纯化水系统安装确认验证方案

1、纯化水系统安装确认考据及方案纯化水系统安装确认考据及方案纯化水系统安装确认考据及方案校正记录/Revisionhistory:1.0版：初始版本Release1.0InitialRelease部门姓名签字日期FunctionNameSignatureDate拟定人考据代表ValidationAuthorrepresentative审察人维涵保养部门代表MaintenanceReviewerrepresentative赞同人QA经理ApproverforQAmanagerEnglishversion赞同人管理者代表ApproverforManagementbilingualrepresentat

2、iveversion.目的/PURPOSE本方案的目的是考据纯化水系统的设计、制造、安装、运行可否吻合要求。1参照法规与文件/DOCUMENTREFERENCES文件编号ReferenceNo.文件标题TitleURS024药业厂房技术要求URSforJVbuildingVP006纯化水系统考据DIwatersystemQualificationVMP转移项目计划EIAtransferPlanSBE-GP-003考据主程序GeneralProcedureforValidation2职责/RESPONSIBILITIES步骤/Steps部门/Department供应商进行安装确认执行测试/Tes

3、tExecutionIQbysupplier考据部门代表测试结果审察/TestVerificationValidationrepresentative考据部门代表考据报告撰写/WritingthereportValidationrepresentative3定义与缩写/DEFINITIONSANDABBREVIATION缩写/Shortform定义/DefinitionPW纯化水PurifiedwaterRO反浸透ReverseosmosisEDI去离子Electro-deionization4系统描述/SYSTEMDESCRIPTION3南通海发水办理工程有限公司供应3m/h一级反浸透+ED

4、I药用纯化水制取装置。ThesupplierHighfineCo.,Ltdprovides2m3/h1RO+EDIPWsystem.水源为南京市自来水公司供应的自来水.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purewate

5、rsystemprocess.原水箱Rawwatertank原水泵Rawwaterpump多介质过滤器Sandfilter活性炭过滤器Activatedcarbonfilter阻垢剂Scaleinhibitor5m精美过滤器5mprecisefilter高压泵Highpressurepump反浸透系统ROsystemPH调治剂PHadjustorRO水箱ROwatertankEDI水泵EDIwaterpumpEDI系统EDIsystem.纯水箱Purewatertank纯水泵Purewaterpump紫外线杀菌器UV0.1m精美过滤器纯化水制备工艺流程上采用：预办理脱盐（一级RO）EDI后办理

6、等步骤。Processofpurifiedwater:pre-treatdesalt(1RO)EDIposttreatment5.1初办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(5m)作前级办理，去除水中的胶体、有机物、悬浮物、余氯、5m以上的微颗粒以及有效降低水中总硬度。5.2脱盐部分采用一级反浸透的方法，这是纯水制取系统中最为要点的一步。本公司反浸透膜采用国际最为先进、回收率、脱盐率最高的卷式复合膜作为组件资料。一级反浸透去除原水中98以上的阴阳离子以及各种有害菌落和热源，以保证水的脱盐收效，从而保证产品水的最后质量。5.3EDI采用德国

7、西门子公司生产的模堆，此装置经过填充在电池模堆中的树脂吸附水中的金属离子，达到脱盐的目的。EDI系统的特点是脱盐率高，树脂无需使用酸碱再生，拥有较高的产水质量，水的电导率可达到0.5S/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办理。同时，EDI系统还拥有占地面积小、出水水质牢固、运行操作花销低、操作管理方便等优点。5.4后办理采用紫外线杀菌器是为了满足用户对细菌控制的要求，0.1m微孔过滤器是将细菌尸体有效的过滤，从而根本上保证了出水的水质。6考据方案设计原由/QUALIFICATIONSTRATEGY将安装和厂商设计规格作比较。对纯化水质量

8、有影响的因素和功能需要考据.Makeaformalcomparisonbetweentheinstallationandthemanufacturerdesignspecifications.Elementandfunctionswithaqualityimpactneedtobequalified.7考据测试/QUALIFICATIONTEST测试方案编号测试名称ReferencesDescriptionIQ006/1Test1设施考据UtilitiesVerificationIQ006/1Test2设施考据DevicesVerificationIQ006/1Test3文件考据Documen

9、tationVerificationIQ006/1Test4安装考据InstallationVerificationIQ006/1Test5校验考据TagandcalibrationcertificatesVerificationIQ006/1Test6资料证明MaterialVerificationIQ006/1Test7盲管死角考据DeadangleVerificationIQ006/1Test8坡度考据SlopesVerificationIQ006/1Test9焊接考据WeldingVerificationIQ006/1Test10压力考据PressureVerificationIQ00

10、6/1Test11冲刷和钝化考据Verificationofcleaning,passivation8经过标准/ACCEPTANCECRITERIA如满足以下条件，可以经过安装考据：InstallationQualificationisacceptedif:完成所有的测试Allactivitieshavebeenperformed没有不可以接受偏差Noblockinganomalyremains撰写报告并赞同Thereportiswrittenandapproved经过安装考据后方可进行操作考据。TheacceptationoftheIQwillallowthestartofOQ.前提/Pre

11、requisite方案已通Thisprotocolhasbeenapproved操作人行的相关培Operatorsaretrainedforprocessvalidationexecution完成/Check步骤No.1234考据项目Stepdescription供配Electricitysupply/consumption操作范可否合理、安装可否吻合要求Checktheoperativerangeisappropriatetothecorrectoperationofthesystemanditsinstallationissuitableforrequireduse用水Rawwater操作

12、范可否合理、安装可否吻合要求Checktheoperativerangeisappropriatetothecorrectoperationofthesystemanditsinstallationissuitableforrequireduse空气Compressedair操作范可否合理、安装(器，)可否吻合要求Checktheoperativerangeisappropriatetothecorrectoperationofthesystemanditsinstallation(filters,valves)issuitableforrequireduse工蒸汽Industrialstea

13、m操作范可否合理、安装可否吻合要求Checktheoperativerangeisappropriatetothecorrectoperationofthesystemanditsinstallationissuitableforrequireduse内容Acceptancecriteria功率率,水温流量管径力力流量管径附件力管径附件考据标准合格与否偏差报告编号ObservedresultsC/NCAnomalyreference11KW380V（3相5）50Hz8-30oC36m/hDN320.25Mpabar,l/h8mm器、BarDN25器、减.步骤/No.备注/Comments测试操

14、作人/Testperformedby:签字/Signature日期/Date测试所用计量仪器/Listofequipmentsused:附件列表/Listofattachments.测试审察人/Testreviewedby:签字/Signature日期/Date合格/Conform不合格/Nonconform备注/Comments:前提/Prerequisite完成/Check本方案已被赞同Thisprotocolhasbeenapproved操作人已接受执行考据的培训Operatorsaretrainedforvalidationexecution目标objective检查主要的部件，考据安

15、装的部件和现有的技术文件可否一致；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.考据项日考据内容考据标准合

16、格与否偏差报告编号StepdescriptionAcceptancecriteriaObservedresultsC/NCAnomalyreference1PH调治装置1计量泵美国帕斯菲达供应商PulsaafeedeSupplierDosagepump:.步骤No.23考据项日Stepdescription01-TV-0101-PD-01紫外线杀菌灯101-UV-01FlowingUVLAMP原水箱01-TV-02rawwatertank考据内容Acceptancecriteria溶解槽Dissolvedgroove:计量泵型号ModelDosagepump序列号Serialnumber扬程H

17、ead流量flow数量Quantity供应商Supplier型号model数量Quantity波长Wavelength资料Material：供应商Supplier数量Quantity考据标准合格与否偏差报告编号ObservedresultsC/NCAnomalyreference苏州大自然SuzhounaturalX0307BAR4.73L/H1套1set南通海发NantonghighfineUV-51台1set254nm304南通海发Nantonghighfine只1pcs.步骤No.考据项日考据内容考据标准合格与否偏差报告编号Stepdescription原水泵401-PC-01rawwa

18、terpump多介质过滤器501-FM-01SandfilterAcceptancecriteria体积volume资料material储水罐附件Thestoragetankisequipedwith-供应商Supplier型号Model序列号Serialnumber扬程Range流量大小flow数量Quantity型号model数量quantity供应商SupplierObservedresultsC/NCAnomalyreference2m3304360o喷水球/360osprayingball液位控制器/Levelcontroller空气呼吸器/Sparenozzleontop人孔/Ma

19、nhole丹麦格兰富GrundfosCR5-9A96517043P1084947.7m5.8T/h1台1setHF-SL-800台南通海发NantongHighfine.步骤No.考据项日考据内容考据标准合格与否偏差报告编号67Stepdescription活性碳过滤器01-AC-01Activatedcarbonfilter阻垢剂01-TV-0302-01-PD-02ScaleinhibitorAcceptancecriteria尺寸size操作压力Operationpressure填充物Fillingmaterialquartzsand石英砂规格/数量：Quartztype/amount供

20、应商Supplier型号model数量quantity尺寸size操作压力Pressure填充物：Fillingmaterial活性炭规格/数量：石英砂规格/数量：计量泵SupplierDosagepump供应商溶解槽Dissolvedgroove:计量泵型号DosagepumpModelObservedresultsC/NCAnomalyreference8004bar石英砂1-2mm300Kg0.5-1mm600Kg南通海发NantongHighfineHF-TL-8001台8004bar活性碳、石英砂Activatedcarbon,quartzsand4-20目250Kg1-2mm150

21、Kg美国帕斯菲达Pulsaafeede苏州大自然SuzhounaturalX030.步骤No.考据项日考据内容考据标准合格与否偏差报告编号Stepdescription精美过滤器801-JMF-01Precisefilter高压泵901-PC-03pressurepumpAcceptancecriteriaObservedresultsC/NCAnomalyreference序列号Serialnumber扬程7BarHead流量4.73L/Hflow数量：1套Quantity1set供应商南通海发SupplierNantonghighfine型号HF-JMF-203model数量：1台Quan

22、tity1set结构可自由更换滤芯滤芯材质PPmaterial外壳材质304material-过滤精度5mprecision-滤芯规格数量：20英寸*3根Amount20ft*3pcs供应商：丹麦格兰富SupplierGrundfos种类CR5-29Type.步骤No.1011考据项日Stepdescription反浸透膜01-RO-01ROmembranesPH调治装置201-TV-0501-PD-03Scaleinhibitor考据内容Acceptancecriteria型号：Model扬程：160mHead流量大小：5.0t/hflow数量：1台Quantity1pcs供应商：Suppl

23、ier型号：model数量：Quantity工作压力：pressure计量泵SupplierDosagepump供应商溶解槽Dissolvedgroove:计量泵型号DosagepumpModel序列号Serialnumber扬程Head流量flow考据标准合格与否偏差报告编号ObservedresultsC/NCAnomalyreferenceA96513392P10844陶氏DOWBW30-404015根15pcs15bar美国帕斯菲达Pulsaafeede苏州大自然SuzhounaturalX0307Bar4.73L/H.步骤No.考据项日考据内容考据标准合格与否偏差报告编号Stepde

24、scriptionRO水箱1202-TV-01ROwatertankEDI水泵1302-PC-01EDIwaterpumpAcceptancecriteria数量：Quantity供应商Supplier体积：volume数量：Quantity资料：material储水罐附件Thestoragetankisequipedwith:供应商：Supplier：型号Model序列号Serialnumber资料：MaterialObservedresultsC/NCAnomalyreference套1set南通海发Nantonghighfine31m1台1set304360o喷水球360osprayin

25、gball液位控制器Levelcontroller空气呼吸器Sparenozzleontop人孔Manhole丹麦格兰富GrundfosCHI4-40C4J518004P10832316.步骤No.考据项日考据内容考据标准合格与否偏差报告编号StepdescriptionEDI膜块1402-EDI-01EDImoduleAcceptancecriteria扬程Head流量flow供应商supplier型号model数量：Quantity工作压力pressure序列号Serialnumber供应商：Supplier数量：Quantity体积：volumeObservedresultsC/NCAn

26、omalyreference28m4.5t/hIONPUREIP-LXM30Z-11个1pcs5bar81704南通海发Nantonghighfine1只1pcs6m315纯水箱02-TV-02资料：material316LStoragetankofpurifiedwater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No.考据项日考据内容考据标准合格与否偏差报告编号Stepdescription纯水泵1602-P

27、C-02Purifiedwaterpump紫外线杀菌灯21702-UV-01FlowingUVLAMP0.1m精美过滤器AcceptancecriteriaObservedresultsC/NCAnomalyreference供应商：丹麦格兰富Supplier种类：CHI12-25Typw型号D4F518025P10914Model资料：316Material扬程：42mHead流量大小：10t/hflow供应商：南通海发SupplierNantonghighfine型号：UV-10model数量：1台Quantity1set波长：254nmWavelength资料：316LMaterial：

28、紫外线系统附件计时器供应商南通海发SupplierNantonghighfine1802-JMF-01型号：JMF4070.1mmicroholefilterModel：数量：1台Quantity：1set.考据项日考据内容考据标准合格与否偏差报告编号步骤No.AcceptancecriteriaObservedresultsC/NCAnomalyreferenceStepdescription结构：可自由更换滤芯外壳材质316Lmaterial滤芯材质PTEFmaterial过滤精度0.1mprecision-滤芯规格数量40英寸*7根Amount40ft*7pcs.步骤/No.备注/Com

29、ments测试操作人/Testperformedby:签字/Signature日期/Date测试所用计量仪器/Listofequipmentsused:附件列表/Listofattachments测试审察人/Testreviewedby:签字/Signature日期/Date合格/Conform不合格/Nonconform备注/Comments:.前提/Prerequisite本方案已被赞同Thisprotocolhasbeenapproved操作人已接受行的培Operatorsaretrainedforvalidationexecution步No.目与准内容StepdescriptionAc

30、ceptancecriteria竣工(管道施和安装平面As-builtdrawings(P&IDsandIsometrics)所有的技格竣工文件TechnicalspecificationsofAsbuiltdocumentation:allequipments完成/Check明文件合格与否偏差告号ObservedresultsC/NCAnomalyreference号Ref:BJY-PW-PID-3BJY-PE-PMT-1号RefBJY-PW-SBGG-1核可否具所有文件Verifythateachdocumentisavailable.1的安装可否吻合每一份文件的要求。字并注明日期以明已。

31、Takeeachreferenceddocument,checktheinstallationinregardwiththedocumentation,signanddateeachdocumentattestingthatthecheckinghasbeendone.电气，气动图表Electric&pneumaticdiagrams操作和保护手册Operationandmaintenancemanuals建议部件清单Recommendedsparepartslist号Ref:HF-R=E-03-33BJY-PW-QL-1号Ref:号Ref:BJY-PW-BPQD-1号相关部件合格证明文件步/

32、No.注/CommentsRef:.测试操作人/Testperformedby:签字/Signature日期/Date测试所用计量仪器/Listofequipmentsused:附件列表/Listofattachments测试审察人/Testreviewedby:签字/Signature日期/Date合格/Conform不合格/Nonconform备注/Comments:.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。Providedocumentaryevidencethatthewatersyste

33、mhasbeeninstalledandiscorrectlyidentifiedinaccordancewithexistentinstallationdrawings(Asbuiltdiagramsandschemes).测试步骤步骤No.Stepdescription1获取一个“竣工图”。2Obtainacopyofthelastversionof“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).Underlineinredany

34、anomaly附上图纸。Joindrawingstothetest.5考据项目AcceptancecriteriaP&ID图管道部件标签仪表操作考据标准合格与否偏差报告编号ObservedresultsC/NCAnomalyreference安装考据中用到的P&ID图编号能识别AsBuiltP&Idsdrawingsusedininstallationverificationareidentified竣工管道设施图中部件被确认ThecomponentsareidentifiedinAsBuiltP&IDdrawings在图中确认的部件在安装中用标签表记Thecomponentsareident

35、ifiedintheinstallationusingtags仪表安装正确，简单读出上面的数字Theinstrumentsarecorrectlyinstalled,theyareaccessibleandtheycanbeeasilyread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:签字/Signature日期/Date测试所用计量仪

36、器/Listofequipmentsused:附件列表/Listofattachments测试审察人/Testreviewedby:签字/Signature日期/Date合格/Conform不合格/Nonconform备注/Comments:.前提/Prerequisite完成/CheckN/A步骤No.考据项目考据内容考据标准Observed合格与否偏差报告编号StepdescriptionAcceptancecriteriaresultsC/NCAnomalyreference检查所有的重要仪器的计量证书，保证计量范围和精确度吻合工作需求Checkthatcalibrationcertif

37、icatesare见下表见下表1availablewhenneededeandthattheSeetablebelowSeetablebelowcalibrationrangeandprecisionofthecalibrationareadequatefortheinstrumentrangeofworkandprecisionrequired可否需要计量标签描述Needtobetagdescriptioncalibrated(YES/NO）PHT-0101原水PH变送器是yesTT-0101原水温度变送器是yesLT-0101原水箱液位变送器否noTI-0101列管式换热器出水温度表是ye

38、sPI-.0101列管式换热器工业蒸汽压力表是yesPI-0102多介质过滤器压力表是yesPressuremeterofsandfilter活性炭过滤器压力表PI-0103Pressuremeterofactivatedcarbon是yesfilter检查计量标签测量范围精确度Conformityof工作范围备注Measure合格与否certificateWorkscalecorrecremarksscale（C/NC）(yesorno)tness5-80-142.50-500-1002.50-3.0m2.50-1000-2001.50-0.4Mpa0-1.6Mpa1.50-0.5Mpa0-

39、0.6Mpa2.50-0.4Mpa0-0.6Mpa2.5.可否需要计量标签描述Needtobetagdescriptioncalibrated(YES/NO）PI-0104精美过滤器进水压力表是yesPressuremeterofprecisefilterPI-0105高压泵进水压力表是yesFeedwaterPressuremeterofpump高压泵出水压力表PI-0106DischargewaterPressuremeterof是yespumpPS-0101高压泵进水压力开关否noPressureswitchofpumpPI-0107反浸透膜浓水压力表是yesWastewaterPres

40、suremeterofROPI-0108反浸透膜纯水压力表是yesWastewaterPressuremeterofROFT-0101反浸透膜纯水流量变送器是yespurewaterflowmeterofROFT-0102反浸透膜浓水流量计是yeswastewaterflowmeterofROCT-0101原料水电导率表是yesConductivitymeterforRWCT-0102反浸透膜电导率表是yesConductivitymeterforROLT-0201RO水箱液位传感器否noLiquidlevelsensorLS-02PI-0201EDI纯水进水压力表是yesFeedpurewa

41、terpressuremeterofEDIEDI浓水进水压力表PI-0202Dsichargewastewaterpressuremeter是yesofEDI检查计量标签测量范围精确度Conformityof工作范围备注Measure合格与否certificateWorkscalecorrecremarksscale（C/NC）(yesorno)tness0-0.3Mpa0-0.6Mpa2.50-0.3Mpa0-0.6Mpa2.50-1.6Mpa0-2.5Mpa2.50-0.2Mpa0-0.3Mpa1.50-1.4Mpa0-2.5Mpa2.50-0.1Mpa0-0.6Mpa2.50-70LPM

42、0-100LPM2.50-30LPM0-100LPM2.50-1000s0-10000s2.50-30s0-100s2.50-3.0m2.50-0.4Mpa0-0.6Mpa2.50-0.3Mpa0-0.6Mpa2.5.可否需要计量标签描述Needtobetagdescriptioncalibrated(YES/NO）EDI纯水出水压力表PI-0203Dischargedpurewaterpressuremeter是yesofEDIEDI浓水出水压力表PI-0204Dischargedwastewaterpressuremeter是yesofEDIFT-0201EDI浓水进水流量计是yesfee

43、dwastewaterflowmeterofEDIEDI纯水出水流量计FT-0202Dischargedpurewaterflowmeterof是yesEDILT-0202纯水箱液位传感器否noLiquidlevelsensorEDI出水电导率表CT-0201ConductivitymeterforDischarged是yeswaterofEDI检查计量标签测量范围精确度Conformityof工作范围备注Measure合格与否certificateWorkscalecorrecremarksscale（C/NC）(yesorno)tness0-0.3Mpa0-0.6Mpa2.50-0.2Mp

44、a0-0.6Mpa2.50-5LPM0-10LPM2.50-60LPM0-100LPM2.50-3.0m2.50-1s0-100s2.5步骤/No.备注/Comments测试操作人/Testperformedby:签字/Signature日期/Date测试所用计量仪器/Listofequipmentsused:附件列表/Listofattachments.测试审察人/Testreviewedby:签字/Signature日期/Date合格/Conform不合格/Nonconform备注/Comments:.前提/PrerequisiteN/A目标objective查察所有与纯水接触资料的证书文

45、件Checktheavailabilityofcertificatesofmaterialsincontactwiththewater.步骤No.考据项目Stepdescription1原水箱2预办理3中间水箱生产纯水管道（预办理、RO、EDI进水）4Loopsformakingpurifiedwater（Pre-treatROEDIinlet）5生产纯水管道（EDI出水）Loopsformakingpurifiedwater（EDIoutlet）纯水储水罐6Storingtankforpurewater7紫外线杀菌器UV80.1精美过滤器步骤/No.完成/Check考据标准考据证明文件合格与

46、否偏差报告编号AcceptancecriteriaObservedresultsC/NCAnomalyreferenceSSAISI304SSAISI304SSAISI304SSAISI304AISI316LAISI316LAISI316LSSAISI316L备注/Comments.测试操作人/Testperformedby:签字/Signature日期/Date测试所用计量仪器/Listofequipmentsused:附件列表/Listofattachments测试审察人/Testreviewedby:签字/Signature日期/Date合格/Conform不合格/Nonconform备

47、注/Comments:.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.测试步骤经过标准步骤No.AcceptancecriteriaStepdescription试验结果合格与否偏差报告编号ObservedresultsC/NCAnomalyreference1测量主管道的下壁到盲管底部的长度。Measurethelongitudefrommainpipewalltothefinaloftheleg.测量盲管的直径M

48、easurethediameterofdeadangle.填写下表Fillintablebelow所有盲管满足L3D,盲管的长度小于它三倍直径的大小AllthedeadlegsfulfilltheL3Drule,whichmeansthatthelongitudeislessthan3timesitsdiameter见附表seetablebelow盲管地址D（直径）DeadLegVerifiedD(DiameterSection)EDI纯水出水压力表25EDI纯水电导率表25EDI出水取样阀253DL（长度）L(LongitudeStretch)751575707570评定备注Evaluati

49、onNotes(C/NC).盲管地址D（直径）3DL（长度）评定备注DeadLegVerifiedD(DiameterL(LongitudeStretch)EvaluationNotesSection)(C/NC)纯水箱排污口38114800.1精美过滤器出水取样阀3811460步骤/No.备注/Comments步骤/No.备注/Comments.测试操作人/Testperformedby:签字/Signature日期/Date测试所用计量仪器/Listofequipmentsused:附件列表/Listofattachments测试审察人/Testreviewedby:签字/Signatur

50、e日期/Date合格/Conform不合格/Nonconform备注/Comments:.前提/Prerequisite完成/CheckN/A备注：在URS024中我们规定管道的坡度最少为0.3%。在这个测试中我们要求最少0.3%，是吻合FDA和GMP法规要求的。Remark:inURS024,wementionedthatthepipingslopesshouldbeatleast1%.Inthistest,wewillcheckthattheyareatleast0,3%,tobeincompliancewithFDAandGMPregulation,andtohavefulldraina

51、geofthesystem.步骤No.测试步骤经过标准试验结果合格与偏差报告编号否Stepdescription测量水平部署的管道坡度Measuretheslopeofpipesinhorizontalparts.在最后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OnthelastversionofdocumentAsBuiltisometricdrawing”,indicatewhichslopehasbeenchecked(highlightinyellow).Underlineinredanyanomaly.填写下表并附上完成后图纸Fillintablebelow,and

52、jointhecompleteddrawing.AcceptancecriteriaObservedresultsC/NCAnomalyreference不得低于0.3%见下表Minimum0,3%Seetablebelow管道地址坡度评定备注PipelineverificationGradientEvaluationComments合格与否C/NCEDI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%0.1精美过滤器出水管道0.1精美过滤器.管道地址坡度评定备注PipelineverificationGradientEvaluationComments合格与否C

53、/NC步骤/No.备注/Comments.测试操作人/Testperformedby:签字/Signature日期/Date测试所用计量仪器/Listofequipmentsused:附件列表/Listofattachments测试审察人/Testreviewedby:签字/Signature日期/Date合格/Conform不合格/Nonconform备注/Comments:.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.考据项目考据内容考据证明文件合格与否偏差报告编号StepdescriptionAcceptancecriteriaObservedresultsC/NCAnomalyreference有经过赞同的焊接步骤WeldingprocedureRef:1ThereareapprovedweldingproceduresavailableBJY-PW-HJ