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1、3.54IndustrialBiotechnologyandCommodityProducts:Single-UseTechnologiesforBiomanufacturingMWJornitz,SartoriusStedimNorthAmericaInc.,Edgewood,NY,USAJ-MCappia,SartoriusStedimFranceSAS,Aubagne,FranceGRao,UniversityofMarylandBaltimoreCounty,Baltimore,MD,USA©2011ElsevierB.V.Allrightsreserv
2、ed.3.54.1Introduction6413.54.2UpstreamActivities6423.54.2.1Mixing6423.54.2.2CellCulture6433.54.2.3CellHarvest6443.54.3DownstreamActivities6453.54.3.1Purification6453.54.3.2Filling6463.54.4GeneralComponents6473.54.4.1LiquidHoldBags6473.54.4.2Filtration6483.54.4.3FluidTransfer6493.54.4
3、.4SterileConnections6503.54.4.5Sensors6503.54.5FutureDesignsandFacilityLayouts650References652Glossaryperformancequalification(PQ)Verificationofproperdesignofexperiments(DoE)Powerfulexperimentalperformancespecifications.paradigmtoexaminemultipleinteractingvariables.processanalyticalt
4、echnology(PAT)AsystemforfluidmanagementsystemSingle-usecomponentsaredesigning,analyzing,andcontrollingmanufacturingassembledtogetherintoafluidmanagementsystemorthroughtimelymeasurements(i.e.,duringprocessing)ofsolutiontomeettherequirementsoffluidprocessing,criticalqualityandperforman
5、ceattributesofrawandstorage,transportation,aseptictransfer,andfinalfilling.in-processmaterialsandprocesseswiththegoalofgammasterilizationSingle-usesolutionsmadeofensuringfinalproductquality.low-densitypolymersarecommonlysterilizedbyusingaqualitybydesign(QbD)Anapproachto‘build-in’gamm
6、airradiationprocess.Thegammairradiationdoseisqualityupfrontintoaprocesssuchthatproductqualityistypicallybetween25and45kGyandachievesasterilityconsistentandpredictable.−6assurancelevelof10.stirredusebioreactor(SUB)Asingle-usebioreactorinstallationqualification(IQ)Verificationoftechnol
7、ogythatmimicsthetraditionalreusableappropriateinstallation.bioreactorsbyinvolvingamagneticmixingdevicemadelevitationmixerAsingle-usemixingtechnologythatofashaftandmultipleimpellers.Stirredtankreactorsinvolvesacryo-refrigeratedsuperconductormagneticfieldoffereffectiveoxygentransferand
8、cultivationo
