PDA TR40气体无菌过滤

January/February2005SupplementVolume58No.S-1TechnicalReportNo.40SterilizingFiltrationofGasesPDAJournalofPharmaceuticalScienceandTechnologyPDATECHNICALREPORTNO.40STERILIZINGFILTRATIONOFGASESDecember4,2004PDASterileGasFiltrationCommitteeFrankBing,AbbottLaboratories(Chair)SrikanthSundaram,Ph.D.,Schering-PloughCorporation(Co-Chair)BarryBardo,MeissnerFiltrationProducts,Inc.ThomasBritton,MilliporeCorporationRobertConway,Ph.D.,CunoInc.TeresaM.Feeser,Ph.D.,EliLilly&Co.HollyHaughney,Ph.D.,PallCorporationAnnMarieJones,FluorCorporationMaikW.Jornitz,SartoriusCorporationStephenLangille,Ph.D.,FDARichardV.Levy,Ph.D.,PAREXELConsultingRussellE.Madsen,TheWilliamsburgGroup,LLCJeroldMartin,PallCorporationLeesaMcBurnie,MeissnerFiltrationProducts,Inc.TheodoreH.Meltzer,Ph.D.,CapitolaConsultingCo.DidierMeyer,laCalhene,FranceGregoryM.Morris,Ph.D.,PfizerIncDavidRidealgh,DomnickHunterLtd.HansG.Schroeder,Ph.D.,InternationalConsultantsAssoc.PaulS.Stinavage,Ph.D.,PfizerIncA.MarkTrotter,SartoriusCorporationSterilizingFiltrationofGasesTechnicalReportNo.40SupplementVol.58,No.S-1January/February2005©2005byPDA1.INTRODUCTION/SCOPESTATEMENT......................................................................................................................72.HISTORICALBACKGROUND.......................................................................................................................................73.HOWGASFILTERSWORK...........................................................................................................................................73.2RetentionofSmallerParticles..............................................................................................................................................73.2.2InertialImpaction.................................................................................................................................................................83.2.3GravitationalSedimentation.................................................................................................................................................93.2.4ElectrostaticAttraction.........................................................................................................................................................93.3NetRetentionEfficiencyinFiltrationofDryGases.............................................................................................................93.4FactorsthatAffecttheRetentionEfficiency.......................................................................................................................104.FILTERSELECTIONANDSYSTEMDESIGNCRITERIA......................................................................................104.1RetentionCapability...........................................................................................................................................................104.2IntegrityTesting..................................................................................................................................................................114.3FiltrationRateandThroughput..........................................................................................................................................114.4MaterialsofConstruction...................................................................................................................................................114.4.1Hydrophobicity...................................................................................................................................................................114.4.2Durability...........................................................................................................................................................................124.4.3Toxicity...............................................................................................................................................................................124.4.4ParticleShedding................................................................................................................................................................124.4.5Gas/FilterCompatibility.....................................................................................................................................................124.5WaterBlockage..................................................................................................................................................................134.6DesignConsiderationsforCondensationControl..............................................................................................................135.EXAMPLESOFSPECIFICAPPLICATIONS.............................................................................................................145.1ProductContactGases..................................................................................................................................................