洁净室功能设计说明FunctiondesignspecificationforCR

洁净室功能设计说明Founction DesignSpecification ofCR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设计及施工说明NO.序号Design and Construction specificationcombustibleand should not useorganic compositematerials.The fire resistance limit of theceiling andpartitionwalls should not be less than

0.5hours,and the fireresistancelimitof the color steel plateson bothsidesof theevacuation walkwayand theceiling should be

21.0hours.洁净区柱子与实体墙面均应采用彩钢板包面墙面与地面、吊顶；墙面与墙面、柱面与墙面交接之阴角以及该区域的墙、柱面阳角均须采用成品圆角

1.9The columnsand solidwalls in the clean area should be coveredwith colored steel plates.Wall andground,suspended ceiling;The internalcorners at the intersectionof walls and columns,as wellas theexternal cornersofwallsandcolumns in the area,must befinished roundedcorners.洁净区内为彩钢板隔断的走廊隔墙，应设置碰撞措施设置不锈钢防撞带

1.10Corridor partitionswith color steel platesin the clean area should be equipped withcollision measures:stainless steelanti-collision beltsshould be installed.穿越洁净墙板、楼板、顶棚的管道应敷设套管或密封垫，套管内的管道不应有焊接，螺纹和法兰，密封垫或套管与管道间的缝隙用硅橡胶密封胶密封

1.11Pipes passing through cleanwall panels,floors,and ceilingsshould belaid withsleeves orsealing pads.Thepipes insidethe sleevesshould not have welding,threads,or flanges.The gapsbetween the sealing padsorsleeves and the pipes should besealed withsilicone rubbersealant.洁净室的门窗构造应平整简洁、不易结灰、容易清洁、表面无划痕、损伤、型材无开焊断裂表面涂层耐腐蚀，密封条可以上下调节，密封条牢固耐用，密封性好，密封条不得卷边、脱槽、缺口及断裂；门和门框的间隙闭合后密封良好；门上把手突出位置，不得有锐边、尖角，应采用圆滑过渡，符合洁净室的要求The structureof the doors andwindows of the clean room should be flat and simple,not easy to ash,easy to

1.12clean,no scratches,damage on the surface,and noopen weldingfracture of the profile.The surfacecoating iscorrosion-resistant,the sealing strip can be adjustedup and down,thesealingstrip isfirm anddurable,thesealing performanceis good,and thesealingstripshall not be crimped,degrooved,notched andbroken;The gapbetween thedoor and thedoorframe iswell sealedafter it is closed;The handleon thedoor isprotruding position,there must be nosharp edges,sharp corners,and asmoothtransition should be adoptedto meet the requirementsof the clean room.安全门应采用向疏散方向单向开启的平开门，并加设自行关闭的闭门器安全门设有关闭件，安装在打开明显位置，破门工具也需要放在明显位置，并有牢靠放置、取出方便的处理The safetydoor shallbe aside hungdoor thatopens inone directionto theevacuation direction,and aself

1.13closing doorcloser shallbe added.The safetydoor should be equipped with relevantclosures,which should be installed in a clearly visiblepositionwhen opened.Door breakingtools shouldalso beplaced inaclearlyvisible positionand have a secureplacementand convenienthandling forremoval.门互锁器应采用电子空气互锁，有状态显示，可延时开启；门互锁，三门互锁与门配合安装时，逻辑合理，安装顺序器，安装牢靠，接触灵敏，暗装；带紧急按钮开启控制功能，且不受次数限制The door interlock shouldadopt electronicair interlock,with statusdisplay,and canbe openedwith adelay;

1.14Door interlock,three-doorinterlockand doorinstallation,logical reasonable,installation sequencer,installation firm,sensitive contact,concealed;The controlfunction isturned onwith anemergency buttonandis not limited to the numberof times.设计及施工说明NO.序号Design and Construction specification照明灯采用平板灯，吸顶式安装，四周打胶，外形美观大方、透光率高灯体表面防腐防锈、LED灯罩不积尘、不掉尘、益清洁、耐擦洗整体钢板喷塑，所用的材料及表面处理需要满足洁净室净化要求及耐耐受杀狗子剂擦拭整体采用密封式结构、具备较强的防水、防尘性能The lightingadopts LEDflat panellights,which are installed ina ceilingmounted mannerand gluedaround,

1.15with a beautiful and elegant appearanceand highlight transmittance.The surface of thelamp body isanti-corrosion andrust proof,the lampshadedoes notaccumulate orfall dust,is beneficialfor cleaning,and isresistant to scrubbing.The overallsteel plate is sprayed with plastic,and thematerials andsurface treatmentusedneed tomeetthe cleanroom purificationrequirements and be resistantto sporekilling agentwiping.The overallstructure adoptsa sealedstructure,with strongwaterproof and dustproof performance.洁净室内的电气管线为暗敷；洁净区的电气管线管口及安装于墙上的各种电器设备与墙体接缝处应与可靠的密封措施；密封材料必须提供材质报告及对洁净厂房无毒害等方面的证明文件The electricallines in the clean room aredark;

1.16There should be reliablesealing measuresat the joints between the electricalpipeline and the wallin the cleanarea and the variouselectrical equipmentinstalled on the wall;The sealingmaterial mustprovide materialreports andcertification documentssuch asnon-toxic to the cleanplant.所有水池下方需配套不锈钢存水弯，表面平整光滑，易清洁；304洁净室内应安装洁净密封型地漏，以防止气味扩散；地漏必须送样确认，并有材料进场验收程序

1.17All poolsneed to beequipped with304stainless steelwater bends,the surface is smoothand easy to clean;Clean and sealed floordrains should be installedin the clean room to preventodor diffusion;The floordrain must be sentfor confirmationand there is amaterial acceptanceprocedure.配电箱，洁净区的配电箱应采用小型暗装型，外表面光滑喷塑处理、不积尘、易清洁门的关闭有良好的密封性能、外形美观大方

1.18The distributionbox in the clean area should be ofa smallconcealed type,with asmooth surfacesprayed withplastic,dust-free,and easyto clean.The closingof thedoor hasgood sealing performance and a beautifulandelegantappearance.消防箱，为暗装式，与围护结构配合进行暗装；整体采用不锈钢材质，厚度不低于焊接平整均匀、牢固，无伤穿、疤痕、箱体由消

3041.2mm,防单位供应、安装，面板与彩钢板结合由机电单位完成；箱门关闭到位后，应与四周框面平齐且有密封处理，下部可放置灭火器；表面平整，易清洁、耐擦洗并能耐受杀抱子剂擦拭及消毒VHPThe firebox,which isconcealed andcooperates with the enclosurestructure forconcealed installation;

1.19The wholeis made of304stainless steel,the thicknessis notless than

1.2mm,the weldingis uniformand firm,thereis no injury,scars,the boxbodyissupplied andinstalled by thefireunit,and thecombination of the paneland the color steel plateis completedbythemechanical andelectrical unit;After thedoor is closed inplace,itshould belevel with the suiToundingframe surfaceandsealed,andafire extinguishercanbeplaced in thelower part;Flat surface,easytoclean,scrub resistantand resistantto sporewiping andVHP disinfection.设计及施工说明序号NO.Design andConstruction specification暖通

二、HVAC风管的制作，符合《规范》中条的规定采用角钢法兰连接GB50243-

20024.1〜

4.

32.1The productionof air ducts shall comply with the provisions of Article

4.1to

4.3of GB50243-

2002.Use angle steel flangeconnection.风管部件与消声器的制作，符合《规范》中条的规定GB50243-2002消音器应消音效果好、气流流通顺畅、内壁抗磨、防腐、防锈并能在一定的高温下正常工作、吸音材料物理性能好、无毒、不产尘、不掉尘

2.2The productionof air duct componentsand silencersshallcomplywith theprovisionsofArticle

5.1-

5.3ofGB50243-

2002.Silencers should have goodsound attenuationeffect,smooth airflow,anti wear,anti-corrosion,rust proofinnerwalls,andbe able towork normallyata certain hightemperature.Sound absorbingmaterials should have goodphysicalproperties,be non-toxic,do notproduce dust,anddonot sheddust.风管为镀锌钢板制作，并采用热镀锌处理，镀锌板材厚度严格按规范要求确定，镀锌层厚度不得小于镀锌层不得有脱落、划痕等现象100g/nfThe air duct is made of galvanized steel plate andtreated withhot dipgalvanizing.The thickness of the

2.3galvanized plateis strictlydetermined according to thespecification requirements,and thethicknessof thegalvanized layer should not beless than100g/m

2.The galvanizedlayershould not haveany peeling,scratches,or otherphenomena.风管不得有横向拼接缝，矩形风管底边宽度小于或等于时，其底边不得有纵向拼接缝，小900mm于且小于或等于时，不得多于条纵向接缝，大于且小于或等于900mm1800mm11800mm2600mm时，不得多于条纵向接缝2The air duct shall nothavetransverse seams.When thewidth of the bottom edge ofa rectangular airductis less

2.4than or equal to900mm,there shallbe nolongitudinal seamsat thebottomedge.When thewidth is less than900mm andless thanor equalto1800mm,there shallbe nomore thanone longitudinalseam,and whenthewidth isgreater than1800mm andless thanor equalto2600mm,there shallbe nomore thantwo longitudinalseams.风管板材拼接的接缝应错开，不得有十字形拼接缝

2.5The joints of the airductpanels should be staggeredand thereshould beno crossshaped joints.矩形风管成型咬缝可采用联合角咬口，不应采用按扣式咬口

2.6The formingseam ofrectangularairduct canuse jointangle seam,and snapseam shouldnot be used.角钢法兰上的螺栓孔和管件上的钾钉间距不应大于不得采用抽芯佛钉，螺栓、螺母、垫150mm,片和钾钉应镀锌

2.7The spacingbetween thebolt holeson the anglesteel flange and the rivetson thepipe fittingsshould notexceed150mm.Blind rivetsshouldnotbe used,and bolts,nuts,washers,and rivetsshould begalvanized.风管与角钢法兰连接时，风管翻边应平整，并紧贴法兰，宽度不应小于并剪去重叠部分，7mm,翻边处裂缝和孔洞应涂密封胶

2.8When connectingthe airduct to theanglesteelflange,the flangeof the airductshould beflat andtightlyattached tothe flange,with awidth of no less than7mm.The overlappingpart should be cutoff,and thecracksand holesat the flange should be coatedwith sealant.通风及空调设备与风管连接处设置柔性短管，材料采用双面涂塑帆布或涂胶帆布，柔性短管的长度宜为接缝的缝制或粘接应牢固、可靠，不应有开裂；成型短管应平整，无扭150mm〜250mm,曲等现象

2.9Flexible short pipesshould beinstalled at theconnection betweenventilation and air conditioningequipmentand air ducts,using double-sided plasticcoated canvasor adhesivecoated canvas.The lengthof theflexibleshort pipeshouldbe150mm〜250mm,and thesewing orbonding of thejointsshouldbe设计及施工说明NO.序号Design andConstruction specificationfirmand reliable,without cracking;The formedshortpipeshouldbeflat andfree fromdistortion and otherphenomena.洁净所有净化空调系统的法兰垫片，均采用闭孔橡塑海绵板，厚度为宽度同法兰垫片5〜8mm,擦洗干净后用粘结剂粘贴在法兰上，并应减少接头，垫片应与法兰齐平，不得凸入风管内Clean allflange gasketsof purifiedair conditioning systems usingclosed cellrubber plasticsponge plates,with

2.10a thicknessof5-8mm and the samewidth as the flange.After cleaningthe gasket,apply adhesivetotheflangeand reducethe numberof joints.The gasketshouldbeflush with theflangeand shouldnot protrudeinto the airduct.风管、静压箱等部位必须保持清洁制作完毕后，用无腐蚀性的清洗液将其内表面的油膜和污物清洗干净，干燥后经检查达到要求即用塑料薄膜及胶带封口清洗后立即安装的可不封口所有风管供货方提供送货清单，检测报告，合格证明，清洁记录

2.11The airduct,static pressurebox,and otherparts mustbe keptclean.After the production iscompleted,cleanthe oilfilm anddirt on the innersurface with a noncorrosive cleaningsolution.After dryingand inspection,seal itwith plasticfilm andtape ifinstalled immediatelyafter cleaning,it maynotbesealed.All air ductsuppliers shallprovide deliverylists,inspection reports,qualification certificates,and cleaningrecords.风管支、吊架或托架间距应符合规范水平安装时，风管大边长小于时，间距不得超过400mm4m,大于或等于时，不得超过垂直安装时，间距不应超过每根立管至少有两个固定400mm3m；4m,点，距离弯头处内必须有一个支吊架1mThe spacingbetween airduct supports,hangers,or bracketsshould complywiththespecifications:when

2.12installed horizontally,the spacingshouldnot exceed4m whenthe largeside lengthof theairductislessthan400mm,and shouldnot exceed3m whenitisgreater thanorequalto400mm;When installingvertically,thespacing shouldnotexceed4m,and eachvertical pipeshouldhaveat leasttwo fixedpoints.There mustbe asupportand hangerwithin Imfrom theelbow.所有在洁净房间内安装的风管以及排风罩全部用不锈钢板制做，风管间及风管与排风罩间的连接全部用焊接

2.13All airducts and exhaust hoodsinstalledinclean roomsare made of stainless steel plates,and theconnectionsbetween airducts andexhaust hoodsare allwelded.净化空调系统风道安装之后，保温之前进行漏风及漏光测试

2.14After installingtheairduct of the purificationair conditioningsystem,conduct airand lightleakage testsbeforeinsulation.空调系统的保温采用符合规范要求的橡塑保温材料，并提供相关防火等级报告，送风、回风、排风、新风风管的保温使用难燃级橡塑保温B

12.15The insulationof theair conditioningsystem adoptsrubber and plastic insulationmaterials thatmeet therequirementsof thespecifications,and providesrelevant firerating reports:the insulationof supply air,returnair,exhaust air,and freshairductsuses flame-retardant Blgrade rubberandplasticinsulation.洁净室内的回风口均采用不锈钢材质，耐消毒VHP

2.16The return air outletsin theclean roomare made of stainlesssteel andresistanttoVHP disinfection.所有风口均安装涡轮蜗杆手动调节阀

2.17All airvents areequipped withworm gearmanual controlvalves.洁净室排风系统设有防倒灌装置

2.18The clean room exhaustsystem is equipped with an antibackflow device.排风口应远离新风口，防止废气重新进入房间

2.19The exhaustoutlet shouldbe keptaway fromthe freshair outletto preventwaste gasfrom re-entering the room.止回阀，水平式、风机停机后阀门关闭时要有很好密封性、整体防腐防锈、叶片耐磨且执行灵

2.20设计及施工说明序号NO.Design andConstruction specificationCheckvalve,horizontal type,shouldhavegood sealingperformance,overall anti-corrosion andrustprevention,blade wearresistance,and flexibleexecution whenthe valve isclosedafter the fan stops.送风总管、回风总管、排风总管及新风总管上，均安装风量测定孔

2.21Air flowmeasurement holesareinstalledon the supplyairmain,returnairmain,exhaust airmain,and freshairmain.定风量阀应为压力无关型风量调节阀，风阀可根据系统所需风量变化自动调整阀板开度，使通过定风量阀的风量维持在恒定值The constant air volume valve shouldbea pressure independent air volume regulating valve.The airvalve can

2.22automatically adjustthe valve plate openingaccording tothe requiredair volumechanges of the system,so thattheair volumepassing through the constant air volume valve ismaintained ata constantvalue.定风量阀外部配有风量设定装置，并标明详细的风量调节范围，可以通过设定装置设定不同的定风量值，调节须简单可靠

2.23The constantair volumevalve isequippedwith an externalair volumesetting device,and thedetailed airvolumeadjustment rangeis indicated.Different constantair volumevalues canbe setthroughthesettingdevice,and theadjustment mustbe simpleand reliable.定风量阀无特别的安装位置限制，无论垂直安装还是水平安装均可使用

2.24The constantair volumevalve hasno specialinstallation positionrestrictions,and canbeusedwhetherinstalled verticallyor horizontally.定风量阀的阀体和阀板材料为镀锌钢板或铝合金材质，轴承免维护，整体需表面洁净、不得有油污、灰尘、无划伤、变形、毛刺等现象

2.25The valve body andvalve plateofthe constantair volumevalveare made ofgalvanized steelplateor aluminumalloymaterial,and thebearings aremaintenance free.The overallsurface shouldbe clean,free ofoil stains,dust,scratches,deformation,burrs,andotherphenomena.定风量阀生产厂家有风量标定测试台，每个定风量阀在出厂前都必须经过风量标定，以保证正常使用和风量控制的精确

2.26The manufactureroftheconstantair volumevalvehas anair volume calibration testbench,and eachconstantair volumevalve mustundergo airvolumecalibrationbefore leavingthe factoryto ensurenormal useandaccurate airvolume control.阀片在阀体内间隙均匀，阀片转动与阀体不干扰，阀片轴及阀片连接可靠、无相对转动The clearancebetween the valve discand the valvebodyis uniform,andtherotation ofthe valve disc doesnot

2.27interfere withthevalvebody.The connectionbetweenthevalvediscshaft andthevalvedisc isreliable andthereisnorelative rotation.所有的高效过滤的散流板应为不锈钢材质，无涂层，散流板表面光滑，色泽一致，散流孔304要分布均匀

2.28All high-efficiency filtrationdiffuser platesshouldbemadeof304stainlesssteelmaterial,uncoated,with asmoothsurface,consistent color,and evenlydistributed diffuserholes.高效送风口，带有压差测定孔、发尘孔

2.29Efficient airsupply outletwith pressuredifference measurementhole anddust generationhole.生产区洁净室的送风需通过安装于房间的末端的液槽式高效过滤器过滤，高效过滤器采用H14型、无隔板过滤器，最易穿透粒子的出厂证书，安装完后应当作测漏，到现场经

99.995%PAO光度计数扫描检测整体泄漏率小于

0.01%o

2.30The airsupply oftheclean room in the productionarea needstobefiltered bythe liquid tank typehigh-efficiency filterinstalledatthe endofthe room,the high-efficiency filteradopts H14type,no partitionfilter,the mosteasytopenetrate

99.995%oftheparticles ofthe factorycertificate,after设计及施工说明序号NO.Design andConstruction specificationinstallationshouldbePAO leakdetection,tothesite byphotometric countscanning detection:the overallleakagerate islessthan

0.01%.所有高效过滤器应满足标准；ENI822每一个高效过滤器要附有带签字和日期的合格证；每个高效过滤器都要有单独的证书和位置；验证时每一块高效均需要初始压差测试

2.31All HEPAfilters should meet EN1822standards;Each HEPAfilter shouldbe accompaniedby acertificate ofconformity withsignature anddate;Each HEPAfilter musthaveaseparate certificateand location;Each pieceof efficiencyrequired aninitial differential pressure testfor verification.高效过滤器保护网采用钢板网喷塑、白色，过滤器上无污染物和损伤，不会出现框架凹凸、扭曲或破裂、涂料层不均匀及剥落

2.32The high-efficiency filterprotection netismadeof steelplate meshsprayedwithplastic andwhite,with nopollutantsor damageon thefilter,and therewill beno unevenness,distortion orcracking ofthe frame,unevencoating layer,or peeling.高效过滤器外框的四个角和拼接处牢固，粘结剂和密封胶无脱胶、开裂滤料在边框中无松动和变形

2.33The fourcorners andsplices ofthe high-efficiency filterouter frameare firm,andtheadhesive andsealant arenotdegummed orcracked.The filtermaterial shouldnotbeloose ordeformed in the frame.图效过滤器与图效送风口配合使用时，液槽内的液面高度不超过槽深的框架各接缝处无渗液2/3,现象，出厂时有安全的成品保护措施

2.34When thehigh-efficiency filteris usedin conjunctionwiththehigh-efficiency airsupply outlet,the liquidlevelin theliquidtankshouldnotexceed2/3ofthetank depth,and thereshouldbeno leakageatthejointsoftheframe.Safe finishedproduct protectionmeasures shouldbe takenwhen leavingthe factory.中效过滤排风箱整体形式要求采用同组合式空调机组的要求，厚双层彩钢岩棉彩钢板外50mm箱，无冷桥铝合金型材拼接，密封处理

2.35The overallform ofthe medium efficiency filtrationexhaust boxrequires thesame requirementsas thecombinedair conditioningunit,witha50mm thickdouble layercolor steelrock woolcolor steelplate outerbox,no coldbridge aluminumalloy profilesplicing,and sealingtreatment.排风箱外形美观、拼缝紧凑、密封性能好；风机固定件如支架、固定螺栓、减震器等应有优质镀锌处理

2.36The exhaust box hasabeautifulappearance,compact seams,and goodsealingperformance;The fixedparts ofthefansuch asbrackets,fixing bolts,shock absorbers,etc.shouldbetreated withhigh-quality zincplating.中效过滤排风箱体内配套不低于袋式中效过滤器，铝合金框架，过滤器应方便更换，可开式F8检修门，配套指针式微压差表

2.37The medium efficiency filterexhaustboxisequippedwithabag typemediumefficiencyfilter ofno lessthanF8,an aluminumalloy frame,andthefilter shouldbe easyto replace.It canbe accessedthrough anopen accessdoorand isequippedwitha pointertype microdifferentialpressuregauge.气流模式应合理并能确保过滤空气能扫过房间并带走粒子；送、回、排风口须合理设计和布置，确保房间空气和送风有效的混合并避免气流死区；洁净区

2.38须按上送侧下回方式Airflow patternsshouldbereasonable andensure thatfiltered airsweeps throughtheroomand carriesawayparticles;NO.设计及施工说明序号Design andConstruction specificationThesending,returning andexhaust outletsmustbereasonably designedand arrangedto ensurethat theroomair andtheairsupply areeffectively mixedand avoidthe deadzone ofthe airflow;The cleanarea shallbe sentupand downin theway ofsending side.o功能说明

7.2Function DescriptionNO.功能说明序号Function description洁净室墙面平整比滑，无色差、无裂缝、打胶饱满、易清洁、不起尘，洁净墙板漆面耐消毒试剂腐蚀The cleanroom wallsurface isflat and smooth,without colordifference,cracks,full glueapplication,easy toclean,anddust-free.The cleanwall panelpaint surface is resistantto corrosionby disinfectantagents.定风量阀为压力无关型风量调节阀，风阀可根据管道的压力变化自动调整阀板开度，使通过定风量阀的风量维持在恒定值，使房间的换气次数恒定不变The constantairvolumevalve isapressureindependentairvolumeregulatingvalve.The airvalve can

3.2automatically adjustthe openingofthevalveplateaccordingtothe pressurechange ofthe pipeline,so thattheair volumepassingthroughtheconstantairvolumevalveismaintained ata constantvalue,andthenumber ofairchanges intheroomremains constant.压差调节后满足压差梯度要求，定变风量系统可根据房间内部环境变化自动调节送、回、排风量，确保压差在合格范围内

3.3After pressuredifference adjustment,the pressuregradient requirementis met.The constantvariable airvolumesystem canautomatically adjustthesupply,return,andexhaustair volumesbased onchanges inthe照明区internal environmentoftheroom,ensuring thatthe pressuredifference iswithin thequalified range.域控制合理，可实现洁净区外权限控制照明开关，内部各房间内均可进行控制

3.4The lightingarea controlis reasonable,which canachieve permissioncontrol oflighting switchesoutside thecleanarea,and canbe controlledin allinternal rooms.修订历史

8.Revision History版本号修订内容/修订原因生效日期Version NO.Revision Content/Revision ReasonsAvailability Date新建文件见签批页批准期H01New documentsSee approvaldate on the signatureand approvalpage目录Index目的

1.Propose本功能说明文件遵循洁净室系统用户需求，对镇江大学园区楼洁净室的各项功能做出说明，并为洁净53#室的设计具有必要的指导信息，也作为编制系统设计说明的依据This functionalspecification documentfollows theuser requirementsofthecleanroomsystem,explains thevariousfunctions ofthecleanroom in53#Building ofZhenjiang UniversityPark,and providesnecessary guidanceinformationfor thedesign ofthecleanroom.It alsoserves asthe basisfor preparingthe systemdesign specification.范围

2.Scope本功能说明范围为洁净厂房及设施包括围护结构、电气、土建、消防，以及系统；包括但不限于HVAC空调负荷计算要求、风管、、中效箱体、高效送风口、高效过滤器等CAVThe scopeof thisfunctional descriptionis theclean workshopand facilities.Including enclosurestructure,electrical,civilengineering,fire protection,and HVACsystem;Including butnotlimitedto air conditioning loadcalculationrequirements,airducts,CAVs,mediumefficiencyboxes,high-efficiency airsupply outlets,high-efficiency filters,空调系统和洁净室的对应关系如下表The correspondingrelationship betweentheairconditioningsystemandthecleanroomis shown inthe tablebelow:空调系统编号洁净室区域洁净级别HVAC NO.Clean RoomArea CleanLevel服务于一层灌装间等区域AHU-101CServing areassuch asfilling room on the first floor服务于一层层析间等区域2AHU-102CServing areassuch aschromatography room2on thefirst floor服务于一层缓冲液配制间等区域AHU-103CServing areassuch asbuffer preparation room on thefirst floor服务于一层层析间等区域1AHU-104CServing areassuch aschromatography room1on thefirstfloor服务于二层发酵间等区域1AHU-201DServing areassuch asfermentation room1on thesecond floor服务于一层发酵间等区域2AHU-202DServing areassuch asfermentation room2on thesecond floor服务于二层培养基准备间等区域AHU-203Serving areassuch asculture mediumpreparationroom2on thesecond Dfloor服务于三层细胞间等区域AHU-301DServing areassuch ascell room2on thethird floor服务于四层上游等区域1AHU-401DServing areassuch asupstream1on the fourth floor服务于四层下游等区域1AHU-402CServing areassuch asdownstream1on thefourth floor服务于四层上游等区域2AHU-403DServing areassuch asupstream2on thefourth floor服务于四层下游等区域2AHU-404CServing areassuch asdownstream2on thefourth floor服务于四层上游等区域3AHU-405DServing areassuch asupstream3on thefourth floor服务于四层下游等区域3AHU-406CServing areassuch asdownstream3onthefourth floor服务于四层上游等区域4AHU-407DServing areassuch asupstream4onthefourth floor空调系统编号洁净室区域洁净级别HVAC NO.Clean RoomArea CleanLevel服务于四层下游等区域4AHU-408CServing areassuch asdownstream4onthefourth floor服务于四层灌装间等区域AHU-409CServing areassuch asfilling roomonthefourth floor服务于四层配液间等区域AHU-410CServing areassuch asliquid dispensingroomonthefourthfloor职责

3.Responsibilities供应商职责

3.1Responsibilities洁净室功能设计说明的编写Preparation ofthe FDS..提供所需要的资料Provide thenecessary information.业主职责

3.2Responsibilities本设计说明的审核和批准Review andapproval ofthis designspecification.参考文件及规范

4.Reference andRegulation《药品生产质量管理规范》年修订）（2010《Good ManufacturingPractice forFinished Pharmaceuticals^,2010version《采暖通风与空气调节设计规范》GB50019-2015《》Code fordesign ofheating ventilationandairconditioning GB50019-2015《通风与空调工程施工质量验收规范》GB50243-2016》^Ventilation andairconditioningengineering constructionquality acceptancecode GB50243-2016欧洲最新版本GMP CurrentGMP ofEU欧盟药品法，指令75/319/EEC EUPharmaceutical legislation,Directive75/319/EEC法规，指令卷和相关附录GMP91/356/EEC4GMP Regulation,Directive91/356/EEC Volume4and applicableannexes第和部分，药品生产质量管理规范FDA-21CFR210211FDA-21CFR Part210,211Good ManufacturingPractice forFinished Pharmaceuticals卷无菌生产设施第版ISPE33ISPE Volume3Sterile ProductManufacturing FacilitiesThird Edition卷调试与确认第版ISPE52ISPE Volume5Commissioning andQualification SecondEdition洁净室和相关的受控环境ISO14644-3:2019Cleanrooms andassociated controlledenvironments术语和缩略语

5.Abbreviations缩写描述Abbreviations Describe功能设计说明FDSFounction DesignSpecification设计确认DQDesign Qualification洁净室CRClean Room标准操作规程SOPStandard OperatingProcedure用户需求说明URSUser RequirementsSpecification药品生产质量管理规范GMPGood ManufacturingPractice安装确认IQInstallation Qualification操作确认OQOperational Qualification供热、通风和空调HVAC、Heating Ventilationand AirConditioning洁净室参数

6.Clean RoonParameters换气次数

6.1Ventilation Rate换气次数如下表Ventilation rateis showninthetable below:洁净等级换气次数Clean GradeVentilation Rate三次/小时25C三25times/hour次/小时215D215times/hour次/小时28CNC28times/hour房间压差

6.2Room PressurreDifference压力控制系统必须保证从高洁净级别房间到低洁净级别的房间的压差为一定数值的正压The pressurecontrolsystem mustensure apositive pressuredifference ofacertainvalue froma highcleanliness level roomtoalow cleanlinesslevelroom:压力级区域压力级区域〉压力级区域,CD CNCPressure C-level areaPressureD-levelareaPressure CNClevel area,不同级别相邻房间的压差，或者洁净与非洁净区域的压差要N目标精度

12.5Pa,-0to+

2.5Pa.The pressuredifferencebetween adjacentrooms ofdifferent levels,or betweenclean andnon cleanareas,shouldbe

212.5Pa,withatarget accuracyof-0to+

2.5Pa温湿度

6.3Temperature andHumidity房间温湿度如下表Temperature andhumidity ofrooms is showninthetable below:洁净等级温度湿度Clean GradeTemperature HumidityC18-26℃45-65℃D18-26℃45-65℃CNC18-25℃NA噪声和照度

6.4Noise andIllumination房间噪声Room noise:非单向流单向流和混合流空态测试W60dBA,W65dBA房间照度Unidirectional flow W60dB A,unidirectional flowand mixedflowW65dB Aair statetestRoom illumination:主要工艺房间工艺区域辅助房间和走道:300Lux,200LuxMain processroom:300Lux,auxiliary roomsand walkwaysintheprocess area:200Lux洁净度和微生物

6.5Cleanliness andMicrobe洁净区各级别悬浮粒子数如下表The numberof suspendedparticles ateach levelinthecleanarea isshowninthetablebelow:悬浮粒子数最大/立方米Maximum suspendedparticle count/cubic meter洁净度级别静态动态Clean gradeStaticstate Dynamicstate

0.5um

0.5um

0.5um

0.5um级A352020352020级B3520293520002900级C3520002900352000029000级不做规定不做规定D352000029000洁净区各级别微生物监控在动态条件下应符合标准如下表The microbiologicalmonitoring ofeach levelinthecleanareashouldmeetthe followingstandards underdynamicconditions:表面微生物沉降菌浮游菌Surface microorganisms洁净度级别Settling bacteriafPlanktonic bacteria接触指手套f55mm5Clean grade90mmCfu/m3手Contact A55mm Cfu/5-finger glovesCfu/Cfu/4h碟套级A1111级B10555级C1005025N/A级D20010050N/A功能设计及施工说明

7.Description ofFunctional DesignandConstruction安装要求及技术规范

7.1Installation Requirementsand TechnicalSpecifications设计及施工说明序号NO.DesignandConstruction specification洁净装修■Clean decoration洁净区的内表面墙壁、地板、天棚应当平整光滑、无裂缝、接口严密、无颗粒物脱落，避免积尘，便于有效清洁所有洁净室材料均不允许使用木质材料

1.1The innersurfaceofthecleanarea wall,floor,ceiling shouldbe smoothand smooth,no cracks,tightinterfaces,no particlesfalling off,avoid dustaccumulation,and facilitateeffective cleaning.Wood materialsarenot allowedin allcleanroom materials洁净室所用的相关材料应该是能耐受型的材料，且必须能够抵抗使用普通洗涤剂、氢VHP20%氧化钠，异丙醇或乙醇表面清洁和擦拭；材质需同时满足臭氧的耐受性，耐受的70%75%VHP测试

1.2The relevantmaterials usedinthecleanroomshouldbeVHP resistantand mustbe resistanttotheuse ofordinarydetergents,20%sodium hydroxide,70%isopropanol,or75%ethanol forsurface cleaningand wiping;The materialmust meetboth ozoneresistance andVHP resistancetesting.原有钢筋混凝土楼板，清理原有环氧面层，用修补砂浆修补完整洁净区采用厚同质聚氯乙烯卷材，专业粘结剂粘贴，转角处用造成圆弧角，接缝严2mm R=50密

1.3Original reinforcedconcrete floorslab,clean theoriginal epoxysurface layer,and repairit completelywithrepair mortar.The cleanareaismadeof2mm thickhomogeneous polyvinylchloride rollmaterial andpasted withprofessionaladhesive.The cornersare madeof R=50arc anglewith tightjoints.地面表面平整、坚硬、干燥、密实、不得有起沙、起皱、麻面、裂缝等

1.4The groundsurfaceisflat,hard,dry,dense,and theremustbeno defectssuch assand,wrinkling,hemp surface,cracks,etc.洁净区墙板采用岩棉手工板，彩钢板采用不小于厚镀锌钢板，外表面通常为灰白色聚酯

0.5mm树脂喷涂墙板厚内衬玻镁板50mm,5mmThe wallpanels inthecleanarea aremadeofrock woolhandmade panels,andthecolorsteelplateismadeof

1.5galvanizedsteelplate witha thicknessofnolessthan

0.5mm.The outersurfaceisusually coatedwith graywhitepolyester resin.The wallpanel is50mm thickand linedwith5mm glassmagnesium board.彩钢板多功能抗老化面层及表面装饰层应与彩钢板结合牢固，饰面不应有起皱、断裂、脱皮现象，配件应与板结合紧密，连接牢靠

1.6The multi-functional anti-aging surfacelayer andsurface decorationlayer ofcolorsteelplate shallbe firmlycombinedwiththecolorsteelplate,the finishshallnotbe wrinkled,broken orpeeled,andtheaccessories shallbetightly connectedwiththeplate.板面的缝隙露于洁净室一侧应用和彩钢板颜色一致的硅胶嵌缝，嵌缝应均匀、连续、严密、光滑

1.7The gapsontheboard surfaceexposed onone sideofthecleanroomshouldbecaulked withsilicone ofthesame colorasthecoloredsteelplate.The caulkingshouldbeuniform,continuous,tight,andsmooth生产区顶棚和墙板及其夹心材料应为不燃烧体，且不应采用有机复合材料，顶棚和隔墙的耐火

1.8极限不应低于

0.5h,疏散走道两侧及吊顶的彩钢板耐火极限，l.OhThe ceilingand wallpanels andtheir sandwichmaterials intheproductionareashouldbe non。