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1、无菌过滤和完整性测试对完整性测试的相关规定完整性测试微生物挑战试验气泡点测试扩散流测试水侵入法测试(WIT)UnitedStatesPharmacopoeiaXXIII(Jan.1995)USPPage1979:"Amembranefilterassemblyshouldbetestedforinitialintegritypriortouse,providedthatsuchatestdoesnotimpairthevalidityofthesystem,andshouldbetestedafterthefiltrationprocessiscompletedt
2、odemonstratethatthefilterassemblymaintaineditsintegritythroughouttheentirefiltrationprocedure.Typicalusetestsarethebubblepointtest,thediffusiveairflowtest,thepressureholdtest,andtheforwardflowtest.Thesetestsshouldbecorrelatedwithmicroorganismretention."美国药典对完整性测试的规定GuidetoGoodPharmace
3、uticalManufacturingPractice(OrangeGuide,U.K.,1983,)Page62,9.82:"Theintegrityofthefilterassemblyshouldbecheckedbyanappropriatemethod,suchasbubble-pointpressuretestorforeward-flowpressuretestimmediatelybeforeandafteruse.Abnormalfiltrationflow-ratesshouldbenotedandinvestigated.Resultsoft
4、hesefilter-integritychecksshouldberecordedinthebatchrecord."GMP对完整性测试的规定（英国）AustralianCodeofGoodManufacturingPracticeforTherapeuticGoods(1990)Page65,1617::"Beforeandaftereachuseofafiltrationsystem(includinggasfiltration)anappropriatecheckofsystemintegrityshouldbemade.Afteruse,thesyste
5、mshouldbere-examinedforincorrectassembly."GMP对完整性测试的规定（澳大利亚）HealthIndustryManufacturersAssociationWashington,D.C.(April1982)HIMADocumentNo.3,Vol.4Bakterien-Belastungs-TestBacteriaChallengeTest"Generally,afilterisconsideredtobeasterilizingfilterwhen,afterbeingchallengedwith1.0x107chall
6、engeorganismspersquarecentimeterofeffectivefilterarea(EFA),theresultingfiltrateissterile.Thisissufficienttochallengeanyoversizedporesinthefilterbecausepreferentialflowwouldbethroughoversizedpores....Pseudomonasdiminuta"(Brevundimonasdiminuta)"(AmericanTypeCultureCollection(ATTC)19146i
7、scommonlyused...."HIMA对完整性测试的规定ASTMF838-83,1993(AmericanSocietyforTestingandMaterials)StandardTestMethodforDeterminingBacterialRetentionofMembraneFiltersutilizedforLiquidFiltrationsimilartoHIMAdocumentbutmoredetailedinformationonculturepreparationtestprocedurePresentationandresultsAST
8、M对完整性
