PDAMetro Glass delamination

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1、GlassDelamination:Risks,RealityandRegulatoriesPDA:AGlobal.DanieleZuccatoR&DProjectManagementNuovaOMPIAssociation–StevanatoGroupAGENDAIntroductiontoglassdelaminationmechanismSGDelaminationstudies&resultsProtocolforearlydelaminationpredictionVialsvs.SyringesRegulatoryaspects

2、GLASSDELAMINATIONSeparationofthinglasslayers(lamellae)thatappearasshiny,needleshapedparticlesfloatinginthecontactliquidTheformationofasilica-richlayerpoorlybondedtothesubstrateisthefirststageofanextendeddelaminationGlass-liquidinteractionsareresponsiblefortheformationofana

3、lteredlayerGLASS–LIQUIDINTERACTIONSFormationofaalkalidepletedlayerWFIorAcidLeachingIncreasingofthelayerthicknessH+Ca++K+Na+CrackingGlassDetachmentofscalesTYPICALFLAKESASPECTDELAMINATIONOFPHARMACEUTICALGLASSThefirststageisalwaystheformationofanalteredlayerWhenvialsarefilled

4、withtheliquidpreparation,thislayerissubjecttoastrongre-hydrationandswellingDELAMINATIONOFPHARMACEUTICALGLASSGlass-flakesOHSomepreparationsmayfavourdelaminationAlkalinesolutionsstronglyaffectthedissolutionofthesilicalayer.SiOconcentrationinthe2extractionliquidincreasessteep

5、lyFlakesappearanceFACTORSAFFECTINGDELAMINATIONOFPHARMAGLASSES•sulfurtreatmentSurface•siliconizationtreatments•coating•speedofthetransformationprocess•burnersflametemperatureConversion•improperannealingstage,tensilestressesprocess•typeofglass•chemistryofthebuffersupportingt

6、heactiveDrugprincipleformulation&•pH&ionicstrengthofthedrugsolutionpost-•organicacidstreatments•sterilizationprocess•storageconditionsORGANICSACIDS«Neutralsolutionsoforganicacidsbehaveasstronglyalkalinesolutionsfavoringdissolutionofsilica»FrankR.BaconandFrankC.Raggon,Journ

7、aloftheAmericanCeramicSociety,42[4]199-205(1959)OPENQUESTIONS•Howcandelaminationbepredicted?•Whatparameterscanbeusedtoinvestigatedelaminationpropensity?!•AreEPvaluesstillagoodindicatorofdelaminationresistance?•WhichglassTypeismoresuitabletowhichpreparation?AGENDAIntroducti

8、ontoglassdelaminationmechanismSGDelaminationstudies&resultsProtocolforearlydelaminationpr