月內(nèi)容sorin spec hvac醫(yī)療器械廠房項(xiàng)目

ScopeTheURSisaproject,whichdescribesadefined,restrictedpartofasystemorconfinedThisistheURSforHVACNormalareaandCleanareathatcoversthedescriptionandspecificationsfornormalareaandcleanareainMedicalbuildingofHVAC.TheURSspecifiesthefunctionofHVACsystemsintheproduction,testing,storingandorhandlingthatisthesubjectofregulatorycompliancerulesandregulations.該文件是一般暖通系統(tǒng)和潔凈室的要求描述，涵蓋了項(xiàng)目暖通系統(tǒng)和潔凈室的描述以及技術(shù)細(xì)節(jié)。該要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.在生產(chǎn)前需要得到的認(rèn)證StatutoryRegulationIngeneral,itistheresponsibilitytoensurethattheHVACsystemhasbeendesignedandinstalledinaccordancewiththelatesteditionsandsubsequentamendmentsofallrelevantregulations,standardsandguidelinesincludingbelowbutnotlimited:總的來說，需要確保HVAC系統(tǒng)按照版的和將要修正的相關(guān)規(guī)范以及和安裝，包括但不限于以CodeofDesignonBuildingFireProtectionandCodefordesignofheatingventilationandairCodeofacceptanceforconstructionqualityofventilationandairconditioningCodefordesignofcleanCodefordesignofpharmaceuticalindustrycleanCodeforconstructionandacceptanceofParticulateairfiltersforgeneralventilation-DeterminationofthefiltrationVentilationforbuildingsAirhandlingunits-MechanicalCleanroomsandassociatedcontrolledOtherrequirementsGB-50016-2006EN779ENENENISOISO供應(yīng)商需提供IQ/OQ草案，經(jīng)過業(yè)主審核后修改至業(yè)主批準(zhǔn)，并執(zhí)行IQ/OQ驗(yàn)證。rneedstoprovideIQ/OQprotocol,andmodifytheprotocolafterclientreviewtillclientapprove供應(yīng)商需提供PQ方案與和方案的執(zhí)行。rneedstoprovidePQprotocolandDescriptionofModuleThisURSdescribetheinstallationofHVACforNormalarea(needcommissioning)andcleanareaareas(needtobequalified),whichsthefollowingareas,withservedAHUsanddehumidifiers,VAVand用戶手冊就普通區(qū)域和潔凈室區(qū)域的HVAC做了相關(guān)描述，包括系統(tǒng)所供給的區(qū)域，服務(wù)的AHUClarificationforCleanInthis ,cleanarearequirementneedstobecomplywithbothGradeDand100000classcleanarea,andhigherrequirementwillbeusedwhentheyareed,detailsasbelow:aparticleisallowed:AtrestOperationalRequirementsforPlanktonicAirborne90mmMicrobeonthe(50*50mmDesignPreconditionsOutdoorsAC.TEMP.VENTTEMPAC.TEMPHEATINGTEMP-4.3-OperationTheHVACequipmentareoperatedbytheBuildingManagementSystem(BMS).HVAC設(shè)備由BMS系統(tǒng)控制ControlandCommunicationAllcontrolishandledbytheAllinternalcommunicationishandledbytheBuildingAirhandlingunits(AHU),separateexhaustfans(Whereappropriate),controlandpowerpanelsarelocatedinbuildingserviceareas,whichareplacedon3/Ffloorofthebuilding.RequirementMajorimpactonGMPrequirement對GMPMinorimpactonanyGMPrequirements對GMP3.1GeneralFunctionVentilationSystemebasicrequirementfortheairconditioningzoneistherealizationoftheroomconditionsneededforthepharmaceuticalproductionprocess.TheproductshouldbeprotectedagainstparticulateandmicrobialThedesigner/contractorhastopayspecialattentiontotheavoidanceofcross-contaminations.AstrictHVACsystemseparationaccordingtocorrespondingcleanlinessclassesandfunctionisrequired.設(shè)計(jì)Betweenroomairandsupplyairatemperaturedifferenceofmax8℃isadmissiblewithoutspecialTheheatloadsoftheproductionequipmentaretobecheckedforplausibilitywhen ngthedesignbySystemself-cleaningtimenotthan20minutesforeachHVACofcleanInsectpreventiondevicetobeinstalledatfreshairintakeandairvent3.2.GeneralFunctionControlSystem(BMS):控制系統(tǒng)消防發(fā)生時(shí)，相應(yīng)區(qū)域的空調(diào)機(jī)組自動停止，排煙機(jī)組應(yīng)自動啟動。應(yīng),能在靜態(tài)時(shí)間低能耗運(yùn)行，以維持潔凈室相對正壓，TemperatureandHumidity:Acontrolloopmeasurestheaveragereturnairtemperatureandhumiditywithsensorsintheroomsandcontrolsthesupplyairtemperatureandhumidity.DependingonthemeasurementtheBMSoutstationcontrolsthecoolingvalve(s)andtheheatingvalve,insequencetominimizeenergyconsumptiontoobtainthesetpointfortemperatureandhumidity.溫度和濕度：控制系統(tǒng)通過房間的傳感器和LocalTemperature:Acontrolloopmeasurestheroomtemperaturewithsensorsintheroomandcontrolsthesupplyairtemperature.DependingonthemeasurementtheBMSoutstationcontrolstheterminalheater,toobtainthesetpointfortemperature.局部溫度：控制系統(tǒng)通過房間的傳感器測量的房間溫度調(diào)整送風(fēng)溫度。BMS根據(jù)測量結(jié)果調(diào)整末端熱盤管來實(shí)現(xiàn)設(shè)Supplypressure:TheBMScontrollermodulatesthefrequencyconverteronthesupplyairfantocontrolsupplyairpressureinthemainsupplyduct,assensedbyapressuretransmitterintheroomsandsomeCAVandVAVisinstalledinbranchairduct(asperblueprintdrawing)tocontroltheairflow.Asetpointforsupplypressurehastobefoundduringruninadjustment.Recirculation:Incleanareastherecirculationshallbeashighaspossibletakingtheairqualityandthepressurizationintoconsideration再循環(huán)：在潔凈區(qū)域，再循環(huán)系統(tǒng)盡可能提供高質(zhì)量的空氣和房間的加壓需DustExtractionsystem:theenduserpointofextractionsystemshallbecontrolledbymanualvalve,theextractionmachinecancommunicatewithBMSsystem,andprovideatleastfollowsignal:on/offstatus,failurestatus.除塵系統(tǒng)：除塵系統(tǒng)的末端使用點(diǎn)通過手動閥來控制，除塵設(shè)備需要提供和BMS的通訊接口，起故障Failure:TheBMSshallprovidealarmwhensensor/equipmentRef./rationale:URSBuildingManagementSystem參考BMS3.4CleanRoomCFDAcleanareaclassificationshallbesatisfiedaccordingtocurrentstandards.CFDA潔凈區(qū)-Req.TargetRangeQTheroomsincleanarea,markedoutinblueprintdrawingReferto2.2in參考本文件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壓力(潔凈區(qū)(非控區(qū)Pressuredifferencesbetweendifferentclassifications,orbetweenclassifiedareaandunclassifiedarea,shallbe≥10Pa.在不同等級的房間或在潔凈區(qū)和非潔凈區(qū)之間的壓差≥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.箱體框架是一個(gè)完全可以拆卸的，以便于維修保養(yǎng)。機(jī)械的穩(wěn)定性需要滿足DINEN1886class1A（T2/TB2），可拆卸，至少達(dá)到50mm厚，外部的板至少是1~1.2mm（涂層至少60um）.內(nèi)板至少是1mm厚的噴涂板或鍍鋅鋼板制作，在加濕段的304不銹鋼。AHU將安裝在屋面，需要是全

箱體的材料需要使用結(jié)構(gòu)聚氨酯或巖棉板（不燃的），保溫厚度不低于50mmThereshouldbealabeloneachfunctionalsectiontoindicateitsfunction.在每個(gè)功能段需要有各自的功能。AllmaterialsusedforthefabricationofAHUsandhumidifiersmustnotsupportmicrobialAHUwillmeetwithAHUThermaltransmittance:(ClassT2)0.5<U≤熱傳遞系數(shù)：(ClassT20.5U1W/m2.KThermalbridgefactor:ClassTB20.6<Kb≤0.75(ClassTB2)umairleakage:≤最大漏風(fēng)率:≤F9filterbypassleakage0.5@400PaF9過濾器旁路漏風(fēng)率:≤0.5%@400PaCentrifugalfanswithbelt-drivenordirectlycoupled-typewillbeinstalledinThefrequencyconvertershouldbedwithfan;thefrequencyconvertershouldhavethecapacitytocommunicatewithBMSsystem.Thefanandmotormustbeerectedonshockabsorptionsupportandtherearethespringorrubbershockabsorberbetweenthesupportandcasing.Aflexibleconnectorisprovidedontheoutletofthefan.Thepowerresourceforfanis380V電力提供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的過濾器需要滿足EN779，并帶有合格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風(fēng)管不得有橫向拼接縫，矩形風(fēng)管底邊寬度小于或等于900mm時(shí)，其底邊不得有縱向拼接900mm1800mm11800mm2600mm2;

GB50243的方法進(jìn)行干管和主管系統(tǒng)的漏風(fēng)檢測。1-56-930%的風(fēng)管并不少于在1:[m3/(h.m2不大于16處為合格；中壓系統(tǒng)風(fēng)管每10m接縫，漏光點(diǎn)不大于1處，且100m接縫平均不大于8DuctdesignshouldbeminimizepressuredropintheThesupportforductneedtobemade-upproductgalvanizedsteelandboltedonsite,itcan’tbeweldedonTheductworkleakageratesshallbewithinlimitsrequirementsin<Codeforconstructionandacceptanceofcleanroom>(GB50591-2010).AllitemsoftheventilationsystemincleanarearoomsshallbeeasytoAllsupplyandextractductworkshallbeinsulatedifthereisariskofcondensationorheatAllinsulationshouldbecarriedoutforeasyThesupplyairgrillshallbeattheceiling,thereturnlouversshallbeinstalledinlowerlevelincleanFlowadjustmentandationforchilledandhotwatersupplyshallbeumAirvelocitiesthroughcoolingcoilsmustnotbeexceededtopreventwaterdropremovaloncoilPre-filtersbeforeHEPAfilters:ThelastfiltrationstepbeforeaHEPAfiltermustbeminF9HEPAAllfiltersatoraboveF7shouldbemadeofOnlystandardHEPAfiltersizesmustbeused,allHEPAfiltershallequipDOPtestingReq.TargetRangeQAllcomponentsshallbeTAGnumberedasperventilationdiagramsandlayoutdrawings.有組件編

Ref./rationale:AllcomponentsshallbeTAG-numberedtoenablechangecontrolandmaintenancehistorytracking.QAllcomponentsshallhaveauniquelocationandTAGnumberinaccordancetoventilationdiagrams.

Ref./rationale:AllcomponentsshallbeTAG-numberedaccordingtodiagramsdrawingstoenablechangecontrolandmaintenancehistoryC ationshallapplyto ationandnecessarydescriptionofthedesignandconstructionofthesystem.

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