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™Tyvek®10.5.15SuccessfulMulti-YearProjecttoTransitiontoNewManufacturingTechnologyforMedicalPackagingWILMINGTON,Del.,Oct.5,2015–Today,DuPontProtectionTechnologies(DuPont)receivednotificationfromtheCenterforDevicesandRadiologicalHealth(CDRH)attheU.S.FoodandDrugAdministration(FDA)affirmingthefunctionalequivalenceoftransitionTyvek®tocurrentTyvek®forsterilemedicalpackaging.ThisdecisionmarksasignificantmilestoneintheDuPont™Tyvek®MedicalPackagingTransitionProject(MPTP),amulti-yearundertakingtohelpthemedicalpackagingindustrytransitiontoTyvek®manufacturedusingupdatedflashspinningequipmentandtechnology,andsignalsthebeginningofcommercialsalesofthetransitionedadvancedmaterial.HealthCanadaalsohasissuedtheirguidanceonfilingamodifiedlicenseamendmentfortransitionTyvek®inCanada.Withaffirmationoffunctionalequivalence,theU.S.FDAstatesthatitisnotnecessaryforMedicalDeviceManufacturerstofileamended510(k)sorPMAswhensubstitutingtransitionTyvek®forcurrentTyvek®duringthemanufactureofapprovedmedicaldevicesinmostcases.CommercialsalesoftransitionTyvek®cannowbegininOctober2015,aspreviouslyannounced.Recognizingthatsomemedicaldevicemanufacturers,especiallythosewithClassIIIdevicessoldinEurope,areawaitingNotifiedBodyapprovals,DuPontisincreasingtheavailabilityofcurrentTyvek®andwillcontinuetoproducethismaterialonaschedulethatisalignedwiththeneedsofourstakeholders.“ReceivingFDAaffirmationoffunctionalequivalenceandHealthCanadaguidanceistheculminationofyearsofpreparation,collaborationandexecutionofameticulousprocess,”saidMichaelH.Scholla,Ph.D.,globaldirector,RegulatoryandStandards,DuPontProtectionTechnologies.“WewouldliketothanktheFDA,HealthCanadaandallthosewhohaveparticipatedinthisprocess;itisagreatdemonstrationofthepowerofaneffectivesupplier-industry-governmentcollaboration.”Announcedin2011,theMPTPisamulti-yearinvestmentbyDuPontofmorethan$30milliontotransitionTyvek®1073BandTyvek®1059Btothelatestflash-spuntechnologyandequipmenttohelpensurethecontinuityandflexibilityoffuturesupplyintomedicalandpharmaceuticalpackagingapplicationsworldwide.DuPontisworkingcloselywithSterilePackagingManufacturers,MedicalDeviceManufacturers,testinglaboratoriesandregulatorybodiesaroundtheworldthroughouteveryphaseofthisproject.“WehaveworkedsuccessfullywithDuPontformanyyears,”saidNickFotis,globalpackagingdirector,CardinalHealth.“Theirhandlingofthiscomplexregulatorychallenge–thewaytheyfacilitatedthechallengingtransitionfortheircustomers,coordinatingwithregulatoryagenciesaroundtheworld–istestamenttowhyDuPontisatrustedpartnerinthemedicalpackagingindustry.DuPonthasbeenaleaderinourindustryformanyyearsandtheircollaborationwithcustomersacrossthesupplychainandthroughoutthiscomplexglobalregulatoryprocess,frompackagedesignandtestingtodatasharingandcommunicationsiswhywechooseDuPont™Tyvek®.”AcopyoftheU.S.FDAletteraffirmingfunctionalequivalence,aswellasotherregulatoryinformation,IndustrySummaryReportsandthelatestMPTPtestingresultsareavailableat®hashelpedtoprotectthehealthofmillionsofpatientsworldwideandtoreducecostsinthehealthcaresettingbymaintainingsterilityofmedicaldevicesandsuppliestothepointofuse.Recognizedasastandardofexcellenceinhealthcarepackaging,thisadvancedmaterialisusedinvirtuallyeveryformofsterilemedicalpackaging,aswellasawidevarietyofpharmaceuticalpackagingapplications.Alongwithphysicalbarrierstoinfectionsuchassterilemedicalpackaging,DuPontalsoisfocusedonthebehavioralandbiologicalbarriers,andthecompanyisworkingcollaborativelytobringsolutionstotheglobalchallengeofinfectioncontrol.DuPont(NYSE:DD)hasbeenbringingworld-classscienceandengineeringtotheglobalmarketplaceintheformofinnovativeproducts,materials,andservicessince1802.Thecompanybelievesthatbycollaboratingwithcustomers,governments,NGOs,andthoughtleaderswecanhelpfindsolutionstosuchglobalchallengesasprovidingenoughhealthyfoodforpeopleeverywhere,decreasingdependenceonfossilfuels,andprotectinglifeandtheenvironment.ForadditionalinformationaboutDuPontanditscommitmenttoinclusiveinnovation,pleasevisit™andTyvek®aretrademarksorregisteredtrademarksofDuPontoritsaffiliates.