PALL颇尔-生物技术领域-除菌滤芯-EKV-双层PES膜滤芯产品资料-英文

USD2461bPallSupor®EKVSterilizingGradeFiltersSuporEKVSterilizingGradeFiltersPallSuporEKVfiltersarevalidatedsterilizinggrademembranesforthemostcosteffectivefiltrationofawiderangeofliquidssuchasbufferstissue,culturemedia,andothers.TheincorporatedPESmembranedemonstratesveryhighcompatibilityoverthewholepHrangeplusverylowproteinbindingtoensurethemaximumtransmissionoftheactiveingredients.ThepatentedUltipleat®filtertechnology,combinedwiththeoptimized,built-inasymmetricprefilterforhigherflowratesandthroughput,allowsverycompactsizingforeasyintegrationindisposablesystems.234Allegro™Systems:TheDisposableSolutionsHighflexibility,minimizedcleaning,cleaningvalidation,enhancedsterility,andcostcontrol,throughthewholedrugdevelopmentcycleandduringfullmanufacturingareclearindustrytargets.TheAllegrodisposablesystems,whichincorporatePallKleenpak™capsules,aretheanswertotheserequirementsastheycompletelyeliminatetheneedforcleaningandrelatedvalidation,minimizingmajorcapitalinvestment,andofferingveryhighflexibilitywhileenhancingthequalityofasepticprocessing.Forliquidsfromseveralmillilitersuptofullproductionscalevolumes,awiderangeofSuporEKVfilterproductsareavailableindisposableformatandcanthusbeintegratedintoAllegrodisposablesystems.™AllegroSystemsTheSingle-UseSolution55MiniKleenpakSyringeSMFiltersPage7ThePallUpScaleProgramSaveTime,GetResultsMiniSuporEKVfiltersareavailableinawiderangeofscalable,encapsulatedformatsKleenpak20whichallowfastandeasyscale-up,tobringyourproducttothemarketfaster.CapsulesPage8Samematerials*Fromsyringefilterstoproductionscale,allproductsMiniincorporatethesamemembraneandtheidenticalKleenpakmaterialsofconstruction.CapsulesPage9*ExceptNovasipCapsules.Seematerialofconstructiontablesforeachproductforfurtherdetails.QualityKleenpakCapsulesEverySuporEKVpleatedfilteris:Page10•Integritytestedduringmanufacture•Identifiedbylotandserialnumberfortotaltraceability•Suppliedwithacertificateoftestconfirmingeachfilter:Novasip•MeetsUSPBiologicalReactivitytestinvivo,CapsulesforclassVI-121°CplasticsPage11•MeetscleanlinessperUSPParticulatesinInjectables•IsNon-Fiber-Releasing•IsNon-PyrogenicperUSPEndotoxins(<0.25EU/mL)KleenpakNova•MeetsTotalOrganicCarbonandWaterCapsulesConductivityperUSPPurifiedWater.Page12,13JuniorFilterCartridgesPage14FilterCartridgesPage156MiniKleenpakSyringeFiltersTypicalLiquidFlowvs.DifferentialPressureMaterialsofConstruction16FilterMembraneHydrophilicPES100014Housing,VentPlugandPolypropylene)SupportMaterialr12)a800ibspm((SealingTechnologyInsertmolding10eerruuss600sseerr8PPllaaiittnn4006eerree(1)ffffOperatingParametersiiDD4MaximumOperating5.4bar(80psi)at20°C200TemperatureandPressure2.1bar(30psi)at60°C2(1)Incompatiblefluidswhichdonotsoften,swelloradverselyaffectthefilteroritsmaterialsofconstruction0001020304050Flowrate(mL/min),waterat20ºCForliquidsotherthanwater,multiplydifferentialpressurebyfluidviscosity(cP).TypicalHoldUpVolumeNominalDimensions<2.5mLCapsuleLength21mm(0.8in.)CapsuleDiameter29mm(1.2in.)Sterilization(2)NominalEffectiveFilterArea(EFA)Pre-sterilized,subjecttoaminimumof25kGyofGamma-irradiation2.8cm2(0.43in2)(2)•Pre-sterilizedMiniKleenpaksyringefiltersmustnotbere-sterilized•MiniKleenpaksyringefiltersmustnotbesterilizedin-situbypassingsteamunderpressureOrderingInformation(3)PallPartNumber:KM2EKVPSShippingFormatPresterilizedusinggammairradiation(3)50filtersperbox7MiniKleenpak20CapsulesTypicalLiquidFlowvs.DifferentialPressureMaterialsofConstruction160FilterMembraneHydrophilicPES140Housing,VentPlugPolypropylene2andSupportMaterial)r120)aibFillingBellPolycarbonatespm((100eeSealingTechnologyThermalbondingrruuswithoutadhesivesssseerr80PPllaa1iittnn60eerree(1)ffffOperatingParametersiiDD40MaximumOperating1.4bardat22°C(20psid)TemperatureandPressure20(1)Incompatiblefluidswhichdonotsoften,swelloradverselyaffectthefilterorits0materialsofconstruction00102030405060Flowrate(mL/min),waterat20ºCForliquidsotherthanwater,multiplydifferentialpressurebyfluidviscosity(cP).TypicalHoldupVolumeNominalDimensions<2.5mLCapsuleLength83mm(3.3in.)CapsuleDiameter67mm(2.7in.)Sterilization(2)NominalEffectiveFilterArea(EFA)Autoclave1x60minutesat125°C20cm2(3.1in.2)(2)•MiniKleenpak20capsulesmustnotbesterilizedin-situbypassingsteamunderpressure•WaterwetSuporEKVcapsulespriortosteamingtoretainfullwaterwettabilityforintegritytesting•Pre-sterilizedMiniKleenpak20capsulesshouldnotbere-irradiatedOrderingInformationPallPartNumber:KM5EKVP2(3)3filtersperboxConnectionCodeShippingFormat(4)100filtersperbox11(4)⁄4–⁄2in.(6–13mm)steppedhoseGNon-sterilebarbwithinnerboretoacceptfemaleGammairradiatable/slipluerinteriorandouterdiameterautoclavabletoacceptfillingbelloutletS(3)Pre-sterilizedusinggammairradiation(maximum25kGy)8MiniKleenpakCapsulesTypicalLiquidFlowvs.DifferentialPressureMaterialsofConstruction300FilterMembraneHydrophilicPES4Support/DrainagePolypropyleneCapsuleShellPolypropylene)r)aib3sFillingBellPolycarbonatepm200((eerruSealingTechnologyThermalbondingusssswithoutadhesiveseerrPP2llaaiittnneerr100e(1)efffOperatingParametersfiiDDMaximumTemperature40°C1MaximumOperatingPressure4.1bar(60psi)at40°CMaximumDifferentialPressure4.1bar(60psi)at40°C0001002003004005006007008009001000(1)Incompatiblefluidswhichdonotsoften,swelloradverselyaffectthefilteroritsmaterialsofconstructionFlowrate(mL/min),waterat20ºCForliquidsotherthanwater,multiplydifferentialpressurebyfluidviscosity(cP).Sterilization(2)NominalDimensionsAutoclave3x60minutesat140°CMaximumdiameter53mm(2.1in.)includingvalvesGammaIrradiationMaximumof50kGyLength-Code2105mm(4.1in.)(2)•Pre-sterilizedMiniKleenpakcapsulesmustnotbere-sterilized.Length-Code873mm(2.9in.)•MiniKleenpakcapsulesmustnotbesterilizedin-situbypassingsteamunderpressure•WaterwetSuporEKVcapsulespriortosteamingtoretainfullwaterwettabilityforintegritytestingTypicalExtractablesinWaterat20°CNominalEffectiveFilterArea(EFA)<5.0mgpercapsule220cm2(0.24ft2)OrderingInformation(3)PallPartNumber:KA02EKVPCodeConnectionCodeShippingFormatOptions112⁄4–⁄2in.(6–13mm)GNon-sterilehosebarbGammairradiatable/autoclavable(3)3filtersperbox138⁄2–⁄4in.(13–19mm)sanitaryflangeS(4)Pre-sterilized(4)SgradewithP2connectionisprovidedusinggammairradiationwithfillingbellonoutlet.Itisremovable(maximum25kGy)forin-lineuse9KleenpakCapsulesTypicalLiquidFlowvs.DifferentialPressureMaterialsofConstruction300FilterMembraneHydrophilicPES4KA2Support/DrainagePolypropyleneKA1KA3EndCap,CoreandCagePolypropylene)r)aib3spmCapsuleShellPolypropylene200((eerruSealingTechnologyThermalbondingusssswithoutadhesiveseerrPP2llaaiittnneerr100ee(1)ffffOperatingParametersiiDDMaximumTemperature40°C1MaximumOperatingPressure5.2bar(75psi)at20°C4.0bar(58psi)at40°CMaximumDifferentialPressure4.0bar(58psi)at40°C00012345678(1)Incompatiblefluidswhichdonotsoften,swelloradverselyaffectthefilteroritsFlowrate(L/min),waterat20ºCmaterialsofconstructionForliquidsotherthanwater,multiplydifferentialpressurebyfluidviscosity(cP).Sterilization(2)NominalDimensionsAutoclave5x60minutesat125°C,KA1KA2KA3slowexhaustDiameterincl.Valves94mm(3.7in.)94mm(3.7in.)105mm(4.1in.)GammaIrradiationMaximumof50kGyLength-Code1117mm(4.6in.)157mm(6.2in.)174mm(6.8in.)(2)•Pre-sterilizedKleenpakcapsulesmustnotbere-sterilizedLength-Code6157mm(6.2in.)197mm(7.7in.)210mm(8.3in.)•Kleenpakcapsulesmustnotbesterilizedin-situbypassingsteamunderpressure•WaterwetSuporEKVcapsulespriortosteamingtoretainfullwaterwettabilityLength-Code16137mm(5.4in.)177mm(7.0in.)192mm(7.6in.)forintegritytestingTypicalExtractablesinWaterat20°CNominalEffectiveFilterArea(EFA)KA1/KA2<5mgpercapsuleKA1375cm2(0.4ft2)KA3<10mgpercapsuleKA2750cm2(0.8ft2)KA31500cm2(1.6ft2)OrderingInformationPallPartNumber:KAEKVPCodeCodeInlet/OutletCodeShippingFormatConnections1111⁄2in.sanitaryflangeGNon-sterile1Gammairradiatable/26⁄2in.(13mm)autoclavablesinglehosebarb31SPre-sterilized161⁄2in.sanitaryflangeinlet1usinggammairradiationand⁄2in.(13mm)single(maximum25kGy)hosebarboutlet10NovasipCapsuleTypicalLiquidFlowvs.DifferentialPressureMaterialsofConstruction300FilterMembraneHydrophilicPES4Support/DrainagePolypropyleneEndCap,CoreandCagePolypropylene)r)aib3spmCapsuleBowlPolyetherimide200((eerruSealingTechnologyThermalbondingusssswithoutadhesiveseerrPP2llHousingHeadPolyetherimidewithTiO2aaiittnneerr100ee(1)ffffOperatingParametersiiDDMaximumTemperature60°C1MaximumOperatingPressure6.5bar(94psi)at40°C2.0bar(29psi)at60°CMaximumDifferentialPressure4.1bar(60psi)at60°C00012345678(1)Incompatiblefluidswhichdonotsoften,swelloradverselyaffectthefilteroritsFlowrate(L/min),waterat20ºCmaterialsofconstructionForliquidsotherthanwater,multiplydifferentialpressurebyfluidviscosity(cP).Sterilization(2)NominalDimensionsAutoclave5x60minutesat125°C,Diameterincl.Valves123mm(4.8in.)slowexhaustOverallLength157mm(6.2in.)In-Line5x60minutesat125°C(2)WaterwetSuporEKVcapsulespriortosteamingtoretainfullwaterwettabilityforintegritytestingTypicalExtractablesinWaterat20°CNominalEffectiveFilterArea(EFA)<10mgpercapsule1500cm2(1.6ft2)OrderingInformationPallPartNumber:C3EKVP1Inlet/OutletCodeVent/DrainConnectionsConnections11⁄2in.sanitaryflangeBlankVent:Quickconnectanddisconnectcoupling(compatiblewithStäubli*fitting)Valvedrain:Hose11barbfor⁄8in.–⁄4in.(4–6mm)i.D.tube,withvalveAVentanddrain:Quickconnectanddisconnectcoupling(Stäubli*compatible)withvalve1BVentanddrain:⁄2in.(13mm)sanitaryflange,novalvesanitaryclamp11KleenpakNovaCapsulesMaterialsofConstructionTypicalExtractablesinWaterat20°CFilterMembraneHydrophilicPES<25mgafter4hoursextraction(per254mmmodule)Support/DrainagePolypropylene*Testedonelementswithoutpre-flushingCore/EndCapsPolypropyleneCagePolypropylenewithTiO2(whitecolored)NominalDimensionsO-ringsSiliconeelastomerIn-lineSealingTechnologyThermalbondingNP6NP7NP8withoutadhesivesMaximumDiameterHousingBowlPolypropyleneincludingvalves154mm(6.1in.)154mm(6.1in.)154mm(6.1in.)HousingHead*PolypropyleneLengthwithhosebarbinlet/outlet397mm(15.6in.)644mm(25.4in.)895mm(35.2in.)*FormulatedwithTiO2whitenerwhichdoesnotcontributetoorganicextractablesLengthwithsanitaryinlet/outlet335mm(13.2in.)584mm(23.0in.)834mm(32.8in.)T-styleOperatingParameters(1)NT6NT7NT8MaximumTemperature40°CMaximumDiameterMaximumOperatingPressure3bar(44psi)at40°Cincludingvalves240mm(9.5in.)240mm(9.5in.)240mm(9.5in.)MaximumDifferentialPressure3bar(44psi)at40°CLength349mm(13.7in.)598mm(23.5in.)848mm(33.4in.)(1)Incompatiblefluidswhichdonotsoften,swelloradverselyaffectthefilteroritsmaterialsofconstructionSterilization(2)NominalEffectiveFilterArea(EFA)Autoclave:1x60minutesat135°C0.6m2per254mmmodule(6.5ft2per10in.module)Gammairradiation:Maximumof50kGy(2)•Pre-sterilizedKleenpakNovacapsulesmustnotbere-sterilized•KleenpakNovacapsulesmustnotbesterilizedin-situbypassingsteamunderpressure•WaterwetSuporEKVcapsulespriortosteamingtoretainfullwaterwettabilityforintegritytesting12KleenpakNova(NP)KleenpakNova(NT)TypicalLiquidFlowvs.DifferentialPressureTypicalLiquidFlowvs.DifferentialPressure6006008850075007))rr))iiaassbb6p6p((mm((400400eerreerruuuu5s5ssssssseerreerr300P300PPPlll4l4aaiiaattiittnnnneerreerr3e3effe200e200ffffiiffiiD1DDD•P6Capsules(⁄2in.hosebarb)22•P1Capsules(sanitaryflange)100100•P9Capsules(1in.hosebarb)•P9Capsules(1in.hosebarb)1•P1Capsules(sanitaryflange)10000020406080020406080Flowrate(L/min),waterat20ºCFlowrate(L/min),waterat20ºCForliquidsotherthanwater,multiplydifferentialpressurebyfluidviscosity(cP).Forliquidsotherthanwater,multiplydifferentialpressurebyfluidviscosity(cP).OrderingInformationPallPartNumber:NEKVPCodeStyleCodeFilterSizeCodeShippingFormatCodeVent/DrainPIn-line6254mm(10in.)GNon-sterileGammaBlankStäubli*ventandsteppedirradiatable/autoclavablehosebarbdrainTT-style7508mm(20in.)SPre-sterilizedusinggammaAStäubli*ventanddrain8762mm(30in.)irradiation(mimimum25kGy)CodeConnectionOptions111–1⁄2in.sanitaryflangeinletandoutlet91in.(25mm)singlebarbhosebarbinletandoutlet1191–1⁄2in.sanitaryflangeinletand1in.(25mm)singlebarbhosebarboutlet(1)16⁄2in.(13mm)singlebarbhosebarbinletandoutlet(1)11161–1⁄2in.sanitaryflangeinletand⁄2in.(13mm)singlebarbhosebarboutlet(2)111H1–1⁄2in.sanitaryflangeinletandoutlet,with⁄2in.sanitaryportoninlet(2)11H91–1⁄2in.sanitaryflangeinletand1in.(25mm)singlebarbhosebarboutlet,1with⁄2in.sanitaryportoninlet(1)ForP-styleonly13(2)ForT-styleonlyJuniorFilterCartridgesTypicalLiquidFlowvs.DifferentialPressureMaterialsofConstruction300FilterMembraneHydrophilicPES4Support/DrainagePolypropyleneEndCap,CoreandCagePolypropylene)r)aib3spmSealingTechnologyThermalbonding200((eewithoutadhesivesrruussssO-ringsSiliconeElastomereerrPP2llaaiittnneerr100ee(1)ffffOperatingParametersiiDDMaximumDifferentialPressure5.2bar(75psi)at40ºC1(1)Incompatiblefluidswhichdonotsoften,swelloradverselyaffectthefilteroritsmaterialsofconstruction00012345678Flowrate(L/min),waterat20ºCForliquidsotherthanwater,multiplydifferentialpressurebyfluidviscosity(cP).Sterilization(2)TypicalExtractablesinWaterat20°CAutoclave5x60minutesat125°C,<10mgperfilterslowexhaustInSituSteam30x60minutesat125°C(2)WaterwetSuporEKVcapsulespriortosteamingtoretainfullwaterwettabilityforintegritytestingNominalEffectiveFilterArea(EFA)1500cm2(1.6ft2)OrderingInformationPallPartNumber:MCY4440EKVPH4O-ringmaterialSiliconeelastomer(Othermaterialavailableonrequest)14FilterCartridgesTypicalLiquidFlowvs.DifferentialPressureMaterialsofConstruction300FilterMembraneHydrophilicPESAB054AB1Support/DrainagePolypropylene250Core/EndCapsPolypropylene)ra)ib32spCagePolypropylenewithTiOm200((e(whitecolored)erruusssO-ringsSiliconeelastomerseerr150PP2lSealingTechnologyThermalbondinglaaiiAB2ttnwithoutadhesivesneerr100eeffffiiAB3DOperatingParameters(1)D150MaximumDifferentialPressure5.5bar(80psi)at40°C(ForwardDirection)4.0bar(58psi)at80°CMaximumDifferentialPressure2.0bar(30psi)at40°C00(ReverseDirection)051015202530Flowrate(L/min),waterat20ºC(1)Incompatiblefluidswhichdonotsoften,swell,oradverselyaffectthefilteroritsForliquidsotherthanwater,multiplydifferentialpressurebyfluidviscosity(cP).materialsofconstructionSterilization(2)IntegrityTestValues:Autoclave30x60minutesat125°C,Valuesfor254mm(10inch)filterat20°CslowexhaustMax.allowableForwardFlowWaterwet17mL/minInSituSteam30x60minutesat125°C(airtestgas)at2760mbar(40psi)5x60minutesat142°CContactPallformulti-elementintegritytestvaluesandrecommendedtestprocedures(2)•WaterwetSuporEKVcapsulespriortosteamingtoretainfullwaterwettabilityforintegritytestingTypicalExtractablesinWaterat20°C(3)NominalEffectiveFilterArea(EFA)(4)<25mgafter4hoursextraction(per254mmmodule)0.6m2per254mmmodule(6.5ft2per10in.module)0.26m2per125mmmodule(2.8ft2per5in.module)(3)Testedonelementswithoutpre-flushing(4)5in.filtersarestandardpleated.OrderingInformationPallPartNumber:ABEKVPH4CodeNominalLengthCodeAdapterStyleO-ringmaterial05125mm(5in.)7Pallcode7doubleO-ringSiliconeelastomerbayonetlockandfin(Othermaterials1254mm(10in.)availableonrequest)Pallcode2double2508mm(20in.)2O-ringbayonetlock,3762mm(30in.)nofin(Code05only)15NewYork-USA+15164845400phoneVisitusonthewebatwww.pall.com/biopharmaceutical+15168019548faxbiotech@pall.come-mailPallCorporationhasofficesandplantsthroughouttheworldinlocationsincluding:Argentina,Australia,Austria,Belgium,Brazil,Canada,China,France,Germany,Portsmouth-EuropeIndia,Indonesia,Ireland,Italy,Japan,Korea,Malaysia,Mexico,NewZealand,Norway,Poland,PuertoRico,Russia,Singapore,SouthAfrica,Spain,Sweden,+44(0)2392303303phoneSwitzerland,Taiwan,Thailand,UnitedKingdom,theUnitedStatesandVenezuela.+44(0)2392302506faxDistributorsarelocatedinallmajorindustrialareasoftheworld.BioPharmUK@europe.pall.come-mailBecauseofdevelopmentsintechnologythesedataorproceduresmaybesubjecttochange.,Pall,Allegro,Kleenpak,NovasipandtheAllegrodesignaretrademarksofPallCorporation.Filtration.Separation.Solution.andtheUpScalelogoareservicemarksofPallCorporation.StaübliisatrademarkofStaübli.PartNumbersquotedaboveareprotectedbytheCopyrightofPallCorporation.®indicatesatrademarkregisteredintheUSA.©2008,PallCorporation.PELWR/MG/05.08/GN08.2279/PDF