PDA_TR13-中英-环境监测计划原则(2014年)

Page1of40北京齐力佳2015PDATECHNICALREPORTNO.13REVISEDFUNDAMENTALSOFANENVIRONMENTALMONITORINGPROGRAM技术报告13：环境监测TableofContents目录1.0INTRODUCTION简介..............................................12.0ENVIRONMENTALCLASSIFICATIONS环境分级..................................13.0SURVEILLANCESUPPORT监视支持................................63.1CleaningandSanitization/Disinfection清洗和杀菌/消毒......................63.2SampleSiteSelection取样位置选择....................................63.3SamplingFrequency取样频率........................................73.4AlertandActionLevels报警和行动等级.................................83.5DataManagement(DataCollection,Analysis,Approach,andInterpretation)数据管理（数据收集，分析，处理方法和解释）..........................................93.5.1DataCollection数据收集..........................................93.5.2DataAnalysis数据分析...........................................93.5.3DataApproach数据处理方法.......................................103.5.4DataInterpretation数据解释.................................113.6CharacterizationofIsolates分离株识别..................................113.7Investigations/CorrectiveActions调查/纠正措施..............................113.8Documentation记录............................................124.0SYSTEMSURVEILLANCE系统监视..................................144.1Introduction简介...............................................144.1.1TerminalSterilization最终杀菌...................................144.1.2AsepticFilling无菌灌装..........................................144.1.3IsolationTechnology隔离技术......................................144.2WaterMonitoring水质监测..........................................144.3CompressedGasMonitoring压缩气体监测.............................154.4AirMonitoring空气监测..........................................154.4.1Non-ViableMonitoring非活性生物监测............................164.4.2ViableMonitoring活性生物监测......................................164.4.3SurfaceMonitoring表面监测.......................................194.5PersonnelMonitoring人员监测...................................214.5.1Description说明.............................................214.5.2Training/CertificationofPersonnelforAsepticManufacturingArea无菌生产区人员培训/证书............................................................214.5.3Retraining再培训..............................................214.6ProductorComponentBioburden产品或部件生物负荷....................214.6.1DeterminationofProductorComponentBioburden产品或部件生物负荷确认........224.6.2ParametricReleaseandBioburden参数放行和生物负荷.....................224.6.3In-ProcessTesting过程中培训........................................234.7EnvironmentalMonitoringDuringRoutineSterilityTesting常规无菌测试过程中的环境监测25Page2of40北京齐力佳20155.0VALIDATION/QUALIFICATIONOFENVIRONMENTALMONITORINGSYSTEMS环境监测系统验证/确认.........................................................255.1Environment/HVACSystems环境/HVAC系统............................255.2Utilities公用工程...............................................265.3ValidationofAsepticProcesses–MediaFills(ProcessSimulationTests)无菌工艺验证-培养基填充（工艺模拟测试）..............................................266.0CONCLUSION总结...............................................26Page3of40北京齐力佳20151.0INTRODUCTION简介Thepurposeofthisdocumentistoidentifymicrobiologicalandparticulatecontrolconceptsandprinciplesastheyrelatetothemanufactureofsterilepharmaceuticalproducts.ItexpandssubstantiallyuponthefirsteditionofTechnicalReportNo.13,FundamentalsofaMicrobiologicalEnvironmentalMonitoringProgram,publishedbyPDAin1990.Whilethispublicationcannotpossiblysupplantthewealthofinformationpublishedonthissubject,itprovidessummaryinformationandappropriatereferencesforthereadertoconsult,ifnecessary.Theobjectivewastocontemporizethefirsteditionthroughtheutilizationofcurrentdefinitions,recognitionofimprovedenvironmentalmonitoringprocedures,andequipment.本文件目的是确定微生物和微粒控制的概念和原则，因为这涉及到无菌药品的生产。文件全称为第13号技术报告第一版，微生物的环境监测计划基础，PDA于1990年出版。尽管本出版物不可能取代题目的信息价值，它提供了读者查阅必要的主要信息及相关参考。其目的是通过使用当前定义，改善后的环境监测程序和设备来与第一版同步。Thisdocumentshouldbeconsideredasguidance;itisnotintendedtoestablishanymandatoryorimpliedstandard.此文件应作为指南；而不是建立任何强制或隐含的标准。Thetaskforceconsistedofmembersrepresentingglobalcompanies,toensurethatthemethods,terminology,andpracticesreflecttheproceduresutilizedglobally.Technicalreviewswereperformedbysomeofthemoreprominentenvironmentalmonitoringscientistsintheworldtoday.工作团队由代表全球性公司的成员组成，以确保方法，术语和规程反映了全球范围内使用的程序。技术审查由一些全球重要的环境监测科学家进行。Thisdocumentservesasasourceoncleanroomenvironmentaltestmethods,andalthoughsomenon-viableparticulateandendotoxintestingdataareincluded,itsprimaryfocusismicrobiologicalcontrol.Theconceptsforsterileproductmanufacturingarethemoststringentapplication,buttheseconceptscanalsobeappliedtonon-sterileproductmanufacture.Thefocusisenvironmentalmonitoringasitrelatestofacilitycontrolandcompliance.Thisdocumentwascompiledtoaidinsettingupaprogramthatismeaningful,manageable,anddefendable.这份文件作为洁净室环境测试方法的来源，虽然包括一些非活性微粒和内毒素检测数据，其主要目的是微生物控制。无菌产品生产的概念是最严格的应用程序，但这些概念也适用于非无菌产品的生产。重点是环境监测，因为它涉及到设施的控制和遵守。编写本文件是为了协助建立一个有意义，易于管理且合理的程序。Inordertoensureaconsistentlyacceptableproductionenvironment,acomprehensiveenvironmentalcontrolprogramsh