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1、Copyright 2010 University of MarylandAll Rights Reserved热杀菌记录热杀菌记录Copyright 2010 University of MarylandAll Rights Reserved杀菌偏差杀菌偏差Daniel GeffinJIFSANMorocco January 2009PROCESS DEVIATIONSDaniel GeffinJIFSANMorocco January 2009不同的偏差不同的偏差21 CFR 113 (低酸罐头) 和 21 CFR 114 (酸化食品) 有不同的部分介绍杀菌偏差.偏差在、 21 CFR 1
2、14.89 和 中分别阐述DIFFERENT DEVIATIONS21 CFR 113 (LOW ACID CANNED FOODS) AND 21 CFR 114 (ACIDIFIED FOODS) HAVE DIFFERENT SECTIONS THAT COVER PROCESS DEVIATIONS.指指导的低酸食品偏差的低酸食品偏差什么是低酸食品偏差根据什么是低酸食品偏差根据21 CFR 113.89?1- 未达到预定杀菌工艺或者或者2- 加工食品或容器系统的其他关键因素失控WHAT IS AN LACF DEVIATION UNDER 21 CFR 113.89?1- LESS T
3、HEN THE SCHEDULED PROCESSOR2- OTHER CRITICAL FACTORS ARE OUT OF CONTROL FOR THE FOOD OR CONTAINER SYSTEM什么是关什么是关键因素因素?21 CFR 113.3(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。.”WHAT IS A “CRITICAL FACTOR”?21 CFR 113.3(f) “Critical factor means any property, characteristic, condition, aspect,
4、 or other parameter, variation of which may affect the scheduled process and the attainment of commercial sterility.”并非局限于并非局限于预定定杀菌菌规程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. IT IS NOT LIMITED TO THE SCHEDULED PROCESSCritical factors exceed the paramet
5、ers established and prescribed in the scheduled process. While time, temperature, venting schedules, fill weights, particle size, viscosity, etc are definitely critical factors. Other things, not mentioned or addressed in the scheduled process are critical factors. 并非局限于并非局限于预定定杀菌菌规程程这些可能包含例如设备运行状况，
6、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. IT IS NOT LIMITED TO THE SCHEDULED PROCESSThese may include things like equipment operating conditions, can seam defects, employee practices, and other things not identified in the scheduled/filed process which can impact the delivery of the sc
7、heduled/filed process and ultimately impact the commercial sterility of the finished product. 什么是偏差的什么是偏差的纠正正?1.完全重新杀菌 保留完整的重新杀菌记录2.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.WHAT IS THE REMEDY FOR A DEVIATION?1.FULLY REPROCESS KEEPING COMPLETE RECORDS OF REPROCESSING2.SET ASIDE THE PRODUCT FOR AN EVALU
8、ATION OF PUBLIC HEALTH SIGNIFICANCE. THE EVALUATION SHALL BE MADE BY A COMPETENT PROCESS AUTHORITY USING RECOGNIZED METHODS. 杀菌主管当局的菌主管当局的评价价除非评价 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. EVALUATION BY A PROCESS AUTHORITYUNLESS THE EVALUATION DEMONSTRATES THAT THE PRODUCT HAD BEEN GIVEN A THERMAL P
9、ROCESS THAT RENDERED IT FREE OF MICROORGANISMS OF PUBLIC HEALTH SIGNIFICANCE IT SHALL BE FULLY REPROCESSED OR DESTROYED. 记录 一个一个记录应由下列由下列组成成 1.偏差偏差2.所用的所用的评价程序价程序3.结果果4.采取的行采取的行动 (处理理)这项记录必必须被保留在被保留在单独的偏差独的偏差资料中料中. A RECORD SHALL BE MADE OF 1.THE DEVIATION2.EVALUATION PROCEDURES USED3.THE RESULTS4.T
10、HE ACTIONS TAKEN (Disposition)THIS RECORD MUST BE KEPT IN A SEPARATE DEVIATION FILE.最最终处理理经过全部的再全部的再杀菌或者主管当局用菌或者主管当局用认可方法可方法证明不存在公共健明不存在公共健康危害康危害 产品可以正常品可以正常销售运售运输.否否则产品必品必须销毁.FINAL DISPOSTIONAFTER FULL REPROCESSING OR A DETERMINATION THAT NO PUBLIC HEALTH HAZARD EXISTS BY A COMPETENT PROCESSING AUT
11、HORITY USING RECOGNIZED PROCEDURESTHE PRODUCT MAY BE SHIPPED IN NORMAL DISTRIBUTION.IF NOT, THE PRODUCT MUST BE DESTROYED.21 CFR 114.8921 CFR 114.100指指导的酸化食品偏差的酸化食品偏差规定的酸化食品偏差是什么？定的酸化食品偏差是什么？1- 与预定杀菌规程的偏差以及以及/或者或者2- 终产品平衡pH高于WHAT IS AN ACIDIFIED FOODS DEVIATION UNDER 21 CFR 114.89?1- DEVIATION FROM
12、THE SCHEDULED PROCESSAND/OR偏差的偏差的补救方法是什么？救方法是什么？1.完全重新完全重新杀菌菌 使用使用杀菌主管当局建立的菌主管当局建立的杀菌工菌工艺足以保足以保证产品的安全品的安全 或者或者2.在在 21 CFR 113 指指导下按照低酸食品下按照低酸食品进行行热杀菌菌(从开始就必从开始就必须满足足Part 113的所有要求的所有要求) 或者或者3.留下留下产品做公共健康品做公共健康评价价WHAT IS THE REMEDY FOR A DEVIATION?1.FULLY REPROCESS USING A PROCESS ESTABLISHED BY A PRO
13、CESS AUTHORITY AS ADEQUATE TO ENSURE A SAFE PRODUCT OR2.THERMALLY PROCESS IT AS A LOW-ACID FOOD UNDER 21 CFR 113 (Starting over, you must meet all the requirements of Part 113) OR3.SET ASIDE THE PRODUCT FOR A PUBLIC HEALTH EVALUATION如果如果留下产品做公共健康评价1.评价应由有资质的杀菌主管当局进行.并且并且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
14、公共健康的危害.IF YOU SET ASIDE THE PRODUCT FOR AN EVALUATION1.THE EVALUATION SHALL BE MADE BY A COMPETENT PROCESS AUTHORITYAND2. SHALL BE IN ACCORDANCE WITH PROCEDURES RECOGNIZED BY COMPETENT PROCESS AUTHORITIES AS BEING ADEQUATE TO DETECT ANY POTENTIAL HAZARD TO PUBLIC HEALTH.如果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
15、安全的杀菌, 留下的食品将: 1. 完全重新杀菌使之安全 或者或者 2. 销毁IF YOU SET ASIDE THE PRODUCT FOR AN EVALUATIONUNLESS THE EVALUATION DEMONSTRATES THAT THE FOOD HAS UNDERGONE A PROCESS THAT HAS RENDERED IT SAFE, THE FOOD SET ASIDE SHALL BE: 1. FULLY REPROCESSED TO RENDER IT SAFE OR 2. DESTROYED记录记录应由以下由以下组成成:1. 偏差偏差2. 识别出的出的产
16、品受影响的部分品受影响的部分 3. 使用的使用的评价程序价程序4. 结果以及果以及 5. 最最终采取的行采取的行动 (处理理). 记录必必须保留在一套独立的偏差文件中保留在一套独立的偏差文件中. A RECORD SHALL BE MADE OF:1. THE DEVIATION2. THE EFFECTED PORTION OF THE PRODUCT IDENTIFIED 3. EVALUATION PROCEDURES USED 4. THE RESULTS AND 5. THE FINAL ACTION TAKEN (Diposition). THIS RECORD MUST BE KEPT IN A SEPARATE DEVIATION FILE.最最终处理理经过全部的再全部的再杀菌或者主管当局用菌或者主管当局用认可方法可方法证明不存在公共健明不存在公共健康危害康危害 产品可以正常品可以正常销售运售运输.否否则产品必品必须销毁.FINAL DISPOSTIONAFTER FULL REPROCESSING OR A DETERMINATION THAT NO PUBLIC H
