化妆品清洗和消毒培训_精品文档.ppt
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化妆品清洗和消毒培训_精品文档.ppt
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DisinfectionPeterJay:
Bioscience,UR&DPSTrumbull,US14-16thNovember2006BackgroundlRecentyearsweaknessesincleaninganddisinfectionhavebeenthemajorcauseofincidents.lRecognisedthatgreateremphasisonadherencetobestpracticeprinciplesisrequired.lOnsitevalidationofproceduresisakeyareathatneedstobeimproved.IncidentLearnings-Disinfection
(1)lWater/DiluteProductResiduesLeftinPlant.PlantNOTdisinfectedpriortouselMANYincidentslDisinfectionprocedureNOTvalidatedlOperatorsINADEQUATELYtrainedlOperatordidNOTfollowdocumenteddisinfectionprocedurelDisinfectionNOTperformedwhenrequiredIncidentLearnings-Disinfection
(2)lDisinfectionprocedureinathirdpartydidNOTfollowanapprovedpractice.lINADEQUATEcontrolofshutdownprocedureslPortableequipmentNOTadequatelycleanedanddisinfectedpriortouse.INCIDENTLEARNING-C&DEnsurewater/productdrainsfromallareasofplantbygooddesignpractice.Ifnondrainableareasareidentified,theyMUSTbemanagedbydisinfectionprocedurespriortouseoftheplantUndrainablepipearrangementUndrainablepumparrangementWater/DiluteProductResiduesLeftinPlantINCIDENTLEARNINGC&DTimeImmediatelypostclean=30bugs/mlGrowthoccurs.24Hourslater=10millionbugs/mlAssumeundrainablepumpholdstwolitresofdiluteproductresidues:
After24hours20,000,000,000bugswillbepresentinthe2litresofwater!
-Wouldyoubathinthis?
-Wouldyoudrinkthis?
-Wouldyoumakeproductwiththis?
Undrainablepipearrangement-LeavingDiluteProductresidues=“BUGFOOD”Water/DiluteProductResiduesLeftinPlantUndrainableCleaningandDisinfectionRulesINCIDENTLEARNINGSEnsureCleaningandDisinfectionprotocolsaredocumentedandoperatorsaretrainedintheprocedures.RegularchecksbylocalhygienistarerequiredtoensurecomplianceWHENWHOHOWMUSTBEDEFINEDANDDOCUMENTEDTRAININGiskeyDISIPLINEINIMPLEMENTATIONisessentialCleaningandDisinfectionDisinfectionlDestructionofmicro-organismsbutNOTusuallybacterialspores.lDisinfectiondoesNOTnecessarilykillallmicro-organismsbutreducesthemtoalevelacceptableforadefinedpurpose,e.g.toalevelwhichisnotharmfuleithertohealthortothequalityofthegoodsbeingprocessed.CleaningandDisinfection-HACCPlCanbehandledasaGMPorasdefinedCCPslPreferredrouteisasCCPslEspeciallywhenstartingonHACCPlConsiderCIPsysteminHACCPstudylConsiderwhereneedmanualinterventionWhyCleanlProcesslPurposetoremoveproductsoilsandresiduestoproducecleanequipmentsurfacesthatwillnottaintthesubsequentproductionofadifferingvariant.lMicrobiologicallPreparationoftheplantsurfacesfordisinfection.Residualproductleftinequipmentcanpreventeffectivedisinfection:
Deactivatesomechemicaldisinfectants.Physicalbarrierpreventingthesuccessfuleliminationofthemicro-organismsbyprotectingthemRemainingproductresidueswillalsoactasafoodsourceforresidentmicro-organisms.Poorcleaningcanincreasetheriskofcontaminationthroughtheformationofdiluteandhencemorehospitableproductresidues(sublethalpreservativelevels).WhyDisinfectlWedoNOToperatesterileprocesseslThereforesomemicro-organismsWILLenterthemanufacturingplantlDisinfectionstrategiesarerequiredtopreventthebuildupofcontaminationintheplanttoalevelthatwillresultinoutofspecificationproductlDisinfectionshouldreducethemicrobialloadonasurfacetoalevelthatwillNOTbecapableofsurvivingorgrowinginfinishedproductDisinfectionlEquipmentmustbecleantobeeffectivelydisinfected.lEquipmentmustbedraineddrytoremaindisinfectedforanyperiodoftime.lDisinfectiononlyprotectsequipmentforalimitedtime.HowtoDisinfectlTwooptions:
lHeatlChemicalsThermalDisinfectionlRecommendedmethodofdisinfectionlTemperaturesof70degreesfor10minuteswilleffectivelydisinfectplant(coldestpartofplantmustreachtheseconditions)lTargettemperatureMUSTbeattainedatthecoldestpartoftheplant/circuitbeingdisinfected.l10minutecontacttimeshallNOTbestarteduntilallpartsofthecircuithavereachedthistemperature.lItmaytakeinexcessof15minutesforallpartsofplantcircuit(varieswithconfiguration/equipment)toreachthistemperature.lValidationtime/temperatureisCRITICALlLowertemperaturesandcontacttimeswillNOTdeliverdisinfection.ThermalDisinfectionlHeatmoreeffectivethanchemicaldisinfectionindestroyingbiofilmslEquipmentmustbeabletowithstandhightemperaturesandbeengineeredcorrectlytoavoidimplosionoftanks.lSteam:
RarelyusedoutsideUSPlantsnotdesigned(seals/instrumentsetc.)tohandlesteamlOnlyeffectiveagainstnonsporeformingmicro-organismslProtectionagainstscaldingrequiredlThermalDisinfectionGuidelinesfortheManufactureofHPCLiquids.ThisdocumentisavailableontheGlobalHygieneSecurityGroupwebsiteunderTechnicalDocuments.ChemicalDisinfectionlReli
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