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QualificationProtocolofPurifiedwatersystem纯化水系统验证方案Preparedby起草：Date日期：Reviewedby审阅：Date日期：Approvedby批准：Date日期：共14页第2页Tableofcontents目录1.0Instruction引言...................................................................................31.1Summarize概述............................................................................31.2Purifiedwatersystemprocess纯化水系统工艺流程......................32.0Purpose验证目的...............................................................................63.0Responsibility验证职责.......................................................................63.1Validationteam验证小组...............................................................63.2Equipmentdepartment设备部.......................................................73.3Qualitydepartment质量部.............................................................83.4Productiondepartment生产部.......................................................84.0Validationscope验证范围...................................................................85.0Validationcontent验证内容.................................................................85.1InstallationQualification(IQ)安装确认.............................................85.2OperationQualification(OQ)运行确认..........................................115.3PerformanceQualification性能确认............................................125.5Re-validationandre-validationperiod拟定再验证及验证周期.....135.5Conclusion验证方案结论............................................................146.0Approvalofvalidationprotocol验证方案最终批准.............................14共14页第3页1.0Instruction引言：1.1Summarize概述：Thissystemispreparedpurifiedwaterfromdrinkingwater;thequalityofrawwater(drinkingwater)shouldmeetthestandardofdrinkingwatertestedbyThirdparty.本系统为从饮用水制取纯化水的设备，所用原水送当地送第三方检测，经化验符合饮用水标准。Manufacturingprocessofpurifiedwater:Rawwater(drinkingwater)→Sandfilter→Activatedcarbonfilter→5μmprecisefilter→RO(1class)→RO(2class)→EDI→Purifiedwater纯化水的制备过程为：饮用水→砂滤→碳滤→5μm精密过滤器→一级反渗透→二级反渗透→EDI→纯化水。Qualityofpurifiedwater：Conductivity≤1.1μs/cm（20℃），OtherCriteriashouldmeettherequirementofpurifiedwaterincurrenteditionUSP.纯化水质控制：电导率≤1.1μs/cm（20℃），其它指标符合USP当前版纯化水项下规定。Samplelocation取样点：Storagetankofpurifiedwater、distributionloopandpoints-of-use纯化水贮水罐、总回水口及各纯化水使用点。1.2Purifiedwatersystemprocess纯化水系统工艺流程：共14页第4页原水箱Rawwatertank原水泵Rawwaterpump多介质过滤器Sandfilter活性炭过滤器Activatedcarbonfilter5μm精密过滤器precisefilter阻垢剂Scaleinhibitor高压泵Highpressurepump反渗透系统ROsystemRO水箱ROwatertankEDI水泵EDIwaterpumpEDI系统EDIsystemPH调节剂PHadjustment纯水箱Purifiedwatertank纯水泵Purewaterpump紫外线杀菌器UV0.1μm精密过滤器precisefilter共14页第5页1.2.1Pre-treatingprocessusesgasflushmultilayerquartzsandfilter（0.5-1；1-2）,activatedcarbonfilter(4-20mu),precisefilter(5μm)toremovecolloid,organs,floatingcircumstances,CLandparticlesover5μm,andtoreducewaterhardness.预处理包括气冲式多层石英砂过滤器（0.5-1；1-2）、活性碳过滤器（4-20目）、蜂房式过滤器(5μm)作前级处理，去除水中的胶体、有机物、悬浮物、余氯、5μm以上的微颗粒以及有效降低水中总硬度。1.2.2DesaltingprocessadoptsthemethodofRO(Twoclasses).ROmembraneisthemostadvancedassembledmembraneofhighestrecoveryanddesaltingrateintheworld.脱盐部分采用二级反渗透的方法。反渗透膜选用国际最为先进、回收率、脱盐率最高的卷式复合膜作为组件材料。InROprocess98％ion,colonyandthermalresourceareremovedtoensurethatthefinalqualityofproductwater.一级反渗透去除原水中98％以上的阴阳离子以及各种有害菌落和热源，以保证产品水的最终品质。1.2.3EDIisof.Inordertodesalting,thedeviceutilizeresininbatterymoduleabsorbmetalioninwater.EDI选用，此装置通过填充在电池模块中的树脂吸附水中的金属离子，达到脱盐的目的。EDIpossessestheadvantagesofhighdesaltingrate,noacidoralkaliregenerationforresin,productwaterofhighqualityaswellaswaterconductivitybelow0.5μS/cm（25℃）and95%waterutilizingrate.Themost共14页第6页obviousfeatureisthatEDIuseelectricitybutnotacidoralkalitoregenerateresin.EDI系统的特点是脱盐率高，树脂无需使用酸碱再生，具有较高的产水质量，水的电导率可达到0.5μS/cm（25℃）以内，水的利用率最高可达95%，其最大特点是利用电能而不是酸碱化学对树脂进行再生处理。1.2.4SelectUVforpost-processinginordertomeettherequirementsofbacteriascontrolling.后处理选用紫外线杀菌器是为了满足对细菌控制的要求。2.0Purpose验证目的：2.1CheckingthePurifiedwatersystemandensurethequalificationofinstallation、operation、performancetomeetdesignedcriteria检查并确认该纯化水系统安装、运行、性能等各项技术指标符合设计要求。2.2EnsurethearchiveofrelativelydataandfiletomeettherequirementofGMP.确保相关资料和文件的存档管理符合GMP要求。2.3InspectPurifiedwaterifit'smeettherequirementofmanufacture.检查处理后的纯化水是否达到生产要求。3.0Responsibility验证职责：3.1Validationteam验证小组：3.1.1Responsibleforapprovalofprotocol负责验证方案审批。3.1.2Responsibletocoordinatetheworkofvalidation,ensuretheimplementofthisprotocoleffectively.负责验证的协调工作以保证本验证方案规定项目的顺利实施。3.1.3Responsibleforapprovalofvalidationreport.负责验证报告的审批。共14页第7页3.1.4Responsibleforsigningandissuethecertificationofvalidation负责验证证书的发放。3.1.5Responsibleforaffirmedtheperiodofvalidation负责验证周期的确认。3.2Equipmentdepartment设备部：3.2.1Responsiblefordrafttheprotocol负责验证方案的起草。3.2.2Responsibleforinstalling,adjustingtheequipmentandrecording.负责设备的安装、调试并作好相应记录。3.2.3Responsibleforthecalibrationofequipmentandmeter.负责仪器仪表的校正。3.2.4Responsibleforcollectedallvalidationdataandsubmittothevalidationteam.负责收集各项验证记录，报验证小组。3.2.5Ifthisprotocolneedtochangebecauseofspecificcause,Equipmentdepartmentshouldberesponsibletofill'theapplicationandapprovalformofprotocolchange.若因特殊原因需变更原验证方案时，应负责填写“验证方案变更申请及批准书”，