純化水系統(tǒng)安裝確認驗證方案

1、純化水系統(tǒng)安裝確認考據(jù)及方案純化水系統(tǒng)安裝確認考據(jù)及方案純化水系統(tǒng)安裝確認考據(jù)及方案校正記錄/Revisionhistory:1.0版：初始版本Release1.0InitialRelease部門姓名簽字日期FunctionNameSignatureDate擬定人考據(jù)代表ValidationAuthorrepresentative審察人維涵保養(yǎng)部門代表MaintenanceReviewerrepresentative贊同人QA經(jīng)理ApproverforQAmanagerEnglishversion贊同人管理者代表ApproverforManagementbilingualrepresentat

2、iveversion.目的/PURPOSE本方案的目的是考據(jù)純化水系統(tǒng)的設(shè)計、制造、安裝、運行可否吻合要求。1參照法規(guī)與文件/DOCUMENTREFERENCES文件編號ReferenceNo.文件標題TitleURS024藥業(yè)廠房技術(shù)要求URSforJVbuildingVP006純化水系統(tǒng)考據(jù)DIwatersystemQualificationVMP轉(zhuǎn)移項目計劃EIAtransferPlanSBE-GP-003考據(jù)主程序GeneralProcedureforValidation2職責(zé)/RESPONSIBILITIES步驟/Steps部門/Department供應(yīng)商進行安裝確認執(zhí)行測試/Tes

3、tExecutionIQbysupplier考據(jù)部門代表測試結(jié)果審察/TestVerificationValidationrepresentative考據(jù)部門代表考據(jù)報告撰寫/WritingthereportValidationrepresentative3定義與縮寫/DEFINITIONSANDABBREVIATION縮寫/Shortform定義/DefinitionPW純化水PurifiedwaterRO反浸透ReverseosmosisEDI去離子Electro-deionization4系統(tǒng)描述/SYSTEMDESCRIPTION3南通海發(fā)水辦理工程有限公司供應(yīng)3m/h一級反浸透+ED

4、I藥用純化水制取裝置。ThesupplierHighfineCo.,Ltdprovides2m3/h1RO+EDIPWsystem.水源為南京市自來水公司供應(yīng)的自來水.TherunningwatersuppliedbyHAIMENRUNNINGWATERCOMPANYistherawwater.純化水水質(zhì)要求達到白敬宇廠房用戶需求文件URS0024中規(guī)定的標準。ProductwatershouldreachesthestandardsasdefinedintheURS0024UserrequirementspecificationforJVbuilding.5純化水系統(tǒng)工藝流程purewate

5、rsystemprocess.原水箱Rawwatertank原水泵Rawwaterpump多介質(zhì)過濾器Sandfilter活性炭過濾器Activatedcarbonfilter阻垢劑Scaleinhibitor5m精美過濾器5mprecisefilter高壓泵Highpressurepump反浸透系統(tǒng)ROsystemPH調(diào)治劑PHadjustorRO水箱ROwatertankEDI水泵EDIwaterpumpEDI系統(tǒng)EDIsystem.純水箱Purewatertank純水泵Purewaterpump紫外線殺菌器UV0.1m精美過濾器純化水制備工藝流程上采用：預(yù)辦理脫鹽（一級RO）EDI后辦理

6、等步驟。Processofpurifiedwater:pre-treatdesalt(1RO)EDIposttreatment5.1初辦理包括氣沖式多層石英砂過濾器（0.5-1；1-2）、活性碳過濾器（4-20目）、蜂房式過濾器(5m)作前級辦理，去除水中的膠體、有機物、懸浮物、余氯、5m以上的微顆粒以及有效降低水中總硬度。5.2脫鹽部分采用一級反浸透的方法，這是純水制取系統(tǒng)中最為要點的一步。本公司反浸透膜采用國際最為先進、回收率、脫鹽率最高的卷式復(fù)合膜作為組件資料。一級反浸透去除原水中98以上的陰陽離子以及各種有害菌落和熱源，以保證水的脫鹽收效，從而保證產(chǎn)品水的最后質(zhì)量。5.3EDI采用德國

7、西門子公司生產(chǎn)的模堆，此裝置經(jīng)過填充在電池模堆中的樹脂吸附水中的金屬離子，達到脫鹽的目的。EDI系統(tǒng)的特點是脫鹽率高，樹脂無需使用酸堿再生，擁有較高的產(chǎn)水質(zhì)量，水的電導(dǎo)率可達到0.5S/cm（25）以內(nèi)，水的利用率最高可達95%，其最大特點是利用電能而不是酸堿化學(xué)對樹脂進行再生辦理。同時，EDI系統(tǒng)還擁有占地面積小、出水水質(zhì)牢固、運行操作花銷低、操作管理方便等優(yōu)點。5.4后辦理采用紫外線殺菌器是為了滿足用戶對細菌控制的要求，0.1m微孔過濾器是將細菌尸體有效的過濾，從而根本上保證了出水的水質(zhì)。6考據(jù)方案設(shè)計原由/QUALIFICATIONSTRATEGY將安裝和廠商設(shè)計規(guī)格作比較。對純化水質(zhì)量

8、有影響的因素和功能需要考據(jù).Makeaformalcomparisonbetweentheinstallationandthemanufacturerdesignspecifications.Elementandfunctionswithaqualityimpactneedtobequalified.7考據(jù)測試/QUALIFICATIONTEST測試方案編號測試名稱ReferencesDescriptionIQ006/1Test1設(shè)施考據(jù)UtilitiesVerificationIQ006/1Test2設(shè)施考據(jù)DevicesVerificationIQ006/1Test3文件考據(jù)Documen

9、tationVerificationIQ006/1Test4安裝考據(jù)InstallationVerificationIQ006/1Test5校驗考據(jù)TagandcalibrationcertificatesVerificationIQ006/1Test6資料證明MaterialVerificationIQ006/1Test7盲管死角考據(jù)DeadangleVerificationIQ006/1Test8坡度考據(jù)SlopesVerificationIQ006/1Test9焊接考據(jù)WeldingVerificationIQ006/1Test10壓力考據(jù)PressureVerificationIQ00

10、6/1Test11沖刷和鈍化考據(jù)Verificationofcleaning,passivation8經(jīng)過標準/ACCEPTANCECRITERIA如滿足以下條件，可以經(jīng)過安裝考據(jù)：InstallationQualificationisacceptedif:完成所有的測試Allactivitieshavebeenperformed沒有不可以接受偏差Noblockinganomalyremains撰寫報告并贊同Thereportiswrittenandapproved經(jīng)過安裝考據(jù)后方可進行操作考據(jù)。TheacceptationoftheIQwillallowthestartofOQ.前提/Pre

11、requisite方案已通Thisprotocolhasbeenapproved操作人行的相關(guān)培Operatorsaretrainedforprocessvalidationexecution完成/Check步驟No.1234考據(jù)項目Stepdescription供配Electricitysupply/consumption操作范可否合理、安裝可否吻合要求Checktheoperativerangeisappropriatetothecorrectoperationofthesystemanditsinstallationissuitableforrequireduse用水Rawwater操作

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

13、m操作范可否合理、安裝可否吻合要求Checktheoperativerangeisappropriatetothecorrectoperationofthesystemanditsinstallationissuitableforrequireduse內(nèi)容Acceptancecriteria功率率,水溫流量管徑力力流量管徑附件力管徑附件考據(jù)標準合格與否偏差報告編號ObservedresultsC/NCAnomalyreference11KW380V（3相5）50Hz8-30oC36m/hDN320.25Mpabar,l/h8mm器、BarDN25器、減.步驟/No.備注/Comments測試操

14、作人/Testperformedby:簽字/Signature日期/Date測試所用計量儀器/Listofequipmentsused:附件列表/Listofattachments.測試審察人/Testreviewedby:簽字/Signature日期/Date合格/Conform不合格/Nonconform備注/Comments:前提/Prerequisite完成/Check本方案已被贊同Thisprotocolhasbeenapproved操作人已接受執(zhí)行考據(jù)的培訓(xùn)Operatorsaretrainedforvalidationexecution目標objective檢查主要的部件，考據(jù)安

15、裝的部件和現(xiàn)有的技術(shù)文件可否一致；記錄名稱，品牌，型號和序列號等其他相關(guān)信息。Characterizethemajorcomponentsoftheinstallationverifyingthattheequipmentinstalledcorrespondswithexistingtechnicaldocumentationandrecordingthefollowinginformationforeachone:designation,brand,model,serialnumberand/orotherrelevantcharacteristics.步驟No.考據(jù)項日考據(jù)內(nèi)容考據(jù)標準合

16、格與否偏差報告編號StepdescriptionAcceptancecriteriaObservedresultsC/NCAnomalyreference1PH調(diào)治裝置1計量泵美國帕斯菲達供應(yīng)商PulsaafeedeSupplierDosagepump:.步驟No.23考據(jù)項日Stepdescription01-TV-0101-PD-01紫外線殺菌燈101-UV-01FlowingUVLAMP原水箱01-TV-02rawwatertank考據(jù)內(nèi)容Acceptancecriteria溶解槽Dissolvedgroove:計量泵型號ModelDosagepump序列號Serialnumber揚程H

17、ead流量flow數(shù)量Quantity供應(yīng)商Supplier型號model數(shù)量Quantity波長Wavelength資料Material：供應(yīng)商Supplier數(shù)量Quantity考據(jù)標準合格與否偏差報告編號ObservedresultsC/NCAnomalyreference蘇州大自然SuzhounaturalX0307BAR4.73L/H1套1set南通海發(fā)NantonghighfineUV-51臺1set254nm304南通海發(fā)Nantonghighfine只1pcs.步驟No.考據(jù)項日考據(jù)內(nèi)容考據(jù)標準合格與否偏差報告編號Stepdescription原水泵401-PC-01rawwa

18、terpump多介質(zhì)過濾器501-FM-01SandfilterAcceptancecriteria體積volume資料material儲水罐附件Thestoragetankisequipedwith-供應(yīng)商Supplier型號Model序列號Serialnumber揚程Range流量大小flow數(shù)量Quantity型號model數(shù)量quantity供應(yīng)商SupplierObservedresultsC/NCAnomalyreference2m3304360o噴水球/360osprayingball液位控制器/Levelcontroller空氣呼吸器/Sparenozzleontop人孔/Ma

19、nhole丹麥格蘭富GrundfosCR5-9A96517043P1084947.7m5.8T/h1臺1setHF-SL-800臺南通海發(fā)NantongHighfine.步驟No.考據(jù)項日考據(jù)內(nèi)容考據(jù)標準合格與否偏差報告編號67Stepdescription活性碳過濾器01-AC-01Activatedcarbonfilter阻垢劑01-TV-0302-01-PD-02ScaleinhibitorAcceptancecriteria尺寸size操作壓力Operationpressure填充物Fillingmaterialquartzsand石英砂規(guī)格/數(shù)量：Quartztype/amount供

20、應(yīng)商Supplier型號model數(shù)量quantity尺寸size操作壓力Pressure填充物：Fillingmaterial活性炭規(guī)格/數(shù)量：石英砂規(guī)格/數(shù)量：計量泵SupplierDosagepump供應(yīng)商溶解槽Dissolvedgroove:計量泵型號DosagepumpModelObservedresultsC/NCAnomalyreference8004bar石英砂1-2mm300Kg0.5-1mm600Kg南通海發(fā)NantongHighfineHF-TL-8001臺8004bar活性碳、石英砂Activatedcarbon,quartzsand4-20目250Kg1-2mm150

21、Kg美國帕斯菲達Pulsaafeede蘇州大自然SuzhounaturalX030.步驟No.考據(jù)項日考據(jù)內(nèi)容考據(jù)標準合格與否偏差報告編號Stepdescription精美過濾器801-JMF-01Precisefilter高壓泵901-PC-03pressurepumpAcceptancecriteriaObservedresultsC/NCAnomalyreference序列號Serialnumber揚程7BarHead流量4.73L/Hflow數(shù)量：1套Quantity1set供應(yīng)商南通海發(fā)SupplierNantonghighfine型號HF-JMF-203model數(shù)量：1臺Quan

22、tity1set結(jié)構(gòu)可自由更換濾芯濾芯材質(zhì)PPmaterial外殼材質(zhì)304material-過濾精度5mprecision-濾芯規(guī)格數(shù)量：20英寸*3根Amount20ft*3pcs供應(yīng)商：丹麥格蘭富SupplierGrundfos種類CR5-29Type.步驟No.1011考據(jù)項日Stepdescription反浸透膜01-RO-01ROmembranesPH調(diào)治裝置201-TV-0501-PD-03Scaleinhibitor考據(jù)內(nèi)容Acceptancecriteria型號：Model揚程：160mHead流量大?。?.0t/hflow數(shù)量：1臺Quantity1pcs供應(yīng)商：Suppl

23、ier型號：model數(shù)量：Quantity工作壓力：pressure計量泵SupplierDosagepump供應(yīng)商溶解槽Dissolvedgroove:計量泵型號DosagepumpModel序列號Serialnumber揚程Head流量flow考據(jù)標準合格與否偏差報告編號ObservedresultsC/NCAnomalyreferenceA96513392P10844陶氏DOWBW30-404015根15pcs15bar美國帕斯菲達Pulsaafeede蘇州大自然SuzhounaturalX0307Bar4.73L/H.步驟No.考據(jù)項日考據(jù)內(nèi)容考據(jù)標準合格與否偏差報告編號Stepde

24、scriptionRO水箱1202-TV-01ROwatertankEDI水泵1302-PC-01EDIwaterpumpAcceptancecriteria數(shù)量：Quantity供應(yīng)商Supplier體積：volume數(shù)量：Quantity資料：material儲水罐附件Thestoragetankisequipedwith:供應(yīng)商：Supplier：型號Model序列號Serialnumber資料：MaterialObservedresultsC/NCAnomalyreference套1set南通海發(fā)Nantonghighfine31m1臺1set304360o噴水球360osprayin

25、gball液位控制器Levelcontroller空氣呼吸器Sparenozzleontop人孔Manhole丹麥格蘭富GrundfosCHI4-40C4J518004P10832316.步驟No.考據(jù)項日考據(jù)內(nèi)容考據(jù)標準合格與否偏差報告編號StepdescriptionEDI膜塊1402-EDI-01EDImoduleAcceptancecriteria揚程Head流量flow供應(yīng)商supplier型號model數(shù)量：Quantity工作壓力pressure序列號Serialnumber供應(yīng)商：Supplier數(shù)量：Quantity體積：volumeObservedresultsC/NCAn

26、omalyreference28m4.5t/hIONPUREIP-LXM30Z-11個1pcs5bar81704南通海發(fā)Nantonghighfine1只1pcs6m315純水箱02-TV-02資料：material316LStoragetankofpurifiedwater儲水罐附件Thestoragetankisequipedwith：360o噴水球/360osprayingball液位控制器/Levelcontroller空氣呼吸器/Sparenozzleontop人孔/Manhole.步驟No.考據(jù)項日考據(jù)內(nèi)容考據(jù)標準合格與否偏差報告編號Stepdescription純水泵1602-P

27、C-02Purifiedwaterpump紫外線殺菌燈21702-UV-01FlowingUVLAMP0.1m精美過濾器AcceptancecriteriaObservedresultsC/NCAnomalyreference供應(yīng)商：丹麥格蘭富Supplier種類：CHI12-25Typw型號D4F518025P10914Model資料：316Material揚程：42mHead流量大?。?0t/hflow供應(yīng)商：南通海發(fā)SupplierNantonghighfine型號：UV-10model數(shù)量：1臺Quantity1set波長：254nmWavelength資料：316LMaterial：

28、紫外線系統(tǒng)附件計時器供應(yīng)商南通海發(fā)SupplierNantonghighfine1802-JMF-01型號：JMF4070.1mmicroholefilterModel：數(shù)量：1臺Quantity：1set.考據(jù)項日考據(jù)內(nèi)容考據(jù)標準合格與否偏差報告編號步驟No.AcceptancecriteriaObservedresultsC/NCAnomalyreferenceStepdescription結(jié)構(gòu)：可自由更換濾芯外殼材質(zhì)316Lmaterial濾芯材質(zhì)PTEFmaterial過濾精度0.1mprecision-濾芯規(guī)格數(shù)量40英寸*7根Amount40ft*7pcs.步驟/No.備注/Com

29、ments測試操作人/Testperformedby:簽字/Signature日期/Date測試所用計量儀器/Listofequipmentsused:附件列表/Listofattachments測試審察人/Testreviewedby:簽字/Signature日期/Date合格/Conform不合格/Nonconform備注/Comments:.前提/Prerequisite本方案已被贊同Thisprotocolhasbeenapproved操作人已接受行的培Operatorsaretrainedforvalidationexecution步No.目與準內(nèi)容StepdescriptionAc

30、ceptancecriteria竣工(管道施和安裝平面As-builtdrawings(P&IDsandIsometrics)所有的技格竣工文件TechnicalspecificationsofAsbuiltdocumentation:allequipments完成/Check明文件合格與否偏差告號ObservedresultsC/NCAnomalyreference號Ref:BJY-PW-PID-3BJY-PE-PMT-1號RefBJY-PW-SBGG-1核可否具所有文件Verifythateachdocumentisavailable.1的安裝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.電氣，氣動圖表Electric&pneumaticdiagrams操作和保護手冊O(shè)perationandmaintenancemanuals建議部件清單Recommendedsparepartslist號Ref:HF-R=E-03-33BJY-PW-QL-1號Ref:號Ref:BJY-PW-BPQD-1號相關(guān)部件合格證明文件步/

32、No.注/CommentsRef:.測試操作人/Testperformedby:簽字/Signature日期/Date測試所用計量儀器/Listofequipmentsused:附件列表/Listofattachments測試審察人/Testreviewedby:簽字/Signature日期/Date合格/Conform不合格/Nonconform備注/Comments:.前提/Prerequisite完成/CheckN/A目標objective給出文件依據(jù)，來說明純水系統(tǒng)已經(jīng)被正確安裝了，和安裝圖上相一致。Providedocumentaryevidencethatthewatersyste

33、mhasbeeninstalledandiscorrectlyidentifiedinaccordancewithexistentinstallationdrawings(Asbuiltdiagramsandschemes).測試步驟步驟No.Stepdescription1獲取一個“竣工圖”。2Obtainacopyofthelastversionof“asbuilt”P&IDdrawings.在圖上用黃色標示出已查過的部分。偏差用紅色下劃線標示。Indicateondrawingswhathasbeenchecked(highlightinyellow).Underlineinredany

34、anomaly附上圖紙。Joindrawingstothetest.5考據(jù)項目AcceptancecriteriaP&ID圖管道部件標簽儀表操作考據(jù)標準合格與否偏差報告編號ObservedresultsC/NCAnomalyreference安裝考據(jù)中用到的P&ID圖編號能識別AsBuiltP&Idsdrawingsusedininstallationverificationareidentified竣工管道設(shè)施圖中部件被確認ThecomponentsareidentifiedinAsBuiltP&IDdrawings在圖中確認的部件在安裝中用標簽表記Thecomponentsareident

35、ifiedintheinstallationusingtags儀表安裝正確，簡單讀出上面的數(shù)字Theinstrumentsarecorrectlyinstalled,theyareaccessibleandtheycanbeeasilyread各部件都可以順利地被操作，而且可以進行維修工作Theaccesstothedifferentcomponentsofthesystemiseasysooperationandmaintenanceworkscanbedone步驟/No.備注/Comments.測試操作人/Testperformedby:簽字/Signature日期/Date測試所用計量儀

36、器/Listofequipmentsused:附件列表/Listofattachments測試審察人/Testreviewedby:簽字/Signature日期/Date合格/Conform不合格/Nonconform備注/Comments:.前提/Prerequisite完成/CheckN/A步驟No.考據(jù)項目考據(jù)內(nèi)容考據(jù)標準Observed合格與否偏差報告編號StepdescriptionAcceptancecriteriaresultsC/NCAnomalyreference檢查所有的重要儀器的計量證書，保證計量范圍和精確度吻合工作需求Checkthatcalibrationcertif

37、icatesare見下表見下表1availablewhenneededeandthattheSeetablebelowSeetablebelowcalibrationrangeandprecisionofthecalibrationareadequatefortheinstrumentrangeofworkandprecisionrequired可否需要計量標簽描述Needtobetagdescriptioncalibrated(YES/NO）PHT-0101原水PH變送器是yesTT-0101原水溫度變送器是yesLT-0101原水箱液位變送器否noTI-0101列管式換熱器出水溫度表是ye

38、sPI-.0101列管式換熱器工業(yè)蒸汽壓力表是yesPI-0102多介質(zhì)過濾器壓力表是yesPressuremeterofsandfilter活性炭過濾器壓力表PI-0103Pressuremeterofactivatedcarbon是yesfilter檢查計量標簽測量范圍精確度Conformityof工作范圍備注Measure合格與否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.可否需要計量標簽描述Needtobetagdescriptioncalibrated(YES/NO）PI-0104精美過濾器進水壓力表是yesPressuremeterofprecisefilterPI-0105高壓泵進水壓力表是yesFeedwaterPressuremeterofpump高壓泵出水壓力表PI-0106DischargewaterPressuremeterof是yespumpPS-0101高壓泵進水壓力開關(guān)否noPressureswitchofpumpPI-0107反浸透膜濃水壓力表是yesWastewaterPres

40、suremeterofROPI-0108反浸透膜純水壓力表是yesWastewaterPressuremeterofROFT-0101反浸透膜純水流量變送器是yespurewaterflowmeterofROFT-0102反浸透膜濃水流量計是yeswastewaterflowmeterofROCT-0101原料水電導(dǎo)率表是yesConductivitymeterforRWCT-0102反浸透膜電導(dǎo)率表是yesConductivitymeterforROLT-0201RO水箱液位傳感器否noLiquidlevelsensorLS-02PI-0201EDI純水進水壓力表是yesFeedpurewa

41、terpressuremeterofEDIEDI濃水進水壓力表PI-0202Dsichargewastewaterpressuremeter是yesofEDI檢查計量標簽測量范圍精確度Conformityof工作范圍備注Measure合格與否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.可否需要計量標簽描述Needtobetagdescriptioncalibrated(YES/NO）EDI純水出水壓力表PI-0203Dischargedpurewaterpressuremeter是yesofEDIEDI濃水出水壓力表PI-0204Dischargedwastewaterpressuremeter是yesofEDIFT-0201EDI濃水進水流量計是yesfee

43、dwastewaterflowmeterofEDIEDI純水出水流量計FT-0202Dischargedpurewaterflowmeterof是yesEDILT-0202純水箱液位傳感器否noLiquidlevelsensorEDI出水電導(dǎo)率表CT-0201ConductivitymeterforDischarged是yeswaterofEDI檢查計量標簽測量范圍精確度Conformityof工作范圍備注Measure合格與否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步驟/No.備注/Comments測試操作人/Testperformedby:簽字/Signature日期/Date測試所用計量儀器/Listofequipmentsused:附件列表/Listofattachments.測試審察人/Testreviewedby:簽字/Signature日期/Date合格/Conform不合格/Nonconform備注/Comments:.前提/PrerequisiteN/A目標objective查察所有與純水接觸資料的證書文

45、件Checktheavailabilityofcertificatesofmaterialsincontactwiththewater.步驟No.考據(jù)項目Stepdescription1原水箱2預(yù)辦理3中間水箱生產(chǎn)純水管道（預(yù)辦理、RO、EDI進水）4Loopsformakingpurifiedwater（Pre-treatROEDIinlet）5生產(chǎn)純水管道（EDI出水）Loopsformakingpurifiedwater（EDIoutlet）純水儲水罐6Storingtankforpurewater7紫外線殺菌器UV80.1精美過濾器步驟/No.完成/Check考據(jù)標準考據(jù)證明文件合格與

46、否偏差報告編號AcceptancecriteriaObservedresultsC/NCAnomalyreferenceSSAISI304SSAISI304SSAISI304SSAISI304AISI316LAISI316LAISI316LSSAISI316L備注/Comments.測試操作人/Testperformedby:簽字/Signature日期/Date測試所用計量儀器/Listofequipmentsused:附件列表/Listofattachments測試審察人/Testreviewedby:簽字/Signature日期/Date合格/Conform不合格/Nonconform備

47、注/Comments:.前提/Prerequisite完成/CheckN/A目標objective確認在純水管道中沒有盲管和死角CheckthattherearenodeadlegsinPurifiedWaterLoopusingthe3Drule.測試步驟經(jīng)過標準步驟No.AcceptancecriteriaStepdescription試驗結(jié)果合格與否偏差報告編號ObservedresultsC/NCAnomalyreference1測量主管道的下壁到盲管底部的長度。Measurethelongitudefrommainpipewalltothefinaloftheleg.測量盲管的直徑M

48、easurethediameterofdeadangle.填寫下表Fillintablebelow所有盲管滿足L3D,盲管的長度小于它三倍直徑的大小AllthedeadlegsfulfilltheL3Drule,whichmeansthatthelongitudeislessthan3timesitsdiameter見附表seetablebelow盲管地址D（直徑）DeadLegVerifiedD(DiameterSection)EDI純水出水壓力表25EDI純水電導(dǎo)率表25EDI出水取樣閥253DL（長度）L(LongitudeStretch)751575707570評定備注Evaluati

49、onNotes(C/NC).盲管地址D（直徑）3DL（長度）評定備注DeadLegVerifiedD(DiameterL(LongitudeStretch)EvaluationNotesSection)(C/NC)純水箱排污口38114800.1精美過濾器出水取樣閥3811460步驟/No.備注/Comments步驟/No.備注/Comments.測試操作人/Testperformedby:簽字/Signature日期/Date測試所用計量儀器/Listofequipmentsused:附件列表/Listofattachments測試審察人/Testreviewedby:簽字/Signatur

50、e日期/Date合格/Conform不合格/Nonconform備注/Comments:.前提/Prerequisite完成/CheckN/A備注：在URS024中我們規(guī)定管道的坡度最少為0.3%。在這個測試中我們要求最少0.3%，是吻合FDA和GMP法規(guī)要求的。Remark:inURS024,wementionedthatthepipingslopesshouldbeatleast1%.Inthistest,wewillcheckthattheyareatleast0,3%,tobeincompliancewithFDAandGMPregulation,andtohavefulldraina

51、geofthesystem.步驟No.測試步驟經(jīng)過標準試驗結(jié)果合格與偏差報告編號否Stepdescription測量水平部署的管道坡度Measuretheslopeofpipesinhorizontalparts.在最后版竣工圖上用黃色標示出已檢查的部分，用紅色下劃線標示偏差部分OnthelastversionofdocumentAsBuiltisometricdrawing”,indicatewhichslopehasbeenchecked(highlightinyellow).Underlineinredanyanomaly.填寫下表并附上完成后圖紙Fillintablebelow,and

52、jointhecompleteddrawing.AcceptancecriteriaObservedresultsC/NCAnomalyreference不得低于0.3%見下表Minimum0,3%Seetablebelow管道地址坡度評定備注PipelineverificationGradientEvaluationComments合格與否C/NCEDI出水進純水箱管道0.4%純水箱出水進純水泵管道0.35%純水箱排污管道0.4%0.1精美過濾器出水管道0.1精美過濾器.管道地址坡度評定備注PipelineverificationGradientEvaluationComments合格與否C

53、/NC步驟/No.備注/Comments.測試操作人/Testperformedby:簽字/Signature日期/Date測試所用計量儀器/Listofequipmentsused:附件列表/Listofattachments測試審察人/Testreviewedby:簽字/Signature日期/Date合格/Conform不合格/Nonconform備注/Comments:.前提/Prerequisite完成/CheckN/A目標objective確認軌道焊接被用到高純度的金屬管道焊接，而且合格的焊接工人利用正確的焊接方法和合格的焊接工具。Checkthatorbitalweldinghasbeenusedforjoininghighpuritymetallicpiping,andthatcertifiedweldershaveusedapprovedweldproceduresandcertifiedequipment.步驟No.考據(jù)項目考據(jù)內(nèi)容考據(jù)證明文件合格與否偏差報告編號StepdescriptionAcceptancecriteriaObservedresultsC/NCAnomalyreference有經(jīng)過贊同的焊接步驟WeldingprocedureRef:1ThereareapprovedweldingproceduresavailableBJY-PW-HJ