《杀菌偏差中英》PPT课件

Copyright2010UniversityofMarylandAllRightsReserved,热杀菌记录,Copyright2010UniversityofMarylandAllRightsReserved,杀菌偏差,DanielGeffinJIFSANMoroccoJanuary2009,PROCESSDEVIATIONS,DanielGeffinJIFSANMoroccoJanuary2009,不同的偏差,21CFR113(低酸罐头)和21CFR114(酸化食品)有不同的部分介绍杀菌偏差.偏差在21CFR113.89、21CFR114.89和21CFR114.100中分别阐述,DIFFERENTDEVIATIONS,21CFR113(LOWACIDCANNEDFOODS)AND21CFR114(ACIDIFIEDFOODS)HAVEDIFFERENTSECTIONSTHATCOVERPROCESSDEVIATIONS.DEVIATIONSARECOVEREDRESPECTIVELYIN21CFR113.89AND21CFR114.89and21CFR114.100,21CFR113.89指导的低酸食品偏差,LOWACIDCANNEDFOODS(LACF)DEVIATIONSGOVERNEDBY21CFR113.89,什么是低酸食品偏差根据21CFR113.89?,1-未达到预定杀菌工艺或者2-加工食品或容器系统的其他关键因素失控,WHATISANLACFDEVIATIONUNDER21CFR113.89?,1-LESSTHENTHESCHEDULEDPROCESSOR2-OTHERCRITICALFACTORSAREOUTOFCONTROLFORTHEFOODORCONTAINERSYSTEM,什么是关键因素?,21CFR113.3(f)“意为指任何属性，特性，条件，方面，或其他参数，当其发生变化时会影响预定杀菌规程和商业无菌的达到。.”,WHATISA“CRITICALFACTOR”?,21CFR113.3(f)“Criticalfactormeansanyproperty,characteristic,condition,aspect,orotherparameter,variationofwhichmayaffectthescheduledprocessandtheattainmentofcommercialsterility.”,并非局限于预定杀菌规程,关键因素超出了预定杀菌规程中建立和规定的参数.尽管时间，温度，排气，装罐量，颗粒大小，粘度等必然是关键因素.其他因素，即使没有在预定杀菌规程中提及或规定，也是关键因素.,ITISNOTLIMITEDTOTHESCHEDULEDPROCESS,Criticalfactorsexceedtheparametersestablishedandprescribedinthescheduledprocess.Whiletime,temperature,ventingschedules,fillweights,particlesize,viscosity,etcaredefinitelycriticalfactors.Otherthings,notmentionedoraddressedinthescheduledprocessarecriticalfactors.,并非局限于预定杀菌规程,这些可能包含例如设备运行状况，罐密封缺陷，雇员操作及其他未在预定杀菌规程中阐明的因素，这些可能影响预定杀菌的进行并最终影响终产品的商业无菌.,ITISNOTLIMITEDTOTHESCHEDULEDPROCESS,Thesemayincludethingslikeequipmentoperatingconditions,canseamdefects,employeepractices,andotherthingsnotidentifiedinthescheduled/filedprocesswhichcanimpactthedeliveryofthescheduled/filedprocessandultimatelyimpactthecommercialsterilityofthefinishedproduct.,什么是偏差的纠正?,完全重新杀菌保留完整的重新杀菌记录留下产品做公共健康显著性评价.评价应由有资质的杀菌主管当局以认可的方法进行.,WHATISTHEREMEDYFORADEVIATION?,FULLYREPROCESSKEEPINGCOMPLETERECORDSOFREPROCESSINGSETASIDETHEPRODUCTFORANEVALUATIONOFPUBLICHEALTHSIGNIFICANCE.THEEVALUATIONSHALLBEMADEBYACOMPETENTPROCESSAUTHORITYUSINGRECOGNIZEDMETHODS.,杀菌主管当局的评价,除非评价证明产品经过热杀菌使之免除具有公共健康显著性的微生物否则产品应全部重新杀菌或销毁.,EVALUATIONBYAPROCESSAUTHORITY,UNLESSTHEEVALUATIONDEMONSTRATESTHATTHEPRODUCTHADBEENGIVENATHERMALPROCESSTHATRENDEREDITFREEOFMICROORGANISMSOFPUBLICHEALTHSIGNIFICANCEITSHALLBEFULLYREPROCESSEDORDESTROYED.,记录21CFR113.89,一个记录应由下列组成偏差所用的评价程序结果采取的行动(处理)这项记录必须被保留在单独的偏差资料中.,RECORDS21CFR113.89,ARECORDSHALLBEMADEOFTHEDEVIATIONEVALUATIONPROCEDURESUSEDTHERESULTSTHEACTIONSTAKEN(Disposition)THISRECORDMUSTBEKEPTINASEPARATEDEVIATIONFILE.,最终处理,经过全部的再杀菌或者主管当局用认可方法证明不存在公共健康危害产品可以正常销售运输.否则产品必须销毁.,FINALDISPOSTION,AFTERFULLREPROCESSINGORADETERMINATIONTHATNOPUBLICHEALTHHAZARDEXISTSBYACOMPETENTPROCESSINGAUTHORITYUSINGRECOGNIZEDPROCEDURESTHEPRODUCTMAYBESHIPPEDINNORMALDISTRIBUTION.IFNOT,THEPRODUCTMUSTBEDESTROYED.,21CFR114.8921CFR114.100指导的酸化食品偏差,ACIDIFIEDFOODS(AF)DEVIATIONSGOVERNEDBY21CFR114.8921CFR114.100,21CFR114.89规定的酸化食品偏差是什么？,1-与预定杀菌规程的偏差以及/或者2-终产品平衡pH高于4.6,WHATISANACIDIFIEDFOODSDEVIATIONUNDER21CFR114.89?,1-DEVIATIONFROMTHESCHEDULEDPROCESSAND/OR2-THEEQUILBRIUMPHOFTHEFINISHEDPRODUCTISHIGHERTHAN4.6,偏差的补救方法是什么？,1.完全重新杀菌使用杀菌主管当局建立的杀菌工艺足以保证产品的安全或者2.在21CFR113指导下按照低酸食品进行热杀菌(从开始就必须满足Part113的所有要求)或者3.留下产品做公共健康评价,WHATISTHEREMEDYFORADEVIATION?,1.FULLYREPROCESSUSINGAPROCESSESTABLISHEDBYAPROCESSAUTHORITYASADEQUATETOENSUREASAFEPRODUCTOR2.THERMALLYPROCESSITASALOW-ACIDFOODUNDER21CFR113(Startingover,youmustmeetalltherequirementsofPart113)OR3.SETASIDETHEPRODUCTFORAPUBLICHEALTHEVALUATION,如果留下产品做公共健康评价,评价应由有资质的杀菌主管当局进行.并且2.应该与主管当局认可的程序保持一致以便探测任何潜在的最公共健康的危害.,IFYOUSETASIDETHEPRODUCTFORANEVALUATION,THEEVALUATIONSHALLBEMADEBYACOMPETENTPROCESSAUTHORITYAND2.SHALLBEINACCORDANCEWITHPROCEDURESRECOGNIZEDBYCOMPETENTPROCESSAUTHORITIESASBEINGADEQUATETODETECTANYPOTENTIALHAZARDTOPUBLICHEALTH.,如果留下产品做公共健康评价,除非评价证明食品经过了使之安全的杀菌,留下的食品将:1.完全重新杀菌使之安全或者2.销毁,IFYOUSETASIDETHEPRODUCTFORANEVALUATION,UNLESSTHEEVALUATIONDEMONSTRATESTHATTHEFOODHASUNDERGONEAPROCESSTHATHASRENDEREDITSAFE,THEFOODSETASIDESHALLBE:1.FULLYREPROCESSEDTORENDERITSAFEOR2.DESTROYED,21CFR114.89and114.100记录,记录应由以下组成:1.偏差2.识别出的产品受影响的部分3.使用的评价程序4.结果以及5.最终采取的行动(处理).记录必须保留在一套独立的偏差文件中.,RECORDS21CFR114.89and114.100,ARECORDSHALLBEMADEOF:1.THEDEVIATION2.THEEFFECTEDPORTIONOFTHEPRODUCTIDENTIFIED3.EVALUATIONPROCEDURESUSED4.THERESULTSAND5.THEFINALACTIONTAKEN(Diposition).THISRECORDMUSTBEKEPTINASEPARATEDEVIATIONFILE.,最终处理,经过全部的再杀菌或者主管当局用认可方法证明不存在公共健康危害产品可以正常销售运输.否则产品必须销毁.,FINALDISPOSTION,AFTERFULLREPROCESSINGORADETERMINATIONTHATNOPUBLICHEALTHHAZARDEXISTSBYACOMPETENTPROCESSINGAUTHORITYUSINGRECOGNIZEDPROCEDURESTHEPRODUCTMAYBESHIPPEDINNORMALDISTRIBUTION.IFNOT,THEPRODUCTMUSTBEDESTROYED.,当你遇到偏差时你还能够做什么?,108.35(d)当偏差本质存在潜在公共健康显著性危害，且这种食品任一批次已经整体或部分进入商业销售时，受雇于低酸密封包装食品热杀菌工艺的商业杀菌员应该迅速向FDA汇报任何腐败例证或者杀菌偏差。,SOWHATELSEDOYOUDOWHENYOUHAVEADEVIATION?,108.35(d)Acommercialprocessorengagedinthethermalprocessingoflow-acidfoodspackagedinhermeticallysealedcontainersshallpromptlyreporttotheFoodandDrugAdministrationanyinstanceofspoilageorprocessdeviationthenatureofwhichindicatespotentialhealthsignificance,whereanylotofsuchfoodhasinwholeorinpartentereddistributionincommerce.,当你遇到偏差时你还能够做什么?,108.35(e)当其中任一批次受微生物污染可能危及健康的该产品已经整体或部分进入销售时.受雇于低酸密封包装食品热杀菌工艺的商业杀菌员应该迅速向FDA汇报任何事例。,SOWHATELSEDOYOUDOWHENYOUHAVEADEVIATION?,108.35(e)Acommercialprocessorengagedinthethermalprocessingoflow-acidfoodspackagedinhermeticallysealedcontainersshallpromptlyreporttotheFoodandDrugAdministrationanyinstancewhereinanylotofsuchfood,whichmaybeinjurioustohealthbyreasonofcontaminationwithmicroorganisms,hasinwholeorinpartentereddistribution.,当你遇到偏差时你还能够做什么?,108.25(d)受雇于酸化食品杀菌的商业杀菌人员应迅速向FDA汇报腐败,杀菌偏差,或者微生物污染,其实质是可能潜在的显著性健康危害，且任何批次该产品已整体或部分进入商业销售时.,SOWHATELSEDOYOUDOWHENYOUHAVEADEVIATION?,108.25(d)AcommercialprocessorengagedintheprocessingofacidifiedfoodsshallpromptlyreporttotheFoodandDrugAdministrationanyinstanceofspoilage,aprocessdeviation,orcontaminationwithmicroorganisms,thenatureofwhichhaspotentialhealthendangeringsignificance,whereanylotofsuchfoo