NE05. evolution of disposable filling technology

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1、Acerta®DisposableFillingSystemTheEvolutionofaNewDisposableFillingTechnologyforSterilePharmaceuticalsPresentedMay4,2004ByJimFurey,ProductManagerMilliporeCorporationInnovativeEnablingTechnologiesforDisposableManufacturingPresentationOutline¢Introduction¢BackgroundonTechnology¢PrototypeSystems¢Current

2、HardwareDesign¢Scale-upofTechnology¢DisposableComponent¢Validation/QualificationIntroductionrd¢Technologyisscheduledtobelaunchedinmiddleof3Quarterofthisyear(notyetcommerciallyavailable)¢Thistechnologywithdisposableandpre-sterileproductcontactspartswaspursuedaspartofourDisposableManufacturingInitiat

3、ive¢Initiativeincludesexpandingourproductlineofferingsbeyondourfiltrationproductlines(Opticap®andMillipak®)toincludeproductmorecompleteprocessunitoperations¢Designedtogivethemarketplaceoptionstohelpspeedthetimetoclinic&marketand/orreducethecapitalinvestmentrequiredforinitialproductdevelopmentalongw

4、ithenhancedprocesssecurity¢TheinitiativealsohasresultedinourrecentBioprocessingAlliancewithHyclonewhichgivesusaccesstotheirBioprocessContainerproductlinewiththeCX5-14FilmWhyAdoptDisposableManufacturingTechnologies?EnhancedProcessSecurityPDA-IdentifiedMajorSourcesofContamination*MinimizeProcessRisk1

5、.Personnelcontamination®Eliminatescleaningafter2.Non-routineactivityuse3.Asepticassembly®ReducedCIPorSIP4.Humanerror5.Mechanicalfailure®Minimizesvalidation6.Airbornecontaminantsefforts7.Impropersanitization8.Surfacecontaminants®Completecontainment9.Materialtransfersofproduct10.Failureof0.2µmfilter®

6、Increasecleanliness,11.FailureofHEPA12.Impropersterilizationreducingrisksforoperators*PDAIndustryAsepticProcessingSurvey2001BackgroundonTechnology¢ShortHistory¢Thepatentscoveringthetechnology“VolumetricFluidDispensingApparatus”byDenisKeyeset.al.werelicensedbyMillipore¢Beforelicensuretherewereafewit

7、erationsofthetechnologyproduced¢Wetookthelastiteration,madesomeimprovementsindesignandperformanceanddesignedasystemfordemonstrationandtestingwiththeassistanceofaconsultingengineerwithabackgroundinfillingmac