药学专业英语视听说教程 课件 下篇 lecture 3 Chemistry,Manufacturing and Control

Lecture3Chemistry,ManufacturingandControlreconciliationvariabilityfriabilitypassagefreeze-dryingassayfermentercentrifugationstartingmaterialgranulationlotefficacyspecificationconsistencystabilityshelflifecompositionlicensesThemanufacturingprocessiswellcontrolledThespecificationsandtestproceduresareadequatelydefinedmarketingthesamefundamentalmanufacturingprocessesandthetestproceduresthesamequalityproductismanufacturedequivalencebeforeandaftertheCMCchangeThequalityofrawmaterialsincludingthestartingmaterialsisnotalwaysthesameThemanufacturingconditionsarenotalwaysstableTheCMCreviewersshareinformationabouttheirreviewprocessmethodsformanufacturingprocesschangeswiththeGMPinspectorsTheGMPinspectorsinformtheCMCreviewersoftheresultsoftheGMPinspectionsTheCMCreviewersmayalsojoininwithGMPinspectionsFFFTFT1.Whatfactorsshouldbeconsideredformanufacturingtablets?Severalfactorsshouldbeconsideredformanufacturingtablets,includingthemanufacturingprocess,thephysiochemicalpropertiesofAPI,thetypesandconcentrationofexcipientsintheformulation,thecompressionforceofthetabletpunch,thetablet’sfriabilityandhardness,andthecosts,etc.2.Whatarethemostcommontabletmanufacturingprocesses?Thethreemostcommontabletsmanufacturingprocessesaredirectcompression,wetgranulation,androllercompaction,alsocalleddrygranulation.3.Howtodeterminetheflowpropertiesofpowders?Theflowpropertiesofpowdersaremeasuredbytheangleofrepose.Asmallangleindicatesgoodflowability.4.Whyisgranulationnecessaryfortabletmanufacturing?Granulationistheprocessofforminggrainsorgranulesfromapowderyorsolidsubstance,producingagranularmaterial.Granulationproducesfree-flowing,dust-freegranulesthatareeasytocompress.5.Whatarethebasicstepsofwetgranulation?Additionofgranulatingfluid→Granulation→Milling→Drying→Sieving→Blendingwithfunctionalexcipients→Readyforcompression

6.Whatarethebasicstepsofdrygranulation?Premixingexcipients→Rollercompaction→Grinding→Sieving→BlendingwithAPI→Compression1.Whatarethekeymanufacturingstepsinvolvedinmanufacturingvaccineonalargescale?----AntigenproductionThefirststeptypicallyinvolvesgrowingvirusesorbacteriaincomplexmediacontainingnutrientslikecarbohydrates,proteins,andvitamins.Bacterialantigensareproducedinlargefermenters,withmultiplegrowthpassagesunderstrictlyasepticconditionstoavoidcontamination.Afterfermentation,thesuspensionundergoesdownstreamprocessing,whichmayincludeconcentration,centrifugation,filtration,orinactivationsteps.Theantigenharvestmaterialisthenstoreduntiltestedandreleasedforfurtherprocessinginthefinalvaccinebatch.Viralantigenproductioninvolvesgrowingvirusesinhostcellssuchasmammalianorinsectcells.Oncethecellsareinfectedwithvirusseeds,thevirusesreplicatewithinthecellsandareharvested.Thebioreactorsareautomatedandmanagedbyspeciallytrainedtechnicians,withdownstreamactivitiessimilartobacterialprocesses.----FinalvaccineproductionTherearetwomajorkindsofvaccines:modifiedlivevaccineswithliveorganismsandinactivatedvaccineswithchemicallyinactivatedorganisms.Duringformulation,antigensarecombinedwithnecessarycomponentsandtransferredtothefillingroominsterilizedlines.Livevaccinesrequirepreservationofactiveorganisms.Sterilizedvialsarefilledwithvaccineunderstrictlycontrolled,asepticconditionsandthenfreeze-driedforlong-termstorage.Inactivatedvaccineshaveasimilarfillingprocessbutaretypicallyfilledinplasticbottlespre-sterilizedbyirradiation.Somevaccinesarealsofilleddirectlyintopre-sterilizedsyringes.----FinalvaccineproductionTherearetwomajorkindsofvaccines:modifiedlivevaccineswithliveorganismsandinactivatedvaccineswithchemicallyinactivatedorganisms.Duringformulation,antigensarecombinedwithnecessarycomponentsandtransferredtothefillingroominsterilizedlines.Livevaccinesrequirepreservationofactiveorganisms.Sterilizedvialsarefilledwithvaccineunderstrictlycontrolled,asepticconditionsandthenfreeze-driedforlong-termstorage.Inactivatedvaccineshaveasimilarfillingprocessbutaretypicallyfilledinplasticbottlespre-sterilizedbyirradiation.Somevaccinesarealsofilleddirectlyintopre-sterilizedsyringes.----PackagingandLabeling:Eachoftheeighteenpackagingcentersisdesignedforspecificoperationsthatincludelabeling,cartoning,bagging,trayloading,flowwrapping,auto-cartoningandmanualpackagingprocessing.2.Whatistraceabilityandwhyisitsoimportant?Howistraceabilityimplementedinmanufacturing?Traceabilityreferstotheabilitytotrackaproductorcomponentthroughallstagesofproduction,distribution,anduse.Itiscrucialbecauseitallowsfortheidentificationandrecallofproductsintheeventofasafetyissueorqualitydefect,ensuringconsumersafetyandregulatorycompliance.Inmanufacturing,traceabilityisensuredbytrackingbatchandlotnumbersthroughlabels,inspections,andadvancedsystems.Uponpackaging,recordsandcomponentsarereconciled,revieweddepartmentally,andfinallyapprovedbyqualityassurancebeforedistribution.3.Whatdoyouknowaboutvaccinesandtheirimpactonhumanhealth?Vaccinesarebiologicalpreparationsdesignedtostimulatetheimmunesystemandprovideprotectionagainstspecificinfectiousdiseases.Theyhaveaprofoundimpactonhumanhealthbyreducingtheincidenceandseverityofdiseases,leadingtodecreasedmortalityandmorbidity.Byensuringwidespreadvaccination,communitiescanachieveherdimmunity,protectingvulnerablepopulationsandpreventingoutbreaks.Vaccinesarecrucialforpublichealthandglobaldiseaseprevention.Forexample,COVID-19vaccinespreventsevereillnessanddeathfromCOVID-19,reducehospitalizations,andhelpcontrolthepandemicbylimitingvirustransmission.Bystimulatingtheimmunesystem,thesevaccinesprovideprotectionagainstSARS-CoV-2,thevirusthatcausesCOVID-19,therebysafeguardingpublichealthandenablingsocialandeconomicrecovery.FTFTTTF1.Whatisacleanroom?Whyarecleanroomsimportantinpharmaceuticalindustry?Acleanroomisanenvironmentwithcontrolledlevelsofcontamination,typicallyachievedbylimitingthenumberandsizeofparticlesintheair.Cleanroomsarecrucialinthepharmaceuticalindustrybecausetheyplayavitalroleintheresearchandmanufacturingofmedicines,vaccines,andothersterilemedicalproducts.Bymaintainingstrictcleanroomrequirements,theUnitedStatesFoodandDrugAdministrationensuresthattheproductsproducedaresafeforhumanuseanddonotposeanydangerousrisks.Cleanroomshelppreventcontaminationandensurethequalityandefficacyofpharmaceuticalproducts,therebysafeguardingpublichealth.2.Whatarethemajorconsiderationsforbuildingacleanroom?----LayoutorderCleanroomsmustbelaidoutintheorderofpeople'sentryfromtheoutside,withthecleanlinesslevelgraduallyincreasing.----AirlocksandtransitionroomsBufferzonescreatedusingairlocksandtransitionroomstomaintaindifferentcleanlinesslevels.----Separateentranceandexitroutes:Topreventcross-contamination.----FlooringselectionResistanttochemicalsandsolvents.Freeofcrackstopreventbacterialaccumulation.Righttexturetoreduceslippingandfallingrisks.----FlowofpeopleandmaterialsImportanttoconsiderwhenplanningthelayout.----CompliancewithregulationsDeterminingapplicablegovernmentregulationsandrequiredclassesfortheprocess.----CostsPotentialcostsofthecleanroomshouldbemodeledandconsidered.3.Whatarethedosanddon’tsinacleanroomenvironment?Pleasecreatealist.DosinaCleanroomEnvironment----Wearappropriateprotectiveclothing:Thisincludesgowns,gloves,headcoverings,andfootweardesignedtopreventcontamination.----Avoidwearingjewelryorcosmetics----UsedesignatedentranceandexitRoutes:Thishelpspreventcross-contaminatio