extractactables and leachables summit 2020 · 2020-03-09 · register now to guarantee your space!...
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PharmaEd Resources, Inc. • 2810 Robeson Park Drive • Champaign, IL 61822tel. 217.721.5774 • web. www.pharmaedresources.com
Extractables & Leachables Summit 2020Ensuring Quality, Safety, Suitability and Regulatory Compliance
for Drugs, Biologics and Medical DevicesJuly 30–31, 2020, Wyndham Philadelphia Historic District
Featuring Lessons Learned and Case Studies from Industry Experts:
With Representation From:
• CDRHScientificPerspectiveonChemicalAnalysisforMedicalDevices
• ISO10993-18:KeyConceptsandPracticesforEffectiveandCompliantChemicalCharacterizationSupportingtheBiologicalEvaluationofMedicalDevices
• UnderstandingtheMajorRevisionstoISO10993andtheNewEuropeanMedicalDeviceRegulations
• CaseStudy:MedicalDeviceToxicologicalRiskAssessmentFollowingNewPrinciplesofISO10993-17
• IdentificationandEvaluationofMaterialQualityAttributes(MQA)ofPolymerics
UsedinCellTherapyProductsManufacturing
• ChemicalInteractionsbetweenLeachablesandBiopharmaceuticals
• TheNeedtoIdentifyUnknownsfromaToxicologicalPerspective
• BPOGE&LforSingle-UseSystems– TheFinalChapter
• UtilizingBPOGdataforselectionandqualificationofSingleUseSystems
• Extractables/LeachablesStudies:AreYouCertainAboutthatUncertainty?
• ReducingResponseFactor(RF)VariationandtheneedforUncertainty
Factors(UFs)inExtractablesandLeachables Analysis
• ComparisonoftheSolubilizationPropertiesofPolysorbate80andIsopropanol/WaterSolventSystemsforOrganicCompoundsExtractedfromThreePharmaceuticalPackagingConfigurations
• ComprehensiveExtractablesStudyofAutoclavablePolyethersulfoneFilterCartridges
• Physics-basedModeltoPredictPatientExposuretoPolymerAdditivesinMedicalDeviceMaterials
• AndMuchMore!
MikeRubertoMaterial Needs
James HathcockPall Biotech
Cherry ShihPall Life Sciences
SteveZdravkovic
PPD
RobertoMenzel
Sartorius Stedim
Eric HillBoston
Analytical
StephenDohertyToxikon
Daniel Norwood
Feinberg Norwood & Assoc.
MarkJordiJordi Labs
PietChristiaensNelson Labs
With Comprehensive Coverage On:
MikeEakinsEakins & Assoc.
DavidSaylorFDA
DennisJenkeTriad Scientific
SherryParkerWuXi AppTec
LisaOlsonNAMSA
Carsten Worsøe
Novo Nordisk
PingWangJohnson &
Johnson
TedHeiseMED Institute
BerkOktemFDA
RonBrownFDA (retired)
CharlesFeliceJanssen R&D
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Extractables & Leachables Summit 2020
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Extractables & Leachables Summit 2020
Recent, largely anecdotal, evidence suggests that thisexpectationofreproducibilitycouldbemoreawishthanarealityandthatextractablesprofilescanvary,insomecasesquitesubstantially,fromlabtolabandpossibilityevenwithinalab.Ifthislackofconsistencyistrueandreal,itcouldhaveasignificantbearingon,forexample,theuseofchemicalcharacterizationinthebiocompati-bilityassessmentofmedicaldevices.
In this presentation we will examine the published andavailableliteratureanddatathatisrelevanttothistopictoestablishwhethertheperceptionisrealityand,ifso,tocon-sideractionsthateitheramplifyorreduce/controlvariation.Furthermore,theavailableliteratureanddatawillbeusedtoquantifyreasonableexpectationsforreproducibility.
10:40 ICHE&LGuidelinesUpdateCarsten Worsøe, Principal Scientist, Novo Nordisk
The InternationalCommittee forHarmonisation (ICH)har approved the procurement of an ICH E&L guide-line.Althoughit isveryearly in the ICHprocessthis
shortpresentationwillgivebackgroundandhistory forthetopicapprovalinICHaswellasthecurrentlyknownprocessfortheICHguideline.
Q&A: Ask the Experts
10:50 E&LRegulatoryPanelDiscussionModerator: Michael Eakins, Owner, Eakins & AssociatesPanel:
• DennisJenke,TriadScientificSolutions • RonaldBrown,Toxicologist,FDA(retired) • BerkOktem,Chemist,FDA
Discussants:TheAudience
11:20 ReducingResponseFactor(RF)Variation andtheneedforUncertaintyFactors(UFs) inExtractablesandLeachablesAnalysis
Dr. Mark Jordi, President, Jordi Labs
Chemical characterization per ISO 10993 has becomean importantcomponentofbiocompatibility testingofmedical devices. Similarly, pharmaceutical packag-ing is characterized for extractables and leachables
toverify thesafetyofdrugproductsperUSP<1663>and<1664>. A major concern regarding the accuracy of ex-tractables and leachables studies is quantitative errordue to response factor (RF) variation. This error occursbecause many extractables do not have commerciallyavailable standards and equal concentrations of differ-ent extractables give different signal responses usingmass spectrometry detectors. Recent publications havehighlightedtherisksposedbyRFvariationforbothLCMSandGCM. The importance of this issue has been recog-nizedbytheFDAresultingintheadditionofanuncertaintyfactor(UF)inthecalculationoftheanalyticalevaluation
Thursday,July30
7:30 Registration & Complimentary Breakfast & Chairperson Mike Eakins’ Welcome
Regulatory Spotlight – Chemical Analysis for Medical Devices
8:10 CDRHScientificPerspectiveonChemicalAnalysisforMedicalDevices
Berk Oktem, Chemist, FDA
AbstractComingSoon
Critical Issues – Identifying Unknowns in E/L Studies
8:55 TheNeedtoIdentifyUnknownsfromaToxicologicalPerspective
Ron Brown, Toxicologist FDA (retired)
When conducting a toxicological risk assessment ofextractableand leachable (E&L) compounds, it is typ-ically assumed by the toxicologist that the extractedcompoundshavebeenidentifiedwithahighdegreeof
certainty.However,becauseofanalyticalchemistrychal-lenges,identificationofthecompoundstothislevelofcer-tainty isnotalwayspossible,especially fornon-targetedextractables. This talk with explore the implications ofconductingatoxicologicalriskassessmentofcompoundsthathavebeenonlytentativelyidentifiedandwillevaluaterecentproposalstoevaluatethesafetyofunidentifiedandpartially identifiedE&Lcompounds.Amongthestrategiesto be addressed in this presentation are the appropriateuseofThresholdofToxicologicalConcern(TTC)valuestoserveasdefaultTIorPDEvaluesforcompoundsthathavenotbeenconfidentlyidentifiedandneedtoidentifywhenacompoundisexpectedtobefoundinanextractbasedonknowledgeof thecompositionof thepolymericmaterialsofconstructionofthedeviceorpharmaceuticalpackaging.
9:35 Coffee & Networking Break
10:00 Extractables/LeachablesStudies:AreYouCertainAboutthatUncertainty?
Dennis Jenke, President, Triad Scientific Solutions
Therearemanywell-establishedandwell-articulat-ed expectations for extractables profiles includingthat all extractables above the AET be discovered,
correctly identifiedandaccurately quantified.A funda-mentalexpectationthathasrarelybeenarticulateduntilrecentlyisthattheextractablesprofilebereproducible.Thatistosaythatifatestarticlewereprovidedtosev-eral expert testing laboratories, the extractables pro-files reportedby those laboratorieswouldbesimilar, ifnot equivalent, in their important details, including thenumber of extractables reported and the identities andconcentrationsofthereportedextractables.
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Extractables & Leachables Summit 2020
Case Studies – Utilizing BPOG data for selection and qualification of Single Use Systems
2:20 UtilizingBPOGDataforSelectionandQualificationofSingleUseSystems
Cherry Shih, Senior Scientist, Pall Life Sciences
The increasing availability of extractable datasetsaligned to standardized protocols (BPOG and USP<665>/<1665>) has led to a deeper understanding of
extractableprofilesindifferentsolvents.WewillsharecaseswherespecificsolventprofilesfromBPOGorUSP<665>canbeleveragedtobestsupportandsimplifytheriskassessmentprocess,forboth,thepurposeofinitialmaterials selection aswell as qualification of amulti-component single use system in a definedmanufactur-ingprocess.Inapplyingstandardizeddatasets,weshareexamplesofhowextractablesprofilesperformedatdif-ferentsurfaceareatovolumeratios(0.4to18sq.cm./mL)comparetotheoreticallyscaledvaluesbasedonsurfaceareaandvolumealone.Thegoalofthesecasestudiesistosimplifyandstrengthenapproachestoqualificationofsingleusematerials.
3:00 Coffee & Networking Break
3:25 ComprehensiveExtractablesStudyofAutoclavablePolyethersulfoneFilterCartridges
Roberto Menzel, Laboratory Supervisor, Extractables & Leachables, Sartorius Stedim
Sterile filters are ubiquitous in biopharmaceuticalmanufacturingprocesses. Theyare in direct contactwiththeprocessfluid,andtheprofilingoftheextract-
ablesisofhighimportance,especiallyinprocesssteps“close topatient”suchassingle-use final fill.The talkwill compare and discuss the extractables profiles ofsterilizing-grade0.2µmpolyethersulfonemembrane fil-ter cartridges from different vendors. Pure ethanol andpurifiedwaterwere used as extractionmedia. SeveralorthogonalanalyticaltechniquessuchasHSGC-MSandGC-MS and LC-HRMS in combination with ICP-MS forsingleanalytedetectionandthesumparameterstotalor-ganiccarbon,non-volatileresidue,conductivity,andpHwereusedtoobtainamostcomprehensiveextractablesprofile.Variousextractableswerefoundsuchasantiox-idantsanddegradationproducts thereof, hydrocarbons,and processing aids. The identified compounds can allassignedtothematerialsofconstruction,suchasplasticpartsormembranes.Focusisgivenalsoonthechalleng-esoneencountersinExtractablesscreeningstudiesforexampleintheanalysisofhydrophilizingagents.Abasictoxicologicalevaluation formaterialsafetyassessmentwillbepresentedshowingtheoveralllowriskoftheex-tractablestowardpatientsafety.
threshold(AET).Whilethisaidsinmitigatingtherisksofunderreportingofextractables,theresultingrevisedAETcreatessignificantanalyticalchallengesoftenexceedingthelimitofdetection(LOD)ofcurrentmassspectrometryinstrumentation and requiring sample concentration. Italso creates questions as to the validity of risk assess-mentsbasedonrelativequantitationvaluesandisoneofthekeyissuesattherootofpoorreproducibilityinrecenthighprofileinterlaboratorystudies.Itisthereforestrong-ly desirable to define improvedmethods for quantitationwithmoreuniversalRFswhichmitigatetheneedforUFs.Inthispresentation,alternativestrategiesforquantitationusing tripledetection liquidchromatographymassspec-troscopy (LCMS)withultraviolet (UV)andchargedaero-soldetection(CAD)aswellasGasChromatographyMassSpectroscopy(GCMS)withsimultaneousFlameIonizationDetection(FID)willbepresented.Datacomparingthere-sponsefactorsavarietyofextractablesbyUV,MS,FIDandCADwillbepresenteddemonstratinganapproachtore-duceoverallRFvariation,theassociatedneedforUFsandincreasingconfidenceintheresultingriskassessments.
12:00 Complimentary Networking Lunch
1:00 IdentificationandEvaluationofMaterialQualityAttributes(MQA)ofPolymericsUsedinCellTherapyProductsManufacturing
Ping Wang, Director, Johnson & Johnson, and Charles Felice, Principal Scientist, Janssen R&D
Cell therapy drug products such as CAR-T presentuniquechallengeswithrespect topolymericmaterialriskscomparedwithmorecommonbiologicprocesses.Themanufacturingprocessofcellproductshasfewerpurification steps, resulting in fewer opportunities toremovepolymeric-relatedimpuritiessuchasparticles,endotoxins,bioburden,andleachables&extractables.
These attributes are material quality attributes (MQAs)thatmustbeassessedand, if the risk ishigh,mitigated.Thispresentationwilldiscussthecorrelationofmanufac-turingprocessesandMQAs,andhowtheseprocesseswillimpacttherisklevelsoftheMQAstothefinaldrugproductqualityandpatientsafety.TheMQArisklevelsofthepoly-mericsateachstepwillbediscussed.
Research Spotlight – Single Use Systems & BPOG
1:40 BPOGE/LforSingleUseSystems–TheFinalChapterCarsten Worsøe, Principal Scientist E&L, Novo Nordisk, and James Hathcock, Senior Director, Regulatory and Validation Consulting, Pall Biotech
Inthispresentation,wewillcoverthefollowingtopics:
• Supplierandend-usercollaboration• Extractablesecosystem• Datareviewprocess• Extractablesprotocolupdate• Communityofpractice
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Extractables & Leachables Summit 2020
MSforvolatileanalytes,Directinjection(DI)GC/MSforsemi-volatileanalytescontainedinsolventextracts,Di-rectinjectionLC/MSfornon-volatileanalytescontainedin solvent extracts, and ICP/MS for elemental analytes.Theconsensusdoesnotincludeallofthedetailsoftheanalyticalmethods since the organizations that agreedon best practices did notwant to be proscriptive. Thispresentation will attempt to discuss the possibility ofestablishing standard methods for extractables/leach-ables. It will describe the requirements for standardmethodsalongwiththeimplicationsforthepharmaceu-ticalindustryoftheimplementationofstandardmethods.Theexperienceoftheenvironmentalindustrywithstan-dardmethodsinthe1970sand1980swillbeconsidered.
5:20 End of Day One
Friday,July31
8:00 Complimentary Breakfast
Critical Issues—Exploring the Major Revisions to ISO 10993-1, -17, & -18: Methodological & Toxicological Considerations
8:30 ToxikonPresentationStephen Doherty, Associate Director, Analytical Chemistry, Toxikon
Abstractcomingsoon
9:00 ISO10993-18:KeyConceptsandPracticesforEffectiveandCompliantChemicalCharacterizationSupportingtheBiologicalEvaluationofMedicalDevices
Ted Heise, Vice President, Regulatory & Clinical Services, MED Institute
TheISO10993seriesofstandardsonbiologicaleval-uationofmedicaldeviceshasbeenevolvingovertheyears,workingtokeepupwithprogressinknowledge
of the subjectmatter. In keepingwith this progress, anupdateofISO10993-1(thetop-levelstandard)publishedin2018.Akeychangeinthisreviseddocumentwastheaddition of a more explicit requirement for chemicalcharacterization of all device types—regardless of thenatureanddurationofpatientcontact.
To meet the heightened focus on chemical characteri-zation—and to update the existing standard—a majorrevision of ISO 10993-18 “Chemical characterizationof medical devicematerialswithin a riskmanagementprocess”wasundertaken.Thereviseddocumentshouldpublishinearly2020.Thisconferencesessionwillfocusonkeypartsofthenewdocument,bringinginexperienceandlessonslearnedfrommulti-stakeholderdevelopmentofthefinalstandard.
4:05 AssessingtheReactivityofLeachableswithBiopharmaceuticals,UsingINSULINasaMarkerCompoundCombinedIn-SilicoModelwithExperimental(Analytical)VerificationofProofofConcept,usingINSULINasaMarkerCompound
Piet Christiaens, Scientific Director, Nelson Labs Europe
In the EPREX case, leachable induced immuno-re-sponsescausedsevereadversereactionstoCKDpa-tients. Although the EPREX case is often referred to
by theE/Lcommunity tostress the importanceofan in-depth E/L evaluation of the C/C-system, it also showedthat the traditional E/L approach for container/closuresystems may not always be adequate in predictingleachables could chemically modify proteins, poten-tially causing immunogenicity through the formation of“anti-drug-antibodies.”
TheFDAGuidanceforIndustry:“ImmunogenicityAssess-mentforTherapeuticProteins”(2014)describesanaphy-laxis, cytokine release syndrome, infusion reactions,non-acutereactionsandcross-reactivitytoendogenousproteinsastheassociatedsafetyconcernswhenconsid-eringimmunogenicityasaresultofchemicalinteractionbetweenleachablesandproteins.
Thepresentationwilladdresstwowaysofpredictingifanyofthechemicalcompounds,foundintheextractionprofileofcontainer/closurecomponent,could lead toachemical interactionifanyof thoseextractableswouldbecomea leachable: (1)howtoperformanin-silicore-activityapproachofaverybroadsetofcommonlyknownextractablecompoundsand(2)achemicalreactivitytesttoactuallyscreenforresidualchemicalreactivity.
Inaddition,achemicalreactionmodel,basedonInsulinasamarkercompoundwasdevelopedtoactuallyverifythein-silicopredictedchemicalreactivityandcomparetheoutcomeof thein-silicoexercisewiththeobservedreactivitybetweenapredefinedsetofextractablesandinsulin.
4:45 StandardMethodsforExtractables/LeachablesProfiling:WhataretheImplications?
Daniel Norwood, Principal Consultant, Feinberg Norwood & Associates
Modern analytical chemistry, in the form of GC/MSand LC/MS,hasbeenat center stage inextractable/leachable assessment since the late 1980s. Various
organizations (PQRI, USP, etc.) have attempted to es-tablish the basic scientific principles for accomplish-ing extractables/leachables assessments along withthe use of these highly sensitive and selective analyti-cal techniques.Overthepast tenyearsorso,ageneralconsensus has been established regarding the suite ofanalytical techniquesapplied toanyassessmentbasedon thevolatilityandchemicalnatureof theanticipatedanalytes.Thisconsensusincludes:Head-space(HS)GC/
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Extractables & Leachables Summit 2020
Q&A: Ask the Experts
10:35 ISO10993PanelDiscussionModerator: Michael Eakins, Eakins & Associates
Panel:
• StephenDoherty,Toxikon• TedHeise,MEDInstitute• SherryParker,WuXiAppTec
Discussants:TheAudience
11:15 CommercialImplicationsofaProperlyPlannedBiologicalEvaluationStrategy,Including theUseofChemicalCharacterization
Lisa Olson, Vice President — North American Laboratory and Global Analytical Services, NAMSA
Since2009, theemphasisonariskmanagementpro-cess and characterization of materials continues to
shiftthebiologicalsafetyparadigm.Putsimply,thedaysof medical product manufacturers simply contractingwithatestinglaboratorytoperformahandfulofbiologi-calsafetytestsisnolongeranacceptedpracticebyanyglobal regulatory body. Medical device regulators arerequiringcarefullyplannedevaluationstrategiesbasedonriskandempiricaldata.
Join this session to learn howawell-planned strategyutilizing chemical characterization can have favorableandevencostsavingimplicationsforthecommercializa-tionofyourproduct.Thissessionwillbeastarttofinish,stepbystep instructiononwhentostartyourplanning,whatstepsto followtoexecutechemicalcharacteriza-tion testing and/or biological testing, and how to keepyourtimelinesasshortorshorterthanwhenperformingconventionalbiologicaltesting.
12:00 Complimentary Networking Lunch
1:00 Physics-basedModelstoPredictPatientExposuretoMedicalDeviceLeachables
David Saylor, Materials Scientist, FDA
Thematerialsthatcomprisemedicaldevicescontainsubstancesthatcanbetransferredtopatients.Patientexposure to thesesubstancesmaybedesirable,e.g.drug delivery, but more generally, there is concern
foradverseeffectsifachemicalisreleasedinsufficientquantities.Historically,thelikelihoodforadverseeffectshasbeenevaluatedusinganimal testing. Toxicologicalriskassessment(TRA)isanalternativeapproachthatcanobviatetheneedforextensiveanimaltesting.TRArelies
Topicstobecoveredwillinclude:
• Navigatingtheflowchart,includingfactorsthatcanhelpdeterminewhethercompositionalinformationmaybeadequateforchemicalcharacterization,oranalyticaltestingofextractsislikelytobenecessary;
• Considerationsfordeterminingextractionconditions;namely,solventselection,temperature,duration,andnatureofextraction(e.g.,simulateduse,exaggerated,orexhaustive);
• DistinctionsbetweenextractablesandleachablesintheapplicationofestablishedE&Lprinciplestomedicaldevices;
• Approachestoperforminganexhaustiveextraction,aswellasdiscussionofhowmultiplestepscanfacilitateuseofpracticalsafetythresholds;
• Qualificationofanalyticalmethods,includingdiscussionofparametersthatmaybecandidatesforuse;and,
• Additionalinsightsdrawnfromregulatorinputduringnumerousdiscussionsofvariouselementsofthestandard.
9:35 CaseStudy:MedicalDeviceToxicologicalRiskAssessmentFollowingNewPrinciplesofISO10993-17
Sherry Parker, Senior Director of Regulatory Toxicology, WuXi AppTec
ISO10993-17,whichwaslastrevisedis2002,hasun-dergoneasignificant revisionand theproposed titleis“ToxicologicalRiskAssessmentofMedicalDevice
Constituents”. The revised standard will expand fromcurrent guidance on establishing allowable limits ofleachablesubstances,toconductingatoxicologicalriskassessment of medical device constituents. Proposedupdates to the standard and its current status will bepresented.Topicswillincludehazardidentification,ex-posureassessment,dose-responseassessment,andriskcharacterization. Therewill be emphasis on the use ofexpertjudgementtodeterminewhetherthetoxicologicalrisksofexposuretoextractableorleachablechemicalsinmedicaldevicesareacceptable,whatadditionalstepsmaybe taken tomitigate risk, includingwhetherexpo-sureestimatescouldbefurtherrefinedthroughaddition-al chemical characterization and when to recommendriskcontrol.Inaddition,thetechnicalspecificationISO/TS 21726:2019, Application of the Threshold of Toxico-logicalConcern (TTC) forAssessingBiocompatibilityofMedicalDeviceConstituents,willbediscussed.Acasestudywillbepresented toprovideexamples todemon-stratetheapplicationofthenewprinciplesproposedinISO10993-17and ISO/TS21726 to the toxicological riskassessmentofmedicaldevices.
10:10 Coffee and Networking Break
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Extractables & Leachables Summit 2020
compatibilityusingthemanufacturingconditionsofuse,including timeand temperature. This extractables test-ingalsoshouldbeperformedusingtheactualsolutionscontacting each SUSmaterial. Case study examples ofextractablestestingformaterialcompatibilityandquali-ficationwillbepresented.
3:30 ComparisonoftheSolubilizationPropertiesofPolysorbate80andIsopropanol/WaterSolventSystemsforOrganicCompoundsExtractedfromThreePharmaceuticalPackagingConfigurations
Steve Zdravkovic, Senior Research Scientist, PPD
It has been reported that the presence of polysor-bate 80 in a pharmaceutical product’s formulationmay increase the number and/or amount of impuri-
tiesleachedfrommaterialsusedduringitsmanufacture,storage,and/oradministration.However, it isuncertainif/how the solubilization properties of this surfactantcompare to non-surfactant solvent systems. The goalof this study is to provide insight into this area of un-certainty by comparing the solubilization properties ofpolysorbate 80 to those of isopropanol/water solutionswhile in contact with a plasticized polyvinylchlorideparenteraldeliverybag,asingle-usetypemanufacturingbag,andapolypropylenebottle.Thesepropertiesweredeterminedviaabindingexperiment, inwhicha setofmodelcompoundswasintroducedintothesolutions,andviaanextractionexperiment,inwhichcompoundswereextracted fromthepackagingmaterialby thesolutions.Inbothexperiments,theamountofeachcompoundpres-entatequilibriumwasassayed todetermine theextenttheywere solubilized by the solution from the packag-ing material. Results from these experiments illustratedifferences in themagnitude of solubilization obtainedfromsolutionscontainingpolysorbate80ascomparedtothose composed of isopropanol/water. However, itwasalso demonstrated that their solubilization propertiescanbelinkedviaamathematicalmodel.
4:10 Close of Program
onexposureestimation,yetexposuredataarechalleng-ingtoobtainandinterpret.Physicsbasedmasstransportmodelsprovideapromisingalternativetoestablishclini-callyrelevantexposureestimates.Thispresentationwillprovideanoverviewofexposuremodelsandtheiruseinbiologicalriskevaluationofmedicaldevices,including:potentialbenefitsandcurrentuseinregulatoryapplica-tions, typesofmodelsthatcaninformTRAs,challengeswithuseinregulatorydecisionmaking,andstrategiestoovercomethesechallenges.
1:55 ManagingtheRiskofLeachablesthroughProactiveMaterialSelectionand
Michael Ruberto, President, Material Needs Consulting
Abstractcomingsoon
2:35 Coffee & Networking Break
2:50 ExtractablesScreeningofSingleUseComponentsforQualification
Eric J. Hill, Director, Boston Analytical
SingleUseSystems(SUS)presentchallengeswithre-gards toextractablesand leachables, however theirease of use, quick change out capability, cost, andconfigurational flexibility provide significant advan-
tagesovertraditionalmanufacturingset-ups.WiththesechallengesregardingE&L,muchattentionhasbeenpaidto extractables data generation for use in vendor andmaterial selection.Ongoing discussions in the industryrevolvearoundtheBioPhorumOperationsGroup(BPOG)Standardized Extractables Testing Protocol for Sin-gle-UseSystems inBiomanufacturingand theproposedUSP<665>monographforsingleusesystems.Regardlessofhow thesediscussions resolveamongst the industry,after an SUS is selected there is still testing thatmustbeperformed.Thedatageneratedduringselectionisof-tennotrobustenoughforqualificationoftheSUSmate-rials for use in the manufacturing setting. It is criticalto perform extractables testing of the SUS formaterial
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