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1、东富龙冻干机的设计与制造基于中国现行药品生产的力容器制造工艺和电器系统相关的安全标准。GMF法规,符合现行中国设计与安全标准,特别是压LyophilizerTechnicalParameters冻干机技术参数表(自动进出料型)1、Lyo-25(SIP,CIP)真空冷冻干燥机Lyophilizer-25(SIP,CIP)制造标准ManufactureStandardscGMPA干燥箱(含26.55m2板层)2Chamber(with26.55mshelves)序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1干燥箱Chamber进口A

2、ISI316L不锈钢1套2板层进口AISI316L不锈钢1套Shelves尺寸:1525X1495X24mm12+1层3箱门DoorAISI316L不锈钢(部分)AISI316Lstainlesssteel(Section)1套4干燥箱视镜Viewingport(chamber)DN-150mm带延时照明灯DN-150mmWithtimedelayheadlamp2个5验证孔Validationport3D设计3Ddesign1个6安全插销门锁系统Doorlocksystemwithsafebolt“东富龙”独特设计UniquedesignbyTofflon1套7制品测温探头Productse

3、nsorsPt-100热电阻A级Pt-100HotresistanceALevel3支8导热油温度探头Temperaturesensors(thermalfluid)Pt-100热电阻A级Pt-100HotresistanceALevel2支性能参数Performanceparameters1设计压力Designpressure0.15Mpa2设计温度Designtemperature128C3光洁度FinishRa|jo/v|oo|J9;U!pue6uijo;!UOLUluspusdspuisipsuBisspp3;U3;edsiqoiq/v;|oqsjesq;i/vlu9;sXspo|jo

4、oa马吴喲迪孕胡军瞰场娶喲口鼬劈寿至阴44視吐孕uo!;ez!|U9;sq6nojoq;josiusiusjinbsjsq;q;i/vspjoooesjoluasjouBissp9|zzoupsoueApe|euoi;euj3;u|壷里匿剖饱呂谢歪44視口易G乙3光洁度FinishRa0.4um4盘管最低温度CoiledtemperatureMin-75C5冷凝器捕冰能力CondenserfrostingCapacity500Kg/批500Kg/batch6冷凝器外型Condensertype卧式圆桶体Horizontalbarrelbody技术优势Technicaladvantages1不锈

5、钢板材均采用进口板材,保证箱体表面光洁度,从而保证无菌要求;Stainlesssteelplatesareallimportation.Ensurethefinishofchambersurfaces,andthenensuretheasepsisrequirement.2冷凝器、盘管采用氦质谱仪进行泄漏检验;Condenserandcoiledpipeareallcarriedouttheleaktestbyheliummassspectrometer.C蘑菇阀Mushroomvalve序号SN名称Name型号/规格/材质Model/Specifications/Material数量Numb

6、er1蘑菇阀MushroomvalveAISI316L不锈钢AISI316Lstainlesssteel1套2蘑菇阀油缸Mushroomvalvecylinder上海“晶盛”1个3压力传感器Pressuresensor意大利“阿托斯”ATOS1个性能参数Performanceparameters1工作动力Motivation液压驱动Hydraulicdriven2蘑菇阀尺寸MushroomvalvedimensionDN-700mm技术优势Technicaladvantages1蘑菇阀球头采用模压制造,球头表面光洁易清洗;Theheadofmushroomvalveismanufactured

7、bymolding,theheadsurfaceisglabrousandeasyclean.2蘑菇阀可通过减压阀进行调整,防止关闭压力过大;Mushroomvalvecanbeadjustedbyreducingvalvetopreventtheoverclosingpressure.3蘑菇阀的“打开”或“关闭”具有反馈信号,能够真实的了解工作状态;WhenmushroomvalveisONorOFFthereisafeedbacksignalwhichcanbeinfavorofknowingtheworkingstatetruly.4新型蘑菇阀具有很高的密封性和准确性,可完全防止内泄漏;

8、New-fashionedplateflangeofmushroomvalveisusedthesecondaryprocesswhichhasveryhighsealingqualityandaccuracy.Thesecanthoroughlypreventtheinsideleak.D制冷系统Refrigerationsystem序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1压缩机型号及数量CompressormodelandNumberKEBELCO日本神户制钢”KS10LTH2台2制冷剂RefrigerantR404a

9、绿色环保型R404aEnvironmentFriendly适量Rightquantity3油分离器Oilseparator中港“特艺”(上海)2个4冷却水流量开关Flowswitchforcoolingwater韩国HFS1个5电磁阀Solenoidvalve丹麦DANFOSS10个6膨胀阀Expansionvalve丹麦DANFOSS6个7顶盖阀Tectumvalve意大禾UCASTEL10个8黄铜丝口闸阀Brakevalvewithscrewedbrass宁波永享2个9除酸干燥过滤器Filterfordisacidifyinganddrying外壳ALCO滤芯ALCOShellALCO,F

10、ilterCoreALCO2套10安全阀Safetyvalve意大禾UCASTEL2个11储液罐角阀Anglevalveforfluidreservetank台湾SY4个12视液镜Viewingport丹麦DANFOSS2个13手动球阀Manualglobevalve法国LEGRIS4个14单向阀CheckvalveHELDO或ARROW2个15油冷却器Oilcondenser中港“特艺”(上海)2个16油压差继电器Oildifferentialpressurerelay日本鹭宫2个17压力表Pressuremeter日本KOBELCO4个18高低压压力继电器Pressurerelay(hig

11、h/lowpressure)日本鹭宫2个19温度指示计Temperatureindicator日本NESS2个性能参数Performanceparameters1板层制冷速度(空载)Shelfcoolingtime(empty)+20-40CX60minutes2冷凝器制冷速度(空载)Condensercoolingtime(empty)+20-40C30minutes技术优势Technicaladvantages1压缩机采用日本神户螺杆机组,性能非常稳定、可靠;AdoptingtheKEBELCOCS1OSTHcompressormakestheperformancebemorestable

12、andrelibale.2采用符合蒙特利尔公约的环保型制冷剂;AdopttheenvironmentalprotectiontyperefrigerantwhichaccordswiththeMontrealConvention.3制冷系统具有各项保护功能,连锁保护;Therefrigerationsystemhasallkindsofprotectionfunctionsandinterlockprotection.4回气温度能够进行控制;Backtemperaturecanbecontrolled.冻干后期低负荷条件下的压力自动调整功能;Theautomaticadjustmentfunc

13、tionofpressureundertheconditionoflowloadinthelateoffreezedryingperiod.制冷系统油压压力多重保护功能;Thepoly-protectionfunctionofoilpressureintherefrigerationsystem.压缩机电机多重保护功能;Thepoly-protectionfunctionofcompressormotor.E、真空系统Vacuumsystem序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1真空泵Vacuumpump英国“爱德华”E

14、DWARDSE2M802台2罗茨泵Rootspump英国“爱德华”EDWARDSEH12001台3泵阱隔离阀Isolationvalveofpumpwell德国“盖米”GEMUDN-125mm1个4泵头阀Pumpheadvalve西玛特SIEGV2个5阀门反馈信号Feedbacksignalofvalve德国ROTECH1套6真空探头Vacuumgauge英国“爱德华”EDWARDSAPG2个性能参数Performanceparameters1极限真空Finalvacuum1Pa2抽气速度Evacuationtime从大气压抽至10pa30minFromatmto10pa30min3泄漏率Le

15、akagerate335X10pa.m/sec技术优势Technicaladvantages1真空系统阀门具有反馈信号,可了解开关的真实性;Thevalveinvacuumsystemhasthefeedbacksignalwhichreflectstheauthenticityofswitch.2高效泵头阀与真空泵同时打开和关闭,可大大防止真空泵油逆向扩散;Theefficientpumpheadvalveandvacuumpumpstartorclosesimultaneously.Thesecanpreventthevacuumpumpoilfromspreadinginreversee

16、ffectively.3罗茨泵可与真空泵同时启动;Therootspumpandvacuumpumpcanbestartedsimultaneously.F、复压掺气系统Aerationsystemforrepressing序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1过滤器Filter0.22卩mPALL1个安装在洁净区2掺气阀Aerationvalve西玛特SIEGV1个3隔膜阀Diaphragmvalve德国GEMl或BURKERT1套4管道PipelineAISI316L不锈钢1套技术优势Technicaladvanta

17、ges1管道全部采用自动焊接,保证内外壁光洁;Allthepipelinesusetheautomaticweldingwhichwillensurethefinishofinnerandoutersurface.2过滤器可进行在位蒸汽灭菌,操作更换方便;Filtercanbesterilizedinplacewhichmakestheoperationandreplacementbemoreconvient.3复压系统预留了可进行充氮气接口;Ainterfacebywhichitcaninjectnitrogenreservesintherepressingsystem.4复压系统能实现过滤

18、器在位手动测试功能;Themanualtestfunctioninplaceoffiltercanbeachievedintherepressingsystem.G循环系统Circulationsystem序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1循环泵Circulationpump德国“威乐”WILOSD80/101台2导热油Thermalfluid低粘度硅油5CSTSiliconoil(lowviscosity)适量Rightquantity3电加热Heater48Kw1支4板式热交换器Plateheatexchange

19、r瑞典“阿法拉伐”ALFALAVAL4个5导热油测温探头Temperaturesensors(thermalfluid)Pt-100热电阻A级Pt-100HotresistanceALevel2支6温度控制器Temperaturecontroller丹麦“丹佛斯”DANFOSS1个7压力控制器Pressurecontroller丹麦“丹佛斯”DANFOSS1个性能参数Performanceparameters1加热速度Heatingrate1C/min2硅油粘度Siliconoilviscosity5cSt25C技术优势Technicaladvantages1电加热采用PID能量调节控制,可以

20、最有效的利用加热能源;ElectricheatingiscontroledbyPIDwhichcanusetheheatingenergymosteffectively.H液压系统Hydraulicsystem序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1液压元件Hydraulicunits意大利“布雷维尼”BREVINI2液压泵Hydraulicpump意大利“布雷维尼”BREVINI1套3液压油Hydraulicoil46#抗磨液压油46#anti-wearhydraulicoil1套4油箱Tank60L1套5在非洁净区增加

21、板层控制开关1套性能参数Performanceparameters1压塞压力Stopperingforce01.0bar(可调)01.0bar(adjustable)技术优势Technicaladvantages1液压系统设置有“背压阀”,在蒸汽灭菌时可对油缸腔室进行泄压,避免损坏;Thereisabackpressurevalveinhydraulicsystembywhichcylinderchambercanreleasepressurewhenitissteamsterilizinginordertopreventdamage.2压塞液压缸具有防滑落装置Stopperinghydrau

22、liccylinderhastheantiskiddevice.3板层实现动态清洗Dynamicwashingforshelvesisachieved.4能准确判断板层是否全部升起和板层是否全部落下Itissurewhetheralltheshelvesriseorfall.5板层能够实现精确定位,确保等高进料的顺利进行Shelvestoachieveprecisepositioning,toensurethesmoothprogressofhighfeedI、气动系统Pneumaticsystem序号SN名称Name型号/规格/材质Model/Specifications/Material数

23、量Number1气动元件PneumaticUnits台湾“金器”MINDMAN1套技术优势Technicaladvantages1带润滑的气动系统可以保证阀门有效开关;PneumaticsystemwithlubricationdevicecanensurethatvalvesturnONorOFFeffectively.2带过滤器的气动系统可以保证阀门稳定性;Pneumaticsystemwithfiltercanensurestabilityofvalves.J、在线清洗、在线灭菌系统(SIP、CIP)CIPandSIPsystem(SIP、CIP)序号SN名称Name型号/规格/材质Mo

24、del/Specifications/Material数量Number1喷嘴Nozzle美国“喷雾”SSC1套2管道PipelineAISI316LASME1套3阀门Vavle德国“盖米”GEMU1套4安全阀Safetyvavle英国GRESSWELL0.14Mpa2个5疏水器Steamtrap日本MIYAWAKA2个6电接点压力表Electroniccontactor德国WIKA1个7压力变送器Pressuretransmitter英国GEMS2个8水环泵Water-ringpump“纳西姆”2BV-51101台9自吸泵日新1台三台设备共用包括所有连接管道技术优势Technicaladvan

25、tages1清洗、消毒管道全部采用符合ASME标准的进口管材,更符合无菌要求;AllthepipesforcleaningandsterilizingaretheimportedpipeswhichaccordwithASMEstandard,andtheyaccordmorewithasepsisrequirement.2管道全部采用自动焊接,内窥镜检查;Adoptautomaticweldingforallpipes,andinspectthembyendoscope.3箱体带有冷却夹套,可以在蒸汽灭菌后迅速对箱体进行冷却;Chamberhassomecoolingjacketswhich

26、cancoolitquicklyaftersteamsterilizing.4排蒸汽冷却装置,避免地漏系统受到蒸汽影响;Coolingdeviceforsteamdrainingpreventsthefloordrainingsystemfrombeingaffectedbysteam5清洗、化霜自动排空阀,防止箱内形成正压;Automaticemptyingvalvesforcleaningandde-icingcanpreventformingpositivepressureinchamber.6排水口设置有过滤网;Afilterscreensetneartheoutfall.7排水系统设

27、置有单向阀及压差控制功能,避免倒吸;Acheckvalvesetindrainsystemandthefunctionofdifferencepressurecontrolcanpreventbackflow.8前箱清洗排水口设置有取样口;Asamplepointsetneartheoutfallofwashingwaterforthechamber.K、电气控制系统Electriccontrolsystem序号SN名称Name型号/规格/材质Model/Specifications/Material数量Number1电气标准ElectricstandardIEC60204-1/2PLCSIE

28、MENS1套3计算机ComputerDELL1台4触摸屏TouchscreenSIEMENS1个5空气开关Breaker瑞典ABB/6交流接触器ACcontactor瑞典ABB/7电气保护等级ProtectionclassIP22/8UPS电源UPSpowerSANTAK1台9软件系统SoftwaresystemTofflonMaster-40001套10软件备份光盘CDforsofrwarebackup1份控制方式Controltype手动及自动控制Manualandautomatic软件功能Softwarefunction1冷冻干燥(手动、自动,可任意切换)Freezedrying(swi

29、tchthetypebetweenmanualandautomaticrandomly)2化霜(水浸泡、蒸汽)De-icing(watersoak,steam)3在线清洗(手动、自动)Cleaninginplace(manual,automatic)4在线灭菌(手动、自动)Sterilizationinplace(manual,automatic)5工艺设定(配方管理)Techniquesetting(recipemanagement)技术优势Technicaladvantages1符合FDA欧盟标准,电子签名,多组密码;ItaccordswithEuropeanstandardFDA.The

30、reareelectronicsignaturesandmultiplepasswords.2自动、手动在任何节点任意切换;Switchthetypebetweenmanualandautomaticatanypointrandomly.3一键式体检功能,为冻干机的健康提供数据保障;Onetouchfunctionforexaminationprovidesdataprotectionforthehealthoflyophilizer.4系统操作可在机房、冻干控制室进行,并且相互具有互锁功能,避免误操作;Theoperationcanbeinthesterilizingroom,machine

31、roomandcontrolroomforfreezedrying.Andtheyhavetheinterlockfunctionswhichpreventfaultyoperation.5无菌室装有液压急停按钮,可在紧急情况下强制停止板层运行;Thereisahydraulicemergencybuttoninsterilizingroom.Itcanstoptheshelvesforciblyinanemergency.6友善的人机界面具有各种部件、阀门工作状态及温度、真空度参数显示;Thereareworkingstateofallkindsofpartsandvalvesandpara

32、meterdisplayoftemperatureandvacuumdegreeonthefriendlyhumanmachineinterface.7“配方管理”可设置无数条冻干工艺曲线;Itcansetcountlesstechnologiescurvesforfreezedryinginthe“recipemanagement”.8“配方管理”可实现:低温进箱、二次回冻(反复预冻)、压力升测试、掺气阀或者小碟阀选择性掺气控制、自动放气和压塞、低温岀箱等个性功能;Thesepersonalizedfunctionssuchasgettinginchamberatlowtemperature

33、,refreezing,testingofpressurerise,selectiveaerificationcontrolbetweenaerationvalveandbutterflyvalve,automaticdegassingandstoppering,andgettingoutchamberatlowtemperatureandsooncanbeachievedinthe“recipemanagement”.9“冷冻干燥”自动过程有阶段显示功能,并可任意跳段;Thereisafunctionfordisplayingbystagesintheautomaticprocessof“f

34、reezedrying”,anditcanskiprandomly.10“冷冻干燥”过程中可对配方进行随时调整;Therecipecanbeadjustedmomentarilyinthe“freezedrying”process.11操作画面具有各个故障点显示功能;Thereisafunctionfordisplayingvarioustroublepointsontheoperationinterface.12具有数据、曲线两种记录功能,可根据批号随时调用或打印;Thereisafunctionforrecordingbothdataandcurveswhichcanbeusedorpri

35、ntedmomentarilyaccordingtothebatchnumber.13可存储无数条数据、曲线记录;Itcansavecountlessdataandcurvesrecords.14各个真空度、温度曲线由多种颜色显示,并可任意设置“显示”或“隐藏”;Eachcurveofvacuumdegreeandtemperatureisdisplayedinmulticolor,anditcanbesetfor“displayed”or“hidden”randomly.15“冷冻干燥”完成后,可将“工艺配方”、“数据曲线”、“历史记录”、“操作记录”、“报警记录”等原始记录一起打印,可作为

36、批产品的详细批记录进行保存;After“freezedrying”itcanprinttheoriginalrecordstogethersuchas“technologyformula,datacurve,historyfile,operationrecord,alarmreportingandsoon.Thesecanbesavedasthedetailedbatchrecordsofabatchofproduct.16“在线清洗”可实现自动控制;“Cleaninginplace”canbeautomaticallycontroled.17“在线消毒”功能具有安全连锁保护;脉动预热消毒Th

37、ereisasafetyinterlockprotectiondeviceinthe“Sterilizationinplace”system,anditsterilizesbypulsantpreheating.18可根据用户实际使用需要增加相应软件功能;Itcanincreasecorrespondingsoftwarefunctionaccordingtoactualrequirementsofcustomer.19软件系统符合FDA21CFRPARTII;SoftwaresystemaccordswithFDA21CFRPARTII.20电子签名,三级用户权限管理,曲线报表不可修改;Th

38、ereareelectronicsignaturesandthreestageauthorizationmanagements.Thecurvechartscannotbemodified.21UPS不间断电源可在紧急停电后20分钟内给PLC及各类传感器提供电力;UPS(uninterruptedpowersupply)willsupplypowertoPLCandvarioussensorsin20minutesafteremergencypowershutoff.F、公用工程清单Utilitylist1总装机功率Totalpower140Kw(380V,50Hz,3Phase,5Wire)

39、2用于制冷系统的冷却水Coolingwaterforrefrigerantcooling35nVhr(1.5P2bar,T4bar,T=80C)4用于气动阀的压缩空气Compressedairforpneumaticvalve100L/min(5P8bar)5SIP纯蒸汽用量PuresteamconsumptionforSIP350kg/hr(2P3bar)6化霜用蒸汽Steamforde-icing110kg/hr(2P3bar)G设备主要参数Theequipmentsmaintechniqueparameter1整机结构Machineconstruction分体式Split2外型尺寸Dim

40、ensionofunit7500*3300*5800mm3整机重量Weightofunit约27TApprox27T4西林瓶装量Fillingvolumeofvial22mn约56,000支16mm约105,000支H1验证文件系统(电子光盘1份)详细验证文件系统Verificationdocumentssystem(onesetofCD)Thedetailsofverificationdocumentssystem序号SN名称Name数量Number1安装确认Installationqualitation(IQ)1套2操作确认Operationqualitation(OQ1套3性能确认Per

41、formancequalitation(PQ1套4工厂验收测试Factoryacceptancetest(FAT)1套5客户现场验收测试Siteacceptancetest(SAT1套6操作手册Operationmanual(OM)1套7维护手册Maintenancemanual(MM)1套8安装手册Installationmanual(IM)1套9平面布置图Layoutdrawing1套10工艺流程图P&ID1套11电气线路图Wiringdrawing1套12主要部件说明书Instructionforthemainparts1套13压力容器质量证书Qualitycertificateforp

42、ressurevessel1套14材质报告Materialreport1套15校验报告Verificationreport1套附加说明AdditionalComments名称Name数量Number复压压力可控二.自动进出料系统参数表AutomaticLoadingAndUnioadingSystemR&R-AL-1000-15/15固定式自动进出料系统制造标准ManufactureStandardscGMPA、LoadingandUnloadingIntegrationSystem进料集成系统.I、IntegrationConveyor集成输送机序号名称型号/规格/材质数量SnNameMod

43、el/Specifications/MaterialNumber1Infeedingbelt(POM)SwitzerlandHabasit3sets输送网带(POM)瑞士Habasit3套SprocketSwitzerlandHabasit3sets2链轮齿瑞士Habasit3套TugwheelUHMWPE3sets拖轮高分子量聚乙烯3套3Bearing轴承Misumi3sets3套4Frequencymotor变频电机Siemens西门子3sets3套5Reducer减速机GermanyNeugart德国Neugart3sets3套6Coupling联轴器GermanyKTR德国KTR3se

44、ts3套7Fence护栏POM3sets3套II、LoadingTransitionDisk进料过渡转盘序号名称型号/规格/材质数量SnNameModel/Specifications/MaterialNumber1RotarytableTOFFLON(POM)1set旋转平台TOFFLOF聚甲醛1套以设计为准2Flange法兰TOFFLON(AL)1set1套3Bracketsubassembly支架组件TOFFLON(304)1set1套4Bearing轴承Misumi1set1套5FrequencymotorSiemens1set变频电机西门子1套6Reducer减速机TaiwanAPE

45、X台湾APEX1set1套7Fence护栏POM1set1套B、AutomaticLoadingSystem自动进料系统I、LoadingPusherSystem进料推进系统序号名称型号/规格/材质数量SnNameModel/Specifications/MaterialNumber1Loadingpusherpositioningsystem进料推进直线定位系统GermanyBAHR德国BAHR3sets3套Servomotoranddriver西门子3sets伺服电机及驱动器Siemens3套2ReducerGermanyNeugart3sets减速机德国Neugart3套3Couplin

46、gGermanyKTR3sets联轴器德国KTR3套4DisplacementsensorGermanyNovotechnik3sets位移传感器德国Novotechnik3套5Limitswitch限位开关GermanySchmersal德国Schmersal3sets3套Pushersubassembly推进组件TOFFLON(304)3sets3套6Guidinglinearbearing直线轴承Misumi3sets3套II、StarWheelSystem星轮系统序号名称型号/规格/材质数量SnNameModel/Specifications/MaterialNumber1Servom

47、otoranddriver西门子3sets伺服电机及驱动器Siemens3套2PositionsensorGermanyTurck3sets位置传感器德国Turck3套3Photoelectricitycounter光电计数器SwitzerlandContrinex瑞士Contrinex3sets3套4StarWheel星轮TOFFLON(POM)3sets3套III、TransitionSystem过渡系统序号名称型号/规格/材质数量SnNameModel/Specifications/MaterialNumber1Transitionpositioningsystem过渡直线定位系统Ger

48、manyBAHR德国BAHR3sets3套2Servomotoranddriver伺服电机及驱动器西门子Siemens3sets3套3Reducer减速机GermanyNeugart德国Neugart3sets3套4Coupling联轴器GermanyKTR德国KTR3sets3套5Displacementsensor位移传感器GermanyNovotechnik德国Novotechnik3sets3套6Limitswitch限位开关GermanySchmersal德国Schmersal3sets3套7TransitionSupportingsubassembly过渡支撑组件TOFFLON(3

49、O4/POM)3sets3套8Guidinglinearbearing导向直线轴承Misumi3sets3套9Protectbellow波纹保护套PTFE3sets3套10Flexiblecombplate活动梳子板TOFFLON(304)3sets3套11Fixedcombplate固定梳子板TOFFLON(304)3sets3套12小门增加过渡板3套IV、Loadingandunloadingconveyor进出料输送系统1Infeedingbelt(POM)输送网带(POM)SwitzerlandHabasit瑞士Habasit3sets3套2Sprocket链轮齿SwitzerlandHabasit瑞士Habasit3sets3套Tugwheel拖轮UHMWPE高分子量聚乙烯3sets3套3Bearing轴承Misumi3sets3套4Servomotor伺服电机Siemens西门子3sets3套5Reducer减速机GermanyNeugart德国Neugart3sets3套6Coupling联轴器Ger

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