3、过滤器完整性测试原理及在线完整性测试-密理博110428

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1、FilterInteggyrityTestandSIP过滤器完整性测试原理及在线完整性测试Content讲座目录©Whywedointegritytestforsterilefilter?Whywedointegritytestforsterilefilter?©为什么要对除菌滤器进行完整性测试？©MethodforIT?完整性测试的方法有哪些？©Whyypbubblepointcouldrepplacebacterialretentiontest?©为什么可以用起泡点的方法代替细菌挑战试验？©WhenshouldwedoIT?WhenshouldwedoI

2、T?©什么时候进行完整性检测？©Bubblepointtheory.起泡点测试原理是什么？©Diffusiontesttheory.扩散流测试原理是什么？©Automaticintegritytester自动完整性测试仪Whatisfilterintegrity?什么是滤膜完整性?Integralmembrane完整滤膜Non-integralmembrane非完整滤膜Contaminant比膜孔大的污染物Contaminant比膜孔大的污染物NocontaminantindownstreamNocontaminantindownstream下游没有污染物C

3、ontaminantindownstream下游污染WhyIntegrityTest?为什么做完整性测试?CommonSense通常理解¢Filtrationisoftenthemostcriticalstepinanoperation¢过滤通常是操作的关键步骤¢Confirmationofmanufacturersspecifications¢确认制造规格¢Detectingleaksduetoo-rings,gaskets,seals¢检测O形环,垫圈,密封垫的泄漏¢Assuringthecorrectporesizefilter¢确认正确的过滤孔经¢A

4、ssuringintegritybeforesterilization¢确认灭菌前完整性¢Assuringintegrityaftersteamingorautoclaving¢确认蒸汽和消毒锅灭菌后完整性BusinessPractice商业惯例¢GovernmentGuidelines&Regulations法规要求¢Partofcorporatestandardoperatingprocedure公司标准操作规程¢Auditingrequirement审计需要Regulationsaboutintegritytest法规中对完整性测试的规定FDAGuid

5、eline指南(2003)°Whateverfilterorcombinationoffiltersisused,validationshouldincludemicrobiologicalchallengestosimulateworst-caseproductionconditionscaseproductionconditions…”对于由一个或多个滤器组成的过滤系统，对它的验证都应该包括在最差条件下进行的微生物挑战试验。Regulationsaboutintegritytest法规中对完整性测试的规定Revisionofannex1toECGuide

6、toGMPforsterilemedicinalproducts(1997)欧盟对于无菌药品GMP指南的附件一(1997版)°“TheintegrityoftheTheintegrityofthesterilizedfiltershouldbeverifiedbeforeuseandshouldfiltershouldbeverifiedbeforeuseandshouldbeconfirmedimmediatelyafterusebyanappropriatemethodsuchasabubblepoint,diffusivefloworpressureh

7、oldtest”°除菌过滤膜应该在使用前及使用后立即采取合适的方法确认其完整性,可以采用泡点,扩散流或压力保持的方法.FDAGuidelineonSterileDrugProductsProducedbyAsepticProcessing(2004)FDA关于无菌工艺生产的无菌药品的指南(2004版)°Integritytestingofthefilter(s)canbeperformedpriortoprocessing,andshouldberoutinelyperformedpost-use.Itisimportantthatintegritytest

8、ingbeconductedafterfiltrat