Cleansteamgenerator纯蒸汽发生器

Cleansteamgenerator纯蒸汽发生器Intendeduse:Designedtogeneratecleansteamforsterilizationofpipelinesandcapacitiveequipmentaswellastoprovidetheworkofsterilizersinpharmaceuticalproduction.用途：产生清洁蒸汽用于消毒管线和电容设备， 同时提供医药生产的消毒工作。Capacity:产能Feedsteampressure,barCapacity,kg/h小时/公蒸汽压力 斤4-6 1000Equipment:设备-FWinjectionpumpmanufacturedbyGrundfos,由Grundfos生产的FW注射泵-systemofmeasurementandadjustmentthelevelincolumns测量和调整塔器水平的系统。-industrialsteamfeedcontrolsystem工业蒸汽供给控制系统-cleansteamfeedcontrolsystem干净蒸汽供给系统。-cleansteamflowmeteringsystem干净蒸汽流量系统-particulatemattersfiltering,separationandcondensateseparationsystemattheinletofindustrialsteamtosteamgenerator在工业蒸汽进入蒸汽发生器入口的细小物体的过滤器，分离和冷凝分离系统-valves/controlproducedbyGemuorBurkert由GemuorBurkert生产的阀-steamandcondensatecomponentsproducedbySpiraxsarco.-由Spiraxsarco生产的蒸汽和冷凝器件。Materials:stainlesssteel,allfeedwaterandcleansteam-contactpartsshouldbemanufacturedofmaterials1.4435/1.4404(accordingtoUSAAISI316LorAISI316Tistandards),otherparts-ofmaterial1.4301(accordingtoUSAAISI304standard).材料：不锈钢：所有注入的水和清洁蒸汽接触的部件按USAAISI316LorAISI316Ti标准，其他部件按USAAISI304标准。Weldedjointsshallbecarriedoutbymeansofinertgaswelding.Allunitsoftheinstallationshouldbeaccessibleforinspectionandeasilydismantled.用惰性气体焊接。所有安装的单位可以拆解检验，并容易拆卸。Surfaces:表面抛光-polishedinside内部Ra<0.6m^-abradedoutside外部 Ra<0.9m^-weldedjointsofthemachineunitsinworkingareasshallbepolishedtothebasemetalstate.Shellmetal-polishedstainlesssteel.设备焊接部件在工作区域应当抛光到基础状态。外壳抛光不锈钢。Basiccontrolandautomationfunctions：础控制和自动功能--PLCcontrollerandsensorcontrolpanelonthebasisofSimaticSiemens用西门子SimaticPLC和传感控制操控台--levelmonitoringofsourcewaterinthefirstdistillercolumn第一个蒸馏塔水位监视--steampressureandheatingcontrol蒸汽压力和加热控制--compressedairpressurecontrol压缩空气压力控制。--cleansteampressurecontrolwithanoutputof(4-20)mAforexternatlabbing4-20mA输出的干净蒸汽压力控制用于外工作台。--permanentcontrolofcleansteamparameterswiththehelpofcleansteamcondensateconductivity,withpossibilityofregistrationofinlet(FWflow)andoutlet(electricconductivityofcondensateandcleansteampressure)parametersfrom(4-20)mAoutputforexternaltabbingofdigitalmonitor在清洁蒸汽冷凝传导的帮助下，(冷凝和清洁蒸汽压力的电传导)出口参数--respiratoryfilterandvalvesforairbleedingfromsteamgenerator通过蒸汽发生器流过的空气呼吸过滤器和阀门theprintoutordigitalversionofPLCcontrollingprogramwithcommentsPLCcontrollingprogramwithcommentscanbeprintout可以打印PLC控制程序内容--thepossibilityofSCADAEthernetinterfaceconnectiontothesystemSCADA以太网界面连接系统Documentation:-pressurevesselcertificatetranslatedintoEnglishanexecutedonformprovidedinAppendix3(GuidelinesonVessels),withdrawings,connectiondiagramandstressanalysisofthevesselanditselements(thevesselshouldbemadewithcomplianeetotheregulationsofStatemonitoringofworksafety)andweldcrackdetection;压力容器证书英文版，带图和连接图表和容器压力分析和原理(所做容器应该和国家安全监察规定相符。-certificateforconnectingpipelines;连接管道证书。-documentsonperformedinspectionandtestingwhileproductionofthepressurevessel;压力容器生产时的检查和测试文件-instructiononequipmentassemblyanddisassembly(installationinstruction安装说明-equipmentmountinginstruction;设备装配说明。-operatinginstruction;操作说明-equipmentcleaninginstruction;清洁说明-maintenanceinstruction(MaintenanceSchedule,servicingandfullrepairworks);维修保养说明(维修计划，服务和全部的修理工作。-problemchecklistandtroubleshootingmethods故障处理表-certificatesforcomponentparts部件的合格证书。-certificationforthevalveandinstructiononthesafetyvalveadjustmentwithindicationofthevalveflowcoefficientforcompressibleandnon-compressiblemediaaswellasinstallationarea;-specificationsforallequipmentelements;-certificatesformaterialsandcontrolvalves;-up-to-datesheetsongauging,validationandcalibrationofmeasuringequipment;-softwarecertificateofconformity;-documentationinEnglish.Descriptionofproducedcleansteam:ValuenamePermissibleratesTemperature(123斗140)°CSpecificconductivity<1,1S/cmat20°CDescriptionWatersteamcondensate-transparentcolourlessliquid,odorlessandtasteless.ChloridesNotmorethan0.00005%(0,5m)pNitratesNotmorethan0.00002%(0,2m)ppH5.0-7.0.HeavymetalsNotmorethan0.00001%(0.1ppm).OxidantsPale-pinkcolourshouldnotdisappearBacterialendotoxinsNotmorethan025MEin1mlTotalorganiccarbonlevel(TOClevel)Upto500ppbFeedwatercharacteristics-thepossibilityofthesteamgeneratorrunningwiththefeedwaterwithspecificconductivityofupto4.3 1at^2S/cmG.Characteristicsofindustrialsteamatthesteamgeneratorinie—pressureof4-6bar,Operatingcosts:Please,providethespareandwearingpartslistaswellasthematerialssubjecttoplannedchangeduringequipmentoperation,theirprice,changeintervalsandmanninglevelnecessaryformaintenancescheduleworksperformanee.Theinformationshouldbetime-ranged:fromthedayofcommissioninguntilthefullrepairsterm.消毒柜Destination:sterilizerforsterilizationinjectabledrugsinglassampouleswiththepossibilitytocontrolhermeticofampoulesbyacrash-testorvacuumtest.Productivity:workingvolumeofsterilizationchambershouldprovidesimultaneoussterilizationof98cassetteswithampoulessize300*300*100mm,withatotalcycletime(sterilization+vacuumcheck+drying)-notmorethan3hours(orsmallersizechamberswithaIongercycletime)Volumeofchamber- 1400- 1500liters.Volumeofcasing(jacket)- 200 -250liters.Numberofampoules 10ml in asingle download -32 000pcsNumberofampoules 5ml in asingle download -47 000pcs.Numberofampoules 2ml in asingle download -80 000pcs.Numberofampoules 1ml in asingle download -80 000pcs.Workingconditions：Workingpressure: -1+2.5bar.Casing: -1 +5,0bar.Workingtemperaturefrom70Cto°37Catthemaximumallowablepresueof2.5bar.AccordingtoDSTUISO11134:2003 “Sterilizationofmedicalproducts.Requirementsforconformityassessmentandstreamingcontrol.Industrialwetheatsterilization.SterilizationeffectFomustbenotlessthan15minutes.Timeofsterilizationmustbenotlongerthan3hours(timeincludessterilization+checkingforleaks+drying).Options:-sterilizationwithpuresteam;-sterilizationwithsuperheatedwater;-sterilizationwithair-steammixture;Thesuppliermustspecifythebenefitsofsterilizationtype,whichhesuggested,withtheratioof:price/quality,costofequipment/operatingcost,timeoftheprocess,usingefficiencyofchambersvolumecomparedwithothertypesofsterilization.Provide:+horizontal,two-door(passingthrough)sterilizertype+temperatureandpressuremanagementandcontrolduringtheprocess(inchamberandcasing)+securitycontrolequipmentinchamberandcasing(jacket)+preseneeofaflexiblesensorformonitoringtemperatureintheproduct+pallfilterforairsupplyintothechamber+thepossibilityofanemergencystop+regulationofsterilizationiscarriedoutbypressureandtemperaturewithconversiontF0+equippedwithdoorsonslidingbearings+possibilitytoadjuststerilizerheight+heat-isolatingoutercasingismadeofsteelAISI304withhigh-qualityisolation+covermustbeeasilyremovable+theabilitytoinstalldoorsforaccesstothetechnicalarea+devicetomeasuretheamountofairandnon-condensedgasinthesterilizationcyclefortheregistrationofpossiblechamberleaks,notidentifiedintheperformaneeofthevacuumtest.+therequirednumberoftemperaturesensors+Controlpanelwith?touch-screen?displaywiththepossibilityofanergonomicallyoptimalinstallation.+thepossibilityofchangesinprocessparameters(temperature,time,pressure,depthofvacuum);+preservationofthevariousprogramsinmemory+registrationofprocessparameters:temperature,time,pressure,storage,programexecutionmemory.+thermalprinterforprintingcheckswiththeprogramparametersperformanee.Checkshows:theidentificationnumberofsterilizer,dateandtimeofsterilization,temperatureandpressurechangesovertime,theprocesscycle.+Abilitytoprintsavedprocessesofpreviouslyperformedsterilization.+theuseofvacuumtestandtheDickBove-testprograms.+manualreleaseofpressureincaseofemergency+doorlockingsystemwhenthechamberisunderpressureandifthereispreseneeofforeignobjectnearthedoors.Provideequipment:Vacuumliquid-packedringpump.Blow-offvalveinchamberandjacket.Allpipelineconnectionsandisolationvalvesmustbe?Tri-clamp?type.Typeofattachment?Tri-clamp?forsterilizationconnectiontoworkshoputilities.SIEMENSSoftware.Trolleyswithdirectingorperforatedshelvesfortransporting,loading,uploading,andsterilizationofampoulesincassettes,inanamountnotlessthan2pieces.Shut-off-and-regulatingfixturesofaverageandmembranousGEMUtype.Material:chromium-nickelsteel.AlldetailswhichconnectswithproductmustbemadeofmaterialsaccordingtostandardUSAAISI316L,therestofmaterialsaccordingtostandardUSAAISI304.Isolationmustprovidethetemperatureofexternaljacketsurfacenotmorethen45C.SealmaterialPTFEorEPDMSurfaces:-polishedinsideRa0,8-fieldweldsofmachineunitsinworkingareasmustbeetchedandpolishedtotheconditionofmainmetal.Materialofjacket-polishedstainlesssteel.SteamautoclaveforclothesandoptionsIntendeduse:Theautoclaveshallprovidesterilizationanddryingof:thepackswithrubberstoppersforinfusionsolutionvials;thepackswithaluminumcapsforinfusionsolutionvials;clean-roomclothingassemblies;adjustabledosingunitsofinfusionandinjectionsolutionsfillingmachines;siliconehoses;Pallsterilefilters;-cassettesforampoulesdimensioned3CXB00X00mm.Theautoclaveshallprovidedryingofrubberstoppersandclothing.Residualhumidityofrubberstoppers<0.2%,Effectivevolume:-Effectivevolumeofchamber-approximately1.5m-theautoclaveshouldmeetthefollowingstandardsrequirements:ISO11134:1994,EN285,HTM2010andNationalStandardsofUkraineISO“Sterilizationofmedicaldevices.Therequirementsforverificationofconformityandinspectioncontrol.Industrialsterilizationwithmoistheat.”-maximumautoclavewidth-2000mm.(1800mmpreferable)-maximumautoclavelength—2500mm.Thesuppliershouldindicatetheadvantagesoftheautoclavetypewhichisbeingofferedinthesenseof:price/qualityrelationship,equipmentcost/operatingcost,sterilizationprocesstime,efficiencyofthechambervolumeusagecomparingtoothersterilizationtypes.Designversion-cleansteamsterilization.Thefollowingshouldbeprovidedfor:+two-door(through-type)sterilizer,horizontal+controlsystemandtemperatureandpressurecontrolduringtheprocess(inthechamberandjacket)+safetysystemmeasuringinstrumentsinthechamberandjacket+flexibletransmitterfortemperaturecontrolintheproduct+Pallfilterforairsupplytothechamber+emergencystopoftheprocess+thesterilizationisadjustedonthebasisofpressureandtemperaturecorrectedtoFo+fittingwithdoorswithslidingguides+sterilizerheightadjustmentoption+surfaceheat-insulatingcovermadeofsteelAISI304withhigh-qualityinsulation.+easy-removablecoat律possibilityofinstallationofdoorstoaccesstheprocessingarea+deviceforestimationoftheairanduncondensedgasesamountduringsterilizationcycletoregisterpossiblechamberleakagesnotdiscoveredwhilevacuumtesting+requiredquantityoftemperaturetransmitters+ergonomically-designedcontrolpanelwithtouchscreendisplay+processparametersmeasuringoption(temperature,time,pressureandvacuumdepth)+memoryretentionofvariousprograms+registrationofprocessrunningaccordingtotheseparameters:temperature,time,pressure,memoryretentionofcompletedprograms.+thermalprinterforprintingofcheckcardwithcompletedprogramparameters.Onthecheckcardsuchinformationshouldbeprinted:sterilizeridentificationcode,dateandtimeoftheprocessing,temperature,pressuretimechanges,cycleofprocess.+possibilityofpreviouslyrunsterilizationprocessesprintout.+applicationofvacuumtestandBowie-Dicktestprograms+manualpressurereliefincaseofemergency+doorinterlockingwhenthechamberisunderpressureorincaseofforeignobjectsinthedoorarea.Materials:Chrome-nickelsteel,allproduct-contactpartsshouldbemanufacturedofmaterials1.4435/1.4404(accordingtoUSAAISI316LorAISI316Tistandards),otherparts—ofmaterial1.4301(accordingtoUSAAISI304standard).Theinsulationshouldprovideexternalsurfacetemperatureofinsulatingshellofnotmorethan45 °C.Surfaces:-polishedinside Ra<0.9-abradedoutside Ra<1.2-weldedjointsofsterilizationchambershallbepolishedtothebasemetalstate.Shellmetal-polishedstainiesssteel.Thefollowingequippingshallbeprovidedfor:Safetyvalvesinthechamberandjacket.Autoclaveiscontrolledwiththecontrolunitwithprogrammablememoryforregisteringofminimum5sterilizationcycles;themenuofcontrolunitdisplayshallbeRussified;-Innertrolleywithshelvesforsterilizedmaterialandtwofloorvehiclesforfeedanddischarge;Water-ringvacuumpumptosupportabsolutepressureof <4KPa,proLemaMEX125;Pressuresafetysystem,mechanicandelectronicdoorinterlockingsystem;The2-doordesignshallprovidefortheopeningofonlyonedoor,whereasanotherdoorshallbehermeticallysealed;SterilizationeffectF0shallcontinuefornotlessthan15min,incompliancewithEuropeanPharmacopoeiarequirements;Condensateshallbedischargedtotheexportheaderdirectly.Allpipe,valvesandfittingsconnectionsshallbeofTri-clamptype.TheconnectionofsterilizertoworkshopenergycarriersshallalsobeTri-clamp.Softwaretype-SIEMENS.ShutoffandcontrolvalvesshallbeofseatanddiaphragmGEMUtype.SteamandcondensatecomponentsproducedbySpiraxsarco.Doorsealdriveshallbeair-driven.Appendix1*.Operatingconditions:maximumworkingpressureinsidethechamber:1-3bar(differential)jacketmaximumworkingpressure:0-3bar(differential)-chamberratedpressure:-1-3,5bar(differential)jacketratedpressure:ratedtemperature:0-3,5bar(differential)140°CDocumentation:pressurevesselcertificatetranslatedintoUkrainianorRussianandexecutedonformprovidedinAppendix3(GuidelinesonVessels),withdrawings,connectiondiagramandstressanalysisofthevesselanditselements(thevesselshouldbemadewithcompliancetotheregulationsofStatemonitoringofworksafety)andweldcrackdetection;certificateforconnectingpipelines;documentsonperformedinspectionandtestingwhileproductionofthepressurevessel;thefinding(certificateofconformity)ofKievTechnicalCentreonconformityoftheautoclavetotheworkingsafetyrequirementsofUkraine;installationandmountinginstruction;operatinginstruction;equipmentcleaninginstruction;maintenanceinstruction(MaintenanceSchedule,servicingandfullrepairworks);problemchecklistandtroubleshootingmethods;certificatesforcomponentparts;certificatesforthevalvesandinstructiononthesafetyvalveadjustmentwithindicationofthevalveflowcoefficientforcompressibleandnon-compressiblemediaaswellasinstallationarea;certificateforspringsusedinthesafetyvalves;-specificationsforallequipmentelements;-certificatesformaterialstheautoclave,valvesandcontrolsaremadeof.-up-to-datesheetsongauging,validationandcalibrationofmeasuringequipment,seeAppendix1*;-twotemperaturetransmitters(registeringoneandcontrollingone);-twopressuretransmitters(registeringoneandcontrollingone);-twopressuregaugesinthechamber(onepereachoutlet),jacket-covered;-documentationintheRussianorUkrainianlanguage.Operatingcosts:Please,providethespareandwearingpartslistaswellasthematerialssubjecttoplannedchangeduringequipmentoperation,theirprice,changeintervalsandmanninglevelnecessaryformaintenancescheduleworksperformance.Theinformationshouldbetime-ranged:fromthedayofcommissioninguntilthefullrepairsterm.Existingutilities:-Compressedair6bar- SteamthecondensateofwhichcorrespondswithWFI 3±0.2bar.-Powersupply380V,50Hz.-Water2-3bar.Inputresources:Please,dientifythequalityandquantityofenergymaterialswhichshouldbesuppliedtoyourequipmenttoprovideitsappropriateandqualitativefunctioning(steam,condensatebleeding,watersupplytovacuumpump,powersupply).Appendix1*1.ThenameplateinRussianorUkrainianshouldbeplacedontheautoclave,stating:-thenameandaddressofthemanufacturer,serialnumberorotheridentificationoftheequipment,-ratedpressureinsidethechamberandmaximumworkingtemperature,-pressureinsidethechamberjacket,-surveillanceinspector'smarkandvesselidentificationlabel,-productiondateofthevessel.2. Therecordingdeviceandcontrolsystemshallbeindependentanddesignedinsuchawaytosoundthealarmincasethedifferencesbetweenthecontrolledandrecordedvariablesexceedtheallowablelimits.Measuringinstruments:Thetemperaturecontroldeviceshouldbe:-digitaloranalogue,-withaccuracyof1%in±herangeofscaleof50-15C°C,-adjustedwithaccuracyof(0,5)CCOfsterilizationtemperaturevalue,withatransmitterprotectedagainstdestruction.Thepressurecontroldeviceshouldbe:digitaloranalogue,withaccuracyof1.6%±intherangeofscaleof0-5bar,withatransmitterprotectedagainstdestruction.thetimershouldbewithaccuracyofnotlessthan±1%fortimeperiodsofmorethan5minutesandnotlessthan2,5%-±fortimeperiodsoflessthan5minutes.3. Calibrationofinstruments(2temperatureand2pressuretransmitters).Thecalibrationprogramshouldbedocumented.Thecalibrationprogramshallmakereferencetoregulatoryrequirements,writtencalibrationproceduresanddirectivesofinstrumentprecision.Instrumentcalibrationshouldbecarriedoutwithintherangeof2°Cofsterilizationvalue(121°Cand132c).4Thepossibilityofindependentselectionofvaluesofsterilizationanddrying(thetemperatureandtimeofsterilization),andthenameofproductbeingsterilized.Therewithpressureinsidethechamber(toobtainpresettemperature)shouldbesetautomatically(onthebasisofthefactorytestsandcalculations).Thereshouldbeautomaticchangingofthesteampressureinsidethejacket.Note:Foruniformdistributionoftemperaturesintheautoclavechamber(