灭菌的方法及注意事项

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1、11Sterilization灭菌AGeneralDiscussionfromCGMPPerspective从CGMP角度的综合讨论22Outline讨论纲要PARTITerminology专业用词的定义GMPRequirementsinTheManufactureofSterilePharmaceuticalProducts无菌药品生产过程中GMP的基本要求PARTIIFacilityDesign生产设施的设计HVACSystem空调系统EnvironmentalMonitoring(EM)环境的监视PharmaceuticalWater制药用水Cleanin

2、g/Sanitation清洁消毒Personnel无菌区操作人员PARTIIIMethodsofsterilization灭菌方法SterileProductionandvalidation无菌生产和验证TheTrendofSterileProduction无菌产品生产趋势3PresentationOutline概要USRegulations美国法规MoistHeatSterilization湿热灭菌DryHeat/Depyrogenation干热/去热原法SterilizationProcessValidation灭菌工艺验证OtherSterilizatio

3、nMethods其他灭菌方法4CodeFederalRegulation美国联邦法规211.84(c)(3)sterileequipment灭菌设备Sterileequipmentandasepticsamplingtechniquesshallbeusedwhennecessary必要时应使用灭菌设备和无菌取样技术。211.94(c)and(d)sterilized(c)Drugproductcontainersandclosuresshallbecleanand,whereindicatedbythenatureofthedrug,sterilizedand

4、processedtoremovepyrogenicpropertiestoassurethattheyaresuitablefortheirintendeduse.药品容器和密封系统应清洁并根据药品的性质和要求，进行灭菌，除热原过程以确保预期的用途。(d)Standardsorspecifications,methodsoftesting,and,whereindicated,methodsofcleaning,sterilizing,andprocessingtoremovepyrogenicpropertiesshallbewrittenandfollow

5、edfordrugproductcontainersandclosures.应建立并执行对药品容器和密封系统的规格或质量标准，测试方法，清洁方法，灭菌和除热原过程的相关书面程序。5CodeFederalRegulation美国联邦法规211.113(a)and(b)sterilization灭菌(a)Appropriatewrittenprocedures,designedtopreventobjectionablemicroorganismsindrugproductsnotrequiredtobesterile,shallbeestablishedandfo

6、llowed.应该建立并执行用于防止非无菌药品被致病菌污染的相关书面程序。(b)Appropriatewrittenprocedures,designedtopreventmicrobiologicalcontaminationofdrugproductspurportingtobesterile,shallbeestablishedandfollowed.Suchproceduresshallincludevalidationofanysterilizationprocess.应该建立并执行用于阻止无菌药品被致病菌污染的相关书面程序。这些程序应包括任何无菌工艺

7、的验证。6CodeFederalRegulation美国联邦法规211.167(a)testing（a）测试Foreachbatchofdrugproductpurportingtobesterileand/orpyrogen-free,thereshallbeappropriatelaboratorytestingtodetermineconformancetosuchrequirements.Thetestproceduresshallbeinwritingandshallbefollowed.对无菌和/或无热原的每批药品应进行相应的实验室测试以确定其与符合

8、要求。测试程序应有书面文