ISO-22519：2019《纯化水和注射用水预处理和生产系》(中英文对照)

ISO22519：2019PurifiedwaterandwaterforinjectionpretreatmentandproductionsystemsISO22519：2019纯化水和注射用水预处理和生产系统1Scope范围2Normativereferences引用标准3Terms,definitionsandabbreviatedterms术语、定义和缩写术语4Designandpractices设计和规范4.1Settingsystemboundaries确定系统边界4.1.1APW/WFIPretreatmentandProductionsystemstartsatthevalve(inclusive)beforethefirstsuppliedwaterfiltercomponent/MMF.PW/WFI预处理和生产系统的系统边界开始于第一个供水过滤器组件/多介质过滤器之前的阀门(包括阀门)。4.1.2APW/WFIPretreatmentandProductionsystemendboundaryisattheinletvalve(inclusive)ofthePWjWFIstoragetankoratthePOUifatankisnotinstalled.PW/WFI预处理和生产系统的系统边界末端位于PW/WFI储罐的进水阀(包括)处，如未安装储罐，则位于使用端。4.1.3ThePW/WFIstoragetankshouldnotbeincludedinthePW/WFIPretreannentandProduction.PW/WFI储罐不应包含在PW/WFI预处理和生产系统中。4.1.4IndustrialtreatmentsystemsupstreamtothePW/WFIPretreatmentandProduction.Includingsupplytootherplantutilitiese.g.steamboilers,potablewaterusage,feedtocoolingtowersetc.shouldnotbeincludedinthePW/WFIPretreatmentandProduction.PW/WFI预处理和生产上游的工业处理系统。包括向工厂其他公用设施的供应，如蒸汽锅炉、饮用水使用、冷却塔进水等，不应包括在PW/WFI预处理和生产系统中。4.2Generalsystemrequirements系统一般要求4.2.1AbuildcleanconceptshallbeemployedduringtheinstallationofPW/WFIPretreatmentandProductionsystems:supplyofpiping/tubingandequipmentincleanconditionandinstallationmethodsthatpreventingressofcontaminants.在安装PW/WFI预处理和生产系统时，应采用洁净施工概念：提供洁净条件下的管道和设备，以及防止污染物进入的安装方法。4.2.2IncomingfeedwatershallmeetlocalstandardsorWHOstandardsforpotablewater.Ifthisisnotthecase,additionalsystemsshallbeinstalledtoimprovethewaterfeedparametersbeforethePW/WFIPretreatmentandProduction.原水应符合当地标准或世卫组织饮用水标准。否则，则应安装额外的系统，以改善PW/WFI预处理和生产系统前端的进水参数。4.2.3ThePW/WFIPretreatmentandProductionwaterqualityshallshowimprovementinallqualityparametersasthewateradvancesthroughthesystem.越往PW/WFI预处理和生产系统的后续阶段，水的所有质量参数应越好。4.2.4Thefollowingparametersshallbesteadilyreducedateachstageinthesystem:在系统每个阶段，应稳步减少以下参数:microbialtotalcount;微生物总数conductivityand;电导率TOCTOC4.2.5PW/WFIqualityshallbeaccordingtothelastrevisionofthelocal/national/relevantPharmacopoeia.Table1providesrecommendedwaterquality.PW/WFI质量应根据当地/国家/相关药典的最新修订版本进行。表1提供了建议的水质。Table1-Recommendedwaterquality表1——建议的水质＃Parameter参数ROfeedRO进水AfterRORO出水PW纯化水WFI注射用水1Hardness(PPMCaCO3)硬度（PPMCaCO3）≤feedwater≤原水1112TOC(ppb)≤feedwater≤原水500500(online)＜500（在线）500(online)＜500（在线）3Endotoxin(EU/ml)细菌内毒素（EU/ml）NANANA0.254Microbialtotalcount(cfu/ml)微生物总数（cfu/ml）50020010010cfu/100ml5FreeChlorine(ppm)余氯（ppm）0.050.050.050.056Pseuldomonas(cfu/100ml)假单胞菌(cfu/100ml)11117E.coli(cfu/100ml)大肠埃希菌(cfu/100ml)11118Totalcoliforms,Fungus,(cfu/100ml)总大肠菌群，真菌(cfu/100ml)11119Conductivity(μS/cm)电导率(μS/cm)Likefeedwater与原水相同101.3(online)＜1.3（在线）1,3(online)＜1.3（在线）Conductivityshallbemeasureduncompensatedat25°CaccordingtoUSP.电导率应根据USP进行无补偿的测量。4.2.6Asamplingprogrammewithacceptancecriteriashallbeinplacetogather;analyseanddocumentthiswaterqualityimprovement.应制定取样方案并有接受标准；分析和记录水质的改善。4.2.7Duringproduction,thePW/WFIPretreatmentandProductionshallcontrolthemaximumwatertemperatureinthesystem.Duringproduction,themaximumtemperatureofthewarmestpointinthesystemshallbenomorethan25°C(guidancevalue).在生产过程中，PW/WFI预处理和生产系统应控制系统中的最高水温。在生产过程中，系统中最暖点的最高温度不应超过25℃(指导值)。4.2.8AllpartsofthePW/WFIPretreatmentandProductionshallbehotwatersanitized,fromthefeedwaterinletvalvetothePW/WFIfillvalve.Duringsanitization,thePW/WFIPretreatmentandProductionshallcontrolthewatertemperatureinthesystem.Duringsanitization,theallthepointsofthesystemshouldbeataminimumof80°C(guidancevalue).PW/WFI预处理和生产系统从进水阀到PW/WFI出水阀的所有部件都应经过热水消毒。在消毒过程中，PW/WFI预处理和生产系统应控制系统中的水温。在消毒期间，系统的所有点应≥80℃(指导值)。4.2.9ThePW/WFIPretreatmentandProductionsystemshallbedesigned,controlled,regulated,operatedandmaintainedtoensurethatthefinalwaterqualityreliablymeetsfinalwaterqualitystandardsetin4.2.5.Thisperformanceshallbestableunderallconditionsincludingcommonworstcasescenarios,changingseasonsorotherfluctuatingenvironmentalconditions.PW/WFI预处理和生产系统应进行设计、控制、规范、操作和维护,以确保最终水质可靠地满足4.2.5中设定的最终水质标准。此性能在所有情况下应保持稳定,包括常见的最坏情况、季节变化或其他环境条件波动。4.3UserRequirementsSpecifications(URS)scope用户需求规范(URS)的范围ThescopeoftheUserRequirementsSpecificationsshallincludethefollowing：用户需求规范的范围包括以下内容：selectionofwatercompendialstandardbasedonproductssupplied;根据所供应的产品选择水标准;specificationofthefinalwaterstandardparameters;最终水标准参数的规范;safetyandGoodManufacturingPracticerequirementsforthesystem;系统的安全和GMP要求;listofmaincomponents;主要组件列表;preliminarysizingofproductionflowrate;生产流速的初步估算;numberofproductionunits;生产单元的数量;functionalrequirements;功能需求materialsofconstruction;材质要求equipmentsurfacefinish;设备表面抛光biologicalcontrolconcept;生物控制要求highlevelcontrol:interlocks.alarmsandwarnings;高级控制：互锁、警报和报警;documentationrequired(seeClause14);所需的文件(见第14条);validationasrequiredbyrespectiveauthoritiesand;根据有关机构的要求进行验证;PerformanceQualification(PQ)monitoringparameters.性能确认(PQ)监控参数。ThescopeoftheUserRequirementsSpecificationsshallincludeanalysisofincomingwateroverallyearlyseasons,bothchemicalandmicrobiological.用户需求规范的范围应包括全年不同季节的原水分析，包括化学和微生物。4.4Detailedsystemcapacitycalculation详细的系统能力计算4.4.1Dataand/orestim