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首页 2011东富龙杯全国大学生制药工程设计竞赛任务书(2011 tofflon Cup Nation…

2011东富龙杯全国大学生制药工程设计竞赛任务书(2011 tofflon Cup National College of pharmaceutical engineering design contest task).doc

2011东富龙杯全国大学生制药工程设计竞赛任务书(2011 t…

袁寒月
2018-12-18 0人阅读 举报 0 0 0 暂无简介

简介:本文档为《2011东富龙杯全国大学生制药工程设计竞赛任务书(2011 tofflon Cup National College of pharmaceutical engineering design contest task)doc》,可适用于社会民生领域

东富龙杯全国大学生制药工程设计竞赛任务书(tofflonCupNationalCollegeofpharmaceuticalengineeringdesigncontesttask)东富龙杯全国大学生制药工程设计竞赛任务书(tofflonCupNationalCollegeofpharmaceuticalengineeringdesigncontesttask)tofflonCupNationalCollegeofPharmaceuticalEngineeringDesignCompetitiontaskbookFirst,designcontesttopic:EngineeringdesignofasepticfreezedryingpreparationworkshopofomeprazolesodiumforintravenousdripTwoDesignscale:Annualproductioncapacity:millionbranchesyearPackagingspecifications:mgmlvialsOutsourcing:bottlessmallboxes,boxesbigboxes,boxesboxesThree,workingclasssystem:daysyear,includingclassesoffreezedryingproceduresandotherpositionsFreezedrytime:batchesdayFour,applicablestandards:ChinaeditionGMPFiveBriefdescriptionofproductanditsprocess:ProductBriefOmeprazole,aprotonpumpinhibitor,canactspecificallyIngastricmucosacells,inhibitgastricacidsecretion,themainclinicaluseInthetreatmentofgastric,duodenalulcer,refluxesophagitisandsoonOmeprazolehasentericcoatedtablets,entericcoatedcapsulesandintravenousdropsInjectionsandotherformulationsofproducts,injectionforacutegastricmucosallesions,pepticulcercausedbyacuteupperdigestionBleedingandunfitfororaluseincriticallyillpatientsThesolubilityofomeprazoleinwaterwasmgmL,andthesolubilityofsodiumsaltincreasedsignificantlyomeprazoleThestabilityofsodiumsaltisaffectedbyvariousfactors,suchaspHvalue,light,metalionandtemperatureEspeciallyinUnderacidicconditions,thechemicalstructurechanges,polymerizationanddiscolorationoccur,sotheproductispreparedbylyophilizationPowderinjectionforclinicaluseTwoformulationsofomeprazolefreezedriedpreparationweredividedintointravenousinfusion(IV)andintravenousinjectionEachinfusioncontainsomeprazolesodiummg(equivalenttoomeprazolemg),twohydrateEthylenediamineomeprazoleFouraceticacidtwosodiummgandadjustthepHvalueofbetweentheappropriateamountofsodiumhydroxidewithmlspecialTheamountofsodiumhydroxidebetweenwasadjustedbyusingthesolventasisotonicphysiologicalsaline,andthepHvaluewasequalIntravenousinjectionofomeprazolesodiummgperbottle,duetothesmallamountofdiluent,injectiontimeisshortItisnotnecessarytoaddEDTAtopreventoxidationdeteriorationmlspecialsolventisaddedandisotonicsalineisusedtopreventoxidationCitricacidcontainingpolyethyleneglycolandpHregulatorOmeprazoleinjectioninstructions:Thisproductdissolvedinsolvent,timelyinjectionofsodiumchlorideinjectionDilutedinliquidmlorGlucoseInjection,intravenousinfusiontimeshouldnotbelessthanmin,dilutionisrequiredFinishedwithinhChinesePharmacopoeiastipulatesthatGlucoseInjectionpHvalueis~,manufacturersoneAcontrolinabout,SodiumChlorideInjection'spHvalueis~,generalcontrolin,soeitherAzolewasmorestableinSodiumChlorideInjectionwithhigherpHvaluethanthatinacidicglucoseinfusionTherefore,Thefollowingrequirementsshouldbefollowedwhenconfiguringtheinfusion:ChooseSodiumChlorideInjectionwithhigherpHvalueanddissolveitGoodomeprazoleinjectionisthebestwaytoconfiguretransfusionThevolumeofsodiumchlorideinfusionshouldbeml,Ifthemlormlinfusionisused,thesolutioninstabilityisincreasedduetothedecreaseofthepHvalueaftertheconfigurationLongerdriptimeismorelikelytodiscolor()omeprazoleinjectionshouldbeusedalone,andgoodtransfusionshouldnotbeaddedAddotherdrugsDisposablesyringesandinfusionsetsusedforomeprazoleshouldbeusedalone,notsuitableforuseTouchotherliquidsTheinfusionshouldbeusedimmediatelyTheconfiguredinfusionshouldbeusedupinhOnthewholeAttentionshouldbepaidtoavoidinglightduringintravenousdripBriefintroductionofprocessdispensingsolutionLiquidcontainershouldconsidermaterialselection,easytoclean,withtheuseofCIPSIP,ensurenocrossPollutionriskItisnecessarytoensurethattheconcentrationofthepreparedsolutionisuniformandthefinalvolumeisadjusted,andthesolutionmustberemovedBacteriaarefiltered(m)andthenenteredintoatemporarycontainerThesystemshouldbeabletofilterintegrityOnlinetestThepressureandtemperatureshouldbecontrolledandrecordedautomaticallyContainerscanbecleanedanddisinfected(CIPSIP)OremptyingCleaningandsterilizationofvialsThevialsmustbecleanedwithpurifiedwater,andthenrinsedwithinjectionwater,andthenfilteredwithbacteriaThecompressedairisdried,sterilizedandpyrogenremovedThecleaningofproductionmaterialsshouldbecarriedoutincorrespondingareas,andthefinishingandcleaningofclothingshouldmeettherequirementsofGMPRequirement。vialsfillingandfreezedryingmachineloadingHowtotransportproductsandmaterialsinthefillingmachineisveryimportant,forexample,thebarriersystem(RABS)canbeused(SHAO)andotheroperationsTheconfigurationofequipmentselectionmustbedescribedindetailAccuratedesignandlocationmustbedonewithEquipmentsupplyagreementIntheprocessoffilling,transportingandloadingpenicillinbottles,theuseofpenicillinbottletransmissionsystemshouldbeconsideredinthedesignofTheheightandinstabilityofMLvialsareaknownchallengeTransmissiondistancefromfillingmachinetoloadingtableShortenasmuchaspossiblefreezedryandunloadAfterthefreezedryingprocess,thevialswereautomaticallypressurizedundermildorhighvacuum,andthenthechamberwasreleasedThewayofunloading,loadingandunloadingofforestbottlesischosenbycontestants(automatic,semiautomatic,etc)rollingcover,inkjetprinting,lampinspectionDuringthecappingoperation,thevialswereprotectedbyalevelairsupplyuntilthecoverwasfinishedAfterrolling,WestTheforestbottleiscodedandautomaticallychecked,andthentransferredtoanotherworkshopforlabelingandpackagingSixSubmitthedesigndocumentofcompetition:DesignManual(includingprocessoverview,cleaninglevel,materialbalance,processequipmentselectiontheory)Ming,themainequipmentlist,workshopprocesslayoutdescription,flowlogisticsprocessProcess,workshoptechnicalrequirements,plantoperationmode,buildingandlayout,interiordecorationmaterials,Keysystems,buildingmaterials,scalability,etc)Cleanfloorlayout(:)TheplanepressuredifferencedistributiondiagramofcleanareaProcessflowchartwithcontrolpoints(includingrelatedcommonmedia,suchascompressedairandnitrogen),Steam,pharmaceuticalwater,etcProcessequipmentlayout(:)FlowchartofpeopleflowTheschematicdiagramoftheprocesscontrolsystem(includingCIPandSIP)forequipmentandpiping(:)Flowchartofwatersystem(purifiedwater,puresteam,injectionwater)LayoutofwatersystemSevenProposescalabledesigncontent:liquidtankdesign,includingsizeandinhibitionofoxidationandothersideeffectsfromenergysavingandalwaysmaintainturbulentstateTheselectionofmaterialandsizeoftheconveyingpipelineforliquidmedicine,purifiedwaterandwaterforinjectionaredescribedinthelightofthedualrequirementsSelectionoftransferpumpmodelmotionsimulationofnondryingbottleloadingandunloadinginfreezedryer,inordertodesignRABSDdesignandroamingdisplayofworkshopandprocesssystemagoodinterfaceisachievedbetweenthedesignproposalandthevalidationwork,suchasprovidingvalidationdocumentsandworkingroomdesignconsiderationsVerifythespacerequiredforthedevelopmentoftheworkDesignschemeofairconditioningpurificationsystemanditsenergyoptimizationandautomaticcontrolSimulationandoptimizationofairflowpatternincleanspaceEight,relatedinstructionstheperformanceindexoftheproductionequipmentisprovidedbytheorganizingcommittee,andtheteamscanalsochoosetheequipmentthemselvesObtaindatafromequipmentmanufacturerthetopographicaldataandmeteorologicaldataoftheprojectsiteareprovidedbytheorganizingcommitteealltheillustrationsandpipemarksareusedinthenationalstandard,andmarkedinthedrawingsThedrawingssubmittedareallinNoAbovedrawingsifnecessary,theorganizingcommitteewillprovideguidancedocumentstotheparticipatingteamsbyemailAnnex:introductiontoRABSlaminarflow(LAF)unitofisolatorTheisolatorisafullyenclosedsystemandVHPisdisinfectedbetweeneachbatchCleanaroundCanDcleanroomTheHVACsystemiscompletelyindependent,andalloperationsareaccomplishedbyglovesoperationPeoplechangeclothesaccordingtoDlevelWhetherornotbefore,after,orafter,allmaterialspassthroughfastTransferport(RTP)orthematerialintotheairlockisolatorTheconventionalcycletimeofVHPdisinfectionforfillinglineisolatorishoursThemainreasonforchoosingisolatororsealedRABSistoprotectoperatorsfromproductharm,suchasfineCytotoxinorlivevirusRestrictiveentrybarriersystem(RABS)isarelativelynewtechnology,anditsdefinitionisalsoduetoitsoriginNotthesameHerearethetechnicaldescriptionsofdifferentRABSconceptsOpenpassiveRABSPassiveRABSmeansthattheRABSsystemisdesignedwiththeHVACsystem,withtheconceptofanexistingworkshoporanewworkshopConsistentadoptionThispartofthedesignmustbeworkedoutThedisadvantageofpassiveRABSisitsworkSupplierswhoareresponsibleforyou,notfillinglinesOpenactiveRABSIfactiveRABSisselected,thesystemispurchasedfromeachsupplier,andthefunction(ClassA)isresponsibleforhimYouguysThegoodthingisthatyouhaveclearresponsibilitiesThedownsideisthatyouhavealternativesuppliersanddesignsmoreLimited,youhavetobuythesupplierprovided,forafullyfillingfacility,whichwillcausedifferentRABSDesignandsuppliersarequitecomplexIfyouchoosethisway,it'simportanttochooseandevaluatesuppliers,ToensurethesupplierhastheabilitytocompletethegooddesignComparedwiththedesignandprocurementofdifferentunits,equipmentsupplyBusinesschargeswillbehigherTypeRABSIntermsofworkingcharacteristics,hermeticRABSislikeanisolator,butusuallyallowsThistechnologyisonlyusedinprojectsthatneedtoprotecttheoperatorandtheenvironmentThechoiceofactiveorpassiveRABSismoreofprojectriskcostmanagement,andifHEInviewofthecurrentindustrytrends,thenumberoffillinglinesinRABSisincreasingworldwideRecognizedasanacceptedtechnologyFDAbelievesthattheisolatoristhepreferredtechnologyinasepticassurancelevel,ButthewelldesignedandrunningRABSsystemhasalsobeenacceptedBothisolatorsandRABStechnologyaremissingThesinkistheglove,thereforeFreeAppendixsoftwaredescriptionengineeringdesignsoftwareTheUnitedStatesAutodeskIncandChinaprocessindustrydistributorsofLeggMasonSoftwareCoLtdwithBeijingIntentionofallparticipatingstudentteamstoprovideprocessplantdesignforAutodeskPlantDesignSuiteFreeuseofthesuite,authorizationandnecessarytraining,includingthelatestAutoCADPlantD,AutoCAD,PID,Navisworks,RevitStructureandInventor,thissuitehasbothChineseversionandChineseindustrySpecificationlibraryInordertoensurethesmoothnessofthereviewprocess,itissuggestedthattheentriesshouldbepaintedinlowereditionssuchasAUTOCADTwodimensionaldesigndrawingairflowfieldsimulationandanalysissoftwareAsiaPacificTechnology(Beijing)Co,LtdagreedtoprovidemonthsforallstudentsparticipatingintheteamFluentsoftwareinstallationguidance,freeuseofauthorizationandnetworktrainingThesoftwarerequiresthestudentteamtosubmitthewrittenapplicationinaccordancewiththecompetitionorganizingcommitteeSpecificimplementationchemicalprocesscalculationsoftwareThecalculationofheatexchangerandotherunitequipment,canusetheexistingASPEN,CHEMCADandothersoftwaretheoperationoftheequipmentsimulation,youcanusetheexistingschoolSOLIDWORKorPROEDgraphic,threedimensionalperspectivecanuseSketchUpandothersoftware

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