月内容sorin spec hvac医疗器械厂房项目

ScopeTheURSisaproject,whichdescribesadefined,restrictedpartofasystemorconfinedThisistheURSforHVACNormalareaandCleanareathatcoversthedescriptionandspecificationsfornormalareaandcleanareainMedicalbuildingofHVAC.TheURSspecifiesthefunctionofHVACsystemsintheproduction,testing,storingandorhandlingthatisthesubjectofregulatorycompliancerulesandregulations.该文件是一般暖通系统和洁净室的要求描述，涵盖了项目暖通系统和洁净室的描述以及技术细节。该要TheuseofthisURSwillensurethatthesystemsarespecified,purchased,installed,operatedandmaintainedinaccordancewiththeprojectqualitystandardsandtheGMPrequirementsasdefinedinURSStructureTheservesbothtodescribethesystemandtolisttherequirements.TheURSisaccordinglystructuredinadescriptivepartandarequirementpart.Inthedescriptivepart(section1and2),generalinformationconcerningsystemdesign,responsibilities,descriptionofmodule,designpreconditions,interface,etc.aredescribed.Intherequirementpart(section3),specificrequirementsarelisted,formingthebasisforthefollowingcommissioningandqualification.Therequirementpartisstructuredincludingthefollowingcategories:FunctionCleanroomclassificationHEPAfiltersRoomdifferentialpressuresAHUsInstallationHSEMaintenance/service以及服RequirementTherequirementsforeachentityaredividedintotwo Willbetestedduringsupervision,factoryacceptancetest(FAT),Commissioningphaseatfactoryand/orsiteacceptancetest(SAT).FAT和SATQualificationRequirements Willbequalifiedaccordingtoauthorities’regulationsandguidelinespriortouseforproductionofMedicalalproduct.在生产前需要得到的认证StatutoryRegulationIngeneral,itistheresponsibilitytoensurethattheHVACsystemhasbeendesignedandinstalledinaccordancewiththelatesteditionsandsubsequentamendmentsofallrelevantregulations,standardsandguidelinesincludingbelowbutnotlimited:总的来说，需要确保HVAC系统按照版的和将要修正的相关规范以及和安装，包括但不限于以CodeofDesignonBuildingFireProtectionandCodefordesignofheatingventilationandairCodeofacceptanceforconstructionqualityofventilationandairconditioningCodefordesignofcleanCodefordesignofpharmaceuticalindustrycleanCodeforconstructionandacceptanceofParticulateairfiltersforgeneralventilation-DeterminationofthefiltrationVentilationforbuildingsAirhandlingunits-MechanicalCleanroomsandassociatedcontrolledOtherrequirementsGB-50016-2006EN779ENENENISOISO供应商需提供IQ/OQ草案，经过业主审核后修改至业主批准，并执行IQ/OQ验证。rneedstoprovideIQ/OQprotocol,andmodifytheprotocolafterclientreviewtillclientapprove供应商需提供PQ方案与和方案的执行。rneedstoprovidePQprotocolandDescriptionofModuleThisURSdescribetheinstallationofHVACforNormalarea(needcommissioning)andcleanareaareas(needtobequalified),whichsthefollowingareas,withservedAHUsanddehumidifiers,VAVand用户手册就普通区域和洁净室区域的HVAC做了相关描述，包括系统所供给的区域，服务的AHUClarificationforCleanInthis ,cleanarearequirementneedstobecomplywithbothGradeDand100000classcleanarea,andhigherrequirementwillbeusedwhentheyareed,detailsasbelow:aparticleisallowed:AtrestOperationalRequirementsforPlanktonicAirborne90mmMicrobeonthe(50*50mmDesignPreconditionsOutdoorsAC.TEMP.VENTTEMPAC.TEMPHEATINGTEMP-4.3-OperationTheHVACequipmentareoperatedbytheBuildingManagementSystem(BMS).HVAC设备由BMS系统控制ControlandCommunicationAllcontrolishandledbytheAllinternalcommunicationishandledbytheBuildingAirhandlingunits(AHU),separateexhaustfans(Whereappropriate),controlandpowerpanelsarelocatedinbuildingserviceareas,whichareplacedon3/Ffloorofthebuilding.RequirementMajorimpactonGMPrequirement对GMPMinorimpactonanyGMPrequirements对GMP3.1GeneralFunctionVentilationSystemebasicrequirementfortheairconditioningzoneistherealizationoftheroomconditionsneededforthepharmaceuticalproductionprocess.TheproductshouldbeprotectedagainstparticulateandmicrobialThedesigner/contractorhastopayspecialattentiontotheavoidanceofcross-contaminations.AstrictHVACsystemseparationaccordingtocorrespondingcleanlinessclassesandfunctionisrequired.设计Betweenroomairandsupplyairatemperaturedifferenceofmax8℃isadmissiblewithoutspecialTheheatloadsoftheproductionequipmentaretobecheckedforplausibilitywhen ngthedesignbySystemself-cleaningtimenotthan20minutesforeachHVACofcleanInsectpreventiondevicetobeinstalledatfreshairintakeandairvent3.2.GeneralFunctionControlSystem(BMS):控制系统消防发生时，相应区域的空调机组自动停止，排烟机组应自动启动。应,能在静态时间低能耗运行，以维持洁净室相对正压，TemperatureandHumidity:Acontrolloopmeasurestheaveragereturnairtemperatureandhumiditywithsensorsintheroomsandcontrolsthesupplyairtemperatureandhumidity.DependingonthemeasurementtheBMSoutstationcontrolsthecoolingvalve(s)andtheheatingvalve,insequencetominimizeenergyconsumptiontoobtainthesetpointfortemperatureandhumidity.温度和湿度：控制系统通过房间的传感器和LocalTemperature:Acontrolloopmeasurestheroomtemperaturewithsensorsintheroomandcontrolsthesupplyairtemperature.DependingonthemeasurementtheBMSoutstationcontrolstheterminalheater,toobtainthesetpointfortemperature.局部温度：控制系统通过房间的传感器测量的房间温度调整送风温度。BMS根据测量结果调整末端热盘管来实现设Supplypressure:TheBMScontrollermodulatesthefrequencyconverteronthesupplyairfantocontrolsupplyairpressureinthemainsupplyduct,assensedbyapressuretransmitterintheroomsandsomeCAVandVAVisinstalledinbranchairduct(asperblueprintdrawing)tocontroltheairflow.Asetpointforsupplypressurehastobefoundduringruninadjustment.Recirculation:Incleanareastherecirculationshallbeashighaspossibletakingtheairqualityandthepressurizationintoconsideration再循环：在洁净区域，再循环系统尽可能提供高质量的空气和房间的加压需DustExtractionsystem:theenduserpointofextractionsystemshallbecontrolledbymanualvalve,theextractionmachinecancommunicatewithBMSsystem,andprovideatleastfollowsignal:on/offstatus,failurestatus.除尘系统：除尘系统的末端使用点通过手动阀来控制，除尘设备需要提供和BMS的通讯接口，起故障Failure:TheBMSshallprovidealarmwhensensor/equipmentRef./rationale:URSBuildingManagementSystem参考BMS3.4CleanRoomCFDAcleanareaclassificationshallbesatisfiedaccordingtocurrentstandards.CFDA洁净区-Req.TargetRangeQTheroomsincleanarea,markedoutinblueprintdrawingReferto2.2in参考本文件2NARef./rationale:CFDAshallbecomplied需要符合CFDA3.5HEPAfiltersSupplyairtoallroomsincleanareasshallpassthroughterminalHEPAfilters(HEPAfilterswillbeinstalledinsomemain/branchductforsomeroomsunderneathmezzanineasperblueprint).Req.QAllterminalHEPAfiltersshallbeatleastclassH13canmeetEN1822Ref./rationale:AllfiltersshallbecorrecttoobtainroomQAllHEPAfiltersshallbedeliveredincl.filterwithsignatureanddateforeachfilter.Ref./rationale:HEPAfiltersshallbedeliveredwithationforcorrectfunctiontoavoidcontaminationproblemsQEachHEPAfiltershallhaveuniqueidentificationandlocation.Ref./rationale:ItshallbepossibletolocateandidentifyHEPAfilterstoensuremaintenanceandchangecontrolQDOPtestingholeshallbeequippedforeachHEPAfilterRef./rationale:ItshallbepossibletohaveaDOPtestforeachHEPAfilter,anditshallbeincludedinOQCPressuredropofeachF9ofairreturnneedtobemonitoredbydifferentpressuregauge.Pressuredropwithclean110Paundernominalflow,max.126Pawithdesignflow,andwithdirty

Ref./rationale:PressuredropoverHEPAfiltersshallbewithinlimitsinordertoreducepowerconsumption3.6RoomDifferentialTheroompressurecontrolsystemmustassurethattheindividualclassified/unclassifiedroomshaveapressure(withreferencetoareferenceroom)Pressure(Cleanarea)>Pressure(CNC)>Normal压力(洁净区(非控区Pressuredifferencesbetweendifferentclassifications,orbetweenclassifiedareaandunclassifiedarea,shallbe≥10Pa.在不同等级的房间或在洁净区和非洁净区之间的压差≥10PaAppropriatepressuredifferencesofroomsshouldbemaintainedbetweenadjacentroomswithdifferentprocessrequirementbutinthesamecleanclassification.Thepressuredifferentialismeasuredacrosstheairlockifthereisanairlockforit,notacrosseachTheroompressuremustbecontrolledrelativetoaspecificchosen“referenceReq.TargetRange(Min-Max)QPositiveroompressurefromcleantowardslesscleanmustbepresenttoensurecorrectairflowbetweenroomsofdifferentclasses.-0to+10Ref./rationale:CFDAGMPshallbecompliedQAllroomsincleanareashallbespecifieddifferentialpressure.-0to+10Ref./rationale:CFDAshallbecompliedwith,andprocessrequirementshallbeTheroompressureshallbeachievedandtestedduringCommissioning,thenqualifiedduringQualificationphase.3.7.AHUs,UnitCasingframeconstructioniscompleydemountablewhichisconvenienttocarryoutmaintenance.ThemechanicalstabilitycomplieswithDINEN1886class1A.Allunitpanelsaredoublewalled,coldbridgefree(T2/TB2),detachable,atleast50mmthick,outsidesheetshouldbeatleast1-1.2mmgalvanizedsheetwithpowdercoatedtoanti-corrosion(coatingthicknessatleast60um).Theinternalsheetshouldbeatleast1mmpowdercoatedsteelorgalvanizedsteel,andtheinternalsheetofhumidifiersectionshouldbe304stainlesssteel.AHUlocatedontheroofshallbeexternaltypeandwaterproofcovershallbeprovided.箱体框架是一个完全可以拆卸的，以便于维修保养。机械的稳定性需要满足DINEN1886class1A（T2/TB2），可拆卸，至少达到50mm厚，外部的板至少是1~1.2mm（涂层至少60um）.内板至少是1mm厚的喷涂板或镀锌钢板制作，在加湿段的304不锈钢。AHU将安装在屋面，需要是全

箱体的材料需要使用结构聚氨酯或岩棉板（不燃的），保温厚度不低于50mmThereshouldbealabeloneachfunctionalsectiontoindicateitsfunction.在每个功能段需要有各自的功能。AllmaterialsusedforthefabricationofAHUsandhumidifiersmustnotsupportmicrobialAHUwillmeetwithAHUThermaltransmittance:(ClassT2)0.5<U≤热传递系数：(ClassT20.5U1W/m2.KThermalbridgefactor:ClassTB20.6<Kb≤0.75(ClassTB2)umairleakage:≤最大漏风率:≤F9filterbypassleakage0.5@400PaF9过滤器旁路漏风率:≤0.5%@400PaCentrifugalfanswithbelt-drivenordirectlycoupled-typewillbeinstalledinThefrequencyconvertershouldbedwithfan;thefrequencyconvertershouldhavethecapacitytocommunicatewithBMSsystem.Thefanandmotormustbeerectedonshockabsorptionsupportandtherearethespringorrubbershockabsorberbetweenthesupportandcasing.Aflexibleconnectorisprovidedontheoutletofthefan.Thepowerresourceforfanis380V电力提供380V50HZ.Theheatingcoilsandcoolingcoilsshallbere-moveableformaintenanceorThecoolingcoilsshallbechilledwatertypewith7ºCwatersupplyand12ºCTheheatingcoilsshallbehotwatertypewith65ºCwatersupplyand50ºCThecoolingcoilsshallbeconstructedfromcoppertubes,aluminousfins,seamlesscopperheader,and304stainlesssteelframes.Finsshallandmakefirmandcontinuouscontactwiththeprimarytubes.Sealingdevicesshallbefittedtotopsandbottomsofcoilstopreventairby-pass.Theheatcoilsshallbeconstructedfromcoppertubes,aluminousfins,seamlesscopperheader,andgalvanizedsteelframes.Finsshallmakefirmandcontinuouscontactwiththeprimarytubes.Sealingdevicesshallbefittedtotopsandbottomsofcoilstopreventairby-pass.DriptraysassociatedwithpipemustcomplywiththefollowingDriptraysaretobeprovidedtoallcoolingcoils,whichmustbewatertight.Externallyinsulatedandmanufacturedfromstainlesssteel.Alltraysaretobefree-drainingandprovidedwithdrainconnection.Thedrainsaretobetrappedwithsufficientwatersealto ethefansuction.ThetraysaretobeeasilyremovedduringThedesignofthetrayistoavoidairby-passandre-evaporationofBeforearrivingsite,allcoilsmustbehydraulicallytestedto1.5timestheworkingpressureor1.0MPa,whicheveristhegreater. usedforhumidificationshallbenocontaminationofhumidifiershouldbeadopted.Thehumidifierandconnectingpartsshallbemanufacturedfrom304stainlessThefiltershouldbeF9canmeetEN779standardwithcertificationF9的过滤器需要满足EN779，并带有合格ThepressuredifferencegaugeandpressuredifferenceswitchforfiltershouldbeindicatedFollowingsectionshouldhaveinspectiondoor:fan,filter,coiling,andThesightglassshouldbeofdoublelayerglass,notlessthan200mm,installedonfansectionwithlightingin24V.NoiseItshouldnotexceed75dB(A)atintakeandnotexceed78dB(A)atoutletwhenmeasuredat1meterawayfromtheunit.Req.Range(Min-37Cwilldforhumidifier.Ref./rationale:CFDAshallbecompliedwithas2,2,1定管 O.0352X=2.490.0352X7000.0352X00352XP01000或L0.0117X0117XP01500)/(h.m23.8.GeneralInstallationRequirements,Galvanizedsteelshallbeusedforthe风管不得有横向拼接缝，矩形风管底边宽度小于或等于900mm时，其底边不得有纵向拼接900mm1800mm11800mm2600mm2;

GB50243的方法进行干管和主管系统的漏风检测。1-56-930%的风管并不少于在1:[m3/(h.m2不大于16处为合格；中压系统风管每10m接缝，漏光点不大于1处，且100m接缝平均不大于8DuctdesignshouldbeminimizepressuredropintheThesupportforductneedtobemade-upproductgalvanizedsteelandboltedonsite,itcan’tbeweldedonTheductworkleakageratesshallbewithinlimitsrequirementsin<Codeforconstructionandacceptanceofcleanroom>(GB50591-2010).AllitemsoftheventilationsystemincleanarearoomsshallbeeasytoAllsupplyandextractductworkshallbeinsulatedifthereisariskofcondensationorheatAllinsulationshouldbecarriedoutforeasyThesupplyairgrillshallbeattheceiling,thereturnlouversshallbeinstalledinlowerlevelincleanFlowadjustmentandationforchilledandhotwatersupplyshallbeumAirvelocitiesthroughcoolingcoilsmustnotbeexceededtopreventwaterdropremovaloncoilPre-filtersbeforeHEPAfilters:ThelastfiltrationstepbeforeaHEPAfiltermustbeminF9HEPAAllfiltersatoraboveF7shouldbemadeofOnlystandardHEPAfiltersizesmustbeused,allHEPAfiltershallequipDOPtestingReq.TargetRangeQAllcomponentsshallbeTAGnumberedasperventilationdiagramsandlayoutdrawings.有组件编

Ref./rationale:AllcomponentsshallbeTAG-numberedtoenablechangecontrolandmaintenancehistorytracking.QAllcomponentsshallhaveauniquelocationandTAGnumberinaccordancetoventilationdiagrams.

Ref./rationale:AllcomponentsshallbeTAG-numberedaccordingtodiagramsdrawingstoenablechangecontrolandmaintenancehistoryC ationshallapplyto ationandnecessarydescriptionofthedesignandconstructionofthesystem.

Ref./rationale:Plantationshallapplyto“asbuilt”inordertoenable3.10.GeneralInstallationRequirements,Ref./rationale:URSBuildingManagementSystem参照BMS3.11.CriticalrequirementsforHealth,SafetyandDesignmust