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洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401设备编号Equipment No.ZJBDU23530009作者Author姓名职务签名日期Print NameOccupation SignatureDate审核Reviewer姓名职务签名日期Print NameOccupation SignatureDate批准Approver姓名职务签名日期Print NameOccupation SignatureDate
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5.书面语及名称Written Wordsand Names使用规范的书面语及名称Standard writtenwords andnames shall be used.文件前后名称要一致The namesshall beconsistent allthrough thedocument.确认项编号名称Verification ItemNo.Name人员确认
9.1Personnel Verification前提条件确认
9.2Prerequisite Verification系统文件确认
9.3System DocumentationVerification仪表校准确认
9.4Instrument CalibrationVerification空调系统关键组件确认
9.5HVAC-key ComponentsVerification风管平面布局确认
9.6Air Duct Layout PlanVerification公用系统连接确认
9.7Utility ConnectionVerification房间布局确认
9.8Room LayoutVerification风口安装确认
9.9Tuyere Installation Verification洁净室安装确认
9.10Clean RoomInstallation Verification高效过液器安装确认
9.11HEPA FilterInstallation Verification
9.确认项Verification Item
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1.人员确认Personnel Verification
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1.目的Purpose检查并确认所有参与该方案执行的人员已得到培训，并在培训表上签字Checkandconfirmthatallpersonnelinvolvedintheimplementationoftheprotocalhavebeentrainedandsign thetraining form.
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2.程序Procedures列出并识别所有参与该方案执行的所有人包括姓名，签字，公司，职位，日期List andidentify allpersonnel involved in the execution of the present protocol Name,Signature andCompany,Position,Date.参与该方案执行的所有人应接受过恰当的培训方案的培训以便于该方案的执行All personnel involved in the execution of thepresentprotocolshould be appropriately trainedIQProtocol trainingin orderto executethe protocol
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3.可接受标准Acceptance Criteria所有的操作者都已记录姓名、签字及公司All theoperators arerecorded byName,Signature andCompany.所有的操作者都已受过培训IQ方案的培训All theoperators have been trainedIQ Protocoltraining.
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4.确认报告Verification Report确认结果填写在《人员确认》表内Fill theVerification results in Personnel Verification.培训内容Training content培训时间培训地点培训者Training TimeTraining LocationTrainer随机提问，根据接受培训者对培训内容的理解和问题的回答，由培训者进行评价，评价结果为通过、失败培训结果评价方式Random questions,according to the traineesunderstanding of the trainingEvaluationof trainingresultscontent and answers to the questions,by thetrainer toevaluate,theevaluation resultsare passedor failed.姓名Name公司职位Position签名日期Date结果Company SignatureResult□通过YES□失败NO口通过YES□失败NO□通过YES□失败NO□通过YES□失败NO□通过YES口失败NO□通过YES口失败NO口通过YES□失败NO□通过YES口失败NO□通过YES□失败NO□通过YES□失败NO□通过YES口失败NO注释/偏差/异常情况/支持性文Comments/Deviations/Exception/Support Documentation代检查人签名/日期Check BySignature/Date审核人签名/日期Reviewed BySignature/Date
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2.前提条件确认Prerequisite Verification
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1.目的Purpose确认所有进行IQ的前提条件都已经得到满足To verifythat theprerequisites for the IQhave beenmet.
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2.程序Procedure确认以下活动已检查Ensure the following prerequisiteshave beenchecked:参与该方案执行的所有人已接收培训All personnelinvolved in the iexecution of the protocol have received training;洁净室和空调机组设计确认报告已执行完毕并得到批准，无未关闭偏差或未关闭偏差不影响IQ的执行；The clean room and air conditioning unit designqualification report has beencompleted and approved,and thereare nounclosed deviations or unclosed deviations that do not affect the execution of IQ;安装确认方案已批准The installationqualification protocolhas been approved.
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3.可接受标准Acceptance Criteria参与该方案执行的所有人已接收培训；All personnelinvolvedinthe execution of the protocolhave receivedtraining;洁净室和空调机组设计确认报告已执行完毕并得到批准，无未关闭偏差或未关闭偏差不影响IQ的执行；The cleanroom andair conditioningunit designqualification reporthas beencompleted and approved,and thereare nounclosed deviationsor uncloseddeviations thatdo notaffect theexecution of IQ;安装确认方案已批准The installationqualification protocolhas beenapproved.
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4.确认报告Verification Report确认结果填写在《前提条件确认》表中，如有偏差记录在偏差报告中Fill the verification resultsin PrerequisitesVerification,and recorddeviations if any inthe DeviationReport.确认描述接受标准确认结果结果Verification DisribleAcceptance CriterionVerification ResultResults确认参与该方案执行的所有人员培训完成日期人已接收培训.参与该方案执行的所有人已Personal trainingcompletion口通过YES接收培训.Verify allpersonnel involveddate:口失败NOin theexecution of the Allpersonnelinvolvedin theprotocolhavereceivedexecution of the protocolhavetraining.received trainingo洁净室设计确认报告批准日期确认洁净室和空调机组设计洁净室和空调机组设计确认DQ reportof cleanroom approval确认报告已执行完毕并得到报告已执行完毕并得到批准，date:批准，无未关闭偏差或未关无未关闭偏差或未关闭偏差不闭偏差不影响IQ的执行影响IQ的执行口通过YESVerifythecleanroomandair The cleanroomandair口失败NOconditioning unit design conditioningunitdesign空调机组设计确认报告批准日期qualification reporthas beenqualificationreporthas beenDQ reportof air conditioning unitcompleted and approved,completed andapproved,andand thereare nounclosed thereare nounclosed approvaldate:deviationsoruncloseddeviationsor uncloseddeviations thatdo notaffectdeviationsthatdonotaffectthe executionofIQ.theexecutionofIQ.确认安装确认方案已批准安装确认方案已批准IQ方案批准日期口通过YESThe installationqualification IQ protocol approvaldate:Verify the installation口失败NOprotocol has beenapproved.qualification protocolhasbeen approved.结论Conclusion□符合Conform□不符合Not Conform注释/偏差/异常情况/支持性文件:Comments/Deviations/Exception/Support Documentation检查人签名/日期Check BySignature/Date审核人签名/日期Reviewed BySignature/Date
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3.系统文件确认System DocumentationVerification
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1.目的Purpose确认系统文件为最新版本，经过批准11足够支持确认活动To verifythat alldocuments forthe system are latest revision,approved andsufficient tosupport theIQactivities.
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2.程序Procedure核实表格中所列的文件名称，编号，并记录版本，确认文件可用Verify thefile namesand numberslisted inthe table,record theversions,and confirmthat thefiles areavailable.
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3.可接受标准Acceptance Criteria文件为最新版本，经过批准且足够支持安装确认活动All documentsforthesystem arelatestrevision,approved andsufficient tosupport theIQ activities.
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4.确认报告Verification Report确认结果填写在《文件确认》表内，如有偏差记录在偏差报告中Fill the verification resultsin DocumentationVerification,and recorddeviations if any inthe DeviationReport序号文件名称文件编号版本是否可用No.Document NameDocument No.Version AvailableAHU-401净化空调系统风量及配管流程图口是YES1E05-215701S-1-02AHU-401Air Volumeand PipingDiagram口否NO四层空调系统区域划分平面图AHU Zoning口是YES2E05-215701S-3-02Plan-4,h Floor口否NO四层送风管布置平面图口是YES3E05-215701S-3-08Supply Air Duct Layout-4th p|oor口否NO四层回风管、排风管布置平面图口是YES4E05-215701S-3-10Exhaust/Return Air Duct Layout-4lh Floor口否NO屋顶设备及风管布置平面图口是YES5E05-215701S-3-11Layout Plan of Roof Equipment and Air Duct□否NO四层风口与设备布置平面图口是YES6E05-215701S-3-06Equipment andAir OpeningLayout-4thFloor口否NO四层安防平面图口是YES口7E18-215701S-1-05Fourth floorfire linkageplan否NO四层平面工艺下水、凝水管道布置图口是YES口8E01-215701S-4-08Process sewer and condensatepiping layout-否NO4th floor四层照明平面图口是YES9E07-215701S-2-02Fourth floorlight plan□否NO结论Conclusion□符合Conform□不符合Not Conform注释/偏差/异常情况/支持性文件:Comments/Deviations/Exception/Support Documentation检查人签名/日期:Check BySignature/Date审核人签名/日期:Reviewed BySignature/Date
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4.仪器仪表校准确认Instrument CalibrationVerification
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1.目的Purpose确认空调设备仪表经过校验，且在校验有效期内Verify that the instrumentsof HVAC and equipment,have been calibrated and are within valid period ofcalibration.
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2.程序Procedure检查仪表的品牌、型号、精度、证书编号、安装位置.、校准日期、校准有效期等关键参数Check thebrand,model,accuracy,certificate number,installation location,calibration date,calibration validityperiodand otherkey parameters of the instrument.目测检查仪表的安装位置及校准标签Visually checkinstrument installation position andcalibration label.复印检查过的校准证书，签上姓名和日期，附在报告中Copy the verified calibrationcertificate,sign thename anddate andattach itto thereport.
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3.可接受标准Acceptance Criteria空调设备仪表经过校验，且在校验有效期以内Instruments of HVACandequipment have beencalibratedandarewithinvalidperiodofcalibration.
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4.确认报告Verification Report确认结果填写在《仪器仪表校准确认》表内，如有偏差记录在偏差报告中Fill theverification tresultsinInstrument CalibrationVerification,and recordif anydeviations inthe DeviationReport.洁净厂房及空调系统安装确认方案AHU-401InstallationQualificationProtocolofCRHVACSystemAHU-401文件编号2ode.版本号/Version页码/Page0119/47仪表校准确认InstrumentCalibrationVerification安装位置序号仪表名称精度证书编号校准日期有效期至品牌Brand型号Type Installation结论ResultsNo.InstrumentName PrecisionCertification.No.CalibrationDate DueDatePosition□通过YES口失1败NO口通过YES口失2败NO□通过YES口失3败NO□通过YES口失4败NO口通过YES5□失败NO仪表校膜证书报告己附在附件_______中,口通过YESInstrumentcalibrationcertificatehasbeenattachedtoattachment_______.□失败NO结论Conclusion□符合Conform□不符合NotConform注的偏知异常情况Zi.并性文件Comments.DeviationException/SupportDocumentation检直人签名，日期:CheckBy Signature/Date审核人悠名/日期ReviewedBy Signature/Date版本修订历史Version RevisionHistory作者变更描述版本日期Version DateAuthor Descriptionof Changes新制订01石兴龙Initial Issuance洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0120/
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5.空调系统关键组件确认HVAC-key ComponentsVerification
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1.目的Purpose确认空调系统的关键组件的信息符合用户需求规范文件和设计确认方案Verify thekey componentsinformation ofHVAC systemto ensurecompliance with URSDesignQualification protocol.
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2.程序Procedure根据以下表格逐项检查空调系统关键组件的信息Check keycomponents of the air conditioner systemaccording to thefollowingtable对照图纸检查机组安装位置，机组仪表位置及各功能段安装顺序Check the installation location of the unit and the unit instrument,and the installation sequenceof eachfunctionalsection according to thedraw观察检查机组内部部件安装情况Observe and check the installation ofinternal components of the unit;检查材质证明及技术资料是否符合用户需求；Check materialproof and technical documents to meetcustomer requirements.核对铭牌参数是否符合用户需求.Check whether the nameplateparameters meet the design requirements
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3.可接受标准Acceptance Criteria空调系统关键组件信息准确无误；HVAC-key Componentsis correctas design;设备信息与用户需求规范文件和设计确认方案保持一致Equipment informationis consistent with URSDesign Qualificationprotocol;机组安装位置，机组仪表位置、各功能段的组装顺序与设计相符；The installationlocation of theunitand theunit instrument,and theassembly sequenceof eachfunctionalsection are consistent with the design机组内部部件安装完好；The internalcomponents of the machineare wellinstalled.组件材质和技术资料符合用户需求Component materialand technical documents meetscustomer requirements；铭牌参数符合用户需求.Nameplate parametersmeet URSrequirements.
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4.确认报告Verification Report确认结果填写在《空调系统关键组件确认》表内，如有偏差记录在偏差报告中Fill theverification resultsin HVAC-key ComponentsVerification,and recordifanydeviations intheDeviation Report.洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0121/47检查项目结论Check theproject Results组合式空气处理机组要有标识和铭牌说明其功能□通过YESThe airconditioner should bealogo andnameplate toexplain itsfunction□失败NO对空调机箱进行目测检查无明显漏风、漏光，安装得当，且具有防冷桥措施口通过YESVisual inspectionof the airconditionerchassis showsno obviousair leakageand light□失败NOleakage.It isproperly installedand has anti-cold bridgemeasures目测检查洁净空调机组初中效过滤器外观完好无损□通过YESVisually inspectthe appearanceof the filter of the clean air conditioningunit□失败NO集水盘有足够的坡度，排水孔设在凝水盘的最低点，并有一定的深度以防止正常操作时发生溢流□通过YESThe condensatepan hassufficient slope,the drainagehole islocated atthe lowestpoint of□失败NOthe condensatepan,andafixed depthto preventoverflow duringnormal operation目视检查加湿器合理且配件完好无损口通过YESVisually check that the humidifier isreasonable andaccessories areintact□失败NO目视检查送/排风机电机转向正常，无反转口通过YESVisually checkthe feed/exhaust fanmotor toturn normallywithout reversal口失败NO检查仪表安装位置正确，且仪表无损坏□通过YESCheck that the installation position of theinstrument is correctand theinstrumentis not口失败NOdamaged设备任何部位不能有锋利的边缘和尖角□通过YESDo nothave sharpedges orcorners atany partof thedevice.口失败NO机组机组震动测试记录□通过YESUnit vibrationtest record□失败NO检查设备噪音测试记录□通过YESCheck equipmentnoise testrecords□失败NO所有检杳门需要有实际热阻断值并且采用相邻内外板材同样的材质为保证安全性和气密性，检查门应设计为向相对压力较高的方向开启□通过YESAllaccess doorsshall haveactualthermalblocking valuesand shallbeofthe samematerial□失败NOas theadjacent innerand outerpanels.To ensuresafety andair tightness,the inspectiondoorshould bedesigned toopen inthe direction of higherrelative pressure.所有风阀为气密式，机组风阀为多叶对开密闭风阀，风阀阀杆需为国标规格尺寸，确保能够让其他承包商配备电动执行器□通过YESAll air valves areair-tight,and the air valveof theunit isa closedair valvewith multiple口失败NOblades.The stemof the airvalveshouldbethe nationalstandard sizeto ensurethat othercontractorscan beequipped withelectric actuators.洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0122/47组件信息技术参数/材质要求检查结果结论Component Technicalspecifications/MaterialCheck ResultResultsInformation requirements风机亿利达，无蜗壳直连风机口通过YESBlower Yilida,no volutefan□失败NO西门子变频电机，配有强冷风机，风机与电机直连口通过YES电机Motor Siemensfrequency conversionmotor,□失败NOequipped withstrong aircooler,fan andmotordirectly connected;风量□通过YES4980m3/hAir volumem3/h□失败NO机外静压□通过YESExternal staticpressure1200paPa口失败NO空调机组所有面板为双层保温板，无冷桥T2/TB2,机组外表层采用彩涂板，内壁板三面采用镀铝锌板，地板304不锈钢板所有的面板用聚氨酯发泡保温材料□通过YES面板panel All the panelsof the air conditioningunit aredouble-layer insulationboard withoutcold□失败NObridge T2/TB
2.The outersurfaceof theunit iscoated withcolor plate,the innerwall iscoatedwith aluminumand zincplate onthree sides,and the floor is304stainless steel plate.Allpanels areinsulated withpolyurethane foam.设备外壳板门的热桥因数要达到TB2级别，传热性能要达到T2级别热桥系数传热性能Thethermalbridgefactoroftheequipmentshell口通过YESCoefficient of thermal plateand doorshould reach TB2level,and the□失败NObridge Theheat transferheat transferperformance shouldreachT2performance level.所有可进入的空调段要配备DC24V照明在空调机组外面板安装连接电缆和开关口通过YESLighting照明All accessibleair conditioningsections shall beequipped withDC24V lighting.Install口失败NOconnecting cablesand switcheson theoutsideboard of the air conditioningunit.初效过滤器袋式初效过滤器G4□通过YESPrimary filterBag typeinitial effect filter G4□失败NO初效过滤器压差表Primary filterdifferential品牌.德威尔口通过YESpressure meterBrand:Dwyer□失败NO口通过YES口中效过滤器Medium袋式中效过滤器F9efficiency filterBag mediumeffectfilterF9失败NO中效过滤器压差表品牌德威尔□通过YESDifferential pressuregaugeof mediumBrand:Dwyer口失败NOefficiency filter洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0123/47组件信息技术参数/材质要求检查结果结论Component Technicalspecifications/MaterialCheck ResultResultsInformation requirements加热量
16.90kw盘管铜管壁厚
0.32mm,翅片预加热盘管为亲水铝箔口通过YESHeat:
16.90kW;The wallthickness of the coilPreheatingcoil口失败NOcopper tube is
0.32mm,and thefin ishydrophilicaluminum foil.制冷量
38.20kw；盘管铜管壁厚
0.32mm,翅片冷水盘管为亲水铝箔口通过YESCooling:
38.20KW;The wallthickness of theCooling coil口失败NOcoil coppertubeis
0.32mm,and thefin ishydrophilicaluminum foil.加热量
17.48kw盘管铜管壁厚
0.32mm,翅片为亲水铝箔热水盘管口通过YES口Heat:
17.48kW;The wallthickness of the coilHeatingcoil失败NOcopper tubeis
0.32mm,and thefin ishydrophilicaluminum foil加湿器喷枪和喷嘴材质为304不锈钢加湿段内表面为304不锈钢材展，加湿滞带有控制阀如加湿器带汽水分离器和夹套加湿器口通过YESThe humidifierspray gunand nozzleare madeHumidifierof304stainless steel.The innersurface of the口失败NOhumidifier sectionis madeof304stainlesssteel,and thehumidifier is equipped with acontrol valvefor example,thehumidifierisequipped witha sodaseparator andjacket.积水盘304不锈钢，厚度
1.2mm口通过YESDrain tray304stainless steel,thickness
1.2mm口失败NO可接受标准结论Acceptance Criteria Results空调系统关键组件信息准确无误；口通过YES口HVAC-key Componentsis correctas design;失败NO设备信息与用户需求规范文件和设计确认方案保持一致口通过YESEquipment informationis consistent withURSDesign Qualificationprotocol.口失败NO机组安装位置，机组仪表位置、各功能段的组装顺序与设计相符；口通过YESThe installationlocation of theunit andtheunitinstrument,and theassemblysequenceof eachfunctionalsection are consistent with the design；口失败NO机组内部部件安装完好口通过YESThe internalcomponentsof the machineare wellinstalled.口失败NO组件材质和技术资料符合用户需求；口通过YESComponent materialandtechnicaldocuments meetscustomer requirements；口失败NO铭牌参数符合用户需求.口通过YESNameplate parametersmeet URSrequirements.口失败NO洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0124/47空调系统关键组件确认相关文件已附在附件_____中HVAC-key Componentsverification has been attached to attachment_______.结论Conclusion□符合Conform□不符合Not Conform注释/偏差/异常情况/支持性文件:Comments/Deviations/Exception/Support Documentation检查人签名/日期Check BySignature/Date审核人签名/日期Reviewed BySignature/Date洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0125/
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6.风管平面布局确认AirDuct Layout PlanVerification
1.
1.1,目的Purpose确认空调系统送、回、排风风管及阀门的安装情况与图纸保持一致To verifythat the installation of air conditioning system sending,return,exhaust ductsand valves isconsistent with the drawings确认风管的保温符合用户需求To verifythat theinsulation of the air duct meets the usersrequirements.
1.
1.2,程序Procedure风管及阀门Duct and valves检查风管和风阀材质是否符合设计要求，复印材质证明文件作为附件；Check whether the duct andvalve material meets the design requirements,and copythe materialcertification document as an attachment;检查风管的制作和清洗记录是否齐全，并复印作为附件Check whether the productionand cleaningrecords ofthe duct are complete and makea copyas anattachment；检查风管的漏风量测试记录是否齐全，并复印作为附件Check whether the airleakage testrecord ofthe air duct is completeand copy itas an attachment:复印一份四层送风管布置平面图和屋顶设备及风管布置平面图，检查送风风管和排风管的分支布局情况和风阀的安装位置是否与图纸保持一致Make acopy ofthe four-layer air supply duct layout and the roofequipment andductlayout,and checkwhetherthebranchlayout oftheairsupply andexhaustductandtheinstallationpositionofthedamperareconsistent with the drawings;复印一份四层回风管、排风管布置平面图和屋顶设备及风管布置平面图，检杳回风风管的分支布局情况和风阀的安装位置是否与图纸保持一致Make acopy ofthe four-layer return air duct and exhaustairductlayout and the roofequipment andductlayout,andcheckwhetherthebranchlayoutoftheairreturnductandtheinstallationpositionofthedamperare consistent with the drawings.用绿色荧光笔标出现场布局安装情况同空调系统各平面布置图一致的部分Highlight ingreen ifthe installationis identicalwith the layout diagramofHVACSystem.用红色荧光笔标出现场布局安装情况同空调系统各平面布置图不一致的部分，并注明偏差的情况，签上姓名和日期HighlightinrediftheinstallationisnotconsistentwiththelayoutdiagramofHVACSystem,andindicatethedeviation,sign anddate.执行人和审核人应在检查过的布置图上签名并标注日期，并作为附件Executor andreviewer shallsign anddate onthe verifiedlayout andattach them.保温Insulation检企风管保温材质是否符合设计要求，复印保温材质证明文件作为附件；Check whether the duct insulation material meets the design requirements,and copythe insulationmaterialcertification documentas an attachment;检查风管保温是否完成洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0126/47Check whetherthe duct insulation is complete.
1.
1.3,可接受标准Acceptance Criteria风管和风阀材质为镀锌钢板；The airductandvalve material is galvanizedsteel;风管的制作和清洗记录齐全；The productionand cleaningrecords ofthe ductare complete风管的漏风量测试记录齐全The airleakage testrecord ofthe airduct iscomplete;风管布局与图纸一致，风阀安装位置和图纸一致The layoutofthe airduct is consistent with the drawings,and the installation position ofthevalves isconsistent with the drawings;风管保温材质为橡塑保温棉；The airductinsulationmaterial isrubber and plastic insulationcotton;风管保温已安装完成Duct insulationhas been installed.
1.
1.4,确认报告Verification Report确认结果填写在《风管平面布局确认》表内，如有偏差记录在偏差报告中FilltheverificationresultsinAirDuctLayoutPlanVerification,andrecordifanydeviationsintheDeviationReport.洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0127/47风管布局确认表DuctLayoutVerification Form确认项参考文件接受标准结论Ver.items ReferenceDocuments Acceptance Criteria Results风管和风阀材质为镀锌钢板四层送风管布置平面图Supply Air口通过YES口失The airductandvalvematerial isDuct Layout-4,h Floorgalvanizedsteel.败NOE05-215701S-3-08风管的制作和清洗记录齐全口通过YESTheproductionandcleaningrecordsofthe四层回风管、排风管布置平面图ductarecomplete.口失败NOExhaust/Return AirDuctLayout-4,h风管、风阀风管的漏风量测试记录齐全Floor口通过YESDuct、valveE05-215701S-3-10The airleakage testrecord ofthe airductis complete.口失败NO屋顶设备及风管布置平面图Layout风管布局与图纸一致，风阀安装位置和图纸一致；PlanofRoofEquipmentandAir口通过YESDuct Thelayoutofthe airductis consistent with口失败NOthe drawings,and the installation positionE05-215701S-3-11ofthevalvesis consistent with thedrawings.风管保温材质为难燃B1级橡塑保温棉，厚度为30mme口通过YESThe airductinsulationmaterial isflameretardant B1grade rubberandplastic口失败NO保温NA insulationcotton,withathickness ofInsulation30mm.风管保温已安装完成口通过YES口失Duct insulationhas been installed.败NO风管布局确认相关文件已附在附件______中Documents relatedto ductlayout verification has been attached to attachment_______.结论Conclusion□符合Conform□不符合Not Conform注释/偏差/异常情况/支持性文件:Comments/Deviations/Exception/Support Documentation检查人签名/日期Check BySignature/Date审核人签名/日期:Reviewed BySignature/Date洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0128/
479.
7.公用系统连接确认Utility ConnectionVerification
1.
7.
1.目的Purpose确认运行需要的公用系统已经正确连接To verifythat utilitiesrequired foroperation havebeen correctlyconnected.确认运行需要的公用系统的参数满足使用要求To verifythat utilityparameters foroperation conformto theuse requirements.
2.
7.
2.程序Procedure复卬一份空调系统风量及配管流程图；Make acopy ofthe airflowchart ofthe air-conditioning systemand piping;检查冷冻水管是否已正确安装，水管部件安装顺序是否与图纸保持一-致，冷冻水系统运行参数是否与设计一致；Check whetherthechilled waterpipe has been installed correctly,whetherthe installation sequenceof thewater pipe componentsis consistent with the drawings,and whetherthe operatingparameters ofthechilled watersystemare consistent with the design;检查热水管是否已正确安装，水管部件安装顺序是否与图纸保持一致，热水系统运行参数是否与设计一致Check whetherthe hot water pipe has been installed correctly,whetherthe installation order ofthe waterpipe componentsis consistent with the drawings,and whetherthe operatingparametersofthe hotwatersystem are consistent with the design;检查蒸汽管是否已正确安装，蒸汽管部件安装顺序是否与图纸保持一致，蒸汽系统运行参数是否与设计一致；Check whetherthe steampipe has been installed correctly,whetherthe installation sequenceof steampipecomponentsis consistentwiththedrawings,andwhetherthesteamsystem operatingparametersareconsistent with the design;用绿色荧光笔标出现场安装情况同图纸一致的部分Highlight ingreen ifthe installationis identicalwith the diagram.用红色荧光笔标出现场安装情况同图纸不一致的部分，并注明偏差的情况，签上姓名和日期Highlight inred ifthe installationis notconsistent with the diagram,and indicatethe deviation,sign anddate.执行人和审核人应在检杳过的图纸上签名并标注日期，并作为附件Executor andreviewer shallsign anddate onthe verifieddiagram andattach them.
3.
7.
3.可接受标准Acceptance Criteria冷冻水管已正确安装，水管部件安装顺序与图纸一致，冷冻水供水温度为6~11℃,供水压力
0.2~
0.4Mpa Thechilled water pipehas beeninstalled correctly,the installationorder ofthe water pipe componentsisconsistent with the drawing,and thechilled water supply temperature is6~11℃,water supply pressure
0.2~
0.4Mpa;热水管已正确安装，水管部件安装顺序与图纸一致，热水供水温度为50~60℃,供水压力
0.2~
0.4Mpa；洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0129/47The hotwaterpipehas beeninstalledcorrectly,theinstallationorder ofthe waterpipe componentsisconsistent with the drawings,and thehotwater supply temperatureis50〜60℃,water supplypressure
0.2~
0.4Mpa;蒸汽管已正确安装，蒸汽管部件安装顺序与图纸一致，蒸汽供气压力为
0.2MPa；The steampipehasbeeninstalledcorrectly,theinstallationorder ofthe steampipe componentsisconsistent with the drawing,and thesteam supplypressure is
0.2MPa;
4.
7.4,确认报告Verification Report确认结果填写在《公用系统连接确认》表内，如有偏差记录在偏差报告中Fill theverification resultsin utilityconnection verification,and recorddeviations ifany inthe DeviationReport.目录
58.
58.
911.1录用笔Recording pens
911.2写栏目Column filling
0.2~
0.4Mpa□失败NOthech川ed watersupplytemperatureis6Tl℃,water supplypressure
0.2-
0.4Mpa.热水管已正确安装，水管部件安装顺序与图纸AHU-401净化空调系统风量及配一致口通过YES管流程图The hotwaterpipehasbeeninstalledcorrectly,口失败NOAHU-401cleanairconditioningthe installationorderofthewaterpipe热水system air volume andpiping flowcomponentsis consistent with the drawings.Hot waterdawing E05-215701S-1-02热水供水温度为50-60℃,供水压力
0.2~
0.4Mpa口通过YESThe hotwatersupplytemperatureis50~60口失败NO℃,watersupplypressure
0.2-
0.4Mpa.蒸汽管已正确安装，蒸汽管部件安装顺序与图纸一致口通过YESThesteampipehasbeeninstalledcorrectly,the□失败NO蒸汽installation orderofthe steampipecomponentsSteam is consistent with the drawing.蒸汽供气压力为
0.2Mpa口通过YESThe steamsupplypressureis
0.2Mpa.口失败NO公用系统连接确认相关文件已附在附件_____中Documents relatedto utilityconnection verificationhasbeenattached toattachment_______.结论Conclusion□符合Conform□不符合Not Conform注释/偏差/异常情况/支持性文件Comments/Deviations/Exception/Support Documentation检查人签名/日期Check BySignature/Date审核人签名/日期Reviewed BySignature/Date洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0131/
479.
8.房间布局确认Room LayoutVerification
9.
8.1,目的Purpose确认洁净区域的房间已按照图纸安装完成To verifythat the rooms inthe cleanarea havebeeninstalledaccording tothe drawings.
9.
8.2,程序Procedure复印一份四层空调系统区域划分平面图；Make acopy ofthe four-layer air-conditioning systemzoning dawing;检查空调系统所服务区域是否与图纸保持一致Check whetherthe areaserved bythe airconditioning systemis consistent with the drawing;检查各房间是否安装完成，房间构造是否与图纸一致；Check whethertheinstallationof eachroom iscompleted and whetherthe room structure isconsistent with thedrawing;检查房间门的开向是否与图纸一致；Check whetherthe openingdirection ofthe roomdoor isconsistentwith the drawing;用绿色荧光笔标出现场安装情况同图纸一致的部分Highlight ingreen iftheinstallationis identicalwith the diagram.用红色荧光笔标出现场安装情况同图纸不•致的部分，并注明偏差的情况，签上姓名和日期Highlight inred iftheinstallationis notconsistentwith the diagram,and indicatethe deviation,sign anddate.执行人和审核人应在检查过的图纸上签名并标注日期，并作为附件Executor andreviewer shallsign anddate onthe verifieddiagram andattach them.
9.
8.3,可接受标准Acceptance Criteria空调系统所服务区域与图纸保持一致；The areaserved bythe airconditioning systemisconsistentwiththedrawing;各房间安装完成，房间构造与图纸一致；The installationof eachroom iscompletedand the roomstructure isconsistentwiththedrawing;房间门的开向与图纸一致The openingdirection ofthe roomdoor isconsistentwiththedrawing.
9.
8.4,确认报告Verification Report确认结果填写在《房间布局确认》表内，如有偏差记录在偏差报告中Fill theverification resultsin roomlayout verification form,and recorddeviations ifany inthe DeviationReport.洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0132/47房间布局确认表Room LayoutVerification Form确认项参考文件接受标准结论Ver.items ReferenceDocuments Acceptance Criteria Results空调系统所服务区域与图纸保持一致口通过YESThe areaserved bytheairconditioningsystemis口失败NOconsistent withthedrawing.四层空调系统区域划分平面图房间布局口通过YES各房间安装完成，房间构造与图纸一致AHU ZoningPlan-4,h FloorRoomlayout口失败NOThe installationof eachroom iscompleted andE05-215701S-3-02theroomstructureisconsistentwiththedrawing.房间门的开向与图纸一致口通过YESThe openingdirectionoftheroomdoor is口失败NOconsistent withthedrawing.房间布局确认相关文件已附在附件_____中Documents relatedto roomlayout verificationhasbeenattached toattachment_______.结论Conclusion□符合Conform□不符合Not Conform注释/偏差/异常情况/支持性文件:Comments/Deviations/Exception/Support Documentation检查人签名/日期:Check BySignature/Date审核人签名/日期Reviewed BySignature/Date洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0133/
479.
9.风口安装确认Tuyere InstallationVerification
9.
9.1,目的Purpose确认房间内风口已按照图纸安装完成，并符合设计要求To verifythattheair ventsintheroom havebeeninstalled in accordance withthedrawings andmeetthe designrequirements..
9.
9.2,程序Procedure检企送风口和回风口材质是否符合设计要求，复印风口材质证明文件作为附件；Check whetherthe materialoftheair supplyoutlet andreturn air outlet meetsthe designrequirements,and copythematerial certificationdocument oftheair outlet as anattachment;复印一份四层风口与设备布置平面图；Make acopy ofthe four-layer air outlet andequipment layoutplan;;检查风口的规格和安装位置是否与图纸保持一致Check whetherthe specificationsand installationlocation oftheairoutlet are consistentwiththedrawing;用绿色荧光笔标出现场安装情况同图纸一致的部分Highlight ingreen iftheinstallationis identicalwiththediagram.用红色荧光笔标出现场安装情况同图纸不一致的部分，并注明偏差的情况，签上姓名和日期Highlight inred iftheinstallationis notconsistentwiththediagram,and indicatethe deviation,sign anddate.执行人和审核人应在检查过的图纸上签名并标注日期，并作为附件Executor andreviewer shallsign anddate onthe verifieddiagram andattach them.
9.
9.3,可接受标准AcceptanceCriteria送风口和回风口材质为不锈钢The materialof air supply andreturn airoutlet is stainless steel;风口的规格和安装位置是与图纸一致；The specificationsand installationlocation oftheairoutlet are consistentwiththedrawing;风口表面平整，光滑，无损伤The surfaceoftheairoutlet is flat,smooth andwithout damage.
9.
9.4,确认报告Verification Report确认结果填写在《风口安装确认》表内，如有偏差记录在偏差报告中Filltheverificationresultsin Tuyereinstallationverificationform,andrecorddeviationsifanyintheDeviationReport.洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0134/47风口安装确认表Tuyere InstallationVerification Form确认项参考文件接受标准结论Ver.items ReferenceDocuments AcceptanceCriteria Results送风口和回风口材质为不锈钢；□通过YESThe materialofairsupply andreturn airoutlet is□失败NOstainless steel;四层风口与设备布置平面图风口的规格和安装位置是与图纸一致口通过YES风口Tuyere Equipmentand OpeningLayoutThe specificationsand installationlocationofthe口失败NO-4th FloorE05-215701S-3-06airoutletareconsistentwiththedrawing.风口表面平整，光滑，无损伤口通过YESThe surfaceoftheairoutletis flat,smooth and□失败NOwithout damage.风口安装确认相关文件已附在附件_____中Documents relatedto tuyereinstallation verificationhasbeenattachedtoattachment_______.结论Conclusion□符合Conform□不符合Not Conform注释/偏差/异常情况/支持性文件:Comments/Deviations/Exception/Support Documentation检查人签名/日期:Check BySignature/Date审核人签名/日期Reviewed BySignature/Date洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0135/
479.
10.洁净室安装确认Clean RoomInstallationVerification
9.
10.
1.目的Purpose确认洁净室的安装情况符合设计要求To verifythatthecleanroom installationmeetsthe designrequirements.
9.
10.
2.程序Procedure地面Floor检查地面材质是否符合设计要求，复印地面材质证明文件作为附件；Checkwhetherthefloormaterialmeetsthedesignrequirements,andcopythefloormaterialcertificationdocumentasan attachment;检查地面是否平整，光滑，无气泡凹坑Check thatwhethertheground is flat,smooth,and free of bubblepits.墙和吊顶Wall andCeiling检查墙和吊顶材质是否符合设计要求，复印墙和吊顶材质证明文件作为附件Check whetherthe walland ceilingmaterial meetsthedesignrequirements,and copythe walland ceilingmaterialcertification documentasanattachment;检查墙和吊顶是否平整，有划痕、破损Check whetherthe wallsand ceilingsare flat,scratched and damaged.门Door检查门的材质是否符合设计要求，复印门的材质证明文件作为附件；Checkwhetherthedoormaterialmeetsthedesignrequirements,andcopythedoormaterialcertificationdocumentasan attachment;检查门是否平整，有划痕、破损Check whetherthe doorsare flat,scratched anddamaged.窗Window检查窗的材质是否符合设计要求，复印窗的材质证明文件作为附件；Check whetherthe windowmaterial meetsthedesignrequirements,and copythe windowmaterial certificationdocumentasanattachment;检查窗是否平齐于周边墙面，有划痕、破损Check whetherthe window is flushwiththesurrounding wall,scratched anddamaged.互锁Interlock复印一份四层安防平面图，检查互锁安装位置是否与图纸保持一致Make acopy ofthe four-layer securityplan andcheck thatthe interlock installationposition isconsistentwith thedrawingo地漏、排水口Floor Drains,Drains Outlet检查地漏的材质是否符合设计要求，复印材质证明文件作为附件；Check whetherthe floor drains materialmeetsthedesignrequirements,and copythe materialcertification documentasanattachment;复印•份四层平面工艺下水、凝水管道布置图，检查地漏和排水口安装位置是否与图纸保持一致；洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0136/47Make acopy ofthelayoutdrawing ofthe four-layer planarprocess sewerand condensatepipes,andcheckwhetherthe installation positions of floor drainsand drainsareconsistentwiththedrawings;检查地漏和排水口是否有防倒灌装置Check whetherthefloor drain anddrain haveanti-backfill devices.照明Lighting检查灯具是否有合格证明，复印合格证作为附件；Check whetherthe lamphas acertificate ofconformity,and copythe certificateasanattachment;复印一份四层照明平面图，检查灯具规格和安装位置是否与图纸保持一致；Make acopy ofthe four-layer lightingplan andcheckthatthe specificationsand installationposition ofthe luminaireareconsistentwiththe drawingo检查灯具是否吸顶安装，灯具内部是否有积灰，表面是否平滑，无破损Checkwhetherthelampisinstalledintheceiling,whetherthereisdustaccumulationinsidethelamp,andwhetherthesurface issmooth andundamaged.密封seal检查密封胶的材质是否符合设计要求，复印材质证明文件作为附件；Check whetherthe sealantmaterialmeetsthedesignrequirements,andcopythe materialcertificationdocumentasan attachment;检查墙板和吊顶板拼缝处是否已双面密封，打胶是否饱满、均匀；Check whetherthe jointsofthewall paneland theceiling panelhavebeen double-sealed,and whetherthe glue is fulland uniform;检查风口、灯具、插座、开关和穿墙管道等和彩钢板连接处是否已密封，打胶是否饱满、均匀Check whethertheairoutlets,lamps,sockets,switches andthrough-wall pipesare sealedwiththecolor steelplateconnection,andwhetherthe glueis full and uniform.用绿色荧光笔标出现场安装情况同图纸一致的部分Highlight ingreen iftheinstallationis identicalwiththediagram.用红色荧光笔标出现场安装情况同图纸不一致的部分，并注明偏差的情况，签上姓名和日期Highlight inred iftheinstallationisnotconsistentwiththediagram,and indicatethe deviation,sign anddate.执行人和审核人应在检查过的图纸上签名并标注日期，并作为附件Executor andreviewer shallsign anddate ontheverifieddiagram andattach them
9.
10.
3.可接受标准AcceptanceCriteria地面Floor地面材质为2mm PVC卷材The floormaterial is2mm PVCmembrane;地面平整，光滑，无气泡凹坑The groundis flat,smooth,and free of bubblepits.墙和吊顶Wall andCeiling墙和吊顶材质是50mm厚双玻镁彩钢板；The walland ceilingmaterial is50mm thick double glass magnesium color steelplate;洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0137/47墙和吊顶平整，无划痕、破损The wallsand ceilingsare flat,free ofscratches anddamage.门Door门的材质是洁净钢质门；The dooris madeof cleansteel门平整，无划痕、破损The dooris flat,freeofscratches anddamage.窗Window窗的材质是双层中空玻璃；The materialofthewindow isdouble insulatingglass;窗平齐于周边墙面，无划痕、破损The windowsare flushwiththesurrounding walls,without scratchesor damage.互锁Interlock互锁安装位置与图纸保持一致The interlockinstallationpositionisconsistentwiththedrawing.地漏、排水口Floor Drains,Drains Outlet地漏的材质是不锈钢；The materialofthefloordrainisstainlesssteel;地漏和排水口安装位置与图纸保持一致The installationpositions offloor drainsand drainsareconsistentwiththedrawings;地漏和排水口有防倒灌装置The floordrain anddrain haveanti-backfill devices.照明Lighting灯具有合格证；The lamphas acertificate ofconformity灯具规格和安装位置与图纸保持一致；The specificationsand installationpositionofthe luminaireareconsistentwiththedrawing;灯具吸顶安装，灯具内部无积灰，表面平滑，无破损The lampceiling installation,no dustaccumulation insidethe lamp,smooth surface,no damage.密封seal密封胶的材质是硅酮；The materialofthesealant issilicone;墙板和吊顶板拼缝处己双而密封，打胶饱满、均匀；The jointsofthewall paneland theceiling panelhavebeendouble-sealed,andtheglueis fulland uniform;风口、灯具、插座、开关和穿墙管道等和彩钢板连接处已密封，打胶饱满、均匀The airoutlets,lamps,sockets,switches andthrough-wall pipesare sealedwiththecolorsteelplate connection,andthe glueis fulland uniform.洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0138/
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4.确认报告Verification Report确认结果填写在《洁净室安装确认》表内，如有偏差记录在偏差报告中Fill theverification resultsin cleanroom installationverificationform,and recordifanydeviations inthe DeviationReport.洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0139/47洁净室安装确认表Clean RoomInstallation Form确认项参考文件接受标准结论Ver.items ReferenceDocuments AcceptanceCriteria Results地面材质为2mm PVC卷材口通过YESThe floormaterialis2mm PVC地面membrane.口失败NON/AFloor地面平整，光滑，无气泡凹坑口通过YESThe groundis flat,smooth,and freeofbubble pits.口失败NO墙和吊顶材质是50mm厚双玻镁彩钢板板口通过YESThe walland ceilingmaterialis50mm口失败NO墙和吊顶thickdoubleglassmagnesiumcolor steelN/AWall andCeiling plate.墙和吊顶平整，无划痕、破损口通过YESThe wallsand ceilingsare flat,free ofscratchesanddamage.口失败NO门的材质是洁净钢质门口通过YESThe dooris madeof cleansteel口失败NO门Door N/A门平整，无划痕、破损口通过YESThe doorisflat,freeofscratches anddamage.口失败NO窗的材质是双层中空玻璃口通过YESThe materialofthewindowisdoubleinsulating glass.口失败NO窗Window N/A窗平齐于周边墙面，无划痕、破损口通过YESThe windowsare flushwith thesurroundingwalls,without scratchesor口失败NOdamage.四层安防平面图互锁安装位置与图纸保持一致互锁Fourth floorfire linkageplan Theinterlockinstallationpositionis口通过YESInterlockE18-215701S-1-04consistentwiththedrawing口失败NOo地漏的材质是不锈钢口通过YESThe materialofthefloordrainis stainlesssteel.口失败NO四层平面工艺下水、凝水管道布置地漏、排水口Floor图地漏和排水口安装位置与图纸保持一致口通过YES口Drains,Drains Processsewerandcondensate Theinstallationpositionsoffloordrains失败NOOutlet pipinglayout-3rd floorand drainsareconsistentwith theE01-215701S-4-08drawings;地漏和排水口有防倒灌装置口通过YESThe floordrain anddrain haveantibackfilldevices.口失败NO口通过YES灯具有合格证四层照明平面图The lamphas acertificate ofconformity.口失败NO照明Third floorlight plan灯具规格和安装位置与图纸保持一致Lighting口通过YESE07-215701S-2-02The specificationsandinstallation positionofthe luminaireareconsistentwiththe口失败NOdrawing;
1.目的Objective本方案的目的是提供书面证据，确保洁净空调系统AHU-401以及其服务的洁净区域是根据业主的详细设计要求、国际/国内标准、行业标准和工厂的要求安装的，且能按照预期的要求运行Thepurpose ofthis protocolisto providewritten evidencetoensure thattheclean airconditioningsystemAHU-401andthe clean areas itserves areinstalledinaccordancewithdetailed designrequirements,international/domesticstandards,industry standards,and factoryrequirements,and canoperate asexpected.
2.范围Scope此方案适用于洁净空调系统AHU-401以及其服务的洁净区域This protocolis applicablefor cleanairconditioningsystems AHU-401and cleanareas servedby it.
3.系统描述System Description洁净空调系统AHU-401采用新风+回风模式，室内气流组织为上送，下侧回房间末端采用H14高效送风口，定风量阀控制送风满足房间洁净度要求，变风量阀控制回风满足室内压差要求The cleanHVAC systemsAHU-401adopt freshair+returnairmode,andtheindoor airdistribution isup supplyanddown return.H14high efficiencyairsupplyoutletisused atthe endoftheroom.The constantairvolumevalve controlstheairsupplytomeet therequirementsof roomcleanliness.The variableair volumevalvecontrols thereturnair tomeetthe requirementsof indoorpressure difference.AHU-401空调系统服务于四层上游1等洁净区域，空调箱设混合段+G4+混合段+加热段+检修段+复合功能段+加湿段+导风段+风机段+检修段+F9+送风段The AHU-401HVAC servescleanareassuch as the fourthfloor upstream
1.The airconditioning boxisequippedwithmixing section+G4+mixing section+heating section+maintenance section+composite functionalsection+humidification section+wind guidesection+fan section+maintenance section+F9+airsupplysection.洁净空调系统AHU-401包括以卜房间ThecleanHVAC systemAHU-401includes thefollowing rooms.序号设备编号房间编号房间名称洁净级别GradeNo.Equipment NumberRoom NumberRoom Name1AHU-4014011上游1DUpstream1物流气闸24012DMAL人员气闸34013DPedestrain airlock人员气闸44013a DPedestrainairlock洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0140/47洁净室安装确认表Clean RoomInstallation Form确认项参考文件接受标准结论Ver.items ReferenceDocuments AcceptanceCriteriaResults灯具吸顶安装，灯具内部无积灰，表而平滑，无破损口通过YES口The lampceiling installation,no dust失败NOaccumulation insidethe lamp,smoothsurface,no damage.密封胶的材质是硅能口通过YESThe materialofthesealant issilicone.口失败NO增板和吊顶板拼缝处已双面密封，打胶饱满、均匀口通过YES口The jointsofthewall panelandtheceiling失败NOpanel havebeendouble-sealed,and theglueisfullanduniform.密封seal N/A风口、灯具、插座、开关和穿墙管道等和彩钢板连接处已密封，打胶饱满、均匀The airoutlets,lamps,sockets,switches口通过YESand through-wall pipesare sealedwiththecolor steelplate connection,andtheglue口失败NOis fullanduniform.洁净室安装确认相关文件已附在附件_____中Documents relatedto cleanroom installationverificationhasbeenattachedtoattachment_______.结论Conclusion□符合Conform□不符合Not Conform注释/偏差/异常情况/支持性文件:Comments/Deviations/Exception/Support Documentation检查人签名/日期Check BySignature/Date审核人签名/日期Reviewed BySignature/Date洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0141/
479.
11.高效过滤器安装确认HEPA FilterInstallationVerification
9.
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1.目的Purpose确认HEPA过海器安装信息完整，HEPA过滤器效率等级与设计相符To verifyHEPA filterinstallation informationiscomplete,and efficiencyrating of HEPA filteris identicalwith design.
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2.程序Procedure检企过滤器合格证及过滤效率确认报告是否存在Verify whetherthefiltercertificate and efficiency testreport arevalid.检查过滤器效率符合的要求Verify efficiencyofHEPAis compliancewiththerequirement.检杳高效箱体是否有气溶胶注入孔和测试孔Check whethethe high-efficiency boxhas aerosolinjection andtest port.检查高效过滤器上有编号标识Verify eachHEPA filteris labeledby tagnumber.
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3.可接受标准AcceptanceCriteria高效过谑器安装信息完整，HEPA过滤器效率等级N
99.95%HEPA filterinstallation informationiscomplete,andefficiencyrating
299.95%.
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4.确认报告Verification Report确认结果填写在《高效过滤器安装确认》表内，如有偏差记录在偏差报告中FilltheverificationresultsinHEPAFilterInstallationVerification,andrecordifanydeviationsintheDeviationReport.洁净厂房及空调系统安装确认方案AHU-401InstallationQualificationProtocolofCRHVACSystemAHU-401洁净厂房及空调系统安装确认方案AHU-401InstallationQualificationProtocolofCRHVACSystemAHU-401文件编号2ode.版本号/Version页码/Page0143/47注杼/偏期异常怙况/支持性文件Comments/DeviattonaException/SupporlDocumentation文件编号2ode.版本号/Version页码/Page0142/47高效过渡器安装确认表HEPAFilterInstallationVerificationForm期望过渔级别实际过滤级别是否有合格证过滤效率房间编号风口编号Air ExpectedFilterActualFilter序列号SerialNo.Certificate是否有效率确认Filtration是否有气溶皎注入口是否正确标识结论RoomNo.OutletNo.报告Efficiency和测试口Aerosol TaggedCorrectlyResultsGrade GradeAvailable EfficiencyVerificationinjectionandtestportReportAvailable available口是YES口是YES口是YES口是丫ES口通过YESS-4011-01H13口否NO口否NO口否NO口否NO□失败NO口是丫ES口口是YES口是YES口是YES□通过YES4011S-4011-02H13否NO口否NO□否NO口否NO□失败NO口是YES□是YES口是YES口是YES口通过YESS-4011-03H13□否NO口否NO口杏NO口否NO口失败NO口是YES□是YES口是YES口通过YES口4012S-4012-01H13□SYES口否NO口否NO口否NO口杏NO失败NO□不符合NoiConform口是丫ES口口是YES口是YES口否口是YES□通过YES4013S-4013-01H13否NO□否NO NO口否NO□失败NO□是YES□是YES口是YES□是YES□通过YES4013a S-4013a-01H13口否NO口否NO口舒NO口有NO口失败NO上述高效过波涔的合格证和效率确认报告已附在附件___________中.□通过YESThecertificatesandefficiencytestreportofaboveHEPAfiltershavebeenattachedtoAttachment_________.口失败NO结论Conclusion□符合Conform注择/偏的异常情况,支轿性文件Comments/DeviattonaExceptioniSupporlDocumentation检杳人签名/日期CheckBy Signature/Date审核人签名/日期:ReviewedBy Signature/Date洁净厂房及空调系统安装确认方案AHU-401InstallationQualificationProtocolofCRHVACSystemAHU-401文件编号2ode.版本号/Version页码/Page0144/
4710.偏差处理DeviationsHandling如l执行过程中出现任何偏差之处.偏差处理表将被收集.在学偏差清单》中汇总所有的偏差，并注明他差状态.IfthereisanydeviationduringtheIQexecution,thedeviationprocessingtablewillbecollected.SummarizealldeviationsintheDeviationListandindicatethestatusofdeviations.如有需要，可按照业主质后管理体系要求进行偏差管理和变更控制，Ifnecessary,deviationmanagementandchangecontrolcanbecarriedoutinaccordancewiththerequirementsofthequalitymanagementsystem.偏差编号Deviation偏差描述状态开放/关闭Status对下一阶段影响结论ResultsNo.DeviationDescription open/close Impactonnextphase口通过YES口失败NO口通过YES口失败NO口通过YES口失败NO口通过YES口失败NO口通过YES口失败NO口通过YES口失败NO洁净厂房及空调系统安装确认方案AHU-401InstallationQualificationProtocolofCRHVACSystemAHU-401文件编号2ode.版本号/Version页码/Page0145/47偏差编号Deviation偏差描述状态开放/关闭Status对下一阶段影响结论No.DeviationDescription open/close ImpactonnextphaseResults口通过YES口失败NO口通过YES口失败NO偏差记录表已附在附件_______中，口通过YESDeviationformhasbeenattachedtoattachment______.口失败NO注择/异常情况支持性文件Comments.1Exceplion^SupportDocumentation检查人签名/日期:CheckBy Signature.Date审核人签名/日期ReviewedBy Signature/Date洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0146/
4711.附件清单Attachment List在附件中记录所有对确认报告数据进行支持的各类文件，如培训记录、校准证书、各种图表等文件应注明附件编号、名称和页数Allattachmentdocumentstothedataincludedintheverificationreport,suchastrainingrecords,calibrationcertificatesand variouskinds ofcharts and drawings,will berecorded inthe Supportive Appendix List,indicating the attachmentNo.,name andnumber of pages附件编号对应测试项名称页数AttachmentNo.Test ItemName Page洁净厂房及空调系统安装确认方案AHU-401Installation QualificationProtocol ofCRHVAC SystemAHU-401文件编号/Code.版本号/Version页码/Page0147/
4712.支持性附录清单SupportiveAppendixList在支持性附录清单中记录所有对附件支持的各类文件，应注明附录编号、名称和页数All supportingdocumentstothe dataincluded inthe attachmentwill berecorded inthe SupportiveAppendixList,indicating the appendix No.,name andnumber ofpages.附录编号可遵循附录所属附件号码，即所属附件1的附录即为附录1如附件中仅有一个附录，则以附录所属附件编号表示，例如附录1,附录4如一个附件中包含多个附录，可按顺序进行编号，例如附录1-1,附录1-2名称为此附录的名称页数为此项附录所包含所有页数The appendixNo.can followtheattachment No.to whichthe appendixbelongs,i.e.,an appendixof attachment1isappendix
1.If thereis onlyone appendixin anattachment,it willbe expressedastheattachmentNo.it belongsto,forexample,appendix1andappendix
4.Iftherearemorethanoneappendixinanattachment,it willbegivenaserialNo.for example,appendix1-1and appendix1-
2.The nameis thename oftheappendix.The pagenumber isthe totalnumberofpagesoftheappendix.附录编号页数AppendixNo.名称Name Page
4.职责Responsibilities
4.
1.供应商职责O Responsibilities起草和提交IQ方案，并根据已批准方案开展执行工作；Draft andsunmint theIQ protocoland performtheverificationaccording tothe protocol;对方案执行人员进行本方案的培训；Conduct trainingofthe protocol forrelevant executionpersonnel;负责安装，调试，并提供相关的测试文件记录；Take theresponsibilities forinstallation andcommissioning andprovide testingresults;记录在方案执行过程中产生的原始数据；Record theraw dataduring theexecutionofthe protocol;收集相关的基础技术资料和图纸；Collect therelevant basictechnicaldocuments anddrawings;提供相关设备或系统的技术参数、手册、图纸和文件Provide thetechnical parameters,manuals,drawing anddocuments ofall relatedequipment orsystems;记录在方案执行过程中发生的偏差；Record thedeviations foundduring theprotocol execution;针对偏差提出解决方案以业主审核和批准后采取纠正措施Propose solutionstothedeviations forto reviewandapprovecorrective action;方案确认过程中发生的偏差则需在确认完成之前关闭All deviationsshallbeclosed prior tothecompletion oftheverification;按照要求整理和汇总所有方案文件；Collect alldocuments andtake necessaryrecordings accordingtotherequirements;提交最终的IQ报告，以业主进行审核和批准Submit thefinal IQ report forto reviewandapprove.
4.
2.业主职责Responsibilities协调供应商提供所有相关设备或系统的技术参数、手册、图纸和文件；Coordinatesuppler providethetechnical parameters,manuals,drawing anddocuments ofall relatedequipmentor systems;IQ方案执行工作前，审核和批准方案；Review andapprove theIQprotocolpriortoexecutionoftheprotocol.派出执行人员见证方案执行；Assign personnelto witnesstheexecutionoftheprotocol;审核确认过程中发生的偏差，批准偏差的解决方案和纠正措施Review andconfirm deviations,approve solutionsand correctiveactions fordeviations.完成方案执行工作后，审核和批准报告Review andapprove theIQreportafter completingtheprotocolexecution work.归档和保存与本方案有关的所有文件和图纸File andsave alldocumentsanddrawings associatedwith thisprotocol.
5.参考文件References•GB/T50243-2016通风与空调工程施工质量验收规范Code ofacceptance forconstruction qualityofventilation andairconditioningwords•GB50457-2019医药工业洁净厂房设计规范Code fordesign ofclean workshopin pharmaceuticalindustry•GB50591-2010洁净室施工及验收规范Code forconstruction andacceptance ofcleanroom•GB51110-2015洁净厂房施工及质量验收规范Code ofconstruction andquality acceptanceofindustrial cleanroom•ISO14644-1洁净及相关受控环境第一部分空气洁净度分级Clean roomsand associatedcontrolledenvironments-Part1:Classification ofair cleanlinessby particleconcentration•ISO14644-3洁净室及相关受控环境第三部分测试方法Clean roomsand associatedcontrolledenvironments-Part3:Test methods•GMP-URS-#53-051镇江53#楼洁净室用户需求说明
6.缩略语Abbreviations缩略语说明Abbreviations ExplanationIQ现场验收测试Site AcceptanceTestingDQ设计确认Design QualificationGDP良好记录规范Good DocumentationPracticeGMP药品生产质量管理规范Good ManufacturingPracticeNA不适用Not ApplicablePID管道仪表流程图Piping andInstrumentation DiagramQA质量保证Quality AssuranceQC质量控制Quality ControlURS用户需求说明User RequirementSpecificationFS功能说明Functional SpecificationFDS功能设计说明Functional DesignSpecificationDS设计说明Design SpecificationAHU组合式空调机组Air HandlingUnitBMS楼宇管理系统Building ManagementSystemEHS环境健康和安全Environmental Healthand SafetyEMS环境监测系统Environmental MonitoringSystemEU欧盟European UnionFAT工厂接收测试Factory AcceptanceTestG4初效过滤器Primary EfficiencyFilterF9中效过滤器Medium EfficiencyFilterHEPA高效空气过波器High EfficiencyParticulate AirHMI人机界ihl HumanMachine InterfaceHVAC暖通空调Heating,Ventilation andAir ConditioningISO国际标准化组织International StandardizationOrganizationMC机械竣工Mechanical CompletionVAV变风量阀Variable AirVolume缩略语说明Abbreviations ExplanationVFD变频器Variable FrequencyDrive
7.文件管理规范Documentation ControlProcedure良好的文件管理规范是在整个验证生命周期的对知识管理的重要支持Good documentationpractices areimportant tosupport knowledgemanagement throughoutthevalidation lifecycle.
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1.记录用笔Recording pens使用蓝色签字笔记录Blue orblack signpens shallbe usedfor recording.
7.
2.填写栏目Column filling所有栏目必须填写Allthecolumns shallbe filled.填写内容与上面栏目相同也应重新填写The fulltext shallbe filledeven ifitisthe sameas thatinthefield above.填写栏目内容，应按照实际确认情况，对确认结果使用对勾“寸填写，只能选择一种测试结果填写Fields shallbe filledaccordingtothe actualverification result.The verificationresult shallbe selectedwith寸and onlyone resultcan beselected.For example如下文件名称是否完整可读Document NameComplete andReadable安装确认方案□4Yes是口No否Installation QualificationProtocol若有单个栏目不需要填入内容，则在空白处填写英文字母“不适用”的简写“N/A”，表示无此项内容If thereis nothingto befilled intoan individualfield,N/A abbreviationfor notapplicable shallbe writteninthis field.若有多个栏目不需要填入内容，应用斜线划掉，斜线下方填写“N/A”，下方签名并注明日期If thereis nothingto befilled inmore thanone neighboringfields,such fieldsshallbecrossed withadiagonal line,with N/A”noted blowthe line,sign thename anddate underthe line.如下
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3.更改错误Correction ofmistakes在错误处划线，填入正确的内容，签名并注明更改门期，确保原先信息仍清晰可识别When anymistakes areto becorrected,the correctrecord shallbe entered,signed anddated forcorrection.The originalinformation shallbe leftclearly readable.如System XXSign签名System，乙Date日期
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4.记录日期Date RecordingFormat口期的格式为yyyy-mm-dd.时间的格式为“时时:分分”或“时时:分分:秒秒”Format ofdate isyyyy-mm-dd.Format oftime ishh:mm orhh:mm:ss.。
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