dg15006 dg01 t该作为测试主用来验证LYOTK0 5冻干机安装和操作与

SITMasterSIT主文Objectives目的

UsethisasthemastertesttoverifythattheLYOTK0.5lyophilizerisinstalledandoperatedinaccordancewiththeURSandtheassociateddesign该文档作为测试主文档，用来验证LYOTK0.5URSCustomerName:用

江苏恒瑞

Author编制NameSignatureDateReviewedBy审核NameSignatureDateApprovedBy批准NameSignatureDateProjectNote:Theexpirydateofapapercopyofthisisthedayitwas注意:Revisionhistory版本记录DateNameDescriptionFirstrevision,SITmasterreleasefortheprojectAdaptfottheprojectListofNomenclatureandAbbreviations术语和缩 Systemdescription系统描 ProjectConfiguration项目配 AcceptanceStandard验收标 ExecutionRequirements执行要 ExecutionRules&Practices执行标准&测 TestEquipmentCalibrationReview测试仪器标定审 FabricationComplianceVerification制造完整性确 VesselVerification压力容器验 ShelfStackVerification板层组验 WeldLogReview焊接记录审 MaterialReviewofTheSterileComponents无菌部件材料审 InstrumentationCalibrationReview测量元件校验审 Designcomplianceverification设计符合性确 GADrawingComplianceReview总图符合性审 P&IDDrawingComplianceReviewP&ID图符合性审 BOMReview材料审 PLCInput/OutputVerificationPLC输入/输出验 HardwareInterlocksVerification硬件互锁验 SecurityAccessVerification安全验 SCADADigitalI/OsVerificationSCADA数字量输入输出验 SCADAogI/OsVerificatiosSCADA模拟量I/Os验 SCADAAlarmsVerificationSCADA验 RecipeDevelopment/MaintenanceVerification配方开发/验 ProcessReportVerification过程报表验 SCADAScreenFunctionsVerification界面功能验 PLCLogicsVerificationPLC逻辑验 PLCAlarmLogicsVerificationPLC逻辑验 ManualControlVerification手动控制验 zeDryingCycleSequenceVerification冻干周期次序验 CondenserDefrostingCycleSequenceVerification冷阱除霜周期次序验 CIPCycleSequenceVerificationCIP周期次序验 SIPCycleSequenceVerificationSIP周期次序验 SystemLeakTestCycleSequenceVerification系统漏率测试周期次序验 ShelfRamBellowsTestCycleSequenceVerification板层波纹管测试周期次序验 MainValveBellowsTestCycleSequenceVerification主轴波纹管测试周期次序验 ShelfTemperaturePerformanceVerification板层温度性能验 CondenserTemperaturePerformanceVerification冷阱温度性能验 VacuumIntegrityTest真空完整性测 MainValveBellowsIntegrityTest主阀波纹管完整性测 ShelfRamBellowsIntegrityTest板层压塞波纹管完整性测 CIPCoverageVerificationCIP覆盖率验 SIPEffectivenessVerificationSIP效力验 NomenclatureandAbbreviationsThefollowingnomenclatureandabbreviationsareallowedtobeusedinthismasterandtheappendices(whereapplicable)本主控文件和附录允许使用以下术语和缩写（适用条件下）： Trukingtechnologylimited BillOfMaterial Bio-ProcessingEquipment CleanInce在 CodeofFederalRegulations DifferentialPressure ElectricalCircuitDiagrams EmergencyStop Firmware FilterIntegrityTest FunctionalSpecifications GeneralArrangement standard国标:中国国标缩写 GoodManufacturingPractices药品生产规 HardwareDesignSpecifications Hardware HumanMachineInterface InputOutput输入/ InternetProtocol InstallationQualification LiquidRingPump(液环泵、水环泵) MaterialTrackingRecords物料记录 NotApplicable不适用 NotMachineRelated Number OriginalEquipmentManufacturer OperatorInterfacePanel OperationQualification PartNumberP&I PiandInstrumentationDiagrams管道和设备原理图设 alComputer个人计算 bleLogicController PurifiedWater SerialNumber Software SupervisoryControlAndDataAcquisition上位机监视控制及 ToBeAgreedToBeDeterminedUninterruptiblePowerSupplyUniversalSerialBusUSBrInternalTestingWaterForInjectionSystemdescriptionProjectConfigurationThefollowinguserrequirementsspecificationdefinetherequirementsforLYOTK0.5Lyophilizer,Thesummarywillhavethefollowingkeyfeatures：LYOTK0.5MainChamberWithIntegratedCondenserSideAccessDoor，Locatedinthesterileroom4+1or2+1Shelves,AndTheDemensionOfTheShelvesWith315mmX455mmX18mm4+12+1层板层,315mmX455mmX18mmShelfInterDistanceBetween2ShelvesWith185mmor100mmInterDistance.185mmTotalShelfAreaOf0.5M2HydraulicStopperingSystem闭锁系FaceSealingMainValveSeparatingCondenserFormChamberStopperingRamCoveredWithStainlessSteelBellowsMainValveRamAlsoCoveredWithStainlessSteelBellowsIntegratedClean ce(CIP).IntegratedInce(SIP)灭PCOperatorInterface,PCOperatorInterfaceWindows7采用电脑操作，电脑操作界面为Windows7PLC.采用的PLC12ChannelYokogawaChartRecorder12SCADAAdoptNETSCADA.SCADA自动化组态软件采用CFR21Part11Compliant符合CFR21第11部VesselCodedInAccordanceWithGB150GB150NozzlesCodedInAccordanceWithASMEBPE管口符合ASMEBPEMetricUnitsOfMeasurement.AcceptanceStandardTheLyoturking0.5Lyophilizershallmeetthefollowingfunctionalacceptancecriteria(asverifiedduringtherInternalTestingandFactoryAcceptanceTesting)Lyoturking0.5冻干机的验收标准符合以下功能要求(适用于制造商内部测试和工厂验收测试FunctionAcceptance1ShelfCoolingTime(20Cto-40C,No板层冷却时间(20Cto-40C,空载液氮制冷452ShelfUltimateCooling(NoLoad)板层最低温度(空载–60.03ShelfHeatingRate(NoLoad)板层加热速率(空载>1.0°C/4ShelfUltimateHeating+805ShelfUniformityBetweenAllShelves(No板层温度均一性(空载6Shelftemperaturecontrolaccuracy+/-2°C(basedonproportionalcontrolofbothheatingandcooling和冷却7Condensorcoolingtimefrom20Cto-4020C至-40C308CondenserUltimateCooling9VacuumPerformanceto0.1mbar30Vacuumcontrolrange0.05to0.5mbar,accuracy0.005mbaroverthecontrolrange.0.05至0.5mbar，在真空范围内精确度为UltimateVacuum0.005mbarVacuumsystemleakagerate0.03mbarL/S(0.003Pam3/CIPCoverageCIP99%CoverageOfMainChamberStopperingRamBellowsIntegrityTopasspumpdownMainValveBellowsIntegrityTopasspumpdownCondenserCapacitySIP灭>121.0°CAtalldrain所有排水温度ExecutionRequirementsExecutionRules&Practices执行标准&Eachtestwillbeperformedaccordingtotheestablishedtestingprocedure.Initialsoftheperformingthetestandthedateinwhichthedatawascollectedwillbeusedtocertifythatthetestwasexecuted.Ifanyadditionalinformationneedstobeed,thecommentssectionwillbeused.Afterthecompletionofeachtest,thedataobtainedwillbereviewedbyasecondtocertifythatthetestwasperformedcompley,thatthetestingnwasfollowedandtoassureadequateationhasbeenprovided.Thiswillinitialanddateeachdataform(ReviewedBy).Theacceptancecriteriaareconsideredtobemetwhenthecollecteddatademonstratethattheequipmentconditionand/oroperationareconsistentwiththerequirementsandacceptancecriteriadescribedinthisprotocol.Anydeviationfromtheprotocol’stestingprocedureoracceptancecriteriamustbeevaluatedimmediay,inordertodeterminetheimpactonnormaloperationoftheequipment.Acorrectiveaction(resolution)shouldbeassignedbeforecompletionofthisprotocol.TheexceptionalconditionandassignedresolutionshallbeedonanExceptionalConditionFormlocatedinsection3.2ofthisprotocol.（与/或操作测试文档中测试程序或验收标准不符的项目必须立即进行评估,以确定导致设备运行的因素，完成测试文档前要做一个纠正方案(解决方案)，将偏差和纠正措施记录在标准偏差表中。Thefollowingarethegeneralationrulesthatapplytothis.本文档遵循以下记录规则Qualifiednelmustperformalltests所有测试必须由有资质人员执行 Allentriesandmanualadditionsandnotesmustbeinitialedanddated.所有条目，手册附件和注释应当Ifamistake(whichisselfevident)ismade,ceasingle-linecrossoutfollowedbyinitials/date.Includeanexnationofthechangeinthecommentsectionornexttothechange.如果发生错误（是不证自AllentriesmustbeinpermanentblueinkAllsupportingationmustbelogged.所有支持文件应当做标识Anyindividualinvolvedintheexecutiononthismustregisteronthesignaturelog.该文档执行Anyblanklineorblankspacemustbefullycrossedthroughwithasinglediagonallineinitialedanddatedalongtheline.所有空白行或空白空间必须划上一条横线，签名并标注日期。Whencompletinginformationonthevariousattaents,writeN/AifnotapplicableorN/AVifnotavailableN/AN/AV。Annotationsand/orhandwrittencorrections,notes,etc.,thataremadeonthetestprotocolsandtestscripmustbeinitialedanddatedbytheindividualmakingtheannotationAnnotationmaynotobscuretheoriginaltextorcontentofthe.Annotationmaybemadeinavarietyofsituations,includingbutnotlimitedto测试主文档中做的注释和/或手写的修正、记录等,必须由个人签字和标注日期，并作出解释。”注释”CorrectionofobvioustypographicalerrorsAnysubstantivechangetopreapprovedprotocol/testscriptrequiresreviewandcreationofaprotocoldeviation.任何对已认可的测试文件或检验的大的变动需要生新评审并指明纠正办法。Crossreference交叉 whoexecutestheprotocolwillsigntheirnameorinitialsanddateintheVerifiedBy/box执试人员必须在”测试人/日期”一栏签字并标注日期 whoreviewstheprotocolwillsigntheirnameorinitialsanddateintheReviewedBy/line审核测试人员必须在”审核人/日期”AlltestsorevaluationmustbeperformedusingthemanualsandanyotherationrelatedtotheequipmenttobetestedinordertoverifyiftheyreflecttheactualconfigurationandfunctionalityoftheExceptthevesselationpackage,anyattachedpaperevidences(includingthescreenprintoutsmustbesignedbytheverifierVerifiedByDate)除了压力容器文档外,任何附加的证明文件(包括屏ThefollowingpracticesareimpliedinthetestexecutionExceptfortestingofsecurityaccess,loginSCADAsystemasanauthorizedoperatoris除了验证安全权限外，以登录SCADA系统是必须的Ifnotspecifiedspecially,thevacuumunitisbarinthemetricunit，absolutepressure(Vacuum)measurement如果没有特别，压力单位为公制单位bar,采用绝对压力（真空）。WhilePLCbitisoperatedviaPLCprogrammingtool.PLCPLCthewordofSwitchONOFF’meansthebitoperatedmanuallycanstillbecontrolledbyPLClogics;“开/关”意味着手动操作位仍然可被PLC逻辑控制;thewordof‘Set/Reset’meansthebitisdON/OFF,andcan’tbedrivenbyPLClogics;“设置/复位”意味着位被强制为开/关，不能被PLC逻辑驱动；thewordof‘RecovermeansreturningthebittotheoriginalstateOncetheseexecutionrequirementshavebeenread,signthesignatureloginSection3.1.1SignatureLogAllnelenteringinformationinthisprotocolmustcompletethesignaturelog.所有执行该测试文档的个人信Name/Dept.公司/部门ExceptionalConditionsThefollowingtestsituationsarerequiredtoberecordedasExceptionalConditionsinExcelspread以下测试情形要求记录偏差在一个ExcelAnacceptancecriteriaisnotmet.Adrawingerrorisidentifiedandannotatedthusmarked“nointhe“Compliant?”columnoftheresultstable.确认并标注的图纸错误；这样的话，应在结果表格的“是否符合？”栏内填写“否”。The“actualresults”donotmatchthe“expectedresults”ofatestscript.“实际结果”“预期结果”Aprotocolgenerationerrorisfoundwhichisnotanobvious(obviouserrorsmaybecommented,initialed&dated).发现测试方案的错误，且该错误不明显（显而易见的错误可以被注解、签名且注明ForeachexceptionlisttheECDescriptionCorrectiveActions,PerformerState,VerifierandDate.异议，须注明编号，描述，修正方式，执行者，，检验者，日期AfteralltheexceptionsareclosedsignandattachtheExceptionalConditionssheetasappendix1.所有的异议1。Pre-TestVerificationTestEquipmentCalibrationReviewObjectivesTorecordthecalibrationinformationforthetestequipmenttobeusedtoexecutethisprotocolandtoverifythatalltestequipmentusediswithinitscalibrationdatesforthedurationofthetesting记录执行主文档测试中使用ProceduresCompletealistoftheinstrumentsusedtoexecutethisprotocol,recordingInstrumentName/Model/SerialNo./CalibrationDate/CalibrationDueDate/Attached?/VerifiedBy/Date.制作一份需在测试中使用到的仪器，该包含仪器名称/型号/序列号/标定日期/附加证明？/验证人/日期。Usethespacesprovidedintheresultstabletoinstruments,andverifyallTestEquipmentisinacalibratedstateatthetimeofuseandcalibrationcertificationisavailable.在结果认定表上记录仪表信息，Attachthecalibration(s)foreachtestinstrumenttothistest.将测试仪表的标定附加在测试AcceptanceCriteriaAllinstrumentsusedtoexecutethetestinginthisprotocolareinacalibratedstateandwillbeforthedurationofthetesting.验证过程中使用的所有测试仪器均已校验，并且在整个测试期间内有效。ResultsTestEquipmentCalibrationReviewModelDueDateAttached?VerifiedBy/AcceptanceCriteria(Yes/No):验收标准符 （是/否

IfnotrefertoECReviewedByDate日期FabricationComplianceVerificationVesselVerificationObjectivesToverifythevesselsarefabricatedaspertheoutlinedrawingsandtechnicalrequirements,andationpackage(includingthematerialsfortheproductcontactparts)areprovidedasverifiedbytheVesselVerificationChecklistNote：theproductcontactpartsincludeanypartwhichisinafluidpathwayorthatcontactstheinteriorofthevessel,suchaspi,dischargedoor,Mainvalve,flangeect.备注:ProceduresObtainacopyofVesselVerificationChecklistwhichisrequiredtobecompletedbythevesselinspectorbeforethevessleisassembled.获得一份容器检验，要求容器检验员在容器装配之前完成。Performaspotcheckofthechecklistonsite,andidentifythoseitemswhichhavebeenverifiednotingasnecessarythoseitemsinnoncompliance.对检查表进行现场，确认检查表中的不合格项。CompletetheresultstableAttachthecopyoftheverifiedVessleVerificationChecklisttothistest.附上检验过的容器检验副件AcceptanceCriteriaThatthevesselfabricatedareinaccordancewiththeVesselVerification制作的容器与容器检验一致-ObtainacopyoftheVesselVerificationChecklist,andrecordthe1informationhere获得一份容器检验，并记录文件信息DoumentNo.文件编号: Date日期: Rev版本: 2VerifythattherequirementsoftheVesselVerificationChecklisthavemet.符合检验容器检验的要求3Verifytheationpackage(includingtheverifiedinthechecklist.确认文件包(包括材质证明)s)4VerifythecopyofverifiedVesselVerificationChecklistissigned/datedAcceptanceCriteriaMet?(Yes No):验收标准符合（是/否

IfnotrefertoECReviewedByDate日期ShelfStackVerificationObjectivesToverifytheinsidedrumisfabricatedasperthedrawings&technicalrequirementsasverifiedbytheStackVerificationChecklist.验证板层组的制造是否按设计图纸和技术要求进行，按照板层组检验进行确ProceduresObtainacopyofShelfstackVerificationChecklist.获得一份板层组检验Followthestepslistedandtheverifiedresultsinthechecklist.Identifythoseitemswhichhavebeenverifiedwithnotingasnecessaryinnoncompliance.按照检验的步骤进行检验，并记录验证结果。同时确认检查表中的不合格项CompletetheresultstableAttachthecopyoftheverifiedShelfStackVerificationChecklisttothis附上检验过的板层组检验副件AcceptanceCriteriaThattheshelfstackfabricatedareinaccordancewiththedrawingsandtechnicalrequirementsasverifiedbytheShelfStackVerificationChecklist.制作的板层组经验证与板层组检验一致，符合图纸和技术要求Results结果ShelfStackverificationObtainacopyoftheShelfStackVerificationChecklist,andrecordthe1informationhere获得一份板层检验，并记录文件信息Reference参见: 2VerifythattherequirementsoftheShelfStackVerificationChecklistbeenmet确认符合板层组检验要3VerifythecopyofverifiedShelfStackVerificationChecklistissigned/andattached.确认验证过的板层组检验已经签名，注明日期并附在后面AcceptanceCriteriaMet?(Yes No):验收标准符合（是/否

IfnotrefertoECReviewedByDate日期WeldLogReviewObjectivesToverifythesupportingationofthesystemweldsisavailableandcomplete.Theationincludesamapwhichidentifieseachproductcontactweldexistingonthecleanpisystem(identifiedbyweldnumber),aweldlog(referencingtheweldjointnumber,material,materialandetc)andasrequiredvisualandinspectioninformation.Thematerialcertificationmustbeclearlycrossreferencedtotheweldnumberstoaidindentification.确认焊接体系的支持文件是有用及完善的。该支持文件包含确定洁净管道中与物料接触部分焊点的示意图（点编号），焊接记录（涉及焊接接头的编号，材料，材质证明等）及必要的形式或形式的检验报告。材料Note:ProductContactWeldincludesanyweldwhichisinafluidpathwaythatcontactstheinteriorofchamberorcondenser(i.e.CIP/SIPpi,pure andsterileairinletpi,etc.).备注：（CIP/SIP入管路等ProceduresObtaintheweldmap,weldLogandvisualandinspectionreportregardingtheproductcontactweldsofthesystem.取得焊点示意图，焊接记录和系统中与物料接触部分焊点的目视和的检查报告Followthestepslistedintheresultstableandtheverifiedresult.按照结果表的步骤进行检查，Attachthecopyofthefollowingtothistest.WeldlogWeldmapMaterialsinvolvedintheweldlog焊接记录中涉及的材质AcceptanceCriteriaAllweldsareedcorrectlyintheweldmapandweldlog.Inadditionallinformation,includingheatnumbersandmaterialsarefullytraceabletotheweldsonthesystem.Results结果WeldLogReview1Entertheweldmapreferencedateandrevision填写相应焊点图，日期和版本Reference参见: 2Entertheweldlogreferencedateandrevision填写相应的焊接记录，日期和版Reference参见: 3VerifythattheWeldMapincludesallproductcontactweldsonthe4VerifythattheWeldLogreferenceallweldsontheWeldMap.5VerifythatthedetailsarecompleteintheirentiretyforeachweldintheLog.6VerifythatweldsthathavebeenvisuallyandinspectedareclearlyidentifiedintheWeldLog.验证焊缝经目视和检验，并在焊接记录上清楚识7Revieweachitemintheweldlog,andverifythetraceabilitytothematerialcertificationiscorrect.Identifyintheweldlogthoseitemswhichhavebeenverifiednotingasnecessarythoseitemsinnoncompliance8Reviewthematerialcerifiactionofthecleanpisysytem,verifythattheinformationinthiscerificationiscomplete.审核洁净管道系统的材质，确认材质上的信息是完善9Verifytherequiredattaentsaresigned/datedandAcceptanceCriteriaMet?(Yes No):验收标准符合（是/否

IfnotrefertoECReviewedByDate日期MaterialReviewofTheSterileComponentsObjectivesToverifysupportingationoftheAS-builtmaterialintheshelfstackandsterilesystemisandcomplete.Thesupportingationincludesasummarymaterialsheetandreferencematerialcertifications.includesasummarymaterialsheetwhichidentifieseachcriticallocationalongwithreferencetothematerialofconstructionwhichissupportedbymaterialcertifications验证无菌系统使用材料的支持文件是有用及完善的，支持文件包含材料汇总表及相关的材料Note备注:ThevesselmaterialsareNOTincludedhereandverifiedin5.1VesselProceduresObtainthesummarymaterialsheet(thesterilesysytem),whichincludedtolistthefollowing(notlimitedto)information取得无菌部分材料汇总表，应包含以下信息：MaterialNamePartNumber(tagnopleaseensuretheasP&IDdrawingisprovidedtolocatethepart.Specification/MaterialType材料规格/Materialreferencecerification(incldingthecertificationNoreferencedtotheapplicablecomponent)材料相关证明材料(含编号以便与相应部件对应)Followthestepslistedintheresultstableandtheverifiedresult.按照结果表的步骤进行检查Attachthecopyofthefollowingtothistest.SummarymaterialsheetofsterilecomponentsMaterialsforthesterilecomponentsreferencedtotheapplicablecomponent涉及到的Ifapplication,theFDAofconformityforthediaphragmsofsterilevalvesshouldbe如适用，无菌阀门的膜片应提供FDA符合性AcceptanceCriteriaAllthesforthesterilecomponentsareprovidedtocreatethematerialtrackingasverifiedintheresultstable.通过结果栏的验证，无菌部件的材料证明已经提供，且能进行材料的追溯。Results结果-MaterialCertificationReview材料审ObtaintheSummaryMaterialSheetfortheSterileComponents,and1thefileinformationhere取得无菌部件的材料汇总表，且记录文件信息Reference参见: 2VerifythematerialtraceabilityinthesheetofSterileComponentsisVerifythematerialsaregroupedasperSterileSystem,and3prefacepageisusedforthegrouptolistthenumberandindex.验证按照无菌系统将材料证明归类，并使用一张封面列出编号和码4Verifytherequiredattaentsaresigned/datedandattached.验证要求的AcceptanceCriteriaMet?(Yes No):验收标准符合（是/否

IfnotrefertoECReviewedByDate日期InstrumentationCalibrationReviewObjectivesTorecordthecalibrationinformationforthesysteminstrumentslocatedontheequipment.ProcedureObtainacopyoftheSystemInstrumentListcontainingtheinstrumentsonthesystemwhichrequireroutinecalibration,ThelistshouldcontaintheappropriateinformationsuchasInstrumentName/TagNo./Manufacturer/Model/SerialNo./No.取得一份系统测量元件汇总表，该表包含元件名称/号/Revieweachinstrumentinthelistagainsttheinstalledonthesystem.Identifyonthelistthoseitemshavebeenverifiednotingasnecessarythoseitemsinnoncompliance对照系统实际安装，验证上元件Calibrateallinstrumentsonlineasverifiedbytheloopcelibrationrecord,recordthecelibrationresults.在Verifythateachcriticalinstrumenthasacalibrationandtheinstrumentisinacalibratedstateatthetimeoftesting验证测量元件有外部校准，且整个测试在校验有效期内。CompletetheresultstableAttachthecopyofthefollowingtothistestSystemInstrumentListLoopcalibrationrecordAcceptanceCriteriaAllsysteminstrumentationwhichrequireroutinecalibrationareinacalibratedstateatthetimeofthetestexecution,withcalibrationsavailable所有需要例行校验的测量元件在测试过程中处于校验有效期内，并-ObtaintheSystemInstrumentationList,andrecordthefileinformation1取得一份系统测量元件汇总表，且记录文件信息Reference参见: 2VerifythattheSystemInstrumentListinformationisthesameasinstalledthesystem验证该与系统实际安装一3Verifythateachcriticalinstrumenthasacalibration(perthenumber)andtheinstrumentisinacalibratedstateatthetimeoftesting.验证测量元件有外部校准(记录号)，标注出来，且整个测试在ObtaintheLoopcalibrationRecord,andrecordthefileinformationhere4一份回路校准记录，且记录文件信息Reference参见: Date日期: Rev版本: 5Verifyallthecalibratationson-linehavebeenfinishedasreviewcalibrationRecord审核回路校准记录，验证所有的校验已经完6VerifytherequiredAcceptanceCriteriaMet?(Yes No):验收标准符合（是/否

IfnotrefertoECReviewedByDate日期DesigncomplianceverificationGADrawingComplianceReviewPurposeToverifythatthe“As-Built”GeneralArrangement(GA)Drawing(s)reflecttheoveralldimension,criticalcomponentlocationandutilityconnectionsastheyareinstalledonthesystemProceduresObtainacopyofthe‘AsBuilt’GADrawing(s),andrecordtheDrawingNo.,DrawingTitle,RevisionandDateintheresultstable.取得一份竣工整体布局图，并在记录表中记录图纸编号、标题、版本号和日期。Followthestepslistedintheresultstable,andtheverifiedresults.IdentifyontheGAdrawing,usinga‘highlighterpen(Ifitiscorrect,makeitonthedrawingbygreencolor;ifitiswrongmakeitonthedrawingbyredcolor),thoseitemswhichhavebeenverifiednotingasnecessarythoseitemsinnoncompliance.逐步填写结果栏，记录检验结果，在整体布局图上用记号笔（如果正确，用绿色在图纸上标AttachtheverifiedGADrawingtothistest,thismustbesignedanddatedbytheAcceptanceCriteriaThe“As-Built”GADrawing(s)reflecttheoveralldimension,criticalcomponentlocationandutilityconnectionsastheyareinstalledonthesystem.-1Obtainthe“AsBuilt”GADrawing(s),andrecordthedrawinginformation取得一份设备竣工总图，并记录图纸信息Reference参见: 2Verifytheoveralldimensions(L×W×H,includingthe+1%5tolerance.检验外形尺寸（长×宽×高，包括sizes尺寸）在+1%3VerifythecriticalcomponentslaidoutasdescribedintheGAdrawings(Noexactmeasurementisrequiredhere.)TheyaretypicallytheCompressors,WaterCondenser(s),VacuumPump(s),Heater,CirculationPump(s),HydraulicStation,Expansion真空泵，加热器，循环泵，站，膨胀箱，热交换器和电气4VerifiedthepositionandconnectorofallutilityconnectionsisasdescribedtheGADrawing(s).5VerifythepositionofallwarningpanelsareasdescribedintheGA6VerifyacopyoftheverifiedGADrawingissigneddatedandattachedAcceptanceCriteriaMet?(Yes No):验收标准符合（是/否

IfnotrefertoECReviewedByDate日期P&IDDrawingComplianceReviewP&IDPurposeToverifythatthe‘AsBuilt’Process&InstrumentationDiagrams(P&ID)reflectthe‘AsBuilt’conditionofPisystemandinstrumentationProceduresObtainacopyofthe‘AsBuilt’P&IDDrawings,andrecordtheDrawingNumber,DrawingTitle,RevisionandDateintheresultstable.Reviewthe‘AsBuilt’P&IDDrawings(includinganysettingvalues)againstthe‘AsBuilt’conditionofthesystem.Identifyonthedrawings,usinga‘highlighter’pen(Ifitiscorrect,makeitonthedrawingbygreencolor;ifitiswrongmakeitonthedrawingbyredcolor),thoseitemswhichhavebeenverifiednotingasnecessarythoseitemsinnoncompliance.审核工艺管道仪表图（包括任何安装阀门）符合系统条件。在检验图纸上用色笔（Completetheresultstable.AttachtheverifiedP&IDDrawingstothistest,whichmustbesignedanddatedbytheAcceptanceCriteriaThe“AsBuilt”P&IDDrawingsreflectthe‘AsBuilt’conditionofthe6.2.4.ResultsP&IDDrawingVerificationP&ID1Obtainthe“AsBuilt”P&ID(s),andrecordthedrawinginformationhere获得竣工的P&ID图一份，记录图纸信息:Reference参见: 2Verfythe“AsBuilt”P&IDDrawingsreflectthe‘AsBuilt’conditionofsystem.竣工P&ID3VerifyacopyoftheverifiedP&IDDrawingsaresigned/datedand确认一份验证过的P&IDAcceptanceCriteriaMet?(Yes No):验收标准符合（是/否

IfnotrefertoECReviewedByDate日期BOMReview材料审PurposeToverifythatthe‘AsBuilt’billofmaterial(BOM)reflectsthe‘AsBuilt’conditionofthe验证竣工版的材料（BOM）反映系统实际制造情况ProceduresObtainthe‘AsBuilt’BOM,andrecordthereference,revisionanddateintheresults获取系统竣工版BOM，并在结果栏中记录参考、版本和注明日期Reviewthe‘AsBuilt’BOMagainstthe‘AsBuilt’conditionsofthesystem.IdentifyonBOMthoseitemswhichhavebeenverifiednotingasnecessarythoseitemsinnoncompliance.对照竣工版BOM表核对系统实际，并在BOM表中标识出那些确定不符合设计的项目Completetheresultstable.AttachacopyoftheverifiedBOMtothistest,whichmustbesignedanddatedbythe将验证过的BOM表附在本测试后，BOMAcceptanceCriteriaThe‘AsBuilt’BOMreflectsthe‘As-Built’conditionofthe竣工版的材料（BOM）反映了系统实际制造情况Results结果-BillOfMaterial(BOM)Verification材料审Obtainthe“AsBuilt”BOM,andrecordthedrawinginformationhere1的材料一份，记录文件信息Reference参见: 2Verfythe“AsBuiltBOMreflectthe‘AsBuilt’conditionofthesystem.料反映系统实际制造情3VerifyacopyoftheverifiedBOMissigneddatedandattached..的材料已经签字，注明日期并附在后面AcceptanceCriteriaMet?(Yes No):验收标准符合（是/否

IfnotrefertoECReviewedByDate日期ObjectivesToVerify验证内容如下theElectricalSchematics(hardwaresettingsincluded)reflectthe‘AsBuilt’conditionsofthe电气原理图(包括硬件设置)theprotectivebondingcircuitcontinuity,insulationtestandvoltagetesttheprotectivedevices(i.e.,shut-offkeyswitches,powercircuitprotectorandcontactor)ofmotorcircuits(includingtheheater)functionwell.电机电路（包括加热器）的保护装置（如关闭开关，主电路保护装置和接触器）功能完好ProceduresObtanacoyfthesBt’ElctricalSchtics,drrdtheragN,vision(asackatheschmaticsshreerevsinmbdDentheresstae获取一份竣工版的电气原理图，并将图纸序号、版本号(作为一个整体，原理图共用一个版本号)和日期记录在栏中。Reviewthe‘AsBuilt’ElectricalSchematics(andanyidentifiedDIPswitchsettings)againstthe‘AsBuilt’conditionofthesystem(100%wiringverificationtobeperformedhere).Anynoncomplianceorerrormustbeannotatedonthedrawingbeingreviewed,andaddressedastheexceptionalcondition.Usea‘highlighter’pentoidentifiedalltheverifiedwiringandcomponents.Theverifiermustsignanddatathe审核竣工版的电路图（DIP开关），并同系统的实际情况相对比（ObtaintheElectricalTestChecklist Whenthemachineisinstalledandelectricalconnectionsarecompleted,includingthosetothepowersupply,followthestepslistedinthechecklistandtheverifiedresults.Here,thetestsofprotectivebondingcircuitcontinuity,insulationandovervoltagearetobeperformedsequentially,andtheprotectivedevices(i.e.,shut-offkeyswitches,powercircuitprotectorandcontactor)ofmotor/heatercircuitsareverifiedtofunctionwell.此，包括绝缘电阻和耐压测试的及保护接地电路连续性按照顺序执行验证，验证马达/加热器回路的保Completetheresultstable完成测试的验证Attachacopyofthefollowingtothistest将如下的测试文件附在本测试后PrefaceandannotatedpageoftheverifiedElectricalSchematicsTheverifiedElectricalTestChecklistAcceptanceCriteriaSeethestatementin5.3.1objectives6.4.1-1Obtainthe‘AsBuilt’ElectricalSchematics,andrecordthedrawingsinformationhere:获得竣工版的电路图，记录图纸信息 -Revision版本 Date日期2Verifythe‘AsBuilt’ElectricalSchematicsreflectthe‘As-Built’conditionofsystem.3ObtaintheElectricalTestChecklist,andrecordthefileinformationhere取得Reference参见 Date日期 Revision版本4Verifytheprotectivebondingcircuitcontinuity,insulationandvoltagetestpassedasverifiedbythechecklist5Verifytheprotectivedevicesi.e.,shut-offkeyswitches,powercircuitprotectorandcontactor)ofmotor/heatercircuitsareverifiedtofunctionwell验证马达/6Verifytherequiredattaentsaresigned/datedandattached..确认要求AcceptanceCriteriaMet?(Yes No):验收标准符合（是/否

IfnotrefertoECReviewedByDate日期PLCInputOutputVerificationPLC输入/ObjectivesToverifythattheoganddigitalinputs/outputsareasdescribedontheelectrical验证PLCProceduresObtainacopyofthe‘AsBuilt’ElectricalSchematicsshowingthePLCDigitalandogI/Os,recordtheDrawingNumber,Revision(asapackag