cytiva Chromaflow 100, Operating Instructions Manual

Page 1: ...Chromaflow Packing Station 50 100 200 and 400 Operating Instructions Original instructions cytiva com...

Page 2: ...Connectcompressedairsupply 48 4 5 3 Guidelinesforconnections 49 4 5 4 Groundingconnection 50 4 5 5 Connectacolumn 51 5 Operation 56 5 1 Prepareyour ChromaflowPackingStation 58 5 1 1 Finalactionsbefor...

Page 3: ...5 1 Contactinformation 89 8 5 2 EuropeanUnionandEuropeanEconomic Area 90 8 5 3 Otherregulationsandstandards 91 8 6 HealthandSafetyDeclarationForm 92 8 7 Furtherinformation 94 Index 95 TableofContents...

Page 4: ...s regu latoryinformation intendeduseofChromaflow PackingStation andalistofassoci ateddocumentation Inthischapter Section Seepage 1 1 Aboutthismanual 5 1 2 Importantuserinformation 6 1 3 Associateddocu...

Page 5: ...ndividual ChromaflowPackingStation referto therelevantinformationinthedocumentationpackageprovidedwitheachproduct Contactyourlocal Cytiva representativeformoreinformation ifneeded Typographicalconvent...

Page 6: ...urposes ChromaflowPackingStation isnotsuitableforoperationinapotentiallyexplosive atmosphereorforhandlingliquidsunderconditionsatwhichtheycouldbeflammable Prerequisites Inordertooperateyour Chromaflow...

Page 7: ...otto proceeduntilallstatedconditionsaremetandclearlyunderstood NOTICE NOTICEindicatesinstructionsthatmustbefollowedtoavoid damagetotheproductorotherequipment Notesandtips Note A note is used to indica...

Page 8: ...ChromaflowPackingStation are Document Abbrevia tion Contents PipingandInstrumenta tionDiagram P ID Schematicoverviewoftheentire processflow includingallcomponents andinstruments GeneralSpecification G...

Page 9: ...resfor your ChromaflowPackingStation Thelabelsontheinstrumentandinformation regardingrecyclingarealsodescribed Inthischapter Section Seepage 2 1 Safetyprecautions 10 2 2 Labels 16 2 3 Emergencyprocedu...

Page 10: ...ation on page 13 Maintenance on page 14 Generalprecautions WARNING Onlyproperlytrainedpersonnelmayoperateandmaintainthe product WARNING Donotoperatetheproductinanyotherwaythandescribedinthe userdocume...

Page 11: ...alandbiologicalagents takeallsuitableprotec tivemeasures suchaswearingprotectiveclothing glassesand glovesresistanttothesubstancesused Followlocaland or nationalregulationsforsafeoperationandmaintenan...

Page 12: ...sarefollowed itisthecustomers responsibilitytoguar anteethesafetyofthepersonnelworkingwiththeproduct CAUTION Lockwheels Thewheelsof ChromaflowPackingStation should belockedduringnormaluse Thewheelssho...

Page 13: ...ecified columnmaximumpressure WARNING Operatinglimits Neverexceedtheoperatinglimitsstatedinthis documentandontheproductlabel WARNING Powerfailureofconnectedsystems Duringapowerfailureofa connectedsyst...

Page 14: ...itisreactivated Asuddenpressureincreasemaycause ruptureofpipingconnectionsandconsequentleakage CAUTION Alwaysturnoffthecompressedairsupplybeforedisconnecting ChromaflowPackingStation fromthecolumn Mai...

Page 15: ...resabovethespecifiedlimits WARNING Pressuremayremaininthecolumnandtubingforanextended periodaftershutdown Makesurethesystemisdepressurized beforeopeningordisconnecting WARNING Forcontinuedprotectionag...

Page 16: ...ves Codeno Codenumberidentifyingtheproductsizeandtype Serialno Serialnumberoftheindividualproduct Yearofmanufacture Manufacturingyear Operatingtemperature TS Allowedfluidtemperaturerange Supplyairpres...

Page 17: ...on page 18for furtherinformationregardingtheemergencystop WARNING Thepumphousingisunderspringpressure CAUTION Pressurecontrolvalveshallbesetto6barg forinstrumentairsupply Earprotectionmustbewornwhenev...

Page 18: ...maflowPackingStation followinganemergencyshutdown Precautions WARNING Pressuremayremaininthecolumnandtubingforanextended periodaftershutdown Makesurethesystemisdepressurized beforeopeningordisconnecti...

Page 19: ...vesselsthatareunderpressure Thisisdoneby openingvalvesanddisconnectinghosescarefully 4 Diagnoseandremedytherootcauseoftheproblem 5 Contact Cytiva iftheproblemcannotbesolved Restartafteremergencyshutdo...

Page 20: ...hattheconditionthatcausedtheemergencystopiscorrected 2 ResettheEMERGENCYSTOPbuttonbyturningitclockwise 2 Safetyinstructions 2 3 Emergencyprocedures 20 ChromaflowPackingStation50 100 200 and400Operatin...

Page 21: ...ttingpriortousingtheSTART RESETbutton toavoidanimmediatehighpressure increaseinthesystemwhenitisreactivated Asudden pressureincreasemaycauseruptureofpipingconnec tionsandconsequentleakage 2 Safetyinst...

Page 22: ...esadescriptionofthe ChromaflowPackingStation Inthischapter Section Seepage 3 1 ChromaflowPackingStation maincomponents 23 3 2 Controlpanels 27 3 3 Flowchart 33 3 Systemdescription 22 ChromaflowPacking...

Page 23: ...The ChromaflowPackingStation isfittedonaskidequippedwithlockablewheels Each ChromaflowPackingStation iscomprisedoftwopumpsandfourdiaphragm valvesthatarelocatedunderneathacabinetwithoperatingcontrolpa...

Page 24: ...3 Systemdescription 3 1 ChromaflowPackingStation maincomponents 24 ChromaflowPackingStation50 100 200 and400OperatingInstructions29046228AD...

Page 25: ...naboutairpressureandflowofbufferand slurry 2 Nozzlecontrol connectioninter face Panelforconnectingtocolumnautomaticnozzlesto allowthesetobecontrolledfroma Chromaflow PackingStation 3 Slurryinlettop SI...

Page 26: ...y procedures on page 18 12 EMERGENCY STOP Buttontostopoperationimmediatelyinanemer gencysituation Forinformationaboutemergencyprocedures see Section 2 3 Emergency procedures on page 18 Note Please not...

Page 27: ...sBandC andbetweencolumnSITandSIB Thelowercontrolpanelistheprimarypointforoperatingyour ChromaflowPacking Station Uppercontrolpanel 1 2 3 4 5 6 7 Theindicatorsandcontrolswitchesontheuppercontrolpanelar...

Page 28: ...ptothebottomnozzleisopen Thetextontheuppercontrolpanelisexplainedinthefollowingtable Part Function A ConnectionfromSOTtotheCOLLECTIONtank B Inlettothe ChromaflowPackingStation that connectstothePACKIN...

Page 29: ...2 3 4 5 6 7 8 Thetablebelowdescribesthelowercontrolpanelfunctions No Part Function 1 AIRSUPPLY PACKINGPUMP Controlstheamountofairsupplytothepacking pump Note This air supply control bypasses the FINEA...

Page 30: ...to 0when the nozzle control function is not used 6 TOPNOZZLE Usedtomovethetopnozzletothefollowingpositions Run settheswitchtoRUN Pack settheswitchtoPACK Unpack settheswitchtoUNPACK Note Only applicab...

Page 31: ...moreinformationseeSection 2 3 Emer gency procedures on page 18 4 FINEADJUST MENTPACKING PUMP Usedtomakefine scaleadjustmentstothepacking pumpairpressure 5 FINEADJUST MENT UNPACKING PUMP Usedtomakefine...

Page 32: ...TTOM NOZZLE Usedtomovethebottomnozzletothefollowingposi tions Run settheswitchtoRUN Pack settheswitchtoPACK Unpack settheswitchtoUNPACK Note Only applicable for automatic nozzles 9 AIRSUPPLY UNPACKING...

Page 33: ...ER SLURRY COLLECTION UNPACKING PUMP P 202 XV 021A XV 021C XV 022A XV 022C SOT SOB MPB MPT COLUMN SIT SIB A B C D EXTENT OF PACKING STATION PSV PSV Note Pressure safety equipment red must be installed...

Page 34: ...SOTtotheCOLLECTIONtank B InletthatconnectstothePACKINGBUFFERtank C InletthatconnectstotheSLURRYtank COLLECTION Collectiontank canbeusedforwasteorrecirculation COLUMN Connectedcolumn D Outletfromtheunp...

Page 35: ...MP P 202 Pumpsfluidsfromthecolumn XV 021A PACKINGBUFFERvalve XV 021C SLURRYvalve XV 022A SITvalve XV 022C SIBvalve 3 Systemdescription 3 3 Flowchart ChromaflowPackingStation50 100 200 and400OperatingI...

Page 36: ...orpersonalsafetyduringthetransportation installation opera tion maintenanceandserviceofcolumns useprotectiveglasses andotherpersonalprotectiveequipmentappropriateforthe currentapplicationatalltimes Th...

Page 37: ...ustbe performedinadherencewithlocalregulations Eveniftheinstructionsintheuserdocumentationandinstruction manualsarefollowed itisthecustomers responsibilitytoguar anteethesafetyofthepersonnelworkingwit...

Page 38: ...evelandwithoutirregularities Inordertoallowconvenientworkingconditionsfortheoperator sufficientspace shouldbeprovidedonallsidesofthe ChromaflowPackingStation whenitis installedattheintendedproductionl...

Page 39: ...Useapalletjackorforkliftwithaminimumcapacitytomatchtheemptyweightof theequipmentplusthetransportbox SeeSection 8 1 Specifications on page 81 regardingweightsanddimensions Makesurethatintendedopeningsa...

Page 40: ...otheintendedprocesscontext Visualinspection Checkthefollowing Checkthatallequipmentisenclosedinthecrateaccordingtothepackinglist Checkthattheequipmentforanyapparentdamage Documentanyfounddamage carefu...

Page 41: ...emarkedbolts fasteningthebeamsontheoutsideofthecrate indicatedbyarrowsinthe image 4 Carefullyremovethetopsupportbeamsfromthecrate Tip When removing the screws on the outside panel of the crate a secon...

Page 42: ...rkedboltsfromthebottomfrontsupportbeam indicated byarrowsintheimage holdingthe ChromaflowPackingStation inplace 4 Installation 4 3 Unpackfromthecrate 42 ChromaflowPackingStation50 100 200 and400Operat...

Page 43: ...owingillustration NOTICE Placeasoftmaterialbetweentheforksoftheforkliftand the ChromaflowPackingStation frameduringlifting operationstohelppreventdamagetothesurfaces This willminimizetheriskofrusting...

Page 44: ...pmentforliftingwithtelphersorsimilarequipment Liftbyplacingliftingequipmentunderthelowerpartof theframe 7 Placethe ChromaflowPackingStation onalevelsurface 4 Installation 4 3 Unpackfromthecrate 44 Chr...

Page 45: ...hewheelbrakesreleased Afterpositioningthesystematitsdesignatedlocation lockthewheelsbypressing downtheflapasshowninthefigurebelow Unlockthewheelsbypressingupthe flap Ifthefloorqualitydoesnotallowrolli...

Page 46: ...9 4 5 4 Groundingconnection 50 4 5 5 Connectacolumn 51 Precautions CAUTION Theproductmaybepartlyfilledwithdenaturedalcohol 18 C2H5OH ethanol 2 C3H7OH isopropanol and80 H2O water atdelivery Thedenature...

Page 47: ...llyassembled The Chromaflow PackingStation isequippedwithwheelsthatallowittobeeasilyrolledtoitsdesig natedlocationofuse Afterthe ChromaflowPackingStation isinpositionandthewheelsarelocked the pneumati...

Page 48: ...e ChromaflowPackingStation airinlet AIRINLET Chromaflow sizes50 100 and200 Chromaflow size400 2 Makesurethatthepressureregulatorforthecompressedairthatisinside thecabinetissettothecorrectbargpressuref...

Page 49: ...ersshallbelocatedasclosetothepackingstationas possible onthesamefloorofthebuilding andarrangedsothatbackpressureand suctionheightremainswithinsystemspecificationlimits Keepthetubinglengthsasshortaspos...

Page 50: ...ndingpointislocatedononeoutercornerof theskid asshowninthefollowingillustration Thelocationofthegroundingpointis alsoindicatedontheskidbyagroundinglabel Agroundingkitisincludedwiththedeliveryofyour Ch...

Page 51: ...mentsinthecolumnandsystemOperating Instructions NOTICE Thesuggestedconnectionschemesareofageneralnature Users maywishtoaltertheconfiguration dependingonspecificneeds If thereisanyquestionaboutsafetyco...

Page 52: ...t on page 33 NOTICE Thepressuresafetyequipmentindicatedinredinthediagram aboveisnotprovidedaspartofthe ChromaflowPackingStation delivery Thediagramindicatestherecommendedplacementof suitablepressuresa...

Page 53: ...n addi tion for a smooth transition from one diameter to another always use conical reducers Connecttanks Makethefollowingconnectionsbetweenthetanksandthe ChromaflowPacking Station Step Action 1 Conne...

Page 54: ...on 1 Installpressuresafetyvalves PSV ontheMPTandMPBports Thevalves shouldhavethesameinnerdiameterasthecolumninlet outlet 2 Connectapressuregauge P recommendedrange0to6bar toMPTafter thepressuresafetyv...

Page 55: ...ablepressuresafetyequipmenttoprotectthecolumnfrom exposuretooverpressureorvacuum Step Action 1 Installpressuresafetyvalves PSV ontheMPTandMPBports Thevalves shouldhavethesameinnerdiameterasthecolumnin...

Page 56: ...steps in the following sections refer to the use of a pressure gauge These particular steps are part of a general procedure suggested by Cytiva although modifications can be made to these instruction...

Page 57: ...onsintheuserdocumentationandinstruction manualsarefollowed itisthecustomers responsibilitytoguar anteethesafetyofthepersonnelworkingwiththeproduct WARNING Forcontinuedprotectionagainstinjuryrisksdueto...

Page 58: ...ation istakenintooperation makesurethatall proceduresinthefollowingchaptersandsectionshavebeenperformed Chapter 4 Installation on page 36and Section 6 1 User maintenance schedule on page 66 Inthissect...

Page 59: ...ChromaflowPackingStation totheinletandoutlet tanks andfromyour ChromaflowPackingStation tothecolumn isproperly connectedinaccordancewiththerespectiveinstructions Checkthatalltubingisingoodconditionand...

Page 60: ...rprimingyour ChromaflowPackingStation andthe connectedcolumn Formoreinformationaboutcolumnpriming refertotheuser documentationforyourcolumn Iffurtherinstructionsareneeded pleasecontactyourlocal Cytiva...

Page 61: ...recautions WARNING Usecolumnsthatwithstandexpectedpressures Alwaysuse appropriatepressurealarms pressureventsorrupturediscs and safetyequipment Ifnot thecolumnsmightrupture resultingin injury NOTICE W...

Page 62: ...reneeded please contactyourlocal Cytiva representative Emptythecolumn Whenemptyingacolumn theconnectionfromtheCOLLECTIONtanktothecolumn mustenableafreeflowofairtoavoidunder pressureinthecolumn Toempty...

Page 63: ...raphyresincanpreventthe membranesfrommovinginsidethepump Disconnect ChromaflowPacking Station Followtheprocedurebelowtodisconnectyour ChromaflowPackingStation fromthe column Step Action 1 Cleanyour Ch...

Page 64: ...informationaboutorderingspareparts contactyourlocal Cytiva representative Inthischapter Section Seepage 6 1 Usermaintenanceschedule 66 6 2 Cleaning 68 6 3 Storage 76 Precautions WARNING Pressuremayrem...

Page 65: ...T LOTO Beforeanymaintenanceor decommissioningworkisperformedonthesystem makesure that thesystemisemptyanddepressurized thesystemisdisconnectedfromprocessfeed electricalpower andpneumaticsupply thesyst...

Page 66: ...k PleasecompletethechecklistintheOn Site Service Health and Safety Declaration FormortheHealth and Safety Declaration Form for Product Return or Servicing dependingonwhethertheinstrumentisgoingtobeser...

Page 67: ...ressure Maintenanceannuallyorasneeded Thetablebelowlistsmaintenanceactionsthatarerequiredannuallyorasneeded Component Action Pump Replaceallwearandtearparts Refertothesystemdocumenta tionfordetails 6...

Page 68: ...aths Thisresultsinapressureincrease orpreventsthe pumpfromstartingduetothatsettledchromatographyresinpreventsthe membranesfrommovinginsidethepump Formoreinformationaboutcleaningtheconnectedcolumn refe...

Page 69: ...columnisproperlydecontaminatedandsanitizedbeforemainte nanceorservice WARNING Flammableliquids Thisproductisnotapprovedforhandling liquidsunderflammableconditions Makesuretouseliquidsonly undercondit...

Page 70: ...pper control panel on page 27 Connections Step Action 1 Connectapieceofflexibletubing A fromSITtotheCOLLECTIONtank or directittowaste 2 ConnectapieceofflexibletubingfromSIBtoSOB 3 Connectapieceofflexi...

Page 71: ...esselC 2 OpeninletCandoutletSIT 3 Startthepumpatmax50 speedandflushtheSITline removingany residualresinparticles Useabout25to50liters 4 OpenoutletSIBtoflushtheSIBline Useabout25to50liters Result Rinsi...

Page 72: ...ndoutletSIT 3 Startthepumpatmax50 speedandflushtheSITlinewithCIPbuffer Use about25to50liters 4 OpenoutletSIBtoflushtheSIBlinewithCIPbuffer Useabout25to50 liters Result CIPbufferwillflushtheSIBlineincl...

Page 73: ...SIT 3 Startthepumpatmax50 speedandflushtheSITlinewithrinsingbuffer Useabout25to50liters 4 OpenoutletSIBtoflushtheSIBlinewithrinsingbuffer Useabout25to50 liters Result RinsingbufferwillflushtheSIBlinei...

Page 74: ...liters 4 OpenoutletSIBtoflushtheSIBlinewithstoragebuffer Useabout10to20 liters Result StoragebufferwillflushtheSIBlineincludingtheunpackingpump 5 OpeninletBandstopthepumpwhenvesselBisempty 6 Closepack...

Page 75: ...ackingStation togetherwiththeconnectedcolumn OpeninletCand outletSITtocleantherestofthepackingstationtogetherwiththeconnectedcolumn Note For explanation of the image text see Upper control panel on pa...

Page 76: ...g andlowenoughto preventevaporation Short termstorage Theprocedureforshorttermstorageisdescribedbelow Thisprocedureisapplicable forstoragedurationsuptoonemonth Step Action 1 Performcleaningasdescribed...

Page 77: ...beintherange4 Cto30 Candstable Theairhumidityandairtemperaturedifferencesshouldbekeptaslowas possibletopreventcondensationandcorrosion Note To prevent microbial growth and evaporation of the storage s...

Page 78: ...oinletoroutletvalveopen Checkvalves Impropercleaningleavingresintosedimentinthepump Ifnoneoftheabove contact Cytiva servicepersonnel Littleorno flow Checkthatconnectedinletisactuallyused Inletcontaine...

Page 79: ...ectionoutlinestroubleshootingforvalverelatedissues Problem Possiblecause correctiveaction ChromaflowPacking Station doesnotfunc tionatstart Valvesmightnotbeworking Checkthat compressedairsupplyissuffi...

Page 80: ...n abouthowtoobtainsupporttraining serviceandsparepartsisalsodescribed Inthischapter Section Seepage 8 1 Specifications 81 8 2 Chemicalresistance 85 8 3 Noiselevel 86 8 4 Recyclinginformation 87 8 5 Re...

Page 81: ...to7barg 6to7barg 6to7barg 6to7barg Airconsumption Airflow500 NL min Airflow1000 NL min Airflow1250 NL min Airflow2000 NL min Ingressprotec tionEN60529 IP55 IP55 IP55 IP55 Operating temperature 4 Cto30...

Page 82: ...cribesthematerialsusedinconstructionof ChromaflowPacking Station Parameter ChromaflowPackingStation Valvebodies Material 316L Wettedpart Yes Valvediaphragms Material EPDM Wettedpart Yes Pumphousings M...

Page 83: ...1mm 1 5 34 8 mm 1 5 34 8 mm 2 5 60 2 mm Flangetypeandsize 1 5 TC50 1 5 TC50 1 5 TC50 2 5 TC78 InletSOB Dimension o d i d 1 22 1mm 1 22 1mm 1 5 34 8 mm 2 47 5mm Flangetypeandsize 1 5 TC50 1 5 TC50 1 5...

Page 84: ...50 Volume 100 Volume 200 Volume 400 InletBtoSIT Includingpacking pump 0 72L 1 7L 3 7L 10 8L InletBtoSIB Includingpacking pump 0 86L 1 8L 4 3L 12 1L SOBtoInletD Includingunpacking pump 0 72L 1 5L 3 7L...

Page 85: ...ighconcentrationsofstrongacids Listofallowedchemicals WARNING Non flammableconditions Someofthechemicalsusedwiththe productmaybeflammableundercertainconditions Makesureto usechemicalsonlyunderconditio...

Page 86: ...imummeasurednoiselevelfor ChromaflowPackingStation is85dB A Note The maximum noise level of individual units may vary slightly CAUTION Useearprotectionwheneverworkingclosetothesysteminopera tion 8 Ref...

Page 87: ...ommissioningandall localregulationsshallbefollowedwithregardtoscrappingoftheequipment Disposal generalinstructions Whentakinga ChromaflowPackingStation outofservice thedifferentmaterialsmust beseparat...

Page 88: ...tapplytotheproduct Inthissection Section Seepage 8 5 1 Contactinformation 89 8 5 2 EuropeanUnionandEuropeanEconomicArea 90 8 5 3 Otherregulationsandstandards 91 8 Referenceinformation 8 5 Regulatoryin...

Page 89: ...information Thetablebelowsummarizestherequiredmanufacturinginformation Requirement Information Nameandaddressofmanufacturer CytivaSwedenAB Bj rkgatan30 SE75184Uppsala Sweden Telephonenumberofmanufactu...

Page 90: ...ththeproduct acopyoftheEUDeclarationofConformityisavailable onrequest CEmarking TheCEmarkingandthecorrespondingEUDeclarationofConformityisvalidforthe instrumentwhenitis usedaccordingtotheOperating Ins...

Page 91: ...irementsfromUnitedStatesPharmacopeia BiologicalReactivityTests InVivo 21CFR177 Indirectfoodadditives Polymers Additionaldesignconsiderations Foradditionaldesignconsiderations suchasASME BPE GMPandcGMP...

Page 92: ...is may require customer to move equipment from normal operating location prior to Cytiva arrival Consumables such as columns or gels have been removed or isolated from the instrument and from any area...

Page 93: ...taminatedprior to service return Provide a telephone number where Cytiva can contact you for additional information concerning the system equipment Telephone No Liquid and or gas in equipment is Water...

Page 94: ...Sparepartsandaccessories Yourlocal Cytiva representativewillbeabletosuggestrecommendedsparepartsand accessories Remainingaspects Contactyourlocal Cytiva representativeforadviceregarding Training Serv...

Page 95: ...turinginformation 89 Methodoptimization 94 MPB 28 34 MPT 28 34 N Notesandtips 7 Nozzlecontrol 26 O Onsiteservice 92 Operation 56 Orderinginformation 94 P Prerequisites 6 Pressuregauge 54 Pressuresafet...

Page 96: ...7 long term 77 short term 76 Systemdescription 22 T Training 94 Transport 39 45 inthecrate 39 unpacked 45 Troubleshooting 78 Typographicalconventions 5 U Uppercontrolpanel 27 W Wettedmaterials 94 Inde...

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Page 98: ...Cytiva Allotherthird partytrademarksarethepropertyoftheirrespectiveowners 2020 Cytiva AllgoodsandservicesaresoldsubjecttothetermsandconditionsofsaleofthesupplyingcompanyoperatingwithintheCytiva busin...