水系统培训

华润医药集团有限公司2019年9月17日WaterSystems水系统知识讲座九新药业国际认证部经理高级工程师徐影华润医药集团有限公司•Toexaminethebasictechnologyandrequirementsfor:检查以下方面的基本技术和要求：1)Watertreatmentsystems水处理系统2)Storagerequirements贮存要求3)Samplingandtesting取样和检测4)Differenttypesofwaterusedinpharmaceuticals制药用水的不同类型5)Microbiallimits,disinfection微生物限度、消毒Objectives目的华润医药集团有限公司C&Q-V-ModelVV华润医药集团有限公司•URS•用户需求URS¤FDS¤DQ¤SAT¤IQ¤OQ华润医药集团有限公司Watersystemdesign水系统的设计1)Pipesslopedsowaterdoesnotpoolandcandraineasily管道要有斜度，以防止积水，易于排空2)Sanitaryfittings&connections洁净配件和接口3)Constructedofsuitablematerialssuchasstainlesssteel建造材料适合，如不锈钢4)Circulatethewater水要循环华润医药集团有限公司Furtherwatertreatmentpurificationstagesdownstreamofthepre-treatmentsystem预处理系统后水的进一步纯化1)Filtration过滤2)Disinfection消毒3)Reverseosmosisorde-ionization反渗透或去离子4)Distillationorultra-filtration蒸馏或超滤华润医药集团有限公司Thereshouldbenodeadlegs不应有死角WaterscoursdeadlegIfD=25mm&distanceXisgreaterthan75mm,wehaveadeadlegthatistoolong.如果D=25mm，X大于75mm，则有较长的死角Deadlegsection死角部分3DFlowdirectionarrowsonpipesareimportant管道中的流向很重要SanitaryValve洁净阀DXWatersystemdesign(1)水系统设计（一）华润医药集团有限公司3.Thewateriscontaminatedasitpassesthroughthevalve当水通过阀门时，被污染2.Bacteriacangrowwhenthevalveisclosed当阀门关闭时，会生长细菌1.Ballvalvesareunacceptable不可使用球阀Stagnantwaterinsidevalve阀门中的死水Watersystemdesign(2)水系统设计（二）华润医药集团有限公司1)Sanitarypumps洁净泵2)ClampsandOringsversusthreadedfittings卡箍和O环，不用螺纹配件3)Heatexchangers换热器4)Sidearmlevelmeasuringdevicesareunacceptable不可使用边侧臂状水位测量装置Watersystemdesign(3)水系统设计（三）华润医药集团有限公司rawwater原水Highpressure高压FeedwaterUnderpressure加压进水RejectWater不合格水Semi-permeableMembrane半渗透膜PermeateWater渗透水drainorrecycle排放或循环Lowpressure低压Purifiedwater纯化水Reverseosmosis(RO)theory反渗透（RO）原理华润医药集团有限公司CationiccolumnAnioniccolumnHygienicpump卫生泵Outletsorstorage.OzonegeneratorUVlightHClNaOHEluatestoneutralizationplantAirbreaktosewer空气断开Drainlinefromwatersoftener软水机WatermustbekeptcirculatingTypicalde-ionizerschematic典型的去离子示意图123456123456Returntode-ioniserCartridgefilter5µmCartridgefilter1µm华润医药集团有限公司BranchBranchCartridgefilter1µmSecondstageROcartridgeFirststagefiltratefeedssecondstageROwithexcessbackto1ststagebuffertank.1ststagerejectconcentrateAirbreaktosewerSecondstagerejectwatergoesbacktofirststagebuffertankSecondstageROwatermeetsPharmacopoeiastandards1ststagebuffertankWaterfromsoftenerorde-ioniserTypical2-stageROschematic典型二级反渗透示意图HygienicpumpFirststageROcartridgeHighpressurepump华润医药集团有限公司•Advantages优点•Disadvantages缺点•Manyuses应用领域–purifiedwater纯化水–feedingofdistillationunitsorultra-filtrationunits蒸馏器或超滤器的进水–WaterforFinalRinse最终冲洗用水–WaterforInjections(ifpermissible)注射用水（如许可）Useofreverseosmosis反渗透的应用华润医药集团有限公司•CanbeusedforWFIorforWaterForFinalRinsingforparenteralmanufacturing(ifpermitted)可用作注射用水或生产注射剂的最终冲洗用水（如许可）•Removesorganiccontaminants,suchasendotoxins去除有机污染物，如内毒素•Operationat65-80°C,andsterilizationat121°C在65-80°C下运行，在121°C进行灭菌Ultra-filtration超滤华润医药集团有限公司•Single-effectdistillation单效蒸馏–simpledistillation,singleeffect简单蒸馏，单效–vapourcompression,thermocompression蒸汽压缩，热压缩•Multieffectdistillation多效蒸馏–multipleeffectstills多效蒸馏机Distillation蒸馏华润医药集团有限公司Typicalwaterstorageanddistributionschematic典型的水贮存和分配示意图WatermustbekeptcirculatingSprayballCartridgefilter1µmAirbreaktodrainOutletsHygienicpumpOptionalin-linefilter0,2µmUVlightFeedWaterfromDIorROHeatExchangerOzoneGeneratorHydrophobicairfilter&burstdisc疏水性呼吸过滤器&安全隔膜华润医药集团有限公司StillStoragetankPumpBallvalves0.22umfilterPlateheatexchangerKEY华润医药集团有限公司StillStoragetankPumpsTCTOCDiaphragmvalvesT-TempprobeC-ConductivityTOC-TotalOrganicCarbonDoubletubesheetheatexchangerKEYSprayballBackPressureRegulator华润医药集团有限公司Watersystemsdesign水系统设计Check检查Why?HowFeedWaterQuality进水质量Subsequenttreatmentstagescannotcopewithunrestrictedmicrobialandendotoxinload其后的处理阶段无法处置未受限制的微生物和内毒素负荷Connections连接Sampling取样Minimalcrevices最小裂缝Inspection检查华润医药集团有限公司Watersystemsdesign水系统设计Check检查Why?HowFinishes抛光Reducebacterialadhesion减少细菌粘着Pipeslopes管道倾斜度Certification证书Drainabilityespeciallyofcondensateaftersteamsanitising排水性,尤其是蒸汽消毒后的冷凝水Inspection检查spiritlevel水平仪Isometrics等容法华润医药集团有限公司Watersystemsdesign水系统设计Check检查Why?HowToproduceunfavourableconditionsformicrobialgrowthandattachment制造不利于微生物生长和附着的条件Sanitisation消毒Flowmeter流速计Records记录Velocityinloop回路中流速Forcontrolofmicrobialproliferationandinresponsetoproblems控制微生物繁殖,解决问题华润医药集团有限公司Watersystemsdesign水系统设计CheckWhy?HowNot“reactive,additiveorabsorptive”不产生反应,添加或吸附Instruments仪器Certificates证书Certificates证书Inspection检查Materialsofconstruction材质Calibrated已校正Sanitary清洁华润医药集团有限公司Watersystemsdesign水系统设计CheckWhy?HowMinimalcrevices最小裂缝Passivation钝化Documentation(WeldersQualification,weldlogs)Samplewelds,Weldinspection文件(焊接工资质确认,焊接日志)焊接取样,焊接检查Documentation(Procedures,Passivationlog)文件(规程,钝化日志)Welding焊接Maximumcorrosionresistance最大耐受腐蚀性华润医药集团有限公司WaterSystemsdesignCheckWhy?HowDemonstrationofconsistentabilitytoproducewaterofrightquality证实有持续产生高品质水的能力MasterPlan,验证主计划Protocols,验证方案summaryreports总结报告Validation验证华润医药集团有限公司•Heat热-Oneofthemostreliablemethodsofdisinfectionofwatersystems最可靠的消毒水系统的方法之一•Ozone臭氧-Producedeasily容易制备-Leavesnoresidue没有残留Disinfection(1)消毒（一）华润医