环境监测风险分析（翻译初稿）

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1、EnvironmentalMonitoringRiskAssessment环境监测风险评估Wednesday,August30,2006-JournalofGXPCompliance,January2006,Volume10,Number2星期三，8月30日，2006-JournalofGXPCompliance，2006年1月，10卷，2号INTRODUCTION引言EnvironmentalMonitoringdescribesthemicrobiologicaltestingundertakeninordertodetectchangingtrendsofmicrobia

2、lcountsandmicro-floragrowthwithincleanroomorcontrolledenvironments.Theresultsobtainedprovideinformationaboutthephysicalconstructionoftheroom,theperformanceoftheHeating,Ventilation,andAir-Conditioning(HVAC)system,personnelcleanliness,gowningpractices,theequipment,andcleaningoperations.环境监测描述了

3、在洁净室或受控环境下，为了监测微生物数量和微生物群落繁殖的变化趋势而进行的微生物测试。所测结果提供关于房间结构，空调系统性能，人员卫生，更衣行为，设备和清洁操作的信息。Overthepastdecade,environmentalmonitoringhasbecomemoresophisticatedinmovingfromrandomsampling,usinganimaginarygridovertheroomandtestingineachgrid,tothecurrentfocusonriskassessmentandtheuseofriskassessmenttool

4、stodeterminethemostappropriatemethodsforenvironmentalmonitoring.在过去十年里，环境监测愈发复杂，从任意取样，按照假想的房间网格进行测试，到现阶段注重风险评估并使用风险评估工具确定环境监测的最佳方法。Thispaperexplorescurrenttrendsintheapplicationofriskassessmenttothepracticeofenvironmentalmonitoringbyexaminingthefollowingkeyareas:本文从以下几个重要方面探讨了将风险分析应用于环境监测的现有

5、趋势：·DeterminingtheFrequencyofMonitoring:Usingtheconcept（理念、观念）ofriskassessmenttodecidehowoftentomonitordifferenttypesofcleanrooms·确定监测频率：按照风险分析理念，确定不同类型洁净室的监测周期。·RiskAssessmentTools（工具）:Applyingriskassessmenttoolstoestablishmethodsforenvironmentalmonitoring。·风险评估工具：运用风险分析工具确定环境监测方法。36/36·Num

6、erical（数字的、数值的）Approaches:Consideringanumericalapproachtoassessriskdatausingacasestudyofanaseptic（无菌的）fillingoperation·数值法：使用无菌灌装操作案例分析考虑采用数值法评估风险数据Theexamplesusedarefromasteriledrugmanufacturingfacilityandfocusmostlyonasepticfilling;however,theconceptsandtoolsareapplicabletotheenvironmental

7、monitoringofothertypesofmanufacturingandpackagingoperations.使用案例来自无菌药品生产设备，大多为无菌灌装；然而，理念和工具也同样适用于其他类型生产和包装操作的环境监控。DETERMININGTHEFREQUENCYOFMONITORING:确定监测频率Indevelopinganadequate（适当的、胜任的）environmentalmonitoringprogramme,thereshouldbeabalancebetween