ISO225192019纯化水和注射用水预处理和生产系中英文对照

ISO22519:2019Purifiedwaterandwaterforinjection

pretreatmentandproductionsystemsISO22519:2019纯化水和注射用水预处理和生产系统Scope范围Normativereferences引用标准Terms,definitionsandabbreviatedterms术语、定义和缩写术语Designandpractices设计和规范Settingsystemboundaries确定系统边界APW/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)。APW/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。ThePW/WFIstoragetankshouldnotbeincludedinthePW/WFIPretreannentandProduction.PW/WFI储罐不应包含在PW/WFI预处理和生产系统中。"Industrial"treatmentsystemsupstreamtothePW/WFIPretreatmentandProduction.Includingsupplytoother plantutilities e.g.steamboilers,potablewaterusage,feedto coolingtowersetc.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。Generalsystemrequirements系统一般要求A"buildclean"conceptshallbeemployedduringtheinstallationofPW/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。Incomingfeed watershall meet localstandardsorWHOstandardsforpotablewater.Ifthisisnotthecase, additionalsystemsshallbeinstalled toimprovethewaterfeedparametersbeforethePW/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。ThePW/WFI Pretreatment andProductionwaterqualityshallshowimprovementinallqualityparametersasthewateradvancesthroughthesystem.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。Thefollowingparametersshallbesteadilyreducedateachstageinthesystem: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TOCTOCPW/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)<feedwaterw原水<1<1<12TOC(ppb)<feedwater<原水<500<500(online)<500(在线)<500(online)<500(在线)3Endotoxin(EU/ml)细菌内毒素(EU/ml)NANANA<0.254Microbialtotalcount(cfu/ml)微生物总数(cfu/ml)<500<200<100<10cfu/100ml5FreeChlorine(ppm)余氯(ppm)<0.05<0.05<0.05<0.056Pseuldomonas(cfu/100ml)假单胞菌(cfu/100ml)<1<1<1<17E.coli(cfu/100ml)大肠埃希菌(cfu/100ml)<1<1<1<18Totalcoliforms,Fungus,(cfu/100ml)总大肠菌群，真菌(cfu/100ml)<1<1<1<19Conductivity(pS/cm)电导率(pS/cm)Likefeedwater与原水相同<10<1.3(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。Asamplingprogrammewithacceptancecriteriashallbeinplacet。gather;analyseanddocumentthiswaterqualityimprovement.应制定取样方案并有接受标准；分析和记录水质的改善。Duringproduction,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)。AllpartsofthePW/WFIPretreatment andProductionshallbehotwatersanitized,fromthefeedwaterinletvalvetothePWWFIfillvalve.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)。ThePW/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。UserRequirementsSpecifications(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Dataand/orestimatesofcurrentandfuturePW/WFIuseshallbeusedtosizetheflowrateofthePW/WFIPretreatmentandProductionSystem.当前和未来PW/WFI使用的数据和/或估算应用于调整PW/WFI预处理和生产系统的流速。Theflowrateshallheanalysedinconjunctionwiththeworst-caseconsumptionscenario.TakingintoaccountPW/WFIstoragetanksize.应结合最差条件下的用水情况分析流速。考虑 PW/WFI储罐大小。Afulltabulationofallusers,presentandfuture,shallbecompiled,listingthequantityofPW/WFIrequired,perday,perhouroveraweekperiod.Thedrawoffflowshallbecalculated,fromtheStorageandDistribution(S&D),perhourofthedayandplotthestoragetanklevelsforafullweek.InsomecaseslistingofrequiredPW/WFIandtakeoffflowcalculationsforaperiodthatexceedsoneweekmaybenecessary.Insuchcasestheevaluationperiodshallbeextendedaccordingly.应编制目前和将来所有用户的完整表格，列出一周内每天每小时所需的 PW/WFI量。应计算储存和分配系统(S&D)每天每小时的排水量，并绘制整个星期的储罐水平。在某些情况下，可能需要列出超过一周的PW/WFI和排水量。在这种情况下，评价周期应相应延长。Oncethisinformation hasbeensummarized, thesizingforthePW/WFIPretreatmentandProductionandPW/WFIstoragetankmaybedetermined.汇总此信息后，可以确定PW/WFI预处理和生产系统以及PW/WFI储罐的尺寸。5Selectingmaterials,methodsandsystemcomponents选择材料、方法和系统组件Recommendedsystemcomponents/treatmentstages推荐的系统组件/处理阶段Pretreatment,ultrafiltrationandmicrofiltration-membranebased processforremovalofsuspendedsolids,bacteriaandTOCupstreamofRO.预处理、超滤和微滤膜工艺，可用于去除 RO上游的悬浮固体、细菌和TOC。NOTEPretreatmentUFisusuallyoperatedwitharejectstreamandcleanedwithabackwash.MMF-removalofcoarseparticulatespreROintherangeof30micron-50microncleanedbybackflushofwatertodrain.多介质过滤器——在RO之前去除30微米-50微米范围内的粗颗粒，通过回水冲洗排出。FlushedScreen/DiscFilters(FS/DF)-removalof coarseparticulatesupstreamofROintherangeof30micron-50micron.冲洗滤网/圆盘过滤器(FS/DF)——去除RO上游30微米-50微米范围内的粗颗粒。Chlorination-dosageand/orgenerationofhypochloriteand/orchlorinetogeneratefreechlorinelevelsinsystemwitharangeof0,2ppm-0,5ppm(withsuitablecontacttime)forcontrolofincomingandsystembacterialevels.氯化——投入或产生次氯和/或氯以使系统余氯水平在0.2ppm-0.5ppm的范围内(具有适当接触时间)，以控制系统本身和引入的细菌水平。Chlorine dioxide(CD)-generationand dosage ofchlorinedioxidetoarangeof0,1ppm-0.4ppm(withsuitablecontacttime)forcontrolofincomingandsystembacterialevels.二氧化氯(CD)——产生和投入二氧化氯以达到0.1ppm-0.4ppm(具有合适的接触时间)，以控制系统本身和引入的细菌水平。Softeners-forreplacementofmagnesium-calcium,bariumandstrontiumwithsodiumtoreducescaleprecipitationontheROmembraneswitharecommendeddownstream10micron-20micronresintrap.软化剂——用于用钠替代镁-钙、钛和钚,以减少RO膜上的结垢沉淀，RO膜下游推荐10微米-20微米树脂疏水阀。Antiscalant(AS)- additionofchemicalstoROfeedwater todeferhardnessprecipitationontheROmembranes.抗垢剂(AS)——在RO进水中添加化学品，以减少RO膜上的硬沉淀。Electricscalecontrol(ESC)-resinfreeelectrolyticprecipitationofscaletostophardnessprecipitationontheROmembranes.Alsousedforheavymetaloxidationand removal.Nonsacrificialanodeandcathode.电子除垢仪(ESC)——树脂无电解沉淀的刻度，以阻止RO膜上的硬沉淀。也用于重金属的氧化和去除。非牺牲阳极和阴极。Activecarbonfilter(ACF)/GranularActiveCarbon(GAC)-removalofoxidizers,chlorine/chloramine,TOC,upstreamofROmembranes.活性碳过滤器(ACF)/颗粒活性炭(GAC)-去除RO膜上游的氧化剂、氯/氯胺、TOC。SodiumBiSulfite(SBS)-(orothersulfitebased)chemicaladditionpreROforreductionofoxidizers,chlorine/chloramine.硫磷钠(SBS)-(或其他基于亚硫酸盐)在RO前添加的化学剂，用于减少氧化剂、氯/氯胺。SodiumHydroxide(NaOH)-additionofchemicalforpHcontrolupstreamofROmembranestocontrolCO2inROpermeate.氢氧化钠(NaOH)-添加用于控制RO膜上游PH的化学剂，以控制RO渗透中的CO2。DegassingCO2contactmembrane(degasser)-watercontactmembraneforreductionofCO2gasinwaterupstreamofROandCDI/EDI/CEDI.Fabricatedegasserhousingfrom SS316Landthemembranewillresisthotwatersanitizationsothedegasserwillbeabletoundergohotwatersanitization.Clean,dry,oilfreecompressedairwillsweepthroughafilterandintothemembranehousingforC02removal.Optionallyifappropriatecompressedairisnotavailable,aircanbedrawnthroughthehousingbyavacuumpump.Theoutsideairshallbefilteredbeforebeingdrawnthroughthehousing.脱气CO2接触膜(脱气膜)-水接触膜，用于减少RO和CDI/EDI/CEDI上游水中的CO2气体。由SS316L制造的脱气器外壳和膜可耐受热水消毒，因此脱气器能够进行热水消毒。洁净、干燥、无油的压缩空气会通过过滤器进入膜壳体以去除 CO2。在没有适当的压缩空气时，可以通过真空泵吸入空气。通过壳体吸入之前，外部空气应进行过滤。UltraViolet(UY)Lamp-irradiationofthewaterfordechlorinationofchlorine/chloramine,upstreamofROmembranes.AUVlampmayalsobeusedformicrobialloadreduction.Thefeedwaterisde-chlorinatedbyexposuretoultravioletirradiationbydegradingthefreechlorineintoanOxygenmolecule(O2)andaChlorideion.Theunitsizingshouldreduceaminimumof0.5ppmfreechlorinetosafelevelsof<0,02ppm.TheunitcanincludeaUV-MPL(mediumpressurelamp)-withwideemissionspectrum.TheunithousingmaybefabricatedfromSS316andtheinternalpartsfromSS316orhigh*gradeQuartz."DesigntheUVforhotwatersanitization.紫外线(UY)灯-RO膜上游水的辐照进行氯/氯胺脱氯。紫外线灯也可用于降低微生物负荷。紫外线灯通过将游离氯降解成氧分子(O2)和氯气，使原水脱氯。装置能力应至少将0.5ppm的游离氯降至安全水平土0.02ppm。该装置可包括一个具有宽发射光谱的UV-MPL(中压灯)。装置外壳可能由SS316制造，内部部件可能由SS316或高等级石英。紫外线等应可以进行热水消毒。SinglePassReverseOsmosis(SPRO)-membranebasedprocessforreductionof:ions,TOC,bacteriaandendotoxin.Alwaysoperatedwitharejectstream.单通反渗透(SPRO)-基于膜的工艺以去除离子、TOC、细菌和内毒素。始终使用拒绝流运行。DoublePassReverseOsmosis(DPRO)-membranebasedprocessforreductionof:ions,TOC,bacteriaandendotoxin.Thefirstpasspermeateisthefeedtothesecondpass.Alwaysoperatedwitharejectstream.双通反渗透(DPRO)——基于膜的工艺以去除离子、TOC、细菌和内毒素。第一个渗透串联到第二个。始终使用拒绝流运行。ContinuousElectroDe-Ionization(CDI/EDI/CEDI)-forreductionofwaterionlevelsdownstreamofROusingelectricallyregeneratedresin.连续电除盐(CDI/EDI/CEDI)-使用电再生树脂降低RO下游的水电水平。PolishingUltrafiltration-isamembranebasedprocessusingmolecularweightcutoff6000orsmallerforreductionofendotoxin,TOCandbacteriaorpostCDI/EDI/CEDI.精制超过滤-基于膜的工艺，使用分子量小于 6000或更少，以减少内毒素，TOC和细菌或用于CDI/EDI/CEDI之后.Advantagesanddisadvantagesofsystemcomponents/treatmentstages系统组件/处理阶段的优缺点Materialsofconstruction-General构造材料——一般要求AllcomponentsinthePW/WFIPretreatmentandProductionsystem shallbemanufacturedfromStainlessSteel(55)316/316L.AllPW/WFIcontactpartstobefabricated fromSS316L.including:piping/tubing,tanks,pumps,heatexchangers,valves,instrumentsandotheraccessories.PW/WFI预处理和生产系统中的所有部件均应由不锈钢(SS)316/316L制造。所有PW/WFI接触部件均由SS316L制造，包括：管道/管道、储罐、泵、热交换器、阀门、仪器和其他附件。Additionalmaterialsthatshallbeusedareasfollowing:应使用的其他材料如下：EPDM:三元乙丙橡胶PTFE-Polytetrafluoroethylene(PTFE);聚四氟乙烯fluoroelastomers(FKMPEEK);含氟弹性体(FKMPEEK)PFA;PFA塑料highgrade(lowimpurity)fusedquartzand;高级(低杂质)熔融石英othernon-corroding.hotwatersanitization(HW5)resistant.non-particlesheddingandnonleachingmaterials.其他非腐蚀、耐热水消毒(HW5)、非颗粒脱落和非脱脂材料。Formaterialsofconstruction,exposuretohotwatersanitizationat80℃-90℃shallbetakenintoaccount.对于构筑材料，应考虑能在80°C-90°C下暴露于热水消毒。Elastomersandplasticsshallbecompatiblewithnationalregulations.弹性体和塑料应符合国家规定。Stainlesssteel(55)piping-General不锈钢管道——一般要求SSpiping/tubingincontactwithfreechlorineand/orlowconductivitywatershallbeSS316/316L与无余氯和/或低电导率的水接触的SS管道应为SS316/316LSStubingshallhavedimensionsaspernationalstandards.SS管的尺寸应达到国家标准。Tubingmaybeseamlessorweldedwithseam.管道可以是一体的，也可以用接缝焊接。MaterialusedforpipingandfittingsshallmeetthepressurerequirementsforthesystemandspecificallyforthehighpressureROfeedandconcentrate.用于管道和配件的材料应满足系统的压力要求，特别是高压 RO进水和浓水。WeldingshallbeperformedwithTIG/GTAW99,97%orbetter,argonshieldgasshallbeused.焊接应使用TIG/GTAW99.97%或更高的氩气保护。Thedimensionsofthephysicalairbreakshallbeatleast50mmfromthebottomofpiping/tubingtothehighestpointonthedrain.Piping/tubingshallhaveidentificationlabelswithin lineof sightofaccessareas.Thecontentofthepipinganddirectionofnowshallbeclearlyindicated.从管道底部到排水口最高点的物理空气隔断的距离应至少为 50mm。管道应在进出口的显眼范围内有识别标签。管道的内容物和方向应明确标明。Gasketsshallbeoneofthefollowing:垫片应为以下之一：EPDMencapsulatedwithPTFEgaskets;使用EPDM（三元乙丙橡胶）覆盖的PTFE（聚四氟乙烯）垫片；fullEPDM;整体为EPDM（三元乙丙橡胶）fullPTFE-Polytetrafluoroethylene（PTFE）;整体为PTFE（聚四氟乙烯）silicon;硅胶fluoroelastomersand;含氟弹性体combinationsofinert,HotWaterSanitization（HWS）resistant,non-particlesheddingandnonleachingelastomers.惰性、耐热水消毒（HWS）、非颗粒脱落和非脱脂的弹性体组合。Deadlegs:死角DeadLegsshallbemeasuredbythetermL/D,whereListhelegextensionfromtheinsidediameterwallnormaltotheflowpatternordirectionandDistheinsidediameteroftheextensionorlegofatubingfittingorthenominaldimensionofavalveorinstrumentand;死角使用L/D测量，其中L是从管道内壁垂直于流动方向死角长度， D是死角内径或者阀门或仪器的公称尺寸；Deadlegsshouldbeavoidedwhereeverpossible.otherwiseL/Dratioshouldbe3:1orless应尽可能避免死角。如不可避免，L/D应为3:1或更少。Non-finalproductwaterpiping/tubinginthePW/WFIpretreatmentandproductionPW/WFI预处理和生产系统中的非最终水管道Onlybuttweldingforpiping/tubingweldingshallbeused.管道焊接只可使用对焊。Butt-weldingmaybemanualorbyorbitalweIdingmachine.Inspectionwithborescopeandpassivationisnotrequired.对焊可以是手动的，也可以是轨道焊接机焊接。无需使用内窥镜进行检测和钝化。Piping/tubingstandardsshallbe3A/foodgradewithflangeorTriClamp(TC)connections.管道标准应为3A/食品级，带法兰或卡箍(TC)连接。Piping/tubinginternalfinishmaybepolishedorstandardmillsurfacefinish.管道内部表面处理可抛光或标准轧机表面抛光Valvesinstalledmaybeofthefollowingtypes:ball,angle,diaphragm,needleandbutterfly.安装的阀门可为：球阀、角阀、隔膜阀、针阀和蝶阀。Threadedconnectionsshallnotbeused.不得使用螺纹连接。Piping/tubingincontactwithPW/WFIproduct与最终PW/WFI接触的管道MinimumacceptableIDpolishshallbeRa<0,6micron.最低可接受ID抛光应为Ra<0.6微米。Butt-weldingshallbebyorbitalweldingmachinewhereeverpossible,aminimumof70%ofautomaticweldsshallbeinspectedand100%ofmanualweldswithborescopeshallbeinspected.对焊应尽可能由轨道焊接机进行，应对 70%的自动焊缝进行检查，并对100%的手动焊缝进行内窥镜检查。WeldingshallbeperformedwithTIG/GTAW,99,997%argonshieldgasshallbeused.焊接应使用TIG/GTAW99.997%氩气保护。Testcouponsshallbeperformedeverystartofworkperdayandperpiping/tubingdiameter.应对每天开始工作和每段管道进行测试取样Weldlogsshallrecordallthepiping/tubingweldsinthesystem.焊接记录应对系统中的所有管道焊接进行记录。Weldlogsshallcontainthefollowingminimuminformation:焊接记录应至少包含以下信息：dateofweld;焊接日期weldername;焊接人名字supervisor/inspector;主管/检查员weldidentificationnumberanddescription;焊缝识别号和描述descriptionofitemsbeingwelded;焊接物品描述itemsdiameterand;物品直径heatnumbersoftheitemsbeingwelded.焊接物品的炉号Passivationshallbeperformedduringcommissioning/startup.应在调试/启动期间进行钝化。Onlycertifiedweldersshallheused.只能使用经过认证的焊工。Piping/tubingconnectionsshallheTriClamp(TC)orothersanitarystyleconnection.管道连接应使用卡箍(TC)或其他卫生方式连接。Threadedorflangedconnectionsshallnotbeused.不得使用螺纹或法兰连接。Drainageslopesshallapplytothefollowing:以下方面应使用排水斜坡：a1%minimumdrainageslopesshallbedesignedwhereeverpossibleand;在可能的情况下，须设计1%最小排水斜坡；theslopedirectionshallbetowardsthepipinglowpoint,whichshallbedrainable.斜坡方向应朝向管道排水的低点。Installedvalvesshallbeoneofthefollowingtypes:diaphragmorotherasepticdesignwithbarrierbetweenvalvemechanismsideandPW/WFIside.安装的阀门应为以下类型之一：隔膜阀或其他无菌设计，阀门机构侧和PW/WFI侧之间有屏障。6Sampling取样Samplingprinciples取样规则Thereshallbeprovisionforsamplingthewaterupstreamanddownstreamofallcomponentsthatcouldaffectthemicrobialorchemicalqualityofthewater.应规定对上游和下游可能影响水微生物或化学质量的所有组件进行取样。Zerodeadlegsamplevalvesshallbeusedthroughoutthesystem,bothonnonPW/WFIpiping/tubingandonproductwaterpiping/tubing.在整个系统中，无论是非最终PW/WFI管道还是最终水管道，均应使用零死角取样阀。Thesamplevalvesshallbeinstalledonshortoutletteessoasnottocontaminatesamplesbybioburdengrowinginthefitting.取样阀应安装在短出口三通上，以免因生物负荷生长而污染样品。Everyprocessrelevantcomponentinthewatersystemshallhaveasamplevalvebeforeandafterthecomponent,e.g.heatexchangerfilter,pumpetc.水系统中每个工艺相关部件的前后应有一个取样阀，如换热器、过滤器、泵等。Thesamplevalvesshallbeaboveatundishdrainthatwillallowfulldrainageofthesamplevalveflowbeforetakingthesample.取样阀应位于漏斗排水管之上，在取样之前，允许将取样阀中的水完全排出。Thereshallbesufficientclearancebetweenthesamplevalveandthetundishtoallowinsertionofallthestandardsamplebottles.取样阀和漏斗之间应有足够的间隙，以便放入所有标准取样瓶。Minimumsamplingpointandlocations最小采样点和位置beforeandafterMMF;多介质过滤器前后atsuppliedwatertankinlet;供水管入口aftercirculationpump;循环泵之后afterhardnessreductionstage;硬度降低阶段后；atthecartridgefiltersinletandoutlet;滤芯过滤器进出口；afterheatexchangers;换热器之后afterdechlorinationstage;脱氯后；aftereachROhousingandattheirjointstreamand;在各RO后，并在其并流处；atROrejectlinesand;RO排出口CDI/EDI/CEDIfeed,productandreject.CDI/EDI/CEDI进水、出水和排水。6.3Samplingconductivity电导率取样Ifanonlineconductivityinstrumentisinstalledandtheonlineconductivityhasalreadymetnationalregulations,thereisnoneedforsamplestobetakenforofflineconductivitytesting.如果安装了在线电导率仪器，且在线电导率已符合国家规定，则无需取样离线测试电导率。Instruments仪器Minimuminstrumentationforinstallation需要安装的最小仪器Pressureindicators(PI):压力表localpressuredisplayshallbeinstalledatinletsandoutletsofmajorcomponents;应在主要组件的入口和出口处安装局部压力显示 ；pressureIndicators(PI)shallbeinstalledatpumpoutlet,beforeandafterfiltrationelementsand;应在泵出口、过滤器元件前后安装压力表(PI)；onlydirectlymountedmembranetypeconnectionsshallbeused.只能使用直接安装的膜式连接。Pressureindicatortransmitter(PIT):压力表变送器•formonitoringthesystempressureinvariouspoints.•用于在不同的点监视系统压力。Conductivityindicatortransmitter(CIT):电导率仪变送器formonitoringthenon-compensatedconductivityand;用于监测无补偿电导率；CITshallbeusedat:RO