05 Sterilization - A to Z

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1、3/27/2012Sterilization–AtozJamesAgallocoJamesAgallocoAgalloco&AssociatesSterilization–AtozSterilizationisacriticalprocessinthepharmaceuticalindustryforthecontrolofmicrobialpopulationsmicrobialpopulations.Whilemostprevalentinthemanufactureofsterileproductsitcanbeusedinavarietyofsettingswheremi

2、crobeshavepotentialimpactonpatientsorproducts.13/27/2012What’stheObjective?Removalofobjectionables/specifiedmicroorganismsControlofmicrobialpopulation¢Reductionincount¢CompleteeliminationIt’simportanttounderstandtherealprocessneedmorecompletelythanprocessneedmorecompletelythanwhatthismightoth

3、erwisesuggest.What’stheTargettobeSterilized?BacterialSporesOrderofResistanceMoldsporesPrionsVegetativeVegetativecellscellsBacterialsporesBacterialsporesNonlipidorsmallvirusesViruses/prionsMoldspores/FungiCombinationsofthe(Aspergillus,Candida)aboveVegetativebacteria(StapSapyous,hyloccus,Pseudo

4、monas)Lipidormedium-sizedviruses23/27/2012WhatProcesstoChoose-1There’saflyinyourlivingroom,whatdoyouusetokillit?¢Aflyswatter¢Ashotgun¢ApieceofartilleryObviouslywewouldusetheflyswatterandthatadviceisappropriateinmicrobialcontrolaswell.Weshouldusetheprocessthatbestfitsthetargetobjectivetargetob

5、jective.Unfortunately,mostpractitionersinmicrobialcontroltaketheprocesstoextremesasamatterofroutine.That’sacceptableattimes,butnotalways.MicrobialControlProcessesDisinfection–aprocessthatwilleliminateinfectiveorganisms.Sanitization–aprocesswillreducetheoverallmicrobialpopulation.Dependingupon

6、theagentthisincludessporesStiliSterilization–aprocessthtthatwilldestroyorremoveallmicrobiallife.33/27/2012What’sWrong?Despitethematurityofthesubject,thepracticeofsterilizationwithintheglobalhealthcareindustryhasdescendedintorotehealthcareindustryhasdescendedintoroterepetitionofwrongheadedexpe

7、ctations.Regulatoryobfuscationandindustryapathyhavecausedallmannerofunnecessarycomplicationsandaddedpatientrisks.Ratherthanmakingproductssafer,wemayhaveactuallyincreasedpatientrisk!WhydiditgoWrong?We’vepaidonlylimitedattentiontothebasicscienc