文稿分析案例d023a spe001 specification for clean room finishing

D023A-SPE001

REV.A

CONTENT

SUBJECT 3

DESCRIPTION 3

REFERENCEDRAWINGSANDS 3

Codes 3

Referencedrawings 3

DEFINITIONS 4

MINIMUMTECHNICALREQUIREMENTS/ERECTIONTOLERANCES 4

Airtightness(underapressureof50Pa): 4

Flatness(underdeadloadsonly): 4

Verticality 4

Imntation 4

Doors 4

Mechanical /Loadingdata 4

Deflection 5

GENERALREQUIREMENTS(FORCLASSC/D/BSL2ROOMS) 5

Scopeofwork 5

Partitions 6

Ceilings 8

Joinery 8

Floor 10

Miscellaneous 11

Protectionduringsiteworkphase 13

Cleaning 14

SPECIFICREQUIREMENTS 14

Coldroom5° 错误!未定义书签。

Noclassifiedarea 14

APPENDIX 14

SUBJECT

Vaccineproductionbuildingextensionproject.

DESCRIPTION

Workingseedslabisseparatedindifferentworkingzones,whichhavedifferentleveloffinishingandcleannesswithregardtotheirfunctionality.

Workingzonesarethefollowing:

Classifiedareas:

ClassB,withairlockandassociatedrooms,

ClassC,withairlockandassociatedrooms,

ClassD

ClassBSL2andassociatedrooms,

Notclassifiedareas(or“greyareas”):

Thiszoneincludesallroomsaroundtheclassifiedroomswherepharmaceuticaloperationsoccur:Entry,Toilet,changingroometc…

REFERENCEDRAWINGSANDS

Codes

codes

Codeofdesignonbuildingfireprotectionandprevention GB50016-2014

Codefordesignofcleanroom GB50073-2001

Codefordesignofpharmaceuticalindustrycleanroom GB50457-2008

Codeforfirepreventiondesignofinteriordecorationofbuildings

GB50222—95(2001Revision)

CGMP(CurrentGoodManufacturingPractice)

ReferencedrawingsLayouts:

D023A-L01013:1STFLOOR N

D023A-L02013:2NDFLOOR N

D023A-LR1013:ROOF N

D023A-C01013:1STFLOORCEILING N

D023A-A05001:DOORS&WINDOWSLIST&DOOR&WINDOWSDETAILS

DEFINITIONS

-: SanofiPasteur

-Contractor: Therofequipmentand/orserviceforthe

MINIMUMTECHNICALREQUIREMENTS/ERECTIONTOLERANCES

Thepartitionandceilinghavetomeetthefollowingsminimumcharacteristicsregardingtheclassifiedrooms(classB,C,D,BSL2).

Airtightness(underapressureof50Pa):

Allwallsandceiling airleakage<1.m3/h.m²

Doorwithrein d airleakage<1.m3/h

Standarddoors airleakage<3m3/h

Flatness(underdeadloadsonly):

Theassemblysystemsbetweenpanelsandbetweenwindowsandpanelsshallensurethefollowingflatnesstolerances:

Flatnessdefault(undera2mruler)<3mm

Offsetbetween2adjacentpanels<1mm

Verticality

umtoleranceofverticalityis5mmforaheightof3m.

Imntation

Squaringandparallelismhavetobestrictlyrespected. umoutofnetoleranceisabout5mm umoverthelengthofpartition.

Doors

umtoleranceofverticalityissetat2mm.

Mechanical/Loadingdata

Partitionsandceilingshallresisttothefollowingloads:

DeadLoads:

Selfweightof partition/ceilingpanels,includingrein mentsforinserts/reservations

Lightingequipments

Electricalequipments(cabletrays,controlpanel,junctionboxes)

Ventilationequipments(Filters,Exhaust)

LiveLoads:

Maintenanceloads:pointloadof150daN

(correspondingtoonoccasionalmaintenance–for1 –withequipment)

Ceilingshallnotbeconsideredasapermanentaccess,usedforheavymaintenanceordensetrafficduringerectionworks.

Airpressure(duetodifferentialpressurebetweenadjacentrooms):130Pa

Deflection

Deflectionshallbelimitedto1/200thofthespan,includingliveloads,forpartitionsandceilings.

GENERALREQUIREMENTS(FORCLASSBC/D/BSL2ROOMS)

Scopeofwork

Scopeofworkincludesallobligationsarisingfromtheapplicationofnormsandregulationsaswellasthatresultingrepairwork.

Particularlytheseinclude:

Installingthestructures

Surveys,design,constructiondrawingsanddetaildrawingsneededforpartition/ceilingerectionandfortheco-ordinationwiththeothersubcontractorsinvolved(includingparticularlytheissueofsynthesisdrawing,coveringallreservationsinthepartitionandceilingsrequestedbyothersubcontractors)incompliancewiththeprojectguidens.

Supplyandinstallationofpartitionsandceilingspecification,asdefinedinthefollowingspecificationsectionsandinthecontractor’sguidedrawings.

Appropriateprotectionofstructureswithregardtotheactivitiesofothersubcontractors.

Interpretation,understandingandacceptanceofgraphic sdefiningtheworks.Anydifficultyinunderstanding,contradiction,omission,impossibilityorerrorfoundbythesubcontractoristobestatedwhensubmittedhisoffer.

Modificationsmadebythesubcontractorcomparedwiththecontractual s.

Acceptanceofthesupportsneededtoworkthesematerials.

SupplyofsamplesattherequestoftheContractoror .

Cleaningofstructures.

Partitions

Generalrequirements

PolyurethaneorStyrenefoamisbanned.Allpartitionandceilingmaterialsshallhavethefollowingcharacteristics:

Notfl ble,

Firestabilityrating:30minutesminimum,Thepartitionwalloftheevacuationcorridorshouldreachonehourfire rating.

Nodischargeorcollectofparticles(allsteelelementshavetobeconnectingtoearthingsystemtodischargestaticelectricity)

Inerttodevelopmentofmicro-organisms,

Resistanttohumidity,

InsensitivetoUVlight,

Resistanttoacidsandalkalis.

Kcoefficient:2,0W/°C.m2fornotclassifiedrooms,o.58W/°C.m2forclassifiedC/Drooms.

Resistanttocleaninganddecontamination,andshallbeeasytoclean(byusingdetergentsandbleach)

Listofpotentialdecontaminationproducts:

Formaldehydefumigation.

H2O2gasandnebulaedform.

Distributionpartitions

Design

Panelsshallbeprefabricatedandself-bearing.Minimumthicknessofthepartitionshallbe60mm.

TheyshallbeerectedandsetwithaU-Shapefixedonconcretefloor.

Additionalrequirements:

Airtightness:

Upperarea,belowtheceilingandlowerareaatfloorlevelbydoublejointmasticcompound.

Betweenpanelsoneachsideofthechamferedsharpedgesbyamasticcompoundseal.

Allverticalandhorizontalangles(exceptontheground)willbecoveredbyaluminiumsectionepoxyprotectedquarter-circleanglemouldings,sealingwillbeprovidedbyasiliconemasticsealbetweenthesectionandthepanel;atthefootofthepartition ofthesectionwillbeadaptedincaseofaverticalplinth.

ThepanelswillbelaidatgroundlevelinaUchannelmadeofgalvanisedsheetsteelfixedtotheground(includingtheuseofshimstoovoiddifferencesinlevel).

Penetrationsshallbeprovidedfor:

Electricity(sandvariouspowers).

Fluidsinlet/outlet.

Switchesandsignalsforinterlocking,

Measuringequipmentforenvironmentalcontrolineachclassifiedroomstorage,coldroomandfillingcoldroom,

Smokedetectors,Sprinklers,extinguishers,motionsensorandsafetyshowers,

Variousaccessoriesandalltheirconstraints.

Materials

Thepanelsshallconsistoftwosmoothsidesmadeofgalvanisedsteelsheet,pre-enamelledfinishwithamineralwoolinsulatingcore.

Non-fl bleand bustible-firerated30minutesminimumatleast(withtestreport).

Hot-dipgalvanised(mini:class2,Z225).

Pre-enamellingistobehouseholdgrade:5+20microns,colourtobeselectedbyfromthemanufacturer’sstandardrange.

Steelsheetthickness:6/10e(0.6mm)minimum.

Themetalfacingofthepanelshallbecoveredbyanadhesivetransparentprotectivefilmwhichwillberemovedonlyaftererectionandbeforesealing.

Doublepartition

Theseshallhavethesameappearanceanddesignasdistributionpartitions.

Theinvisiblesideshallbesmoothandgalvanised.

Liningpartitions

Thesewillbeofidenticalappearanceanddesigntothe(distribution)(double).

Theinvisiblesideistobesmoothandgalvanised.K=2.0W/°C.m2

Sheetmetallinings

Thesheetmetalliningsaretobeofthesametypeasforpartitionfacings,

Colouristobeidenticaltothatofthepartition,

Thedesignoftheliningsshallprovideperfectorslightlyprojectingflushtothepanelswithnovisiblemeansofatta ents(e.g.rivets)

Allfacingsshallbesealedwithasiliconecompound.

Ceilings

Design

Prefabricatedpanelshavetobeself-supportingorsuspended.Theirminimumthicknesswillbe100mm(unles ceptionallystatedotherwiseinthespecifications)

ThebraceswillbeOmegatypeorother.

Panels’assemblywillbedonebymeansofsingleordoubleinterlock(maleandfemaleedges),invisibleonbottomface.

Jointsalongthechamferededgesonbothsidesofthepanelwillbedoublesealedwithsiliconecompound.

Alluppersealsaretobeprotectedbygalvanisedmetalsealcovers.

Asuitablecornerpiecewillcoveralljointsbetweenhorizontalandverticalpanels.Itshallconsistofaquartercircleshapedepoxyprotectedaluminiumsheeting,withsealingbymeansofsiliconecompoundbetweenthesheetmetalandthepanel.SuitablefinishingpiecesaretobeincludedoppositethePVCrisingplinthandatthemeetingpointsoftheverticalandhorizontalcorners.

Remark:Alltheverticalandhorizontalcornerpiecesshallbeinstalledwithoutintermediatecutouts.

K=0.43W/°C.m2(classifiedandnoclassified)

Materials

Thepanelsshallconsistoftwosmoothsidesmadeofgalvanisedsteelsheet,pre-enamelledfinishwithamineralwoolinsulatingcore.

Hot-dipgalvanised(mini:class2,Z225).

Pre-enamellingistobehouseholdgrade:5+20microns,colourtobeselectedbyfromthemanufacturer’sstandardrange.

Steelsheetthickness:6/10e(0,6mm)minimum.

Non-flbleand bustible-firerated15minutesminimumatleast(withtestreport).Theceilingoftheevacuationcorridorshouldreachthefire ratingofonehour.

Themetalfacingofthepanelshallbecoveredbyanadhesivetransparentprotectivefilmwhichwillberemovedonlyaftererectionandbeforesealing.

Joinery

Windows

Theframesaretobeflushonbothsideswiththefollowingcharacteristics:

Punch-outsandfittedglassaretobecarriedoutinthefactory.

Airistobeextractedfrombetweentheglasspanelsandtheareaistobedehydratedandsealed.

Windowsaretobedouble-glazedwithtoughenedglassbothsidesflushandminimumthicknessofeachglasspanel:6mm.

Siliconcompoundwillbeusedforperipheralsealingoftheframe.

Doors

Bothsidesofdoorsaretobeflushandmeetthefollowingminimumcharacteristics:

Frame:

Thesolidblockcasingshallbeingalvanisedsteel,pre-enamelledfinishedandsetintothepartition.

Leaf

Thepanelshallconsistoftwosmoothfacesingalvanisedsteel(minimumthickness75/100ths)andofaninsulatingcore,thickness60mm.Pre-enamelledfinished.

Thesubcontractorshallsupplyadjustablelouver(“clonet”)inthelowersectionforair-tightness.

Enamelling

ThecolourwillbespecifiedbySanofiPasteur.

Ironmongery

Rein mentoftheleafbystainlesssteelhinges(thetywilldependuponthedoorweightanddimensions).

Fortwo-leafeddoors,thesemi-fixeddoorwillbefastenedwithonecontrolbutton.Thefloorlevellatchisincludedinthescopeofwork.

Thenylondoorstopssetintotheflooringormountedonthepartitions,colourshallmatchwithotherfittings.

Thefittingswillconsistoflockingbarsanddouble-lockingknopsmadeofrein dnylonwithasteelcoreandreturnspringsetinthelockingbars.

Colourwillbeselectedby ,fromthemanufacturer’sstandardrange.

Sealing

Sealsaroundtheperipheryoftheleaf(3sides)and“Clonet”onthefeet,

Eyepiece

Rectangularshapedeyepiecetypeglasswithflushdoubletoughenedglass,glued,dittofortheglassframes,sizewillbestatedinthespecification.

Doorcasesandframes

Thedoorcoatinginthebasewillhavethesamecharacteristicsasthoseofthepartitions.Sealingwillbeensuredbytubulargasketssetintotheframeandbyaseal.Theframesaretobeequippedwithabrand,lockpin,fittedbytherandcontrolledbyabadge-reader;connectionwillbeunderresponsibilityoftheelectricalr.

Whenorderingthesignallights,itipectedthataproximitydetectorwillbemountedonateinthecrosspieceofthedoor.Ametalflatpiecewillbegluedabovethedoorframe.Thecontractorforthisworkwillhavetoallowforthepassageoftheproximitydetectorinthecrosspieceandallowspaceforthejunctionboxandfurtherspaceabovethedoortocompensatefortethicknessandenclosureofthisspaceinthepartition.Oneothersystemcouldbeinstalled.

Whitecolouredbuildinghardwareistobeused.Safetyorlaminatedglassistobeusedinthebullseyewindows,thesewillbemountedinthedoorfacingandsiliconesealed.

Closedoor

Allthedoorsofthisprojectmusthaveoneautomaticclosedoor.

Airtightdoor

ATDstructure.

Thereareair-filledbarsinthedoorframetoguaranteethesealingofthedoor.

Thereisavisionportonthedoor.

Thedoorcanbeinterlockedtoensurenomorethanonedoorisopenedatthesametime.

Inanemergency,thedoorshouldbecutoffandcanbeopened.

Emergencydoor

Theemergencydoorshouldmeettherequirementsof"buildingglassapplicationtechnologyspecificationJGJ113-2009".

Theglassshouldusesafeglass.

Thereshouldbeobvioussignsontheemergencydoor,topreventthestaffhittheglassbymistake.

Betweenthedoorframeandwallshouldbesealedtight,thegapusesfoodgradesiliconetoseal.

Emergencydoorshouldsetupsafetyhammer.

Floor

Afterpolishingconcretefloors,thewholecleanroomssurfaceshallbecoveredwithaPVCflooringwhichwillmeetthefollowingcharacteristics:

Flooringinwidthselementstype

Mechanicalperformancesgrading:PVCmaterialshallresisttocirculationofmanualtrolleys.

Maxpointload:200daN

Maxbearingpressure:30daN/cm²

Soundproofing:>3dB

Thickness:2mm

Layingbygluingwithacrylicemulsion

Bacteriologicalandfungistatictreatment(inManufacturer’sfactory)

CarryingoutaccordingtotheManufacturerspecifications

againstmechanicalshocks,loads(trolleywithnylonwheels),punching,scratchesandwear

JointtreatmentbyPVCcordheatweldedandofcolourmatchedwiththeflooring.

Colourchosenby inther’srange

Workswillalsoinclude:

allthenecessaryjointsaroundholesandsealingsiftheyarecarriedoutbeforeorduringthelayingofthefloorings,

allthenecessaryjointsoncleanroompartitions,including:PVClayingoncurvedplinth,perfectlylevelledandflushwiththepartitionsexternalleavesandfinishedwithsiliconjoint.

allthesurfaceshallbecovedbyPVCsheet.

Miscellaneous

Siliconcompound

Themasticistobecategory1asperqualification,forapplicationwithoutprimeronglass,aluminiumandcoatings.

Themasticwillbeantifungalandbactericidalwithexcellentageing properties,particularlytoUV(noyellowing)andwillwithstandconventionalcleaningproductsaswellasformaldehydegas,ammoniaandH²O².

Themasticistobetranslucent,whiteorgreydependinguponthezonestobetreated.Innocasehisstripwidthwillexceed10mm.

Pre-cutinpartitions

Mostcuttingwillbecarriedoutintheworkshopinaccordancewiththeconstructiondrawingstobedbyothersubcontractorsforthetechnicallotsaftercontractorapproval.

Reservationshallcover:

Air-conditioningextractorgrids,tobeconfirmedbytheair-conditioningcontractor,

Fluidpipecrossings,

Smallelectricappliance(wallsockets,switches,signallights)

Spaceforadjustingstructurealreadyinsitu

Forequipmentpenetrations,

Forenvironmentcontrolmeasuringdevices.

Thecuttingedgeswillhavetobeprotectedbyagalvanizedsheetwhichwillbefoldedoverthesurfaceandunderthepanelfaceandwillbeadjustedtotheequipmentinordertobeinvisible

Nobareedgeswillbeaccepted.

Pre-cutinceilings

Mostcuttingwillbecarriedoutintheworkshopinaccordancewiththeconstructiondrawingstobedbytheothersubcontractorsaftercontractorapproval.

Penetrationshallcover:

laminarflowequipment,

lightingequipment,forventilatorgrids,(blowerandextractor)forprocessequipment,

LaminarAirFlowinthewraproom

environmentcontrolmeasuringdevices,

Firedetectorsandsprinkler

Pipepenetrationsandsuspendedequipment

Motionsensor

Theedgesresultingfromcuttingaretobeshieldedbyenamelledsheetingthesizeofwhichwillfitwiththeequipmentandwillbeinvisible,

Sharpedgeswillnotbeaccepted.

Peripheralsealingofthisequipmentisincludedinthescopeofworkandistobeimplementedwithsiliconestriponthegridsandwithadjustedsteelsheetssealedwithsiliconescriponthecableandpiperuns.

Reinmentshallbesupply,ifpenetrationislocatedonabracingdevice.

Hepafilterbox

Thefilterboxincorporatedintheceiling,madeofgalvanizedsteelpre-enamelledfinished,musthaveone umoverflushingof2mmmustbefixedabovetheceiling,andsealedwithsiliconcompoundattheperipheralbetweenboxandceiling.

Light

Thelightingequipmentincorporatedandfixedontheceiling,madeofgalvanizedsteelpre-enamelledfinished,musthaveone umoverflushingof2mm,andwithpossibilitytoremovethelampsandballastfromaboveoftheceiling,andsealedwithsiliconcompoundattheperipheralbetweenboxandceiling.

Thelightingequipmentshallprovide350luxat1mroomthefloorallproductionroomand300luxat1mfromthefloorforthestorage,coldroomandchangeroom.

Electricalequipment

Theelectricalequipmentswitchesasocket;pushbuttonect…incorporateandfixedonthepartitionpanelmusthaveone umoverflushingof2mmifpossible.

Trans-wallorPassthru

Thetrans-wallincorporateandfixedonthepartitionpanelmadeofstainlesssteelshalleasiercleaningandopeningshallbesealedwithfireproofsiliconcompoundattheperipheralbetweenboxandceiling.

Fireproofpenetrationmaterials:anywallpenetrations,suchasairductsandcabletrays,shouldbesealedwithFMapprovedfirestopmaterials.

Locatedaccordingtolayoutdrawing.

Protectionduringsiteworkphase

Safetyprotectiononceilings

Assoonasaholehasbeenmadeintheceilingthesubcontractorshallsupplyandfitashutterorplugconsistingofawoodpanelboard,minimumthickness30-mmforaholeofsize:

0.60mifnormalpanelsareused,

0.75mifCTB-Hpanelsareused.

Thesizeofthesealingpanelswillbeatleastequaltothepenetrationsection+0.10m(e.g.holes0.50x0.50=0.60x0.60panel)

Thesepanelsshallbelockedwithsidestop-piecestoensurethattheyareheldincewithnoriskofslippage.

Protectionofceilingpanels

Supplyandinstallationoftemporaryclipboard