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1、完整性测试原理toconfirmtheintegrityofthefilterpriorto(outofbox,afterSIP/autoclaving)andafteruse(releaserequirement)todetectsystemleaks(housings,tubes,o-rings,etc.)asaSOPandauditingrequirementasaregulatoryrequirementIntegritytestingoffilterisnecessary...在使用前（开包装、在线蒸汽灭菌/
2、高压灭菌）和使用后（产品放行要求）验证过滤器的完整性。监测系统泄漏（钢壳、管道、O形圈等）SOP和审计要求相关法规的要求过滤器的完整性测试是必要的“Normally,integritytestingofthefilterisperformedafterthefilterunitisassembledandsterilizedpriortouse.Moreimportantly,however,suchtestingshouldbeconductedafterthefilterisusedinordertodetecta
3、nyfilterleaksorperforationsthatmayhaveoccurredduringthefiltration.Forwardflow,bubblepointandpressureholdtestsareacceptableintegritytests.“FDAGuidelineonsteriledrugproductsproducedbyasepticprocessing,1987RegulationsforIntegrityTesting法规要求（1）FDA无菌工艺生产无菌药品指南，1987通常
4、完整性测试是在过滤器安装和灭菌之后、正式使用前进行的。另外，使用后进行完整性测试在发现过滤过程中的意外泄漏或穿透现象显得尤为重要。可接受的完整性测试方法如扩散流、气泡点测试、稳压测试。完整性测试的相关法规ECGMP(Annex1,Filtrationofmedicinalproductswhichcannotbesterilisedintheirfinalcontainer,(June2001))85.„Theintegrityofthesterilisedfiltershouldbeverifiedbeforeuse
5、andshouldbeconfirmedimmediatelyafterusebyanappropriatemethodsuchasabubblepoint,diffusivefloworpressureholdtest...Theintegrityofcriticalgasandairventfiltersshouldbeconfirmedafteruse.Theintegrityofotherfiltersshouldbeconfirmedatappropriateintervals.“Regulationsfor
6、IntegrityTestingCriticalgasandairventfilters:e.g.lyophilization,BFS,asepticfilling,long-termapplication(WFI)完整性测试的相关法规法规要求（2）ECGMP（附录1，不能在终端容器中灭菌的药品过滤，1995）除菌过滤器在使用前和使用后及时用适当的方法进行完整性测试，方法如：气泡点、扩散流、稳压测试……关键的气体或空气过滤器在使用后应该进行完整性验证。其他过滤器也应定时作完整性测试。关键的气体或空气过滤器如：冷冻干燥、
7、BFS、无菌灌装、长期应用的液体（WFI）。UnitedStatesPharmacopoeia24(USP24)<1211>SterilizationandSterilityAssurance"Amembranefilterassemblyshouldbetestedforinitialintegritypriortouse,providedthatsuchatestdoesnotimpairthevalidityofthesystem,andshouldbetestedafterthefiltrationproces
8、siscompletedtodemonstratethatthefilterassemblymaintaineditsintegritythroughouttheentirefiltrationprocedure.Typicalusetestsarethebubblepointtest,thediffusiveairflowtes
