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洁净室设计确认方案Design Qualification Protocol for Clean Room人员职务姓名签名/日期Personnel OccupationName Signature/Date制订人Prepared by技术审核TechnicalReview技术审核TechnicalReview技术审核TechnicalReview质量批准QualityApproval培训确认
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4.Training Verification培训确认Training Verification培训内容培训地点TrainingContent TrainingLocation培训时间讲师Training DateTrainer序号培训人员签到Trainee序号部门培训人员签到部门No.Department signatureNo.Department Traineesignature15263748确认结果Result确认结果通过未通过Result PassaFaila备注Comments确认人/日期复核人/日期Performed by/DateReviewed by/Date先决条件确认
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2.Prerequisite Verification目的
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1.Purpose用户需求可取得并获得批准URS is available and approved.程序
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2.Procedure确认可取得最新的并获得批准，在章节中记录结果URSVerify thelatest URS is available and approved,Record theresults in Section
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4.可接受标准
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3.Acceptance criteria用户需求已取得并获得批准URS is available and approved.已记录文件编号和版本号Document number and revision number are recorded.结果
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4.Result描述结果和/或附参考接受标准Acceptance CriteriaDescriptionResult and/or referenceto enclose已取得并批准URS结果Result[Y/N]:___________URSis availableand approved.洁净室已取得并批准URS Clean用户需求编号URS No:RoomURS is available andapproved已记录文件编号和版本号Documentnumber and revision number arerecorded用户需求版本URS version:备注Comments确认人/日期复核人/日期Performed by/DateReviewed by/Date文件确认
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3.Document Verification目的
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3.
1.Purpose设计文件可取得并获得批准Design Docuemntsis availableand approved程序
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2.Procedure获得设计文件列表Get the design documentslist将每个设计文件逐条记录入结果表格Record eachdesign documentsin theresult table在章节中记录设计文件的编号和版本号Record documentname andrevisionnumberinSection
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3.
4.可接受标准
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3.Acceptance criteria设计文件已取得并获得批准.Design Docuemntis availableand approved已记录文件编号和版本号Document numberandrevisionnumberarerecorded.结果
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4.ResultApproved文件/图纸名称文件/图纸编号当前版本通过？是/否Document/Drawing TitleDoc/drawing No.Current VersionYes/No设计和施工说明E□Yes DNoSpecification of Design and Construction建筑设计总说明1E□Yes CNoGeneral Description of Architectural Design1一层平面图E□Yes DNoFirst floor layout二层平面图E□Yes DNoSecondfloor layout三层平面图E□Yes DNoThird floor layout四层平面图E□Yes DNoFourth floor layout一层净化区压差布置平面图E□Yes DNoPressure difference plan in clean zone-1stfloor二层净化区压差布置平面图E□Yes DNoPressuredifference planin clean zone-2nd floorApproved文件/图纸名称文件/图纸编号当前版本通过？是/否Document/Drawing TitleDoc/drawing No.Current VersionYes/No三层净化区压差布置平面图E□Yes DNoPressuredifference planin cleanzone-3rdfloor四层净化区压差布置平面图E□Yes DNoPressuredifference planin cleanzone-4thfloor设计和施工说明E□Yes DNoSpecification of Design and Construction工程做法E□Yes DNoEngineeringpractices安防平面图E□Yes DNoSecurity plan四层平面工艺下水，凝水管道布置图Layout planof processwater andcondensate pipeson E□Yes DNothefourth floor备注Comments确认人/日期复核人/日期Performed by/DateReviewed by/Date设计要求确认
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4.Design RequirmentsVerification目的
8.
4.
1.Purpose用户需求说明的要求是否在设计过程中被考虑并在设计文件中有所描述确认设计工作满足用户需求说明的要求.The URS requirements hasbeen consideredduring designphase anddescribed indesign documents.Verify the designsatisfies user requirements specification.程序
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2.Procedure将用户需求说明中的要求填入章节中844Record eachURSrequirementinto section
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4.测试人员对照用户需求核对设计文件在设计文件的复印件上，用蓝色笔标出相关内容，附在相关检查测试项中，测试人员在测试文件上签名签日期、Tester verifythe URagainst thedesign docuements.Mark the relevant contentwith bluepen on the copyof thedesigndocument,attach thedocument to the relevanttest andsign withtester name and date.可接受标准
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3.Acceptance criteria中的所有要求都已经被考虑URSAll of the URSrequirements havebeen addressed.洁净室设计确认方案GenScripte PROBIODesign Qualification Protocol for Clean Room文件编号/Code.版本号/Version页码/PageDQ-CR-001115/38结果
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4.Result是否符合要求编号内容URS设计文件名称Design Doc.NameWhether itmeetsURS ID URS Contentrequirement洁净室的建造应满足中国版、及欧盟的要求GMP2010FDA GMP设计和施工说明Specification ofDesign andURS001The constructionof the clean room should meetthe requirements of ChinaGMP2010□Yes DNoConstruction EW05-215801S-2-01version,FDA andEU GMP.供应商需要完成本项目范围内与洁净室、等所有相关的所有验证活HVAC动,并完成报告的汇总URS002NA□Yes DNoSuppliersare required to completeall validationactivities relatedto cleanrooms,HVAC,etc.within thescope of the projectand completea summaryof reports.本车间的消毒方式为消毒，洁净室所用的相关材料应该是能耐受型VHP VHP的材料并需提前送检，且必须能够抵抗使用普通洗涤剂、氢氧化钠，异20%70%丙醇或乙醇表面清洁和擦拭；本项目预留臭氧空间消毒，材质需同时满足75%臭氧的耐受性，耐受的测试，需由机电施工方确认和验证，并提交测试报VHP建筑设计总说明1告URS003GeneralDescription ofArchitecturalDesign1□Yes DNoThedisinfection methodof thisworkshop is:VHP disinfection,therelevantmaterials usedinE09-21570IS-1-01the clean roomshould be ableto withstandVHP typematerials andneed to be sentforinspection in advance,and must be ableto resistthe useof ordinarydetergents,20%sodiumhydroxide,70%isopropanolor75%ethanolsurfacecleaningandwiping;Thisprojectreservesozonespacefordisinfection,andthematerialneedstomeettheresistanceofozoneatthesametime,and thetest ofVHP resistanceneeds to be confirmedand verifiedby themechanical andelectricalconstruction party,and thetest reportshall be submitted.本项目所有验证相关文件以中英文双语书写，本的所有内容应由供应商完URS成最终确认并完成中英文双语文件的翻译，双语内容有任何歧义的地方，以中URS004文为准NA□Yes DNoAll verification relateddocuments of this projectshall be written in Chinese and English,andall contentsofthisURS shall be finalizedby the supplier and the洁净室设计确认方案e PROBIOGenScriptDesign Qualification Protocol for Clean Room文件编号/Code.版本号/Version页码/PageDQ-CR-001116/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSID URSContentmeets requirementtranslationof Chinese and English bilingual documentsshall be completed,and anydiscrepanciesin thebilingual contentshall besubject toChinese.层平面图1-41-4floor layoutE09-215801S-2-01E09-215801S-2-02所有功能间布局须和设计图纸一致，所有文件中应同时体现房间名称及房间编号中英文E09-215701S-2-01E09-215701S-2-02URS005□Yes DNoThelayout of all functionrooms must be consistentwith thedesign drawings,and theroomname androom numberChinese andEnglish should be reflectedin alldocuments.参考洁净分区图，在静态时最大允许悬浮粒子数按照中附录一，CFDAGMP第三章，第九条中的规定URS006NA□Yes DNoReferto the cleanzonemap,the maxinnimallowable numberof suspendedparticles atrest:inaccordance with the provisionsof AppendixI,Chapter III,Article9of theCFDA GMP.生产操作全部结束、操作人员撤出现场并经分钟自净后，洁净区的悬浮粒15-20子应达到对应级别静态标准URS007NA□Yes DNoAfterall productionoperations arccompleted,operators withdrawfrom thesite andself-cleaning after15-20minutes,the airborneparticles in the clean area shouldreach thecorrespondinglevel ofstatic standards.最大允许微生物数按照中附录一，第三章，第十一条中的规定URS008CFDA GMPNA□Yes DNoMaximumallowable numberof microorganisms:in accordance with theprovisions ofAppendixI,Chapter III,Article11of theCFDA GMP.换气次数设计和施工说明Specification ofDesign andURS009D级区域换气次数正常工作时间至少每小时15次；□Yes DNoConstruction EW05-215801S-2-01级区域换气次数正常工作时间至少每小时次C25洁净室设计确认方案e PROBIOGenScriptDesign Qualification Protocol for Clean Room文件编号/Code.版本号/Version页码/PageDQ-CR-001117/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSID URSContentmeets requirementNumberof airchanges:NumberofairchangesintheClassDarea,normalworkinghoursareatleast15timesperhour;Class C area airchanges:normal workinghours areat least25per hour.温湿度要求房间为级区域，温度要求为、湿度要求为C/D15-30230-70%设计和施工说明Specification ofDesign andURS010Temperature andhumidity requirements:□Yes DNoConstruction EW05-215801S-2-01The roomisaC/D class area with a temperaturerequirement of15-30℃andahumidityrequirement of30-70%.房间压差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压力级区域压力级区域压力级区域C D CNC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目标精度
212.5Pa,-0to+
2.5Pa.如有需要同级别相邻房间要保持至少的压差，目标精度具体5Pa-
2.5to+
2.5Pa净化区压差布置平面图Pressuredifferenceplanin以设计图纸为准URS OilcleanzoneE05-215801S-3-03E05-215801S-3-04□Yes ONoRoompressure difference:The pressurecontrol systemmust ensurethat thedifferential pressurefrom aroom witha highE05-215701S-3-03E05-215701S-3-04cleanliness levello aroom witha lowcleanliness levelisacertain positivepressure:Pressure Class CareaPressure Class D areaPressure CNCclassareaThe differentialpressurein adjacent rooms ofdifferent classes,or betweenclean and non-clean areas,shouldbe，
12.5Pa,and thetarget accuracyshould be-0to+
2.5Pa.If necessary,maintain adifferential pressureof at least5Pa inadjacentroomsof the sameclass,and thetarget accuracyis-
2.5to+
2.5Pa.Specific designdrawings shallprevail.洁净室设计确认方案e PROBIOGenScriptDesign Qualification Protocol for Clean Room文件编号/Code.版本号/Version页码/PageDQ-CR-001118/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSID URSContentmeets requirement气流模式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；洁净区须按上送侧下回方式设计和施工说明Specification ofDesign andAirflowmode:URS012□Yes DNoAirflowpatternsshouldbereasonableandensurethatfilteredairsweeps through theroomand ConstructionEW05-215801S-2-01carries awayparticles;Thesending,returningandexhaustoutletsmustbereasonablydesignedandarrangedtoensurethat theroom airand the air supplyare effectivelymixed and avoid thedead zoneof theairflow;The cleanarea shall be sentup anddown in the wayof sendingside.照度在米的操作面高度上检测不低于
0.8〜
1.0主要工艺房间300Lux工艺区域辅助房间和走道:200Lux机房:150Luxo设计和施工说明Specification ofDesign andTheilluminance detectedat theheight of the operatingsurface of
0.8-
1.0meters is not lessURS013□Yes DNothan:ConstructionEW07-215701S-3-01Main processroom:300LuxProcess areaauxiliary roomsand walkways:200LuxMachine room:150Lux.总体要求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URS014NA□Yes DNo所有洁净室材料均不允许使用木质材料General requirements:The innersurface of the cleanarea wall,floor,ceiling should be smoothand smooth,nocracks,tight interfaces,no particlesfalling off,avoid dustaccumulation,and洁净室设计确认方案e PROBIOGenScriptDesign Qualification Protocol for Clean Room文件编号/Code.版本号/Version页码/PageDQ-CR-001119/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSID URSContentmeets requirementfacilitateeffective cleaning.Wood materials are notallowed inall cleanroommaterials生产区地面确保地面表面平整、坚硬、干燥、密实、不得有起沙、起皱、麻面、裂缝等缺陷；工程做法URS015最后铺设2mm同质透心PVC卷材□Yes DNoEngineeringpractices E09-215701S-1-03Production areafloor:Ensure that the groundsurface isflat,hard,dry,dense,and theremust beno defectssuch assand,wrinkling,hemp surface,cracks,etc.;Finally,2mm homogeneoustransparent PVCcoil islaid.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；URS016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NA□Yes DNoThestructure of the doorsand windowsof the clean roomshould beflat andsimple,not easytoash,easy toclean,no scratches,damage on the surface,andnoopen weldingfracture of theprofile.The surfacecoating iscorrosion-resistant,the sealingstrip can be adjustedup anddown,the scalingstrip isfirm anddurable,the scalingperformance isgood,and thesealingstrip shallnot becrimped,degrooved,notched andbroken;The gapbetween the door and thedoorframe iswell sealedafter it is closed;The safetydoor is equipped witha closingpart,which is installed in an obvious position ofopening,and thedoor breakingtool alsoneeds to be placed inanobviousposition,and hasastable placementand easyhandling totake out;目录目的
1399.95%后应当作PAO测漏，到现场经光度计数扫描检测整体泄漏率小于
0.01%；所有高效过滤器应满足标准；EN1822每一个高效过滤器要附有带签字和口期的合格证；每个高效过滤器都耍有单独URS021NA□Yes DNo的证书和位置；验证时每一块高效均需要初始压差测试双面保护网采用白色喷塑网HEPA filterrequirements:The airsupply of the clean room in the productionarea needs to befiltered by the liquidtanktype high-efficiency filterinstalled atthe end of theroom,thehigh-efficiency filteradoptsH13type,no partitionfilter,the mosteasy topenetrate
99.95%of theparticles of the factorycertificate,after installationshould bePAO leakdetection,to thesite byphotometric countscanningdetection:the overallleakage rateis less than
0.01%;All HEPA filters shouldmeet ENI822standards;Each HEPAfilter should be accompaniedby acertificate of conformity withsignature anddate;洁净室设计确认方案e PROBIOGenScriptDesign Qualification Protocol for Clean Room文件编号/Code.版本号/Version页码/PageDQ-CR-001122/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSID URSContentmeets requirementEachHEPAfiltermust havea separatecertificate andlocation;Each pieceof efficiencyrequired aninitial differentialpressure testfor verification.Thedouble-sided protectivemesh adoptswhite spraymesh.风管材质要求如下在风管制作方面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行镀锌层不得有脱落、划痕等现设计和施工说明lOOg/象URS022Specification ofDesign andConstruction□Yes ONoThematerial requirementsfor the duct arcas follows:EW05-215801S-2-01In termsof ductproduction:theductis madeof galvanizedsteel sheet,and adoptshot-dipgalvanizing treatment,the thicknessof thegalvanized sheetis strictlydetermined according totherequirements ofthespecification,and thethicknessofthegalvanizedlayer shallnotbelessthan100g/m2The galvanizedlayershallnot falloff,scratches and other phenomena.设计和施工说明风管部件与消声器的制作，应符合规范中第节规定GB50243-20165URS023Theproductionofductcomponentsandmufflersshallcomplywith theprovisionsofSection5Specification ofDesign andConstruction□Yes DNoof the specificationGB50243-
2016.EW05-215801S-2-01设计和施工说明Specification ofDesignand洁净室排风系统应有设有防倒灌装置URS024ConstructionEW05-215801S-2-01□Yes DNoThe clean roomexhaust systemshould beequipped withan anti-backfill device.净化空调系统风道安装之后，保温之前应进行漏风检查（采用漏光法检查漏点，保压法测定是否漏风）；URS025NA□Yes ONo风管保温前需验收完成，并验收合格签字确认后，方可保温After the air ductof thepurified air conditioningsystem isinstalled,theairleakage inspectionshould be carried out beforeheal preservation（the leakagemethod is洁净室设计确认方案e PROBIOGenScriptDesign Qualification Protocol for Clean Room文件编号/Code.版本号/Version页码/PageDQ-CR-001123/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSID URSContentmeets requirementused to checkthe leakagepoint,and thepressure holdingmethod isusedtodetermine whetherthere is airleakage;Before theair ductinsulation,the acceptanceneedsto becompleted,and theacceptance issigned and confirmedbefore itcan beinsulated.空调系统的保温应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，保温厚度按设计及规范要求按严执行设计和施工说明Specification ofDesign andURS026Theinsulationoftheairconditioningsystem shoulduserubberandplasticinsulationmaterials□Yes ONothatmeettherequirementsof thespecification,andprovide relevantfireratingreports,andthe ConstructionEW05-215801S-2-01insulation thicknessshouldbestrictly implementedaccordingto thedesignand specificationrequirements.送风总管、回风总管、排风总管及新风总管上，均需安装风量测定孔设计和施工说明Specification ofDesign andURS027Airvolumemeasurementholesneedtobeinstalledonthesupplyairmainpipe,returnairmain□Yes ONoConstructionEW05-215801S-2-01pipe,exhaust main pipe andfresh airmainpipe.所有风口、不管图纸是否有设计，均必须安装蜗轮蜗杆式手动调节阀设计和施工说明Specification ofDesign andURS028AH airoutlets,whether ornot thedrawing isdesigned,must beequipped withworm geartype□Yes DNoConstructionEW05-215801S-2-01manual controlvalves.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设计和施工说明Specification ofDesign andConstantair volumevalve:URS029□Yes DNoItshouldbea pressure-independent airvolume regulatingvalve,and thedamper canConstructionEW05-215801S-2-01automatically adjustthe valveplate openingaccording tothechange ofairvolume requiredbythe system,so that theairvolume throughthe constantairvolumevalve ismaintained ataconstant value.洁净室设计确认方案e PROBIOGenScriptDesign Qualification Protocol for Clean Room文件编号/Code.版本号/Version页码/PageDQ-CR-001124/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSID URSContentmeets requirement所有风口、格栅和其他部件需要有独立的编号，编号及安装应和设计流程图匹配URS030NA□Yes ONoAHair vents,grilles andother componentsneed tohave independentnumbers,and thenumberingand installationshould matchthedesignflow chart.中效过滤排风箱设备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50mm外箱，无冷桥铝合金型材拼接，密封处理；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；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F8式检修门，配套指针式微压差表Medium fillerexhaust box:URS031NA□Yes ONoTheoverall formof the equipment requires the samecombined air conditioning unitrequirements,50mm thickdouble-layer color steel rockwool colorsteel plateouter box,nocold bridgealuminum alloyprofile splicing,scaling treatment;Beautiful appearance,compact seam,good sealingperformance;Fan fixingparts such as brackets,fixing bolts,shock absorbers,etc.shouldbetreated withhigh-quality galvanizing;The boxisequipped with notless thanF8bag typemedium-efficiency filter,aluminum alloyframe,the filtershouldbeeasy toreplace,the openableaccess door,and thepointer microdifferentialpressure gauge.设备、风管和水管的安装应有效防止虫子和其他动物进入洁净室设计和施工说明SpecificationofDesign andURS032Theinstallationofequipment,airductsandwaterpipesshouldeffectivelypreventinsectsand□Yes DNoConstructionEW05-215801S-2-01other animalsfrom enteringtheclean room.URS033消防箱，为暗装式，与围护结构配合进行暗装；NA□Yes DNo洁净室设计确认方案e PROBIOGenScriptDesign QualificationProtocol for Clean Room文件编号/Code.版本号/Version页码/PageDQ-CR-001125/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSID URSContentmeets requirement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、
3041.2mm,疤痕、箱体由消防单位供应、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 withthe enclosurestructure forconcealedinstallation;The wholeis madeof304stainless steel,the thicknessis notlessthan
1.2mm,the weldingisuniform andfirm,thereisno injury,scars,the boxbody issupplied andinstalled by the fireunit,and thecombination ofthe paneland thecolorsteelplate iscompleted by the mechanicalandelectrical unit;After thedoor isclosed inplace,it shouldbe levelwiththesurrounding framesurface andsealed,andafire extinguishercanbeplacedin the lowerpart;Flat surface,easy toclean,scrub resistantand resistantto sporewiping andVHP disinfection.照明:向明灯采用面板平板灯，吸顶式安装URS034LED NA□Yes DNoIlluminating:The lightingadopts LEDpanel light,ceiling installation.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，且不受次数限制安防平面图Thedoor interlockshouldadoptelectronic airinterlock,withstatusdisplay,andcanbeopenedURS035withadelay;Securityplan□Yes ONoDoorinterlock,thrcc-door interlockand doorinstallation,logical reasonable,installation E18-215801S-I-04sequencer,installation firm,sensitive contact,concealed;The controlfunction isturned onwithan emergencybutton andisnot limited to the numberof times.洁净室设计确认方案e PROBIOGenScriptDesign QualificationProtocol forClean Room文件编号/Code.版本号/Version页码/PageDQ-CR-001126/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSID URSContentmeets requirement线管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有可靠的设计和施工说明密封措施URS036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SpecificationofDesignandConstruction□Yes ONoConduit:EW07-215701S-3-01The electricallines in theclean room aredark;There shouldbe reliablesealing measuresatthejoints betweenthe electricalpipeline and thewall in thecleanarea and the variouselectrical equipmentinstalled on the wall;The sealingmaterial must provide material reports andcertification documentssuch asnon-toxic totheclean plant.干手器为高速干手器，快干、省时、低能耗、设计新颖、美观大方，有超温超时超流多重保护；采用红外线感应、感应灵敏，外壳采用优质工程塑料、坚固耐用，须有接水盒装置，使用时避免弄湿地面；风速60m/s以上、干手时间10s以内、感应距离12cm；电源采用220v-240\，、电流保险丝10A、防水等级lp*l、挂壁安装、安装方便；URS037NA□Yes DNo供后方提供产品说明、质保证书、合格证书Hand dryerisahigh-speed handdryer,fast drying,time-saving,low energyconsumption,novel design,beautiful andgenerous,with multipleprotection ofovertemperature overtimeandovercurrent;It adoptsinfrared sensing,sensitive induction,the shellis madeof high-quality engineeringplastic,strong anddurable,must havea waterbox device,and avoidwetting theground whenusing;Wind speedabove60m/s,dry timewithin10s,sensing distance12cm;洁净室设计确认方案GenScripte PROBIODesign QualificationProtocol forClean Room文件编号/Code.版本号/Version页码/PageDQ-CR-001127/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSID URSContentmeets requirementThepowersupplyadopts220V-240V,current fuseI0A,waterproofgrade IP*1,wall-mountedinstallation,easy installation;The supplierprovides productdescription,quality guaranteeand certificate ofconformity.URS038NA NA□Yes DNo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；四层平面工艺下水，凝水管道布置图LayoutplanURS039地漏必须送样确认，并有材料进场验收程序of processwater andcondensate pipeson thefourth□Yes DNoAllpools need tobeequipped with304stainless steelwater bends,the surfaceissmoothand floorE01-215701S-4-08easy toclean;Clean andsealed floordrains shouldbe installedintheclean roomto preventodor diffusion;The floordrain must be sentfor confirmationand thereisamaterial acceptanceprocedure.设备任何部位不能有锋利的尖角；电源，风机，照明等应设置断路器URS040NA□Yes DNoNopart oftheequipmentcan havesharp sharpcorners;Power supplies,fans,lighting,etc.shouldbeequippedwithcircuit breakers.噪声水平应低于限定值以保证良好的工作环境竣工后最大60dB AoURS041NA□Yes DNoThenoise levelshouldbebelow thelimit valueto ensurea goodworking environment.60dBA maximumupon completion.所有设备连接拐角处，平滑过渡，避免划伤URS042NA□Yes DNoAlldevices arcconnected aroundcorners forsmooth transitionsandavoidscratches.夹层内需安装适量照明灯具，灯具开关安装在夹层进门处，合理划分照明控制URS043区域NA□Yes DNo洁净室设计确认方案e PROBIOGenScriptDesignQualificationProtocolforClean Room文件编号/Code.版本号/Version页码/PageDQ-CR-001128/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSID URSContentmeets requirementAnappropriateamountoflightingfixturesneedtobeinstalledinthemezzanine,andthelampswitch isinstalled atthe entrancedoor ofthe mezzanineto reasonablydivide thelightingcontrol area.供应商需提供至少两年的维护保养及易损件更换方案，分为月度、季度、年度，且方案需满足需方文件资料管理规程要求URS044NA□Yes DNoSuppliersare requiredto provide at leasttwo yearsof maintenance and wearpartsreplacementsolutions,dividedintomonthly,quarterlyandannual,andthesolutionsmustmeetthe requirements ofthe requirements ofthe demandersdocument managementregulations.所有第三方配件必须提供型号及供货商系统质保期间的维护保养，由供应商执行URS045NA□Yes DNoAllthird-party partsmustbesupplied withthe modelnumberandsupplier.Maintenance duringthe systemwarranty periodis performedby the supplier.供应商需提供至少两年的维护保养及易损件更换方案，分为月度、季度、年度，且方案需满足需方文件资料管理规程要求URS046NA□Yes DNoSuppliersare requiredto provideatleasttwo yearsof maintenanceand wearpartsreplacementsolutions,dividedintomonthly,quarterlyandannual,andthesolutionsmustmeetthe requirementsoftherequirementsofthe demandersdocument managementregulations.成品门窗供货方提供合格证书、性能检验报告，防火门还要提供产品送检证明、防火报告URS047NA□Yes DNoThe supplier offinished doorsand windowsprovides acertificateofconformity andperformanceinspection report,and thefire doormust alsoprovideaproduct inspectioncertificateand firereport.供应商须提供彩板产品质量证书、产品证明文件、产品结构图、产品送检报告、URS048防火报告NA□Yes DNo洁净室设计确认方案e PROBIOGenScriptDesignQualificationProtocolforClean Room文件编号/Code.版本号/Version页码/PageDQ-CR-001129/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSID URSContentmeets requirementSuppliersmust providecolorplate productquality certificate,productcertification documents,product structurediagram,product inspectionreport,fire preventionreport.所有风管供货方须提供送货清单，检测报告，材料报表，合格证明，清洁记录URS049NA□Yes ONoAllduct suppliersmustprovidedelivery lists,test reports,materialreports,certificates ofconformity,and cleaningrecords.文件要求同时提供电子版和纸质版，纸质文件一式两份，文件必须以中英文提交，还需提供文件清单及列表URS050NA□Yes DNoDocumentsarerequiredtobeavailableinbothelectronic andpaperversions,paperdocumentsin duplicate,documents mustbesubmittedin English and Chinese,andalist and list ofdocumentsmustbeprovided.提供对需方的响应情况对照表，对照表中应说明如何实现的要求，偏URS URS离项必须要说明偏离的原因；提供文件必须包括纸质版文件及一个电子版本MS格式，需方可以直接编辑WordURS051NA□Yes ONoProvidea comparisontable ofresponse todemand-side URS,which shouldexplain howtoachievetherequirementsofURS,andthereasonforthedeviationmustbestated;TheprovideddocumentmustincludeahardcopyandanelectronicversionMSWordformat,whichcanbeedited directlybytherequest.提供中英文双语的方案，方案必须经需方批准后才能实施，并完成最终报SAT告的整理并最终提交给需方，提供文件包括纸质版文件及一个电子版本MSWord格式，需方可以直接编辑URS052NA□Yes DNoProvideChineseandEnglishbilingualSAT protocolthe protocolmustbeapproved bythedemander beforeimplementation,and complete the finalreport collationand finallysubmit tothe demander,the provideddocuments includepaper versionand anelectronic versionMSWord format,the demandercan directlyedit.目的
1.Purpose设计确认的目的是确保镇江大学园区楼洁净室进行的设计工作至少满足及用户需求说明的要求53#GMPThe purposeof design qualification isto ensurethatthedesign workcarriedoutfor thecleanroom53#Building ofZhenjiangUniversity Parkmeets atleast therequirementsofGMP anduserrequirements.范围
2.Scope本次设计确认仅适用于楼洁净室的设计确认包括空调机组、高效过滤器、洁净室等53#This designqualification isonly applicabletothedesignqualificationofthecleanroomof53#Building.System includesairconditioning units,high-efficiency filters,clean rooms,etc.空调系统和洁净室的对应关系如下表The correspondingrelationship betweentheair conditioningsystem and thecleanroomis showninthetable below: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 areassuchasfilling roomonthe first floorCCCDDDDDCDCDCDCC洁净室设计确认方案e PROBIOGenScriptDesignQualificationProtocolforCleanRoom文件编号/Code.版本号/Version页码/PageDQ-CR-001130/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSID URSContentmeets requirement验证服务要求供应商必需能够提供详细的符合相关规范、标准的验证文件、验证实施及合格报告包含但不限于项目质量计划、关键组件分析、QPP CCA可追溯文件、、、等，并在投标书中详细说明风险分析、可RTM DQIQ OQRA追溯文件、、、等的主要文件目录，提供项目实施的资料、文件、RTM DQIQ OQ图纸等，协同需方进行相关的验证工作，验证实施资料必须为原始资料•，并提供中英文电子版供审查；所有验证相关文件均需要经过需方批准；文件必须包括一个电子版本格式，需方可以直接编辑MS WordURS053NA□Yes DNoThe verification servicerequiresthesupplier tobe ableto providedetailed verificationdocuments,verification implementationand conformityreports including but not limited to:project qualityplan QPP,key componentanalysis CCA,traceability documentsRTM,DQ,IQ,OQ,etc.,and detailthe maindocument catalogof riskanalysis RA,traceabilitydocuments RTM,DQ,IQ,OQ,etc.inthetender,and provideproject implementationmaterials,documents,drawings,etc.Cooperate withthe demander to carry out relevantverificationwork,andtheverification implementationmaterials mustbe originalmaterials,and provideelectronic versionsinChineseandEnglishfor review;Allverificationdocuments aresubject todemand-side approval;ThedocumenlmustincludeanelectronicversionMSWordformalthatcanbeediteddirectlyby request.供应商应提供由本供应商采购安装的所有相关设备及系统的资料包含但不限于以下内容设备合格证、使用说明书；主要技术参数；URS054主要部件说明书；NA□Yes DNo操作手册、维护和保养手册（维护手册包含但不限于以下文件所有制造商，包括所有五金和配件的制造商的名称、地址、电话制造商建议的维护期，服务，清洁，检测和替换细节，以便根据要求，建立日常维护洁净室设计确认方案GenScripte PROBIODesignQualificationProtocolforCleanRoom文件编号/Code.版本号/Version页码/PageDQ-CR-001（）131/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSID URSContentmeets requirement和清洁在正常使用时，避免外形的损坏和褪色所有可移动和运行的部分，需确保及时和妥善的维护及替代产品数据安装方法说明和允许的修订制造商代表（如前所述）的认证报告）；操作，清洁和维修的SOP；设备厂家质量体系认证证书设备安装说明/指南；设备出厂质量证明、安全性法规证书、产品合格证等；现场测试报告；相关的仪器校准证书（可追溯的国家参考标准仪器及其校准程序）设备售后服务承诺书、质量保证书；装货清单；上述资料要求提供硬纸张版本和电子版本（SOP等文件提供可中英文的编辑版本）Supplier shall provide informationon allrelevant equipment and systemsprocured andinstalledby Supplier,includingbutnotlimitedtothe following:Equipment certificate,instruction manual;Main technicalparameters;Main componentmanuals;Operating manuals,maintenanceandmaintenance manuals（maintenance manualsinclude,but arenotlimitedto,the followingdocuments:Name,address,telephone numberof allmanufacturers,including manufacturersof allhardwareand accessories.The manufacturersrecommended maintenanceperiod,service,cleaning,inspection andreplacement detailsin orderto establishroutine maintenanceandcleaning uponrequest.Under normaluse,avoid damageand fadingoftheshape.All movableandoperational partsneed tobe maintainedand replacedinatimely andproper manner.Product datadescription ofinstallation methodsand permissiblerevisions ofthemanufacturers representative（as previouslydescribed inthe certificationreport）;SOPs fbroperation,cleaning andrepair;洁净室设计确认方案GenScripte PROBIODesignQualificationProtocolforCleanRoom文件编号/Code.版本号/Version页码/PageDQ-CR-001132/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSID URSContentmeets requirementEquipmentmanufacturer qualitysystem certificationequipment installationinstructions/guides;Equipment factoryquality certificate,safety regulationcertificate,product certificate,etc.;Field testreport;Relevant instrumentcalibration certificatestraceable nationalreference standardinstrumentsand theircalibration procedures;Equipment after-sales servicecommitment,quality assurancecertificate;Loading list;The abovematerialsarerequiredtobe availableon hardpaper andelectronically documentssuchas SOPsare availablein bothEnglishandChinese.供应商应提供所有车间/现场加工制作及安装的详细记录，送样、报验及过程验收资料等所有工程实施的相关资料；供应商应提供所有安装在设备上仪表的文件和清单，包括型号、供货商、精度、范围，并且配有仪表安装图纸；提供所有的竣工图纸并盖竣工图章，竣工图纸必须与现场安装一致Thesupplier shall providedetailed recordsof all workshop/on-sitc processingand installation,URS055NA□Yes ONosampledelivery,inspection andprocess acceptancedata andother relevantinformation fortheimplementation ofall projects;Supplier shallprovide documentationandlistofallinstruments installedontheequipment,including model,supplier,accuracy,range,and installationdrawings ofthe instrument;Provide allas-built drawingsand stampas-built drawings,which mustbe consistentwith theon-site installation.在调试期间供应商应在现场负责测试和调试，以检测其设计、制造、运行效果URS056等并提供所有测试和调试所需的工具、材料、仪器NA□Yes DNo洁净室设计确认方案GenScripte PROBIODesignQualificationProtocolforCleanRoom文件编号/Code.版本号/Version页码/PageDQ-CR-001133/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSID URSContentmeets requirementDuringcommissioning,suppliers shouldbe responsiblefor testing and commissioningon sitetotest theirdesign,manufacturing,operation effects,etc.All tools,materials,instrumentsrequired fortestingand commissioning arcprovided.洁净系统施工供应商，应当在适当的时间节点完成整体施工工作界面的精细净化保洁工作，包含但不限于如下区域非洁净控制区、洁净区、技术吊顶、空调机房含空调箱、风管等区域精细净化保洁结束后，需双方进行现场验收后才可视为验收合格URS057Thecleansystem constructionsupplier shallcompletethefine purificationand cleaningwork NA□Yes DNooftheoverallconstructionworkinterfaceatanappropriatetimenode,includingbutnotlimitedto thefollowing areas:non-clean controlarea,cleanarea,technical ceiling,air conditioningroomincluding airconditioning box,air ductandotherareas.After theendoffinepurification andcleaning,both partiesneedtocarryouton-site acceptancebefore itcan beregardedas qualified.供应商应提供所有车间/现场测试和检验的详情测试和试运转程序开始安装测试的前两周，供应商应提交份批准的测试和调试流程1URS058NA□Yes DNoSuppliershallprovidedetails ofallworkshop/field testsand inspections.Testing andcommissioningprocedures:Two weeksbefore startingthe installationtest,thesuppliershallsubmit1approved testandcommissioningprocess.供应商应对需方使用人员进行洁净厂房及系统的使用培训，培训需达到以下标准维护人员熟练掌握设备基本原理，具备基本维护能力；操作人员能够熟练操作设备；培训结果由需方确认URS059NA□Yes DNoThesuppliershalltrain the demandertouse thecleanplantand system,andthetraining shallmeetthefollowingstandards:the maintenancepersonnel arcproficient inthe basicprinciplesof theequipmentandhave thebasic maintenanceability;The operatoris ableto operatetheequipment proficiently;The trainingresults areconfirmed bythe demander.URS060NA NA□Yes ONo洁净室设计确认方案GenScripte PROBIODesignQualificationProtocolforCleanRoom文件编号/Code.版本号/Version页码/PageDQ-CR-001134/38编号内容URS设计文件名称Design Doc.Name是否符合要求Whether itURSIDURSContentmeets requirement系统交付需方使用后，供应商每年派技术人员进行回访，对系统的使用状况进行了解，对用户提出的意见和条件进行纪录，并解决用户提出的任何疑问，对需方可能存在的问题进行帮助，满足用户的合理要求URS061After thesystemisdelivered tothedemander,thesuppliersends technicalpersonnel tovisit NA□Yes DNothesystem everyyear tounderstand theuse statusofthesystem,record theopinions andconditionsput forwardbythe user,solve anydoubts raisedbytheuser,help thepossibleproblems ofthedemander,and meetthe reasonablerequirementsoftheuser.备注Comments确认人/日期复核人/日期Performed by/DateReviewed by/Date4洁净室设计确认方案k GenScriptbPROBIODesignQualificationProtocolforCleanRoom文件编号版本号页码/Code./Version/PageDQ-CR-0010135/38偏差
9.Deviations偏差表
9.
1.List ofDeviations下表按顺序号罗列偏差，以保证所有的偏差都会被改正如果需要，可以复印此页In thistable thedeviations arelisted andcontinuously numberedto ensurethat alldeviations arecorrected.If required,this pagecanbe copied.如有需要，可按照金斯瑞质量管理体系要求进行偏差管理和变更控制If necessary,deviation managementand changecontrol canbe carriedout inaccordancewiththerequirementsofthegenscriptquality managementsystem.偏差列表List ofDeviations关键？状态Status偏差号偏差描述Critical是/关闭/开放Deviation No.Descriptionofdeviation否Yes/No Close/Open4洁净室设计确认方案k GenScriptbPROBIODesignQualificationProtocolforCleanRoom文件编号版本号页码/Code./Version/PageDQ-CR-0010136/38附件列表
10.List ofAttachment附件编号.附件名称页数Attachment No.Attachment TitlePage4洁净室设计确认方案k GenScriptbPROBIODesignQualificationProtocolforCleanRoom文件编号版本号页码/Code./Version/PageDQ-CR-0010137/38修订历史
11.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日期01New documentsSeeapproval dateonthe signature andapproval page4洁净室设计确认方案k GenScriptbPROBIODesignQualificationProtocolforCleanRoom文件编号版本号页码/Code./Version/PageDQ-CR-0010138/38洁净室设计确认报告Design ReportforCleanRoom人员职务姓名签名/日期Personnel OccupationName Signature/Date制订人Prepared by技术审核TechnicalReview技术审核TechnicalReview技术审核TechnicalReview质量批准QualityApproval空调系统编号洁净室区域洁净级别HVAC NO.CleanRoomArea CleanLevelC术语和缩略语
3.Abbreviations缩写描述Abbreviation Description设计确认DQ DesignQualification偏差报告DR DeviationReport用户需求URS UserRequirement Specification系统描述
4.System Description大学园区楼根据使用功能的不同，分成相应的三个控制区域，三个区域的净化级别分别为核心53#1-2FGMP生产区为的生产车间，上游为级，其中接种间为级，下游为级洁净室，辅助功能区为级；GMP DC CCNC其中组合式空调机组为服务于二层上游级净化区域，服务于一层下游级净化区JK-201〜203D JK-101〜104C域System description:The53#building ofthe universitypark isdivided intothree correspondingcontrol areasaccording tothedifferent functionsused,andtheclean levelsofthethree areasare:1-2F GMPcore productionarea isGMPproduction workshop.Upstream isD level.Inoculation roomis Clevel.Downstream isC cleanroom.Auxiliary functionareais CNClevel;Among them,the combinedairconditioningunit isJK-201〜203serving theupstream D-level cleanarea ofthesecond floor,and JK-101〜104serving thedownstream C-level purificationareaofthefirstfloor.的实验室，其中细胞间为级区域空调系统，其余房间为为区域3F QC/AD/PD3002D JK.301CNC QC/AD/PDlaboratory on3F,where3002cells areintheclass Darea JK-301airconditioningsystemandthe remainingrooms areCNCareas.的生产车间，上游为级，下游为级洁净室，罐装间为级洁净室其中组合式空调机组为、4F GMProDCC JK-
401、、服务于四层上游级净化区域，、、、服务于四层下游JK-403JK-405JK-407D JK-402JK-404JK-406JK-408C级净化区域，服务于层罐装车间净化区域JK-4094The GMProproduction workshoponthe4F isClassDupstream,ClassCcleanroomdownstream,and ClassC cleanroominthefilling room.Among them,the combinedairconditioningunits areJK-401,JK-403,JK-405and JK-407serve thefour-layer upstreamD-level purificationarea,JK-402,JK-404,JK-406,JK-408serve thefour-layerdownstream C-level purificationarea,and JK-409serves thefour-layer canningworkshop purificationarea.参考文件
5.Reference Documents文件名称文件编号版本Document NameDocument NumberVersion洁净室用户需求说明GMP-URS-05101User RequirementsSpecification forCleanRoom职责
6.Responsibilities供应商职责
6.
1.Responsibilities负责设计确认方案和报告的起草；Responsible fordrafting designqualification plansand reports;负责设计确认方案的执行；Responsible forthe implementationof designqualification schemes;设计确认执行过程种偏差和变更的发起及后续整改活动Initiation andsubsequent rectificationactivities ofdeviations and changes duringthe implementationof designvalidation.（业主）
6.
2.Genscript Responsibilities负责设计确认方案和报告的审核和批准；Responsible forreviewing andapproving designqualification plansand reports;偏差和变更整改措施的批准Approval ofcorrective actionsfor deviationsandchanges.文件管理规范
7.Document ManagementSpecification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 throughoutthe validationlifecycle.记录用笔
7.
1.Recording pens使用蓝色字笔记录Blue orblack signpens shall be usedfor recording.签名
7.
2.Signature经过培训的人员为授权人员The trainedpersonnel areauthorized personnel.被授权的人员才能签署文件Only authorizedpersons cansign onany documents.应签全名，除非文件另有规定Unless otherwisespecified,the fullname shallbe usedas thesignature.填写栏目
7.
3.Column filling所有栏目必须填写All thecolumns shallbe filled.填写内容与上面栏目相同也应重新填写The fulltext shallbe filledeven ifitisthesameas 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填写，只能选择一种测试结果填写Fields shallbefilled accordingtotheactual verificationresult.Theverificationresult shallbe selectedwith“J andonly oneresult canbeselected.如下For example文件名称是否完整可读Document NameComplete andReadable设计确认方案是否□4Yes□NoDesign QualificationProtocol若有单个栏目不需要填入内容，则在空白处填字母“不适用”的简写“NA”，表示无此项内容If thereis nothingtobefilled intoan individualfield,NA abbreviationfor notapplicable shallbewrittenin thisfield.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，下方签名并注明日期“NA”If thereis nothingtobefilled inmorethanone neighboringfields,such fieldsshallbecrossed witha diagonalline,withNA notedbelong the line,sign thename and date undertheline.如下——-------------------____---------------------------—------------------------------NA...t+nc:/CcS________________________________签名/日期Stgn/uaiLFor example更改错误
7.
4.Correction ofmistakes在错误处划线，填入正确的内容，签名并注明更改日期，确保原先信息仍清晰可识别When anymistakes aretobecorrected,the correctrecord shallbe entered,signedanddated forcorrection.The originalinformationshallbeleft clearlyreadable.如System XXSigri签名System-¥ZDate日期审核人应对修改人的修改内容进行确认并在修改人签名和修改日期旁签署姓名和日期The reviewershould verifythe modifiedcontent andsign thenameanddate besidethesignatureanddateof themodifier.记录日期
7.
5.Date RecordingFormat日期的格式为时间的格式为“时时:分分”或“时时:分分:秒秒”yyyy-mm-ddoFormat ofdate isyyyy-mm-dd.Format oftime ishh:mm orhh:mm:ss.书面语及名称
7.
6.Written Wordsand Names使用规范的书面语及名称Standard writtenwords andnames shallbe used.文件前后名称要一致The namesshallbeconsistent allthroughthedocument.确认项目8,Verification Items培训确认
8.
1.Training Verification目的
8.
1.
1.Purpose确认所有参与方案实施的人员经过验证活动培训Confirm thatall personnelinvolved inthe implementationofthescheme havebeen trainedin validationactivities.程序
8.
1.
2.Procedure在方案执行前，由本方案起草人或具有相当资历的人员对所有参加测试人员进行培训，确保理解方案DQ DQ内容在《培训确认》中签名，并提供要求的信息Prior tothe implementationofthe DQ protocoldrafter ofthe programor personnelwith equivalentqualifications willprovidetraining toall participantsto ensurethat theyunderstand thecontent oftheDQprogram.Sign in
8.
1.4*TrainingCon firmationuand providethe requiredinformation.可接受标准
8.
1.
3.Acceptance criteria所有方案实施人员已经过洁净厂房方案培训，培训效果合格DQAll protocolimplementation personnelhave receivedDQ schemetraining inclean workshop,andthetraining effectisqualified.。
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