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VERSAflux System Operating Instructions Original instructions
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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

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    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

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    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

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    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

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    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 System description3.3 Standard equipment3.3.4 Feed pump and feed line

  • 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 System description3.3 Standard equipment3.3.6 Permeate line

  • 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 System description3.5 Hollow fiber (HF) configuration

  • 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 System description3.5 Hollow fiber (HF) configuration3.5.2 VERSAflux 400 HF configuration

  • 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 System description3.7 Flow charts3.7.1 External connections

  • 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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    3 System description3.7 Flow charts3.7.2 Flow diagrams

  • 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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    3 System description3.8 Control system

  • 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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    3 System description3.8 Control system

  • 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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    3 System description3.8 Control system

  • 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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  • 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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  • 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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  • 4.1 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 Installation4.4 Setup

  • 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


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