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TR70FundamentalsofCleaningandDisinfectionProgramsforAsepticManufacturingFacilitiesTR70无菌清洁消毒原理1/119FundamentalsofCleaningandDisinfectionProgramsforAsepticManufacturingFacilities无菌生产设施的清洁消毒程序原理TechnicalReportNo.70第70号技术报告ParenteralDrugAssociation,Inc.注射剂协会本书由以下人员联合翻译章节翻译1-6章julia7-8章道路漫长黑暗9章kool51010-14章lumang15-20章llb197821-24章millyTR70FundamentalsofCleaningandDisinfectionProgramsforAsepticManufacturingFacilitiesTR70无菌清洁消毒原理2/119TableofContents目录1.0INTRODUCTION概述1.1Purpose目的1.2Scope范围2.0GLOSSARYOFTERMS术语3.0SANITIZER,DISINFECTANT,ANDSPORICIDECLAIMSANDCLASSIFICATIONS杀菌剂、消毒剂、杀孢子剂声明和分类4.0REGULATORYEXPECTATIONS法规要求4.1RegulationsandGuidance法规和指南4.2RegulatoryInspections法规检查5.0QUALIFICATIONOFNEWSUPPLIERSANDAGENTS新供应商和代理的确认5.1QualificationTesting确认测试5.2EfficacyTesting有效性测试5.2.1In-SuspensionStudies混悬研究5.2.2CarrierSurfaceStudies载体表面研究6.0IN-USEEXPIRATIONDATING使用有效期7.0CONTROLOFTHEENVIRONMENT环境控制7.1IntroductionofCleanRoomManufacturingSupplies洁净间生产供应介绍7.1.1TypesofCleanRoomDisinfectingAgents洁净间消毒剂类型7.1.2IntroductionofTanks,Vessels,Carts,andEquipmentintotheAPA罐、槽、车和设备引入APA7.1.3IntroductionofCleaningSuppliesandEquipmentintotheAPA清洁供应和设备引入APA7.1.4IntroductionofComponentsintotheAPA部件引入APA7.2EnvironmentalMonitoringDataAnalysis环境监测数据分析7.3AttainingandSelectingEnvironmentalIsolates环境隔离器获取和选择8.0IN-SITUFIELDSTUDIES现场研究8.1EnvironmentalMonitoringBeforeandAftertheStart-upofaFacilityorArea设施或区域试车前后的环境监测8.2EnvironmentalMonitoringBeforeandAfterCleaningandDisinfectionDuringRoutineOperation常规运行中清洁和消毒前后的环境监测9.0CLEANINGANDDISINFECTION清洁和消毒9.1AreaClassificationsandCleaningandDisinfectingApproaches区域分级和清洁消毒方法9.1.1CleaningandDisinfectingGradeA(ISO5)andGradeB(ISO5atRest,6/7inoperation)AreasA级和B级区（ISO5静态，ISO6/7动态）清洁和消毒9.1.2CleaningandDisinfectingGradeC(ISO7atrest/ISO8inoperation)andGradeD(ISO8atrest)AreasC级（ISO7静态/ISO8动态）和D级（ISO8静态）区清洁和消毒9.2ApplicationMethods应用方法9.3CleaningandDisinfectingMaterialsandWorkstations清洁和消毒物料和工作场所9.3.1CleaningandDisinfectingCurtains.清洁和消毒幕帘9.3.2CleaningandDisinfectingUnidirectionalAirflowHoods,Benches,andBiosafetyCabinets清洁和消毒非直流气流罩、操作台和生物安全柜9.4CleaningandDisinfectingEquipmentSurfaces清洁和消毒设备表面9.4.1Non-product-contactEquipmentSurfaces不与产品接触的设备表面TR70FundamentalsofCleaningandDisinfectionProgramsforAsepticManufacturingFacilitiesTR70无菌清洁消毒原理3/1199.4.2WorkSurfaces工作表面9.4.3NonstructuralCleanRoomandHard-to-CleanSurfaces非结构化清洁间和难清洁表面9.5CleaningandDisinfectingTools清洁和消毒工具9.6CleaningandDisinfectingWaterPointsofUse清洁和消毒用水点9.7DisinfectingDrains消毒地漏9.8ReducingCorrosionandDeteriorationofSurfaces减少表面腐蚀和变差9.9CleaningandDisinfectionofNonclassifiedAreas未分级区域清洁和消毒10.0FREQUENCYFORCLEANINGANDDISINFECTION清洁和消毒频次11.0RESISTANCEANDROTATION12.0RETURNFROMASHUTDOWN停产后复产13.0HOLDTIMESFORCLEANEDAREAS,NON-PRODUCT-CONTACTEQUIPMENT,ANDUTENSILS已清洁区域、不与产品接触的设备和工器具的保持时间14.0TRAINING培训14.1BasicMicrobiology基本微生物知识14.2ContaminationSourcesandRisks污染源和风险14.3FacilityDesignandAirflow设施设计和气流14.4Gowning更衣14.5CleanRoomBehaviorandPersonalHygiene清洁间行为和人员卫生14.6BasicEnvironmentalMonitoring基本环境监测14.7AspectsofaCleaningProgram清洁计划14.8AspectsofaDisinfectionProgram消毒计划14.9AssessmentofUnderstandingandQualification知识评估和确认15.0CONDUCTINGINVESTIGATIONSRELATEDTOCLEANINGANDDISINFECTION实施与清洁和消毒有关的调查16.0CONCLUSION结论17.0APPENDIXI:HISTORYOFDISINFECTION附录1：消毒的历史17.1DisinfectingTechnologiesofthePast过去的消毒技术17.2DisinfectingTechnologiesintheAgeofChemistry化学时代的消毒技术17.3DiscoveringMicroorganismsasaBasisofDisease发现微生物是疾病的原因17.4MicrobiologicalContaminationControlToday今天的微生物污染控制18.0APPENDIXII:REGISTRATIONOFSANITIZERS,DISINFECTANTSANDSPORICIDES附录2：杀菌剂、消毒剂和杀孢子剂的注册19.0APPENDIXIII:OVERVIEWOFTHEU.S.ENVIRONMENTALPROTECTIONAGENCY附录3：美国环境保护署概述20.0APPENDIXIV:OVERVIEWOFTHEEUBIOCIDALREGULATIONS附录4：欧洲生物杀灭产品法规概览21.0APPENDIXV:EPA-RELATEDSAFETYLABELINGINFORMATION附录5：EPA相关安全标识信息22.0APPENDIXVI:AOACPROTOCOLTESTINGFORDISINFECTANTREGISTRATION附录6：AOAC消毒剂注册测试方案23.0APPENDIXVII:ENTESTSFORDISINFECTIONEFFICACY附录7：EN消毒有效性测试24.0APPENDIXVIII:LARGE-SCALEGASSINGORFOGGINGOFCLEANROOMS附录8：洁净间大容量气雾TR70FundamentalsofCleaningandDisinfectionProgramsforAsepticManufacturingFacilitiesTR70无菌清洁消毒原理4/11925.0REFERENCES参考文献26.0SUGGESTEDREADING推荐阅读FIGURESANDTABLESINDEX图表索引Table5.2.1-1CommonlyUsedNeutralizationAgents常用中和剂Table5.2.2-1RecommendedAcceptanceCriteria推荐的可接受标准Figure7.0-1ConsiderationstoMaintainLowLevelsofContamination维护低水平污染的考虑Table9.1-1AreaClassifications:CleanroomStandards-AirborneParticulateLimits区域分级：洁净区标准—尘埃粒子限度Table9.1-2EnvironmentalMonitoringRequirements/Guidance环境监测要求/指南Table9.4.3-1ExamplesofSurfaces表面举例Figure10.0-1ExampleRisk-BasedApproachforSelectionofRoutineCleaningandDisinfectionFrequenciesforClassifiedManufacturingAreas基于风险在洁净生产区选择常规清洁消毒频次的方法举例Table21.0-1ToxicityCategories毒性分类Table21.0-2PrecautionaryStatementsbyRouteofEntry进入途径预防声明Table23.0-1SummaryofENTestCriteriaforRegistrationforEstablishedClaims已有声明注册EN测试标准汇总TR70FundamentalsofCleaningandDisinfectionProgramsforAsepticManufacturingFacilitiesTR70无菌清洁消毒原理5/1191.0Introduction概述Whilesterileproductmanufacturinghasthemoststringentapplication,theseconceptscanalsobeusedtodesignap