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VERSAflux System
Operating Instructions
Original instructions
Page intentionally left blank
Table of Contents51 Introduction ..........................................................................................................61.1 Important user information .............................................................................................................91.2 Associated documentation ..............................................................................................................
102 Safety instructions ...............................................................................................112.1 Safety precautions ...............................................................................................................................202.2 Labels .........................................................................................................................................................232.3 Emergency procedures ......................................................................................................................272.4 Recycling information .........................................................................................................................282.5 Declaration of Hazardous Substances (DoHS) ........................................................................
313 System description ..............................................................................................323.1 Overview ...................................................................................................................................................333.2 VERSAflux systems layout ................................................................................................................343.2.1 Illustrations of VERSAflux 120 system ..................................................................................383.2.2 Illustrations of VERSAflux 400 system ..................................................................................423.3 Standard equipment ...........................................................................................................................433.3.1 Skid and electric cabinet .............................................................................................................453.3.2 Automation .......................................................................................................................................463.3.3 Connections and drains ..............................................................................................................483.3.4 Feed pump and feed line ............................................................................................................513.3.5 Retentate line ...................................................................................................................................553.3.6 Permeate line ...................................................................................................................................573.4 Optional equipment .............................................................................................................................583.4.1 Dummy filters ..................................................................................................................................593.4.2 Hose kit ...............................................................................................................................................603.5 Hollow fiber (HF) configuration .......................................................................................................613.5.1 VERSAflux 120 HF configuration .............................................................................................623.5.2 VERSAflux 400 HF configuration .............................................................................................633.5.3 HF cartridges ....................................................................................................................................653.6 Meters and sensors .............................................................................................................................663.7 Flow charts ..............................................................................................................................................673.7.1 External connections ....................................................................................................................693.7.2 Flow diagrams ................................................................................................................................723.8 Control system .......................................................................................................................................
944 Installation ............................................................................................................954.1 Site requirements ..................................................................................................................................974.2 Transport ..................................................................................................................................................994.3 Unpack VERSAflux ................................................................................................................................
1014.4 Setup ...........................................................................................................................................................1024.4.1 Assembly ............................................................................................................................................1044.4.2 Process component connections ............................................................................................1064.4.3 Power supply ...................................................................................................................................
VERSAflux System Operating Instructions 29-0900-27 AA 3
Table of Contents
1095 Run preparations .................................................................................................1115.1 Sample handling ...................................................................................................................................1145.2 Starting VERSAflux ...............................................................................................................................1155.3 Filter installation ....................................................................................................................................1165.4 Priming the rotary lobe pump .........................................................................................................
1176 Operation ..............................................................................................................1196.1 Perform the run .....................................................................................................................................1216.2 PID control and feedback tuning ...................................................................................................1226.2.1 Introduction ......................................................................................................................................1246.2.2 Using PID-control ...........................................................................................................................1256.2.3 More information ...........................................................................................................................1276.3 Procedures after use ...........................................................................................................................
1287 Maintenance .........................................................................................................1297.1 User maintenance schedule ...........................................................................................................1307.2 Cleaning ....................................................................................................................................................1327.3 Storage ......................................................................................................................................................1347.4 Disassembly and assembly .............................................................................................................
1388 Troubleshooting ...................................................................................................
1429 Reference information ........................................................................................1439.1 Specifications .........................................................................................................................................1479.2 Process wetted materials .................................................................................................................1489.3 Chemical resistance ............................................................................................................................1509.4 More information ..................................................................................................................................
151Index .......................................................................................................................
4 VERSAflux System Operating Instructions 29-0900-27 AA
Table of Contents
1 Introduction
Purpose of this documentThe Operating Instructions provide you with the instructions needed to install, operateand maintain VERSAflux in a safe way.
Scope of this documentThis manual is valid for all variants of standard VERSAflux systems. The system configu-ration for your system is described in the General Specification and on the system label.Detailed information regarding Hollow Fiber Cartridge is not covered.
About this chapterThis chapter contains important user information, description of safety notices, regulatoryinformation, a general description of VERSAflux and its intended use, and a list of asso-ciated documentation.
In this chapterThis chapter contains the following sections:
See pageSection
61.1 Important user information
91.2 Associated documentation
VERSAflux System Operating Instructions 29-0900-27 AA 5
1 Introduction
1.1 Important user information
Read this before operatingVERSAflux
All users must read the entire Operating Instructions before installing, operating ormaintaining 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 maycause damage to the equipment.
Intended use of VERSAfluxVERSAflux systems are intended for pilot to production scale biological separations.
The systems are configured to operate hollow fiber cartridges suited for microfiltrationapplications such as cell clarification/harvesting, or hollow fibers for ultrafiltration appli-cations, such as protein concentration and diafiltration in downstream unit operations.
VERSAflux is not suitable for operation in a potentially explosive atmosphere or for han-dling flammable liquids.
VERSAflux shall not be used in any clinical procedures, or for diagnostic purposes.
WARNINGDo not operate VERSAflux in any other way than described in theOperating Instructions.
6 VERSAflux System Operating Instructions 29-0900-27 AA
1 Introduction1.1 Important user information
PrerequisitesIn order to operate VERSAflux safely, and according to the intended purpose, the followingprerequisites must be met:
You should be acquainted with the use of bioprocessing equipment and with thehandling of biological materials.
The system must be installed according to the instructions in Chapter 4 Installation,on page 94.
Safety noticesThis user documentation contains WARNINGS, CAUTIONS and NOTICES concerning thesafe use of the product. See definitions below.
Warnings
WARNINGWARNING indicates a hazardous situation which, if not avoided,could result in death or serious injury. It is important not to proceeduntil all stated conditions are met and clearly understood.
Cautions
CAUTION
CAUTION indicates a hazardous situation which, if not avoided,could result in minor or moderate injury. It is important not to pro-ceed until all stated conditions are met and clearly understood.
Notices
NOTICE
NOTICE indicates instructions that must be followed to avoiddamage to the product or other equipment.
VERSAflux System Operating Instructions 29-0900-27 AA 7
1 Introduction1.1 Important user information
Notes and tipsA note is used to indicate information that is important for trouble-free andoptimal use of the product.
Note:
A tip contains useful information that can improve or optimize your procedures.Tip:
Typographical conventionsSoftware items are identified in the text by bold italic text. A colon separates menu levels,thus File:Open refers to the Open command in the File menu.
Hardware items are identified in the text by bold text (for example, Power).
8 VERSAflux System Operating Instructions 29-0900-27 AA
1 Introduction1.1 Important user information
1.2 Associated documentation
System-specific documentationIn addition to the Operating Instructions, the documentation package supplied withVERSAflux also includes detailed specifications and traceability documents.
The most important documents in the documentation package with regard to technicalaspects of VERSAflux are:
Purpose/ContentsAbbreviationDocument
Schematic overview of the entire processflow, all components and instrumentsand the control system.
P&IDPiping and Instrumenta-tion Diagram
Technical data for the system.GSGeneral Specification
Physical layout. Provides all dimensionaldata.
ADAssembly Drawing
List of spare parts available from GEHealthcare.
SPLSpare Part List
Major components specificationEQLEquipment List
VERSAflux System Operating Instructions 29-0900-27 AA 9
1 Introduction1.2 Associated documentation
2 Safety instructions
About this chapterThis chapter describes safety precautions and emergency shutdown procedures forVERSAflux. The labels on the system and information regarding recycling are also de-scribed.
Important
WARNINGBefore installing, operating or maintaining VERSAflux, all usersmust read and understand the entire contents of this chapterto become aware of the hazards involved.
Failure to do this may cause human injury or death, or damage tothe equipment.
In this chapterThis chapter contains the following sections:
See pageSection
112.1 Safety precautions
202.2 Labels
232.3 Emergency procedures
272.4 Recycling information
282.5 Declaration of Hazardous Substances (DoHS)
10 VERSAflux System Operating Instructions 29-0900-27 AA
2 Safety instructions
2.1 Safety precautions
IntroductionThe 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
Some of the safety precautions in this chapter may concern components orsituations described in other VERSAflux product documents.
Note:
General precautions
WARNINGPerform a risk assessment for any risks due to the process or pro-cess environment. Evaluate the effects the use of VERSAflux andthe operational processes may have on the classification of thehazardous area. The process might cause the area to increase orthe zone classification to change. Implement the risk reductionmeasures needed, including use of personal protection equipment.
WARNINGMake sure that all installation, maintenance, operation and inspec-tion is carried out by qualified personnel who are adequatelytrained, understand and adhere to local regulations and the oper-ating instructions, and have a thorough knowledge of VERSAfluxand the entire process.
VERSAflux System Operating Instructions 29-0900-27 AA 11
2 Safety instructions2.1 Safety precautions
WARNINGVERSAflux is designed for fixed installation. No main power supplycable plug is provided. Connect the system directly to the electricalcabinet or use other type of fixed installation.
WARNINGDo not operate VERSAflux in any other way than described in theOperating Instructions.
WARNINGProtective earth. VERSAflux must always be connected toprotective earth when energized.
WARNINGDo not use VERSAflux if it is not working properly, or if it has sufferedany 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 explosiveenvironment
WARNING: EXPLOSION HAZARDFlammable liquids.VERSAflux isnotapproved to handle flammablefluids.
12 VERSAflux System Operating Instructions 29-0900-27 AA
2 Safety instructions2.1 Safety precautions
Personal protection
WARNINGWhen using hazardous chemical and biological agents, take allsuitable protective measures, such as wearing protective glassesand gloves resistant to the substances used. Follow local and/ornational regulations for safe operation and maintenance ofVERSAflux.
WARNINGPersonal Protective Equipment (PPE).Whenever packing, unpack-ing, transporting or moving VERSAflux, wear:
Protective footwear, preferably with steel lining.
Working gloves, protecting against sharp edges.
Protective glasses.
WARNINGOnly personnel authorized by GE Healthcare may open the cabinetdoors. There is high voltage inside the cabinet that can causehuman injury or death.
CAUTION
Do not touch the system while pumping fluid through the systemthat has a temperature above the normal working temperature.Do not touch the system until you are sure that this can be donewithout risk and when all components in the system have reachedthe normal working temperature range.
CAUTION
Avoid spillage and overflow. Make sure that the waste tubing isinserted in an appropriate waste container and secured in place.
VERSAflux System Operating Instructions 29-0900-27 AA 13
2 Safety instructions2.1 Safety precautions
CAUTION
Use ear protection whenever working close to the system in oper-ation.
Installing and moving
WARNINGVERSAflux must be installed and prepared by GE Healthcare per-sonnel or third party authorized by GE Healthcare.
WARNINGMove transport crates. Make sure that the forklift has capacity tosafely lift the crate weight. Make sure that the crate is properlybalanced so that it will not accidentally tip when moved.
WARNINGHeavy object.Because of the significant weight of VERSAflux, greatcare must be taken not to cause squeezing or crushing injuriesduring movement. At least two, but preferably three or more, per-sons are recommended when moving the unit.
WARNINGAccess to power switch and power cord. The power switch mustalways be easy to access. The power cord must always be easy todisconnect.
14 VERSAflux System Operating Instructions 29-0900-27 AA
2 Safety instructions2.1 Safety precautions
CAUTION
To prevent bacterial growth, VERSAflux may be partly filled withdenatured 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 thedenatured Ethanol or Sodium Hydroxide before assembling, testingor integrating VERSAflux into the intended process context.
CAUTION
The wheels of VERSAflux should be locked during normal use. Thewheels should be unlocked only when moving the unit.
CAUTION
Make sure that all tubing, hoses and cables are placed so that therisk 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 sprayingwater.
CAUTION
Make sure that correct air pressure is always maintained. Too highor too low air pressure may be hazardous and may cause erroneousresults and leakage.
VERSAflux System Operating Instructions 29-0900-27 AA 15
2 Safety instructions2.1 Safety precautions
Power supply
WARNINGVERSAflux must always be connected to a grounded power outlet.
WARNINGNational Codes and standards (NEC, VDE, BSI, IEC, UL etc.) and localcodes outline provisions for safely installing electrical equipment.Installation must comply with specifications regarding wire types,conductor sizes, plug, branch circuit protection and disconnectdevices. Failure to do so may result in personal injury and/orequipment damage.
WARNINGAll electrical installations must be performed by authorizedpersonnel only.
System operation
WARNINGSafe distance. Always maintain a safe distance fromVERSAflux during drainage or other activities that may involvesplashing.
WARNINGBefore operation, all process connections and the piping systemmust be tested for leakage at maximum pressure for continuedprotection against injury risks due to fluid jets, burst pipes or poten-tially explosive atmosphere.
16 VERSAflux System Operating Instructions 29-0900-27 AA
2 Safety instructions2.1 Safety precautions
WARNINGNever exceed the operating limits stated in this document and onthe system label. Operation of VERSAflux outside these limits maydamage equipment and bodily harm or death may occur.
WARNINGEmergency stop. Pressing the EMERGENCY STOP will not shut offmains power to the cabinet.
WARNINGPower failure. During a power failure, or if the EMERGENCY STOPbutton is pressed, VERSAflux may remain pressurized. Opening aline or vessel at this point could result in the release of potentiallyhazardous 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.
WARNINGAlarm signals. All alarm signals must be set within the limitsspecified in the system documentation. Pressure and temperaturecontrol must be activated while the system is in use to prevent thepiping system to leak or break.
NOTICE
Only use chemicals that have been proven not to be harmful tothe wetted parts of the unit.
NOTICE
Make sure that large particles are prevented from entering theVERSAflux system during operation, otherwise the filters may be-come clogged and the feed pump may malfunction.
VERSAflux System Operating Instructions 29-0900-27 AA 17
2 Safety instructions2.1 Safety precautions
NOTICE
Do not start the rotary lobe pump before it is primed.
Maintenance
WARNINGThe electric cabinet doors may only be opened when VERSAflux istaken out of operation and subject to LOCK OUT / TAG OUT.
WARNINGOnly personnel authorized by GE Healthcare may perform service,installation, and maintenance of components inside the VERSAfluxcabinet.
WARNINGLOCKOUT / TAGOUT! Before any maintenance or decommission-ing work is performed on VERSAflux, make sure that:
it is empty and depressurized.
it is disconnected from process feed, electrical power andpneumatic supply.
it is prevented from accidentally becoming re-energized duringmaintenance.
it is clearly tagged as taken out of operation.
all process wetted areas are clean and decontaminated.
18 VERSAflux System Operating Instructions 29-0900-27 AA
2 Safety instructions2.1 Safety precautions
WARNINGFor continued protection against injury risks due to fluid jets, burstpipes or potentially explosive atmosphere, the piping system mustbe tested for leakage at maximum pressure:
After assembly or maintenance
Before operation or CIP
CAUTION
Do not climb on any parts of VERSAflux except where clearly al-lowed. Follow local regulations and make sure that equipment isproperly secured when inspecting VERSAflux at high level.
NOTICE
Although system filter type reconfiguration can be performed bya properly skilled user, GE Healthcare recommends that a GEHealthcare service engineer is assigned for this work.
Contact your GE Healthcare representative for more informationon changing filter configurations if required.
VERSAflux System Operating Instructions 29-0900-27 AA 19
2 Safety instructions2.1 Safety precautions
2.2 Labels
IntroductionThis section describes the various labels on VERSAflux and their meaning.
System label illustrationThe illustration below shows an example of a system label.
Actual data is specific for each individual system and may vary from systemto system.
Note:
20 VERSAflux System Operating Instructions 29-0900-27 AA
2 Safety instructions2.2 Labels
System label description
DescriptionLabel text
This symbol indicates that the product contains hazardousmaterials in excess of the limits established by the Chinesestandard SJ/T11363-2006 Requirements for ConcentrationLimits for Certain Hazardous Substances in Electronics.
System serial number.Serial number
Manufacturing year.Year of manufacture
Max. system pressure at temperature.Max. systempressure/temperature
Pneumatic supply pressure requirement.Pneumatic supply
Overall protection class, ingress protection according toIEC 60529. This cover all components of the system exceptthe electric cabinet.
Overall protection class
Supply voltage system.Supply voltage system
Supply voltage pump.Supply voltage pump
Supply voltage frequency.Frequency
Max. current consumption system.Max. currentconsumption system
Max. current consumption pump.Max. currentconsumption pump
Protection class.Protection class
VERSAflux System Operating Instructions 29-0900-27 AA 21
2 Safety instructions2.2 Labels
Safety labelsThe table below describes the various safety labels that may be found on VERSAflux.
DescriptionSymbol/text
WARNING! Read the user documentation before usingthe system. Do not open any covers or replace partsunless specifically stated in the user documentation.
WARNING! High Voltage. Always make sure that thesystem is disconnected from electric power beforeopening the cabinet doors or disconnecting any electricdevice.
EMERGENCY STOP label, yellow with black text.(emergency stop button is red).
Refer to Section 2.3 Emergency procedures, on page 23for further information regarding the emergency stop.
WARNING! High voltage inside cabinet! Authorizedpersonnel only! For continued protection against fire,only replace fuses with the same type and rating.For continued protection
against fire replace only withsame type and rating of fuse
High voltage inside cabinet!Authorised personnel only!
WARNING!
CAUTION! Hot surface. Risk of burning injuries.
CAUTION! Use ear protection whenever working closeto 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.
CAUTION!Pressure control valve
shall be set to 5.5 7 bar g
for instrument airsupply
22 VERSAflux System Operating Instructions 29-0900-27 AA
2 Safety instructions2.2 Labels
2.3 Emergency procedures
IntroductionThis section describes how to perform an emergency shutdown of VERSAflux, and theresult in the event of power failure.
Precautions
WARNINGEmergency stop. Pressing the EMERGENCY STOP will not shut offmains power to the cabinet.
WARNINGPower failure. During a power failure, or if the EMERGENCY STOPbutton is pressed, VERSAflux may remain pressurized. Opening aline or vessel at this point could result in the release of potentiallyhazardous process or cleaning fluid, and cause bodily harm.
When recovering from a power failure or emergency shutdown,make sure all lines and vessels are depressurized before opening.
VERSAflux System Operating Instructions 29-0900-27 AA 23
2 Safety instructions2.3 Emergency procedures
Emergencystopbuttonandmainpower switch
VERSAflux 120 - front
A
VERSAflux 120 - rear
AB
24 VERSAflux System Operating Instructions 29-0900-27 AA
2 Safety instructions2.3 Emergency procedures
VERSAflux 400
A
B
FunctionPart
EMERGENCY STOP buttonA
MAIN SWITCH, powerB
Emergency shutdown
ResultActionStep
Press the EMERGENCY STOPbutton (A).
1 Pumps stop immediately.
The built-in computer (HMI) and PLCremain powered.
Red indicator lamp is lit.
Buzzer is activated.
No data is lost.
If required, also switch off themains power supply using theMAIN SWITCH, power (B), dis-connect the power cord orswitch off the fixed power sup-ply circuit breaker.
2 The entire system, including the HMIand PLC, becomes powerless.
Data and run status may be lost.
VERSAflux System Operating Instructions 29-0900-27 AA 25
2 Safety instructions2.3 Emergency procedures
Power failureThe system power is lost if the MAIN SWITCH on the cabinet is turned off or the mainscable is disconnected or the power supply is lost.
Pump stops if the electrical power to the system is lost. All valves will immediately revertto default positions. Any data that has not been saved at that time may be lost.
Restart after emergencyshutdown or power failure
Follow the instruction below to restart VERSAflux after emergency shut down or powerfailure.
ActionStep
Make sure that the condition that caused the power failure or emergencystop is corrected.
1
2
Reset the EMERGENCY STOP button by twisting it clock-wise.
Press the Start button on the HMI.3
NOTICE
If the system does not restart as expected, contact your local GEHealthcare representative for assistance.
26 VERSAflux System Operating Instructions 29-0900-27 AA
2 Safety instructions2.3 Emergency procedures
2.4 Recycling information
IntroductionThis section contains information about the decommissioning of VERSAflux.
DecontaminationVERSAflux shall be decontaminated before decommissioning and all local regulationsshall be followed with regard to scrapping of the equipment.
Disposal, general instructionsWhen taking VERSAflux out of service, the different materials must be separated andrecycled according to national and local environmental regulations.
Recycling of hazardoussubstances
VERSAflux contains hazardous substances.
Disposal of electricalcomponents
Waste electrical and electronic equipment must not be disposed as unsorted municipalwaste and must be collected separately. Please contact an authorized representativeof the manufacturer for information concerning the decommissioning of equipment.
VERSAflux System Operating Instructions 29-0900-27 AA 27
2 Safety instructions2.4 Recycling information
2.5 Declaration of Hazardous Substances (DoHS)
IntroductionThe following product pollution control information is provided according to SJ/T11364-2006 Marking for Control of Pollution caused by Electronic Information Products.
SJ/T11364-2006
Symbols used in pollution controllabel
MeaningLabel
This symbol indicates the product contains hazardous materials in ex-cess of the limits established by the Chinese standard SJ/T11363-2006Requirements for Concentration Limits for Certain Hazardous Sub-stances in Electronic Information Products. The number in the symbolis the Environment-friendly Use Period (EFUP), which indicates the periodduring which the toxic or hazardous substances or elements containedin electronic information products will not leak or mutate under normaloperating conditions so that the use of such electronic informationproducts will not result in any severe environmental pollution, anybodily injury or damage to any assets. The unit of the period is Year.
In order to maintain the declared EFUP, the product shall be operatednormally according to the instructions and environmental conditionsas defined in the product manual, and periodic maintenance schedulesspecified in Product Maintenance Procedures shall be followed strictly.
Consumables or certain parts may have their own label with an EFUPvalue less than the product. Periodic replacement of those consumablesor parts to maintain the declared EFUP shall be done in accordancewith the Product Maintenance Procedures.
This product must not be disposed of as unsorted municipal waste,and must be collected separately and handled properly after decom-missioning.
28 VERSAflux System Operating Instructions 29-0900-27 AA
2 Safety instructions2.5 Declaration of Hazardous Substances (DoHS)
MeaningLabel
SJ/T11363-2006
List of hazardous substancesandtheir concentrations
Indication for each major part if substance exceeds limit
MeaningValue
Indicates that this toxic or hazardous substance contained in all of thehomogeneous materials for this part is below the limit requirement inSJ/T11363-2006.
O
SJ/T11363-2006
Indicates that this toxic or hazardous substance contained in at leastone of the homogeneous materials used for this part is above the limitrequirement in SJ/T11363-2006.
X
Data listed in the table represents best information available at thetime of publication
SJ/T11363-2006
VERSAflux System Operating Instructions 29-0900-27 AA 29
2 Safety instructions2.5 Declaration of Hazardous Substances (DoHS)
List of hazardous substances
Hazardous substance
Componentname
PBDE
PBB
Cr6+
Cd
Hg
Pb
00000XVERSAflux
30 VERSAflux System Operating Instructions 29-0900-27 AA
2 Safety instructions2.5 Declaration of Hazardous Substances (DoHS)
3 System description
About this chapterThis chapter provides an overview of the technical properties of VERSAflux.
In this chapterThis chapter contains the following sections:
See pageSection
323.1 Overview
333.2 VERSAflux systems layout
423.3 Standard equipment
573.4 Optional equipment
603.5 Hollow fiber (HF) configuration
653.6 Meters and sensors
663.7 Flow charts
723.8 Control system
VERSAflux System Operating Instructions 29-0900-27 AA 31
3 System description
3.1 Overview
GeneralThese 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 theentire 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 microfiltrationapplications such as cell clarification/harvesting, or hollow fibers for ultrafiltration appli-cations, such as protein concentration and diafiltration in downstream unit operations.
Material complianceAll plastic and polymer materials that come in contact with buffers and samples arecompliant 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 theSystem-specific documentation, on page 9.
32 VERSAflux System Operating Instructions 29-0900-27 AA
3 System description3.1 Overview
3.2 VERSAflux systems layout
In this sectionThis section contains the following subsections:
See pageSection
343.2.1 Illustrations of VERSAflux 120 system
383.2.2 Illustrations of VERSAflux 400 system
VERSAflux System Operating Instructions 29-0900-27 AA 33
3 System description3.2 VERSAflux systems layout
3.2.1 Illustrations of VERSAflux 120 system
VERSAflux 120: Front view
1 2
3
46
7
8
5
FunctionPart
EMERGENCY STOP buttons1
Human machine interface (HMI)2
Indicator lamps3
Electrical connectors4
Cartridge drain outlet connection5
Feed inlet connection6
Permeate outlet connection7
Retentate outlet connection8
34 VERSAflux System Operating Instructions 29-0900-27 AA
3 System description3.2 VERSAflux systems layout3.2.1 Illustrations of VERSAflux 120 system
VERSAflux 120: Rear view
1011
12
13
14
15
9
FunctionPart
Retentate drain connection9
Swivelling caster with brake (4 pcs)10
Adjustable floor supports11
Electric cabinet12
System label13
MAIN SWITCH, power14
Connectors on top15
VERSAflux System Operating Instructions 29-0900-27 AA 35
3 System description3.2 VERSAflux systems layout
3.2.1 Illustrations of VERSAflux 120 system
VERSAflux 120: Externalconnectors
Electrical connectors
1 2 3 4 5 6 12
8 9 10 117
FunctionConnector
Weight Signal Input1
Compressed air to PCV-3412
PT-1133
TT-1614
FIT-142 Signal5
FIT-142 Power6
Emergency stop HS37
PT-1118
PT-1129
FIT-141 Signal10
36 VERSAflux System Operating Instructions 29-0900-27 AA
3 System description3.2 VERSAflux systems layout3.2.1 Illustrations of VERSAflux 120 system
FunctionConnector
FIT-141 Power11
USB connector12
Top connectors
1 2 3
FunctionConnector
Compressed air inlet1
Main power supply2
Power supply for P-2013
VERSAflux System Operating Instructions 29-0900-27 AA 37
3 System description3.2 VERSAflux systems layout
3.2.1 Illustrations of VERSAflux 120 system
3.2.2 Illustrations of VERSAflux 400 system
VERSAflux 400: Front view
1
2
3
4
6
5
7
FunctionPart
EMERGENCY STOP buttons1
Human machine interface (HMI)2
Indicator lamps3
MAIN SWITCH, power4
Feed inlet connection5
Permeate outlet connection6
Retentate outlet connection7
38 VERSAflux System Operating Instructions 29-0900-27 AA
3 System description3.2 VERSAflux systems layout3.2.2 Illustrations of VERSAflux 400 system
VERSAflux 400: Rear view
9
10
11
8
12
FunctionPart
Adjustable floor support (2 pcs)8
Swivelling caster with brake (4 pcs)9
System label10
Connectors on top11
Retentate drain connection12
VERSAflux System Operating Instructions 29-0900-27 AA 39
3 System description3.2 VERSAflux systems layout
3.2.2 Illustrations of VERSAflux 400 system
VERSAflux 400: Externalconnectors
Side panel connectors
1 2 3 4 5 6
13
7
8 9 10 11 12
FunctionConnector
Power Converter to Motor1
Load cell Signal Input2
Compressed air to PCV-3413
PT-1134
TT-1615
FIT-142 Signal6
FIT-142 Power7
Emergency stop HS38
PT-1119
PT-11210
40 VERSAflux System Operating Instructions 29-0900-27 AA
3 System description3.2 VERSAflux systems layout3.2.2 Illustrations of VERSAflux 400 system
FunctionConnector
FIT-141 Signal11
FIT-141 Power12
USB connector13
Top connectors
1 2 3
FunctionConnector
Compressed air inlet1
Main power supply2
Power supply for P-2013
VERSAflux System Operating Instructions 29-0900-27 AA 41
3 System description3.2 VERSAflux systems layout
3.2.2 Illustrations of VERSAflux 400 system
3.3 Standard equipment
About this sectionThis chapter provides an overview of the technical properties of VERSAflux.
In this sectionThis section contains the following subsections:
See pageSection
433.3.1 Skid and electric cabinet
453.3.2 Automation
463.3.3 Connections and drains
483.3.4 Feed pump and feed line
513.3.5 Retentate line
553.3.6 Permeate line
42 VERSAflux System Operating Instructions 29-0900-27 AA
3 System description3.3 Standard equipment
3.3.1 Skid and electric cabinet
Skid
The rigid stainless steel structure supports and protects all process components andthe electric cabinet. The structure is designed for handling in a production environmentand is easy to move and keep clean.
The structure occupies a small box-shaped space that makes it easy to fit into any loca-tion in the production facility.
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3 System description3.3 Standard equipment
3.3.1 Skid and electric cabinet
Electric cabinet
The electric cabinet contains all electrical and pneumatic equipment. When the door isclosed, the entire cabinet is ingress protected according to IP54.
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3 System description3.3 Standard equipment3.3.1 Skid and electric cabinet
3.3.2 Automation
Control system
The VERSAflux System is automated by means of the WinCC Advanced (TIA Portal) V11Ccontrol 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 startingprocedure is required for the HMI.
For HMI specifications, refer to the product documentation package.
User interfaceThe display and input devices are ergonomically designed for use in a clean productionenvironment.
CommunicationsAll communication with controlled components mounted outside the cabinet uses theHART industry standard communication protocol and hardware.
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3 System description3.3 Standard equipment
3.3.2 Automation
3.3.3 Connections and drains
DescriptionA standard VERSAflux system is provided with the following process connections:
Feed inlet
Filter inlet, outlet and drain connections
Retentate outlet
Permeate outlet
Pump outlet located before filters and meters.
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3 System description3.3 Standard equipment3.3.3 Connections and drains
Illustration
VERSAflux 120 VERSAflux 400
B1
P1
P2
P3
P4
P5
FunctionLabel on systemPart
Feed inlet to systemFEEDB1
Retentate outletRETENTATEP1
Permeate outletPERMEATEP2
Feed drain pointFEED DRAINP3
Cartridge drain pointCARTRIDGE DRAINP4
Retentate drain pointRETENTATE DRAINP5
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3 System description3.3 Standard equipment
3.3.3 Connections and drains
3.3.4 Feed pump and feed line
DescriptionThe main purposes of the feed line is to transfer product (or feed) from the recirculationtank, to the filter, FILTER and to raise the pressure of the feed so that correct transmembrane pressure (TMP), filter pressure and feed flow is achieved. This is done by thefeed pump, P-201.
To protect the system against over pressure, one pressure sensor, PT-111 is installedafter the pump. If the system pressure rises over pre-set value, an alarm will be triggeredin HMI and the pump will stop, to make sure that the system is not subject to over pres-sure. The feed line for VERSAflux 120 has a temperature sensor, TT-161 (optional), installedbefore 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 productwithin a favorable range with regard to the flow range for each system.
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3 System description3.3 Standard equipment3.3.4 Feed pump and feed line
Feed: VERSAflux 120
B1
P-201
HV-301
TT-161
PT-111
F
P3
ME1
FunctionLabel on systemPart
Feed inletFEEDB1
Spare port on feed lineME1ME1
Feed pumpP-201P-201
Feed drain valveHV-301HV-301
Feed drainFEED DRAINP3
Temperature sensorTT-161TT-161
Pressure sensorPT-111PT-111
Hollow fiberFILTERF
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3 System description3.3 Standard equipment
3.3.4 Feed pump and feed line
Feed: VERSAflux 400
B1
P-201
HV-301PT-111
F
P3
ME1
FunctionLabel on systemPart
Feed inletFEEDB1
Spare port on feed lineME1ME1
Feed pumpP-201P-201
Feed drain valveHV-301HV-301
Feed drainFEED DRAINP3
Pressure sensorPT-111PT-111
Hollow fiberFILTERF
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3.3.5 Retentate line
DescriptionParticles / molecules too large to pass through the filter pores are retained by the filteras retentate.
Retentate is led out from the filter (FILTER) through the retentate connection and thenguided to the retentate outlet.
A sensor for pressure, PT-112 is located on the retentate outlet line. For VERSAflux 400System, 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 controlsoftware, or is controlled by the manual diaphragm valve PCV-331 in alternative option.
The entire retentate line can be shut off by closing the retentate valve HV-302 (optional)combined with PCV-341 (optional), or by closing PCV-331 in alternative option.
The retentate line is drained through the drain valve HV-306.
All retentate drain valves on VERSAflux 120 and 400 use uniformed tag, HV-303.
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3 System description3.3 Standard equipment
3.3.5 Retentate line
Retentate: VERSAflux 120
PCV-341 HV-302FIT-141PT-112F
P1P5HV-303
PCV-331
FIT-141PT-112F
P1P5HV-303
FunctionLabel on systemPart
Retentate outletRETENTATEP1
Retentate drainRETENTATE DRAINP5
Hollow fiberFILTERF
Pressure sensorPT-112PT-112
Retentate drain valveHV-303HV-303
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3 System description3.3 Standard equipment3.3.5 Retentate line
FunctionLabel on systemPart
Flow sensorFIT-141FIT-141
Manual diaphragm valvePCV-331PCV-331
Pressure control valvePCV-341PCV-341
Manual butterfly valveHV-302HV-302
Retentate: VERSAflux 400
PCV-341 HV-302FIT-141PT-112F
P1P5 TT-161HV-303
PCV-331FIT-141PT-112F
P1P5 TT-161HV-303
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3 System description3.3 Standard equipment
3.3.5 Retentate line
FunctionLabel on systemPart
Retentate outletRETENTATEP1
Retentate drainRETENTATE DRAINP5
Hollow fiberFILTERF
Pressure sensorPT-112PT-112
Retentate drain valveHV-303HV-303
Flow sensorFIT-141FIT-141
Temperature sensorTT-161TT-161
Manual diaphragm valvePCV-331PCV-331
Pressure control valvePCV-341PCV-341
Manual butterfly valveHV-302HV-302
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3 System description3.3 Standard equipment3.3.5 Retentate line
3.3.6 Permeate line
DescriptionParticles / molecules small enough to pass through the filter pores are collected aspermeate.
Permeate is led out from the filter through the permeate connection (FILTER) and guidedto the permeate outlet through valve HV-304.
Sensors for pressure, PT-113 (optional), and flow, FIT-142 (optional) are located on thepermeate outlet line. The temperature sensor, TT-161, for VERSAflux 120 is located onthe Feed line.
Permeate: VERSAflux 120
FIT-142 PT-113 FP2 HV-304
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3 System description3.3 Standard equipment
3.3.6 Permeate line
Permeate: VERSAflux 400
FIT-142 PT-113 FP2 HV-304
FunctionLabel on systemPart
Hollow fiberFILTERF
Pressure sensorPT-113PT-113
Permeate flow meterFIT-142FIT-142
Manual diaphragm valveHV-304HV-304
Permeate outletPERMEATEP2
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3.4 Optional equipment
About optionsThe VERSAflux suite of filtration systems comes in a basic setup, as described in previoussections.
Additionally, a selection of options are available to extend the functionality of the instru-ment.
In this sectionThis section contains the following subsections:
See pageSection
583.4.1 Dummy filters
593.4.2 Hose kit
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3 System description3.4 Optional equipment
3.4.1 Dummy filters
DescriptionDummy filters allow the system to operate with liquid but without filtering capability.These can be either purpose made dummies or decommissioned filters.
Usage can be for tests and set-up where running the system is required but actual filtra-tion is not.
Contact your local GE Healthcare representative for more information regarding dummyfilters.
Illustration: Dummy filters
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3 System description3.4 Optional equipment3.4.1 Dummy filters
3.4.2 Hose kit
DescriptionTo connect the feed tank to a corresponding VERSAflux 120 or 400 system, a set of hosesis required. Hose kits are available as an option from GE Healthcare. The hoses are madeof reinforced PT-cured silicone and are designed to meet the tank and system specifica-tions.
Illustration: Hose kit
Basic hose kitThe basic kit contain the following hoses:
Cartridge permeate port to permeate line;
Cartridge drain port to cartridge drain line.
Optional hose kitsOptionally, depending on the tank and VERSAflux system configuration, the followinghoses can be included if requested:
Feed from transfer pump to tank
Feed from tank to system
Retentate from system to tank
Permeate recycle from system to tank
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3 System description3.4 Optional equipment
3.4.2 Hose kit
3.5 Hollow fiber (HF) configuration
OverviewWhen the VERSAflux systems are operated with hollow fiber cartridges, required compo-nents of the piping system must be installed.
The retentate line must be in the upper position.
In this sectionThis section contains the following subsections:
See pageSection
613.5.1 VERSAflux 120 HF configuration
623.5.2 VERSAflux 400 HF configuration
633.5.3 HF cartridges
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3.5.1 VERSAflux 120 HF configuration
Illustration: Hollow fiber sizes 75,55 and 35
21
4
2 2
4 43 3
75 55 35
An optional spool piece kit is needed to mount size 55 and 35 hollow fibers to the system,see feed line extension pipes in the next table.
Description of HF components
FunctionPart
Retentate line1
Hollow fiber cartridges2
Feed line extension pipe3
HF cartridge drain hose4
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3 System description3.5 Hollow fiber (HF) configuration
3.5.1 VERSAflux 120 HF configuration
3.5.2 VERSAflux 400 HF configuration
Illustration: Hollow fiber sizes 85,65 and 45
21
4
2 2
4 43 3
85 65 45
An optional spool piece kit is needed to mount sizes 65 and 45 hollow fibers to the system,see feed line extension pipes in the Description of HF components, on page 61.
Description of HF components
FunctionPart
Retentate line1
Hollow fiber cartridges2
Feed line extension pipe3
HF cartridge drain hose4
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3.5.3 HF cartridges
Illustration: HF cartridge
Description of HF cartridgesHollow fiber (HF) cartridges contain numerous very thin hollow fibers glued together atthe 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, thecut-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 cartridgesVERSAflux is designed to adopt hollow fiber cartridges of different sizes. These cartridgesare described in the Ambio hollow fiber filter user guide, GE Healthcare article no.18-1165-30, and in theHollow fiber selection guide , GE Healthcare article no. 18-1165-29.
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3 System description3.5 Hollow fiber (HF) configuration
3.5.3 HF cartridges
HF cartridge draining
VERSAflux 120 VERSAflux 400
Hollow fibre cartridges are provided with two connections to the permeate compartment,one at each end.
When mounted vertically, which is the case for all VERSAflux systems, the bottom con-nection serves as a drain for the permeate. This allows for more complete recovery ofthe permeate.
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3 System description3.5 Hollow fiber (HF) configuration3.5.3 HF cartridges
3.6 Meters and sensors
Pressure sensorsThree pressure sensors are provided. The pressure sensor, PT-111, provides pressuredata for the feed pump outlet and filter feed inlet pressure, PT-112, measures retentatepressure and PT-113 (optional) measures permeate pressure.
The pressure drop (delta P) is calculated by the control software by subtracting the re-tentate pressure from the feed pressure.
The transmembrane pressure (TMP) is calculated by the control software by subtractingthe permeate pressure from the average of the feed and retentate pressure.
The pump outlet pressure sensors also provide overpressure protection for the feedpump and system.
Flow sensorsTwo flow sensors are provided. A magnetic flow meter for the retentate, and a magneticflow meter for the permeate flow.
FIT-141 (optional) measures the retentate flow and FIT-142 (optional) measures thepermeate flow.
The feed flow is calculated by adding the permeate flow to the retentate flow.
TemperatureOn 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 sensorTT-161 (optional) .
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3 System description3.6 Meters and sensors
3.7 Flow charts
In this sectionThis section contains the following subsections:
See pageSection
673.7.1 External connections
693.7.2 Flow diagrams
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3 System description3.7 Flow charts
3.7.1 External connections
IntroductionThis section describes the external connections between VERSAflux 120 and 400 andthe optional tank.
Connection diagram
P1
P2
P5
P4
P3
B1 ME1
Legend
DescriptionColorSymbol
OutletsBlue
InletsOrange
Interface pointsGreen
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3 System description3.7 Flow charts
3.7.1 External connections
Battery limits"Battery limits" represent all interface points between the VERSAflux and the customerprocess 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.
DescriptionLocationTag
Feed inletSystemB1
Retentate outletSystemP1
Permeate outletSystemP2
Feed drainSystemP3
Cartridge drainSystemP4
Retentate drainSystemP5
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3.7.2 Flow diagrams
VERSAflux 120: Flow diagram
F
ME1
P
P
P F
PT-112
PT-113
FIT-142 H
V-30
4
HV-
302
HV-
301
PT-111
P-20
1
P3
P2
FILT
ER
B1
P1
HV-303
FILT
ER
P5
T TT-161
HV-304.4
HV-305.4
HV-304.1
HV-305.1 P4
HV-304.3
HV-305.3
HV-
305
HV-
306
FIT-141
PCV-
341
PCV-
331
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3 System description3.7 Flow charts
3.7.2 Flow diagrams
VERSAflux 400: Flow diagram
F T
ME1
P
P
P F
PT-112
PT-113
FIT-142
HV-
304
HV-
302
HV-
301
PT-111
P-20
1
P3
P2
FILT
ER
B1
P1
HV-303
P5
TT-161
FILT
ER
HV-304.4
HV-305.4
HV-
304.
1 H
V-30
5.1
P4
HV-304.3
HV-305.3
HV-
305
HV-
306
FIT-141
FILT
ER
FILT
ER
HV-
306.
1 H
V-30
7.1
HV-306.4
HV-307.4
HV-
307
HV-
308
HV-306.3
HV-307.3 PC
V-34
1
PCV-
331
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Component description
DescriptionTag
FeedB1
RetentateP1
PermeateP2
Feed drainP3
Cartridge drainP4
Retentate drainP5
System pumpP-201
Feed pump outlet pressure meterPT-111
Retentate pressure meterPT-112
Permeate pressure meter (optional)PT-113
Temperature meter, VERSAflux 120 on Feed, VERSAflux 400 onRetentate (optional)
TT-161
Retentate flow meter (optional)FIT-141
Permeate flow meter (optional)FIT-142
Manual butterfly valve HV-302 used together with PCV-341, onRetentate (alternative option PCV-331)
HV-302
Pneumatic pressure control valve PCV-341 together with HV-302,on Retentate (alternative option PCV-331)
PCV-341
Manual pressure control valve, on Retentate (alternative optionPCV-341 together with HV-302)
PCV-331
Not included in the systemTANK
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3 System description3.7 Flow charts
3.7.2 Flow diagrams
3.8 Control system
IntroductionVERSAflux is operated and monitored using the HMI (Human machine interface) that isdisplayed on the screen. The screens and the structure of the HMI are described below.All set range and data in this chapter are for VERSAflux 400 system.
Cabinet indicators
1 2 3
FunctionColorLabelPart
Power onGreenPower1
Pump onYellowRun2
AlarmingRedAlarm3
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Structure of the HMI
Welcome screen
ActionStep
Start the VERSAflux1
Result: The welcome screen appears.
Wait until the system is ready, as shown by the System Starting countdownand appearance of the Logon button.
2
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3 System description3.8 Control system
ActionStep
Click on the Logon button.3
Result:
Enter the correct information for User and Password, then press OK.4
Result:
Confirm that USB memory stick is installed on the cabinet, then click YES.5
Result: The system moves on to the Home screen.
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Home screenThe Home screen provides an overview and is the main control screen for systemoperation.
Displays ...Area/IndicatorPart
Important parameters that always display onscreen
Head display area1
Flow SchemePiping & Flow diagram2
Instrument Reading
Instrument live data trendLive trend3
Alarm informationInstance Alarm andAcknowledge area
4
Instance AlarmAcknowledge and Resetarea
5
Warning and System events
Acknowledge and reset
Pump Control mode selectionControl mode area6
PCV Control parameters
Start and stop for the pumpOn and Off buttons7
Switch between different screensFoot display area8
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3 System description3.8 Control system
Head display areaThe Head display area shows up on all screens. It only displays the selected importantparameters.
Deci-mal
RangeDescriptionName
10.0~100.0%Pump actual speed set pointPump Set
20.00~6.00 barPT-111 actual valueFeed Pressure
20.00~4.00 barTrans-membrane pressureTMP
20.00~4.00 barDelta P = Feed pressure - Permeatepressure
Delta P
0-Accumulated retentate flow volume, thisvalue can only be reset manually.
Acc. VOL1:Retentate
0-Accumulated permeate flow volume, thisvalue can only be reset manually.
Acc. VOL2:Permeate
--Batch running time. It starts from pumprunning, can be paused by alarm signals,and reset manually.
Acc. Time
--Time reading from the system HMI.System time
--Display logged on user name.User
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Piping and Flow Diagram areaThe flow scheme area displays as Piping& FlowDiagram (PFD), as shown in the followingexample:
All instruments with corresponding settings can be found in this area, as shown in thefollowing table (Range data for VERSAflux 400 system):
UnitDecimalRangeInstallationName
Bar in default20.00~6.00DefaultPT-111
Bar in default20.00~6.00DefaultPT-112
Bar in default20.00~4.00OptionalPT-113
Degree Celsius10.0~150.0OptionalTT-161
l/min10.0~600.0OptionalFIT-141
l/min10.0~95.0OptionalFIT-142
%010~100OptionalPCV-341
%10.0~100.0DefaultP-201
kg10.0~1200.0OptionalWIT-176
If an optional instrument is not selected, it will disappear from the PFD areatogether with its corresponding settings and related processes.
Note:
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3 System description3.8 Control system
Related processesOptional instrument
PT-113 PT-113 reading
PT-113 alarm setting
TMP value
TMP control
TMP alarm setting
TT-161 TT-161 reading
TT-161 alarm setting
FIT-141 FIT-141 reading
FIT-141 alarm setting
Constant retentate flow control
Constant retentate flow control alarm setting
Acc. VOL1
FIT-142 FIT-142 reading
FIT-142 alarm setting
Acc. VOL2
PCV-341 PCV-341 setting
Delta P control
Delta P control alarm setting
WIT-176 WIT-176 reading
WIT-176 alarm setting
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3 System description3.8 Control system
Live trend display area
The Live Trend area displays instance values for the following:
Displayed live trend of ...Name
Retentate flow meter (FIT-141) readingFIT-141
Feed pressure meter readingPT-111
Pressure difference between Feed and RetentateDelta P
Temperature readingTT-161
Instance Alarm and Acknowledge area
The InstanceAlarm&Acknowledgearea indicates instance alarm, warnings and systemevents. The alarm background will become yellow when acknowledged.
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3 System description3.8 Control system
Acknowledge and Reset area
The Acknowledge & Reset area comprises the buttons that are used to acknowledgeand reset information, as shown in the following table.
FunctionButton
Reset retentate accumulated flowReset Acc. VOL 1
Reset permeate accumulated flowReset Acc. VOL 2
Reset accumulated batch timeReset Acc. Time
Restore system after alarm has disappearedReset Fault
Alarms acknowledged by operator, after which the alarm dis-appears from the window
Alarm Ack.
Control mode area
The Control mode area displays the different control modes that can be selected.
Clicking the icon allows selection of the control mode to be used.
The parameter table below allows the user to choose the proper control parameters,control modes and settings:
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Control group 1:
Deci-mal
Set RangeDescriptionPumpControlGroup
10.0~100.0%Manual pump speed control set point.Pump Set
20.00~4.00 barDelta P control set point,
Delta P = P_feed P_retentate.
Delta P Set
10.0~400.0l/min
Retentate flow control set point,
Constant flow control.
Flow Set
Control group 2:
Deci-mal
RangeDescriptionPCV ControlGroup
110.0~100.0%Manual PCV valve opening control setpoint.
PCV Set
20.00~4.00 BarTMP control set point,
TMP = (P_feed + P_retentate)/2 P_per-meate.
TMP Set
Start and Stop Buttons
The Start and Stop Buttons area allows the user to start and stop the pump.
FunctionName
Start pump if the system is OK.On button (green)
Stop pumpOff button (red)
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3 System description3.8 Control system
Foot display area
The Foot Display area shows up on all screens. It displays the different screen selectionpossibilities for the system.
FunctionDescriptionName
Switch to Home page.Page ButtonHome
Switch to instrument alarm/warning settingspage.
Page ButtonSetting1
Switch to miscellaneous settings including PID,dry run protection, etc.
Page ButtonSetting2
Switch to history trend page.Page ButtonTrend
Switch to alarm log page.Page ButtonAlarmLog
Switch to user administration page.Page ButtonUserAdmin
Switch between English and Chinese.Function ButtonLanguage
Log off the current user.Function ButtonLog Off
Exit current runtime with admin authority.Function ButtonExit
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Setting1 screenThe Setting1 screen includes theAlarmandWarning settings range and enable/disablefunctions for the installed in-line instruments.
Click the Setting1 button in the Foot display area to go to the Setting1 screen.
RemarkDescriptionArea / IndicatorPosi-tion
Red: DisabledCorresponding alarmwill be disabled
Alarm disable switches1
Green: Enabled
Need Admin account tomodify; data will be re-tained during poweroff.
User settings for eachinstrumentAlarm/Warning
Alarm parameter set-tings
2
The detailed information for instrument Alarm/Warning settings are shown in the followingtable:
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3 System description3.8 Control system
UnitDecimalRangeTag
bar20.00~6.00PT-111 HA
bar20.00~6.00PT-111 LA
bar20.00~6.00PT-111 HW
bar20.00~6.00PT-111 LW
bar20.00~6.00PT-112 HA
bar20.00~6.00PT-112 LA
bar20.00~6.00PT-112 HW
bar20.00~6.00PT-112 LW
bar20.00~4.00PT-113 HA
bar20.00~4.00PT-113 LA
bar20.00~4.00PT-113 HW
bar20.00~4.00PT-113 LW
Degree Celsius10.0~150.0TT-161 HA
Degree Celsius10.0~150.0TT-161 LA
Degree Celsius10.0~150.0TT-161 HW
Degree Celsius10.0~150.0TT-161 LW
l/min10.0~600.0FIT-141 HA
l/min10.0~600.0FIT-141 LA
l/min10.0~600.0FIT-141 HW
l/min10.0~600.0FIT-141 LW
l/min10.0~95.0FIT-142 HA
l/min10.0~95.0FIT-142 LA
l/min10.0~95.0FIT-142 HW
l/min10.0~95.0FIT-142 LW
kg10.0~1200.0WIT-176 1 HA
kg10.0~1200.0WIT-176 LA
kg10.0~1200.0WIT-176 HW
kg10.0~1200.0WIT-176 LW
1 WIT-176 is the load cell signal from a tank. It is valid only when the system is connected to a specific tank and the EnableTank button is enabled on the Setting2 page.
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Setting2 screenThe Setting2 screen includes theAlarm andWarning settings range, the enable/disablefunctions and the PID settings for the different control modes together with the Miscfunction settings (such as unit switch from bar to PSI, tank load cell enable/disablefunction, 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.
RemarkDescriptionArea/Indicator
Posi-tion
Red: DisabledCorresponding alarm will be disabled fordifferent control modes:
Alarmdisableswitches
1
Green: Enabled
Delta P
TMP Alarm
Retentate Flow Control (RFC Alarm )
Need Admin ac-count to modify;data will be keptduring poweroff.
User settings for corresponding Alarm/Warning for different control modes:
Delta P
TMP
Retentate Flow Control (RFC)
Alarmparametersettings
2
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3 System description3.8 Control system
RemarkDescriptionArea/Indicator
Posi-tion
Detailed PIDtuning refers toSection 6.2 PIDcontrol andfeedback tuning,on page 121.
PID parameter settings for different con-trol modes:
Delta P
TMP
Retentate Flow Control (RFC)
PIDParametersettings
3
Red: DisabledDifferent kinds of functions enable/dis-able switches:
Misc.switches
4
Green: Enabled
Unit switch: bar-PSI
Enable Tank
Buzzer enable/disable
Compress air alarm enable/disable(Pneumatic)
Abnormal flow alarm enable/disable(Flow Abnormal)
Once the Enable Tank button has been enabled, a Tank will appear on thePFD on the Home page. Otherwise the Tank is hidden.
Note:
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Detailed information for instrument Alarm/Warning settings is shown in the followingtable:
UnitDecimalRangeTag
bar in default10.0~4.0Delta P HA
bar in default10.0~4.0Delta P LA
bar in default10.0~4.0Delta P HW
bar in default10.0~4.0Delta P LW
bar in default10.0~4.0TMP HA
bar in default10.0~4.0TMP LA
bar in default10.0~4.0TMP HW
bar in default10.0~4.0TMP LW
l/min10.0~400.0RFC HA
l/min10.0~400.0RFC LA
l/min10.0~400.0RFC HW
l/min10.0~400.0RFC LW
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Trend screenAll 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 flowrateand temperature (FIT-141, FIT-142, TT-161), and the Y axis to the right shows the mea-surement for pressure (PT-111, PT-112, PT-113, TMP, Delta P).
The user can drag the marker over the trend curve to read the process data from thedata table below the trend curve area.
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AlarmLog screenThe 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 backgroundwill turn yellow. It will remain yellow when the user acknowledges the alarm and willturn blue when the fault is corrected and the system is reset.
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The UserAdmin screenTheUserAdmin screen provides tools to edit specific user and administrator informationas shown in detail below.
Click the UserAdmin button in the Foot display area to go to the UserAdmin screen:
Important information for all users:
OP (operator)Admin (adminnistrator)
Change own password
Modify own logoff time
Create new user account
Add/Remove/Edit all user informa-tion (e.g. change own and otherspassword)
Modify logoff time for all users
Change alarm and warning set-tings
Functions
Change alarm range set-ting
Create new account
Exit the program
NoneRestric-tions
Default Password: 000000Default Password: 123456Remark
Default logout: 60 minutesDefault logout: 5 minutes
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Create new user account
ActionStep
Click the User pane.1
Result: the User pane is activated and a keyboard pops up:
Enter the new user name.2
Click the Password pane.3
Result: The Change password window appears:
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ActionStep
Enter the new password and confirm it.4
Click the Group pane.5
Result: the Group pane is activated:
Choose the correct acount level for the new user.6
Click the Logoff time pane.7
Result: the Logoff time pane is activated and a keyboard pops up:
Enter the automatic Logoff time for the new user in minutes (default).8
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Functional ButtonsThe Language, LogOffand Exitbuttons in the Foot display area are all functional buttons.
LanguageBy clicking the Language button in the Foot display area the user can switch betweenEnglish and Chinese language display.
Log OffBy clicking the Log Off button in the Foot display area, the current user will be loggedoff 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 onto the system.
ExitOnly the administrator can exit the current filtration software interface and go back tothe Window CE interface by clicking the Exit button.
Data recordingThe 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 fora number, starting from 0, 1, 2, etc.
All the warnings and alarms will be recorded as Alarm Log[X].csv, where X stands for anumber, starting from 0, 1, 2, etc.
The *.csv files can be opened and edited by the Microsoft Excel software on anyother computer.
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4 Installation
About this chapterThis chapter provides information required to enable users and service personnel tounpack, install, move and transport VERSAflux.
Precautions
WARNINGBefore attempting to perform any of the procedures described inthis chapter, you must read and understand all contents of thecorresponding section(s) in the Section 2.1 Safety precautions, onpage 11 as listed below:
General precautions, on page 11
Personal protection, on page 13
Installing and moving, on page 14
Power supply, on page 16
In this chapterThis chapter contains the following sections:
See pageSection
954.1 Site requirements
974.2 Transport
994.3 Unpack VERSAflux
1014.4 Setup
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4 Installation
4.1 Site requirements
Space and floor loadFor space and floor requirement, see external dimensions and weights in Section 9.1Specifications, 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 floormust be level and without irregularities.
In order to allow convenient working conditions for the operator, sufficient spaceshould be provided at all sides of the combined VERSAflux system and VERSAfluxtank when installed at the intended production location.
Ambient environmentAvoid:
Direct sunlight.
Strong magnetic or electric fields.
Vibrations.
Corrosive gas.
Dust.
Electrical powerRefer to Section4.4.3 Power supply, on page106andSection9.1 Specifications, onpage143for 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 theinstrument.
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Media supplyRefer to Section9.1 Specifications, on page143 regarding requirements for media supplyand delivery.
Supply must be arranged so that piping dimensions, piping lengths, valves and heightdifferences do not obstruct processing.
ComputerVERSAflux 120 and 400 has an industrial built-in HMI installed.
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4.2 Transport
In the transport crate
WARNINGMove transport crates. Make sure that the forklift has capacity tosafely lift the crate weight. Make sure that the crate is properlybalanced so that it will not accidentally tip when moved.
WARNINGPersonal Protective Equipment (PPE).Whenever packing, unpack-ing, transporting or moving VERSAflux, wear:
Protective footwear, preferably with steel lining.
Working gloves, protecting against sharp edges.
Protective glasses.
Use a pallet jack or fork-lift with a minimum capacity to match the empty weight of thesystem plus the transport crate. Refer to Section9.1 Specifications, on page143 regardingsystem weight.
Make sure that intended openings and apertures are large enough to allowpassage of the crate when lifted from the floor for transport.
Note:
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Unpacked
WARNINGHeavy object.Because of the significant weight of VERSAflux, greatcare must be taken not to cause squeezing or crushing injuriesduring movement. At least two, but preferably three or more, per-sons are recommended when moving the unit.
VERSAflux can be rolled by hand on hard and level surface with wheel brakes released.
If the floor quality does no allow rolling the VERSAflux on its own wheels, it can bemoved with a pallet jack or fork-lift.
For minimum door aperture size, refer to Section 9.1 Specifications, on page 143.
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4.3 Unpack VERSAflux
Tools required Suitable lifting device, forklift or similar. Refer to Section9.1 Specifications, on page143
for dimensions and weight to be handled.
13 mm wrench (or ratchet with 13 mm socket).
Electrical screwdriver no. 2 bit.
Knife.
Lever.
Visual inspectionCheck:
that all equipment is enclosed in the crate according to the packing list.
the equipment for any apparent damage and document carefully if found.
If any equipment is missing or damages are found, contact your GE Healthcare repre-sentative immediately.
Precautions
CAUTION
To prevent bacterial growth, VERSAflux may be partly filled withdenatured 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 thedenatured Ethanol or Sodium Hydroxide before assembling, testingor integrating VERSAflux into the intended process context.
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4 Installation4.3 Unpack VERSAflux
General unpacking instructionsRefer to the unpacking instructions attached to the outside of the crate whenunpacking the crate. In absence of the unpacking instructions, follow thegeneral unpacking instructions below.
Note:
ActionStep
Remove the front, side and back panels by loosening the bolts.1
Remove the accessories and documentation package.2
Use a forklift or similar lifting equipment to move the system out from thecrate.
3
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4.4 Setup
In this sectionThis section contains the following subsections:
See pageSection
1024.4.1 Assembly
1044.4.2 Process component connections
1064.4.3 Power supply
Precautions
CAUTION
To prevent bacterial growth, VERSAflux may be partly filled withdenatured 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 thedenatured Ethanol or Sodium Hydroxide before assembling, testingor integrating VERSAflux into the intended process context.
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4.4.1 Assembly
Lock the wheelsThe VERSAflux system is delivered fully assembled. No further specific assembly proce-dures are required.
After positioning the system at its designated location, lock the wheels (figure).
Connect compressed air supply
Locate your air inlet as in the previous figure, and connect to the compressed air supply.
For air supply requirements, refer to Compressed air, on page 95.
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Control system
VERSAflux 120 and 400 are delivered with the WinCC Advanced (TIA Portal) V11 systemcontrol software.
WinCC Advanced (TIA Portal) V11 is pre-installed and configured on the built-in HMI withno additional specifications required.
For more information see Section 3.3.2 Automation, on page 45.
Filter setupIf the system is configured for the intended filter type, there is no need for further config-uration upon arrival at the process site or inbetween processing runs.
If the system needs to be reconfigured for different size of HF cartridges, refer to Sec-tion 7.4 Disassembly and assembly, on page 134.
Feed pump and CFF filterprotection
To protect the system from feed containing particles that may clogg the CFF-filter ordamage the pump, use upstream normal flow filtering as described in Section5.1 Samplehandling, on page 111.
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4.4.1 Assembly
4.4.2 Process component connections
IntroductionThis section provides guidelines for the connection of process components to VERSAflux.
Recommended hoses andconnections
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 batterylimits to the plant interface points.
Refer to Section9.1 Specifications, on page143 for information regarding connection typeand size.
General guidelines forconnections
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 equalto the corresponding diameter of the system.
Inlet and outlet containers shall be located and arranged so that back pressure andsuction height remains within system specification limits, refer to Section9.1 Specifi-cations, on page 143 or the Section 1.2 Associated documentation, on page 9 (GS).
Keep the tubing lengths as short as possible to minimize hold-up volume in the sys-tem.
Route the tubing to minimize the risk of tripping when operating the instrument andconnected device.
If the hoses should be violently pulled, for example caused by an accidental tripping,they should be checked for damage, leakage and mechanical rigidity before contin-uing operation.
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The chemical properties of the tubing used shall meet or exceed the propertiesspecified in Section 9.3 Chemical resistance, on page 148.
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4.4.2 Process component connections
4.4.3 Power supply
Power requirementsThe power supply requirements are specified in Section 9.1 Specifications, on page 143.
InstallationConnect 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 industrialsafety regulations and/or electrical codes.
If the leak current exceeds 10 mA, a high leakage current earth connection must beprovided and confirmed before connecting power supply. Refer to the product doc-umentation package for information regarding the leak current for your system.
The integrity of all ground connections must be periodically checked.
Circuit breakerA circuit breaker must be present in the fixed power supply.
Breaking the power supply to the VERSAflux system by using this breaker must beequivalent to disconnecting the power cord for a non-fixed connected instrument.
Power supply cableThe mains power supply cable is shielded LFLEX of