................................

Optional equipment .............................................................................................................................

Dummy filters ..................................................................................................................................

Hollow fiber (HF) configuration .......................................................................................................

VERSAflux 120 HF configuration .............................................................................................

Meters and sensors .............................................................................................................................

External connections ....................................................................................................................

Control system .......................................................................................................................................

Site requirements ..................................................................................................................................

VERSAflux System Operating Instructions 29-0900-27 AA

Run preparations .................................................................................................

Sample handling ...................................................................................................................................

Perform the run .....................................................................................................................................

Procedures after use ...........................................................................................................................

User maintenance schedule ...........................................................................................................

Reference information ........................................................................................

VERSAflux System Operating Instructions 29-0900-27 AA

Purpose of this document

Scope of this document

About this chapter

1.1 Important user information

1.2 Associated documentation

VERSAflux System Operating Instructions 29-0900-27 AA

Important user information

Read this before operating

Intended use of VERSAflux

VERSAflux System Operating Instructions 29-0900-27 AA

The system must be installed according to the instructions in Chapter 4 Installation,

VERSAflux System Operating Instructions 29-0900-27 AA

Notes and tips

A note is used to indicate information that is important for trouble-free and

VERSAflux System Operating Instructions 29-0900-27 AA

Piping and Instrumentation Diagram

Schematic overview of the entire process

Technical data for the system.

Physical layout. Provides all dimensional

Spare Part List

List of spare parts available from GE

Major components specification

VERSAflux System Operating Instructions 29-0900-27 AA

About this chapter

2.1 Safety precautions

2.3 Emergency procedures

2.4 Recycling information

2.5 Declaration of Hazardous Substances (DoHS)

VERSAflux System Operating Instructions 29-0900-27 AA

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

Some of the safety precautions in this chapter may concern components or

VERSAflux System Operating Instructions 29-0900-27 AA

damage to the power cord or its plug