7 - Risk Assessment of Filters in Aseptic Processes

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1、RiskAssessmentofFiltersinAsepticProcessesModule8CopyrightMerckMillipore2011.1RegulatoryAspects法规事务AsepticProcessingRisks无菌工艺风险FilterCategories过滤器种类SomeRiskAssessmentTools风险评估工具Examplesof2TypicalSchematics典型图表案例Definitions定义SterilizingfilterreuseinasepticprocessingReference

2、s参考CopyrightMerckMillipore2011.2AsepticProcessing-Risk-BasedApproach无菌工艺-基于风险的方法AsepticProcessingrequires“Astrictdesignregime,notonlyontheprocessarea,butontheinteractionswithsurroundingareasandthemovementofpeople,materialsandequipmentsoasnottocompromisetheasepticconditions

3、.”无菌工艺要求“严格的设计制度，不仅限于工艺本身，还包括与周围环境和人员活动，材料和设备，以免破坏无菌的环境”–[ISPESterileManufacturingFacilitiesGuide,Volume3,January1999]ISPE无菌生产设备指南“Eachprocesscouldintroduceanerrorthatultimatelycouldleadtothedistributionofacontaminatedproduct.Anymanualormechanicalmanipulationofthesterilize

4、ddrug,components,containers,orclosurespriortoorduringasepticassemblyposestheriskofcontaminationandthusnecessitatescarefulcontrol.”“每个过程都有可能生成导致产品污染的差错。任何无菌药品、容器的手动或机械操作，或无菌安装前或安装时可能产生的任何染污风险必须严格控制”–TechnicalFramework:FDAGuidanceforIndustrySterileDrugProductsProducedbyAsept

5、icProcessing—CurrentGoodManufacturingPractice2004FDA指南关于无菌工艺工业化生产无菌药品CopyrightMerckMillipore2011.3Highestrisk–theSterileCore最高风险-无菌核心中的过滤器AsepticFacilityProcessingProcess工艺Personnel&Room*Line*•personnelflow人员流动人员设备&房间无菌生产线•materialflow材料流动•layout设计布局Daily“SterilityMediaFil

6、lsAssurance”HVAC/培养基灌装日常无菌保障Utilities*公用工程QA/QCDisinfectionDeviations&质量保障/PracticesEnvironmental质量控制消毒业务ControlTrends偏差&环境控制趋势*Includesbothdesignandmaintenance包括设计和维修CopyrightMerckMillipore2011.4RememberthePurposeofSterileFiltration铭记无菌过滤目的Sterilization除菌Removalofbacteri

7、afromprocessfluids去除料液中的细菌–Preventcontaminationofthefermentation预止发酵过程染菌–Cellculturemediaandair细胞培养基和空气Removalofbioburdeninpurificationprocesssteps在纯化工艺步骤中降低生物负荷–Lowbioburdenmeanslowendotoxin低生物负荷代表低内毒素–LowbioburdenmeanslowlevelorganicandproteincontaminationSterilization

8、ofinjectabledrugs注射剂药品除菌–Protectthepatientfrominfection防止病人感染SterileFiltrationisanexample