纯化水系统安装确认验证与方案

......批准人批准人ApproverforEnglishversionQA经理QAmanager批准人Approverforbilingualversion管理者代表Managementrepresentative修订记录/Revisionhistory:1.0版：初始版本Release1.0InitialRelease部门Function姓名Name签名Signature日期Date制定人Author验证代表Validationrepresentative审核人Reviewer维修保养部门代表Maintenancerepresentative目的/PURPOSE目的/PURPOSE本方案的目的是验证纯化水系统的设计、制造、安装、运行是否符合要求。1参考法规与文件/DOCUMENTREFERENCES2职责/RESPONSIBILITIES3定义与缩写/DEFINITIONSANDABBREVIATION4系统描述/SYSTEMDESCRIPTION南通海发水处理工程有限公司提供3m3/h一级反渗透+EDI药用纯化水制取装置。ThesupplierHighfineCo.,Ltdprovides2m3/h1RO+EDIPWsystem.水源为南京市自来水公司提供的自来水.TherunningwatersuppliedbyHAIMENRUNNINGWATERCOMPANYistherawwater.纯化水水质要求达到白敬宇厂房用户需求文件URS0024中规定的标准。ProductwatershouldreachesthestandardsasdefinedintheURS0024UserrequirementspecificationforJVbuilding.5纯化水系统工艺流程purewatersystemprocess文件编号ReferenceNo.文件标题TitleURS024药业厂房技术要求URSforJVbuildingVP006纯化水系统验证DIwatersystemQualificationVMP转移项目计划EIAtransferPlanSBE-GP-003验证主程序GeneralProcedureforValidation步骤/Steps部门/Department执行测试/TestExecution供应商进行安装确认IQbysupplier测试结果审核/TestVerification验证部门代表Validationrepresentative验证报告撰写/Writingthereport验证部门代表Validationrepresentative缩写/Shortform定义/DefinitionPW纯化水PurifiedwaterRO反渗透ReverseosmosisEDI去离子Electro-deionization原水箱原水箱Rawwatertank原水泵Rawwaterpump多介质过滤器Sandfilter活性炭过滤器Activatedcarbonfilter5μm精密过滤器5μmprecisefilter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PHadjustor

77验证测试/QUALIFICATIONTEST测试方案编号References测试名称DescriptionIQ006/1Test1设施验证UtilitiesVerificationIQ006/1Test2设备验证DevicesVerificationIQ006/1Test3文件验证DocumentationVerificationIQ006/1Test4安装验证InstallationVerificationIQ006/1Test5校验验证TagandcalibrationcertificatesVerificationIQ006/1Test6材料证明MaterialVerificationIQ006/1Test7盲管死角验证DeadangleVerificationIQ006/1Test8坡度验证SlopesVerificationIQ006/1Test9焊接验证WeldingVerificationIQ006/1Test10压力验证PressureVerificationIQ006/1Test11清洗和钝化验证Verificationofcleaning,passivation8通过标准/ACCEPTANCECRITERIA如满足以下条件，可以通过安装验证：InstallationQualificationisacceptedif:-完成所有的测试Allactivitieshavebeenperformed-没有不可接受偏差Noblockinganomalyremains-撰写报告并批准Thereportiswrittenandapproved通过安装验证后方可进行操作验证。TheacceptationoftheIQwillallowthestartofOQ.......前提前提/Prerequisite完成/Check1.方案已经通过Thisprotocolhasbeenapproved2.操作人经过执行验证的相关培训Operatorsaretrainedforprocessvalidationexecution步骤No.验证项目Stepdescription验证内容Acceptancecriteria验证标准Observedresults合格与否C/NC偏差报告编号Anomalyreference1供配电Electricitysupply/consumption操作范围是否合理、安装是否符合要求Checktheoperativerangeisappropriatetothecorrectoperationofthesystemanditsinstallationissuitableforrequireduse功率11KW电压380V（3相5线）频率50Hz2饮用水Rawwater操作范围是否合理、安装是否符合要求Checktheoperativerangeisappropriatetothecorrectoperationofthesystemanditsinstallationissuitableforrequireduse,水温8-30ºC流量6m3/h管径DN32压力0.25Mpa3压缩空气Compressedair操作范围是否合理、安装(过滤器，调压阀)是否符合要求Checktheoperativerangeisappropriatetothecorrectoperationofthesystemanditsinstallation(filters,valves…)issuitableforrequireduse压力6bar,流量50l/h管径8mm附件过滤器、调压阀4工业蒸汽Industrialsteam操作范围是否合理、安装是否符合要求Checktheoperativerangeisappropriatetothecorrectoperationofthesystemanditsinstallationissuitableforrequireduse压力3Bar管径DN25附件过滤器、减压阀步骤/No.备注/Comments测试操作人/Testperformedby:签名/Signature日期/Date测试所用计量仪器/Listofequipmentsused:附件列表/Listofattachments测试审核人/Testreviewedby:签名/Signature日期/Date合格/Conform不合格/Nonconform备注/Comments:目标objective检查主要的部件，验证安装的部件和现有的技术文件是否一致；记录名称，品牌，型号和序列号等其他相关信息。Characterizethemajorcomponentsoftheinstallationverifyingthattheequipmentinstalledcorrespondswithexistingtechnicaldocumentationandrecordingthefollowinginformationforeachone:designation,brand,model,serialnumberand/orotherrelevantcharacteristics.步骤No.验证项日Stepdescription验证内容Acceptancecriteria验证标准Observedresults合格与否C/NC偏差报告编号Anomalyreference1PH调节装置1供应商计量泵SupplierDosagepump:美国帕斯菲达Pulsaafeede前提/Prerequisite完成/Check1.本方案已被批准Thisprotocolhasbeenapproved2.操作人已接受执行验证的培训Operatorsaretrainedforvalidationexecution步骤步骤No.验证项日Stepdescription验证内容Acceptancecriteria验证标准Observedresults合格与否C/NC偏差报告编号Anomalyreference01-TV-0101-PD-01溶解槽Dissolvedgroove:苏州大自然Suzhounatural计量泵型号ModelDosagepumpX030序列号Serialnumber08012200370扬程Head7BAR流量flowL/H4.73数量Quantity1套1set2紫外线杀菌灯1UV-0101-FlowingUVLAMP供应商Supplier南通海发Nantonghighfine型号modelUV-5数量Quantity1台set1波长Wavelength254nm材料Material：3043原水箱01-TV-02rawwatertank供应商Supplier南通海发Nantonghighfine数量Quantity1只1pcs步骤步骤No.验证项日Stepdescription验证内容Acceptancecriteria验证标准Observedresults合格与否C/NC偏差报告编号Anomalyreference体积volume2m3材料material304储水罐附件Thestoragetankisequipedwith-360º喷水球/360ºsprayingball液位控制器/Levelcontroller空气呼吸器/Sparenozzleontop人孔/Manhole4原水泵01-PC-01rawwaterpump供应商Supplier丹麦格兰富Grundfos型号ModelCR5-9序列号SerialnumberA96517043P10849扬程Range47.7m流量大小flow5.8T/h数量Quantity1台1set5多介质过滤器01-FM-01Sandfilter型号modelHF-SL-800数量quantity1台供应商Supplier南通海发NantongHighfine步骤步骤No.验证项日Stepdescription验证内容Acceptancecriteria验证标准Observedresults合格与否C/NC偏差报告编号Anomalyreference尺寸sizeφ800操作压力Operationpressurebar4填充物Fillingmaterialquartzsand石英砂石英砂规格/数量：Quartztype/amount1-2mm300Kg0.5-1mm600Kg6活性碳过滤器01-AC-01Activatedcarbonfilter供应商Supplier南通海发NantongHighfine型号modelHF-TL-800数量quantity1台尺寸sizeφ800操作压力Pressure4bar填充物：Fillingmaterial活性碳、石英砂Activatedcarbon,quartzsand活性炭规格/数量：石英砂规格/数量：4-20目250Kg1-2mm150Kg7阻垢剂01-TV-0302-01-PD-02Scaleinhibitor供应商计量泵SupplierDosagepump美国帕斯菲达Pulsaafeede溶解槽Dissolvedgroove:苏州大自然Suzhounatural计量泵型号DosagepumpModelX030步骤步骤No.验证项日Stepdescription验证内容Acceptancecriteria验证标准Observedresults合格与否C/NC偏差报告编号Anomalyreference序列号Serialnumber08012200364扬程Head7Bar流量flow4.73L/H数量：Quantity1套1set8精密过滤器01-JMF-01Precisefilter供应商Supplier南通海发Nantonghighfine型号modelHF-JMF-203数量：Quantity1台set1结构可自由更换滤芯滤芯材质materialPP外壳材质material304-过滤精度precision5μm-滤芯规格数量：Amount20英寸*3根20ft*3pcs9高压泵01-PC-03pressurepump供应商：Supplier丹麦格兰富Grundfos类别TypeCR5-29步骤步骤No.验证项日Stepdescription验证内容Acceptancecriteria验证标准Observedresults合格与否C/NC偏差报告编号Anomalyreference型号：ModelA96513392P10844扬程：160mHead流量大小：5.0t/hflow数量：1台Quantity1pcs10反渗透膜RO-0101-ROmembranes供应商：Supplier陶氏DOW型号：modelBW30-4040数量：Quantity15根15pcs工作压力：pressure15bar11PH调节装置2TV-0501-01-PD-03Scaleinhibitor供应商计量泵SupplierDosagepump美国帕斯菲达Pulsaafeede溶解槽Dissolvedgroove:苏州大自然Suzhounatural计量泵型号DosagepumpModelX030序列号Serialnumber08012200390扬程Head7Bar流量flow4.73L/H步骤步骤No.验证项日Stepdescription验证内容Acceptancecriteria验证标准Observedresults合格与否C/NC偏差报告编号Anomalyreference数量：Quantity1套set112RO水箱02-TV-01ROwatertank供应商Supplier南通海发Nantonghighfine体积：volume1m3数量：Quantity1台1set材料：material304储水罐附件Thestoragetankisequipedwith:360º喷水球360ºsprayingball液位控制器Levelcontroller空气呼吸器Sparenozzleontop人孔Manhole13EDI水泵PC-0102-EDIwaterpump供应商：Supplier：丹麦格兰富Grundfos型号ModelCHI4-40序列号SerialnumberC4J518004P10832材料：Material316步骤步骤No.验证项日Stepdescription验证内容Acceptancecriteria验证标准Observedresults合格与否C/NC偏差报告编号Anomalyreference扬程Head28m流量flow4.5t/h14EDI膜块02-EDI-01EDImodule供应商supplierIONPURE型号modelIP-LXM30Z-1数量：Quantity1个1pcs工作压力pressure≤5bar序列号Serialnumber8170415纯水箱02-TV-02Storagetankofpurifiedwater供应商：Supplier南通海发Nantonghighfine数量：Quantity1只pcs1体积：volume6m3材料：material316L储水罐附件Thestoragetankisequipedwith：360º喷水球/360ºsprayingball液位控制器/Levelcontroller空气呼吸器/Sparenozzleontop人孔/Manhole步骤步骤No.验证项日Stepdescription验证内容Acceptancecriteria验证标准Observedresults合格与否C/NC偏差报告编号Anomalyreference16纯水泵02-PC-02Purifiedwaterpump供应商：Supplier丹麦格兰富类别：TypwCHI12-25型号ModelD4F518025P10914材料：Material316扬程：Head42m流量大小：flow10t/h17紫外线杀菌灯202-UV-01FlowingUVLAMP供应商：Supplier南通海发Nantonghighfine型号：modelUV-10数量：Quantity1台1set波长：Wavelength254nm材料：Material：316L紫外线系统附件计时器180.1μm精密过滤器JMF-0102-0.1μmmicroholefilter供应商Supplier南通海发Nantonghighfine型号：Model：JMF407数量：Quantity：1台1set步骤步骤No.验证项日Stepdescription验证内容Acceptancecriteria验证标准Observedresults合格与否C/NC偏差报告编号Anomalyreference结构：可自由更换滤芯外壳材质material316L滤芯材质materialPTEF过滤精度precision0.1μm-滤芯规格数量Amount40英寸*7根40ft*7pcs步骤步骤/No.备注/Comments测试操作人/Testperformedby:签名/Signature日期/Date测试所用计量仪器/Listofequipmentsused:附件列表/Listofattachments测试审核人/Testreviewedby:签名/Signature日期/Date合格/Conform不合格/Nonconform备注/Comments:前提前提/Prerequisite完成/Check2.本方案已被批准Thisprotocolhasbeenapproved3.操作人已接受执行验证的培训Operatorsaretrainedforvalidationexecution步骤No.验证项目与标准Stepdescription验证内容Acceptancecriteria验证证明文件Observedresults合格与否C/NC偏差报告编号Anomalyreference1竣工文件Asbuiltdocumentation:核对是否具备所有文件Verifythateachdocumentisavailable.检查设备的安装是否符合每一份文件的要求。签字并注明日期以证明已经过检查。Takeeachreferenceddocument,checktheinstallationinregardwiththedocumentation,signanddateeachdocumentattestingthatthecheckinghasbeendone.竣工图(管道设施和安装平面图As-builtdrawings(P&IDsandIsometrics)编号Ref:BJY-PW-PID---3页BJY-PE-PMT---1页所有设备的技术规格Technicalspecificationsofallequipments编号RefBJY-PW-SBGG---1页电气，气动图表Electric&pneumaticdiagrams编号Ref:HF-R=E-03---33页BJY-PW-QL---1页操作和维护手册Operationandmaintenancemanuals编号Ref:……………建议零件清单Recommendedsparepartslist编号Ref:BJY-PW-BPQD---1页相关部件合格证明文件编号Ref:……………步骤/No.备注/Comments测试操作人测试操作人/Testperformedby:签名/Signature日期/Date测试所用计量仪器/Listofequipmentsused:附件列表/Listofattachments测试审核人/Testreviewedby:签名/Signature日期/Date合格/Conform不合格/Nonconform备注/Comments:前提前提/Prerequisite完成/CheckN/A目标objective给出文件依据，来说明纯水系统已经被正确安装了，和安装图上相一致。Providedocumentaryevidencethatthewatersystemhasbeeninstalledandiscorrectlyidentifiedinaccordancewithexistentinstallationdrawings(Asbuiltdiagramsandschemes).步骤No.测试步骤Stepdescription验证项目Acceptancecriteria验证标准Observedresults合格与否C/NC偏差报告编号Anomalyreference1获取一个“竣工图”。Obtainacopyofthelastversionof“asbuilt”P&IDdrawings.在图上用黄色标示出已查过的部分。偏差用红色下划线标示。Indicateondrawingswhathasbeenchecked(highlightinyellow).Underlineinredanyanomaly附上图纸。Joindrawingstothetest.P&ID图安装验证中用到的P&ID图编号能识别AsBuiltP&Idsdrawingsusedininstallationverificationareidentified2管道部件竣工管道设施图中部件被确认ThecomponentsareidentifiedinAsBuiltP&IDdrawings3标签在图中确认的部件在安装中用标签标识Thecomponentsareidentifiedintheinstallationusingtags4仪表仪表安装正确，容易读出上面的数字Theinstrumentsarecorrectlyinstalled,theyareaccessibleandtheycanbeeasilyread5操作各部件都可以顺利地被操作，而且可以进行维修工作Theaccesstothedifferentcomponentsofthesystemiseasysooperationandmaintenanceworkscanbedone步骤/No.备注/Comments测试操作人/Testperformedby:签名/Signature日期/Date测试所用计量仪器/Listofequipmentsused:附件列表/Listofattachments测试审核人/Testreviewedby:签名/Signature日期/Date合格/Conform不合格/Nonconform备注/Comments:前提前提/Prerequisite完成/CheckN/A步骤No.验证项目Stepdescription验证内容Acceptancecriteria验证标准Observedresults合格与否C/NC偏差报告编号Anomalyreference1检查所有的重要仪器的计量证书，保证计量范围和精确度符合工作需求Checkthatcalibrationcertificatesareavailablewhenneededeandthatthecalibrationrangeandprecisionofthecalibrationareadequatefortheinstrumentrangeofworkandprecisionrequired见下表Seetablebelow见下表Seetablebelow标签tag描述description是否需要计量Needtobecalibrated(YES/NO）检查计量标签Conformityofcertificate(yesorno)工作范围Workscale测量范围Measurescale精确度correctness合格与否（C/NC）备注remarksPHT-0101原水PH变送器是yes5-80-142.5TT-0101原水温度变送器是yes0-50℃0-100℃2.5LT-0101原水箱液位变送器否no0.-1.8m0-3.0m2.5TI-0101列管式换热器出水温度表是yes0-100℃0-200℃1.5PI-.0101列管式换热器工业蒸汽压力表是yes0-0.4Mpa0-1.6Mpa1.5PI-0102多介质过滤器压力表Pressuremeterofsandfilter是yes0-0.5Mpa0-0.6Mpa2.5PI-0103活性炭过滤器压力表Pressuremeterofactivatedcarbonfilter是yes0-0.4MpaMpa0-0.62.5

标签标签tag描述description是否需要计量Needtobecalibrated(YES/NO）检查计量标签Conformityofcertificate(yesorno)工作范围Workscale测量范围Measurescale精确度correctness合格与否（C/NC）备注remarksPI-0203EDI纯水出水压力表DischargedpurewaterpressuremeterofEDI是yesMpa0-0.3Mpa0-0.62.5PI-0204EDI浓水出水压力表DischargedwastewaterpressuremeterofEDI是yesMpa0-0.20-0.6Mpa2.5FT-0201EDI浓水进水流量计feedwastewaterflowmeterofEDI是yes0-5LPM0-10LPM2.5FT-0202EDI纯水出水流量计DischargedpurewaterflowmeterofEDI是yes0-60LPM0-100LPM2.5LT-0202纯水箱液位传感器Liquidlevelsensor否no0.-2.8m0-3.0m2.5CT-0201EDI出水电导率表ConductivitymeterforDischargedwaterofEDI是yes0-1μs0-100μs2.5步骤/No.备注/Comments测试操作人/Testperformedby:签名/Signature日期/Date测试所用计量仪器/Listofequipmentsused:附件列表/Listofattachments测试审核人/Testreviewedby:签名/Signature日期/Date合格/Conform不合格/Nonconform备注/Comments:前提前提/Prerequisite完成/CheckN/A目标objective查看所有与纯水接触材料的证书文件Checktheavailabilityofcertificatesofmaterialsincontactwiththewater.步骤No.验证项目Stepdescription验证标准Acceptancecriteria验证证明文件Observedresults合格与否C/NC偏差报告编号Anomalyreference1原水箱SSAISI3042预处理SSAISI3043中间水箱SSAISI3044生产纯水管道（预处理、RO、EDI进水）Loopsformakingpurifiedwater（Pre-treatROEDIinlet）SSAISI3045生产纯水管道（EDI出水）Loopsformakingpurifiedwater（EDIoutlet）SSAISIL3166纯水储水罐StoringtankforpurewaterSSAISI316L7紫外线杀菌器UVSSAISIL31680.1μ精密过滤器SSAISI316L步骤/No.备注/Comments测试操作人/Testperformedby:签名/Signature日期/Date测试所用计量仪器/Listofequipmentsused:附件列表/Listofattachments测试审核人/Testreviewedby:签名/Signature日期/Date合格/Conform不合格/Nonconform备注/Comments:前提前提/Prerequisite完成/CheckN/A目标objective确认在纯水管道中没有盲管和死角CheckthattherearenodeadlegsinPurifiedWaterLoopusingthe3Drule.步骤No.测试步骤Stepdescription通过标准Acceptancecriteria试验结果Observedresults合格与否C/NC偏差报告编号Anomalyreference1测量主管道的下壁到盲管底部的长度。Measurethelongitudefrommainpipewalltothefinaloftheleg.测量盲管的直径Measurethediameterofdeadangle.填写下表Fillintablebelow所有盲管满足L<3D,盲管的长度小于它三倍直径的大小AllthedeadlegsfulfilltheL<3Drule,whichmeansthatthelongitudeislessthan3timesitsdiameter见附表seetablebelow盲管位置DeadLegVerifiedD（直径）D(DiameterSection)3DL（长度）L(LongitudeStretch)评定Evaluation(C/NC)备注NotesEDI纯水出水压力表257515EDI纯水电导率表257570EDI出水取样阀257570盲管位置盲管位置DeadLegVerifiedD（直径）D(DiameterSection)3DL（长度）L(LongitudeStretch)评定Evaluation(C/NC)备注Notes纯水箱排污口38114800.1μ精密过滤器出水取样阀3811460步骤/No.备注/Comments步骤/No.备注/Comments测试操作人测试操作人/Testperformedby:签名/Signature日期/Date测试所用计量仪器/Listofequipmentsused:附件列表/Listofattachments测试审核人/Testreviewedby:签名/Signature日期/Date合格/Conform不合格/Nonconform备注/Comments:前提前提/Prerequisite完成/CheckN/A备注：在URS024中我们规定管道的坡度至少为%0.3。在这个测试中我们要求至少0.3%，是符合FDA和GMP法规要求的。Remark:inURS024,wementionedthatthepipingslopesshouldbeatleast1%.Inthistest,wewillcheckthattheyareatleast0,3%,tobeincompliancewithFDAandGMPregulation,andtohavefulldrainageofthesystem.步骤No.测试步骤Stepdescription通过标准Acceptancecriteria试验结果Observedresults合格与否C/NC偏差报告编号Anomalyreference1测量水平安置的管道坡度Measuretheslopeofpipesinhorizontalparts.在最终版竣工图上用黄色标示出已检查的部分，用红色下划线标示偏差部分Onthelastversionofdocument"AsBuiltisometricdrawing”,indicatewhichslopehasbeenchecked(highlightinyellow).Underlineinredanyanomaly.填写下表并附上完成后图纸Fillintablebelow,andjointhecompleteddrawing.不得低于0.3%Minimum0,3%见下表Seetablebelow管道位置Pipelineverification坡度Gradient评定Evaluation合格与否C/NC备注CommentsEDI出水进纯水箱管道0.4%纯水箱出水进纯水泵管道0.35%纯水箱排污管道0.4%0.1μ精密过滤器出水管道0.1μ精密过滤器管道位置管道位置Pipelineverification坡度Gradient评定Evaluation合格与否C/NC备注Comments步骤/No.备注/Comments测试操作人/Testperformedby:签名/Signature日期/Date测试所用计量仪器/Listofequipmentsused:附件列表/Listofattachments测试审核人/Testreviewedby:签名/Signature日期/Date合格/Conform不合格/Nonconform备注/Comments:前提前提/Prerequisite完成/CheckN/A目标objective确认轨道焊接被用到高纯度的金属管道焊接，而且合格的焊接工人利用正确的焊接方法和合格的焊接工具。Checkthatorbitalweldinghasbeenusedforjoininghighpuritymetallicpiping,andthatcertifiedweldershaveusedapprovedweldproceduresandcertifiedequipment.步骤No.验证项目Stepdescription验证内容Acceptancecriteria验证证明文件Observedresults合格与否C/NC偏差报告编号Anomalyreference1有经过批准的焊接步骤ThereareapprovedweldingproceduresWeldingprocedureavailableRef:BJY-PW-HJCX-01BJY-PW-HJCX-022有焊接工人有效证书Weldersareidentifiedandcertificated电焊工证书WeldercertificationavailableRef:TS6JNTG715233有焊接报告Thereisaweldingdiaryavailable(WeldReport)焊接报告WeldreportavailableRef:BJY-PW-HJBG-01