3.4殺菌偏差(中英文)

1、Copyright 2010 University of MarylandAll Rights Reserved熱殺菌記錄1Copyright 2010 University of MarylandAll Rights Reserved2殺菌偏差Daniel GeffinJIFSANMorocco January 20093PROCESS DEVIATIONSDaniel GeffinJIFSANMorocco January 20094不同的偏差21 CFR 113 (低酸罐頭) 和 21 CFR 114 (酸化食品) 有不同的部分介紹殺菌偏差.偏差在21 CFR113.89、 21 CFR

2、 114.89 和 21 CFR 114.100中分別闡述5DIFFERENT DEVIATIONS21 CFR 113 (LOW ACID CANNED FOODS) AND 21 CFR 114 (ACIDIFIED FOODS) HAVE DIFFERENT SECTIONS THAT COVER PROCESS DEVIATIONS.DEVIATIONS ARE COVERED RESPECTIVELY IN 21 CFR113.89 AND 21 CFR 114.89 and 21 CFR 114.100621 CFR 113.89指導(dǎo)的低酸食品偏差7LOW ACID CANNED

3、FOODS (LACF) DEVIATIONSGOVERNED BY 21 CFR 113.898什么是低酸食品偏差根據(jù)21 CFR 113.89?1- 未達(dá)到預(yù)定殺菌工藝或者2- 加工食品或容器系統(tǒng)的其他關(guān)鍵因素失控9WHAT IS AN LACF DEVIATION UNDER 21 CFR 113.89?1- LESS THEN THE SCHEDULED PROCESSOR2- OTHER CRITICAL FACTORS ARE OUT OF CONTROL FOR THE FOOD OR CONTAINER SYSTEM10什么是關(guān)鍵因素?21 CFR 113.3(f) “意為指任

4、何屬性，特性，條件，方面，或其他參數(shù)，當(dāng)其發(fā)生變化時會影響預(yù)定殺菌規(guī)程和商業(yè)無菌的達(dá)到。.”11WHAT IS A “CRITICAL FACTOR”?21 CFR 113.3(f) “Critical factor means any property, characteristic, condition, aspect, or other parameter, variation of which may affect the scheduled process and the attainment of commercial sterility.”12并非局限于預(yù)定殺菌規(guī)程關(guān)鍵因素超出了

5、預(yù)定殺菌規(guī)程中建立和規(guī)定的參數(shù). 盡管時間，溫度，排氣，裝罐量，顆粒大小，粘度等必然是關(guān)鍵因素. 其他因素，即使沒有在預(yù)定殺菌規(guī)程中提及或規(guī)定，也是關(guān)鍵因素. 13IT IS NOT LIMITED TO THE SCHEDULED PROCESSCritical factors exceed the parameters established and prescribed in the scheduled process. While time, temperature, venting schedules, fill weights, particle size, viscosity,

6、etc are definitely critical factors. Other things, not mentioned or addressed in the scheduled process are critical factors. 14并非局限于預(yù)定殺菌規(guī)程這些可能包含例如設(shè)備運行狀況，罐密封缺陷，雇員操作及其他未在預(yù)定殺菌規(guī)程中闡明的因素，這些可能影響預(yù)定殺菌的進(jìn)行并最終影響終產(chǎn)品的商業(yè)無菌. 15IT IS NOT LIMITED TO THE SCHEDULED PROCESSThese may include things like equipment operati

7、ng conditions, can seam defects, employee practices, and other things not identified in the scheduled/filed process which can impact the delivery of the scheduled/filed process and ultimately impact the commercial sterility of the finished product. 16什么是偏差的糾正?完全重新殺菌 保留完整的重新殺菌記錄留下產(chǎn)品做公共健康顯著性評價. 評價應(yīng)由有資

8、質(zhì)的殺菌主管當(dāng)局以認(rèn)可的方法進(jìn)行.17WHAT IS THE REMEDY FOR A DEVIATION?FULLY REPROCESS KEEPING COMPLETE RECORDS OF REPROCESSINGSET ASIDE THE PRODUCT FOR AN EVALUATION OF PUBLIC HEALTH SIGNIFICANCE. THE EVALUATION SHALL BE MADE BY A COMPETENT PROCESS AUTHORITY USING RECOGNIZED METHODS.18 殺菌主管當(dāng)局的評價除非評價 證明產(chǎn)品經(jīng)過熱殺菌使之免除具有

9、公共健康顯著性的微生物 否則產(chǎn)品應(yīng)全部重新殺菌或銷毀.19 EVALUATION BY A PROCESS AUTHORITYUNLESS THE EVALUATION DEMONSTRATES THAT THE PRODUCT HAD BEEN GIVEN A THERMAL PROCESS THAT RENDERED IT FREE OF MICROORGANISMS OF PUBLIC HEALTH SIGNIFICANCE IT SHALL BE FULLY REPROCESSED OR DESTROYED.20 記錄 21 CFR 113.89一個記錄應(yīng)由下列組成 偏差所用的評價程序

10、結(jié)果采取的行動 (處理)這項記錄必須被保留在單獨的偏差資料中.21 RECORDS 21 CFR 113.89A RECORD SHALL BE MADE OF THE DEVIATIONEVALUATION PROCEDURES USEDTHE RESULTSTHE ACTIONS TAKEN (Disposition)THIS RECORD MUST BE KEPT IN A SEPARATE DEVIATION FILE.22最終處理經(jīng)過全部的再殺菌或者主管當(dāng)局用認(rèn)可方法證明不存在公共健康危害 產(chǎn)品可以正常銷售運輸.否則產(chǎn)品必須銷毀.23FINAL DISPOSTIONAFTER FUL

11、L REPROCESSING OR A DETERMINATION THAT NO PUBLIC HEALTH HAZARD EXISTS BY A COMPETENT PROCESSING AUTHORITY USING RECOGNIZED PROCEDURESTHE PRODUCT MAY BE SHIPPED IN NORMAL DISTRIBUTION.IF NOT, THE PRODUCT MUST BE DESTROYED.2421 CFR 114.8921 CFR 114.100指導(dǎo)的酸化食品偏差25ACIDIFIED FOODS (AF) DEVIATIONSGOVERNED

12、 BY 21 CFR 114.8921 CFR 114.1002621 CFR 114.89規(guī)定的酸化食品偏差是什么？1- 與預(yù)定殺菌規(guī)程的偏差以及/或者2- 終產(chǎn)品平衡pH高于4.627WHAT IS AN ACIDIFIED FOODS DEVIATION UNDER 21 CFR 114.89?1- DEVIATION FROM THE SCHEDULED PROCESSAND/OR2- THE EQUILBRIUM PH OF THE FINISHED PRODUCT IS HIGHER THAN 4.628偏差的補救方法是什么？1.完全重新殺菌 使用殺菌主管當(dāng)局建立的殺菌工藝足以保證

13、產(chǎn)品的安全 或者2.在 21 CFR 113 指導(dǎo)下按照低酸食品進(jìn)行熱殺菌(從開始就必須滿足Part 113的所有要求) 或者3.留下產(chǎn)品做公共健康評價29WHAT IS THE REMEDY FOR A DEVIATION?1.FULLY REPROCESS USING A PROCESS ESTABLISHED BY A PROCESS AUTHORITY AS ADEQUATE TO ENSURE A SAFE PRODUCT OR2.THERMALLY PROCESS IT AS A LOW-ACID FOOD UNDER 21 CFR 113 (Starting over, you

14、must meet all the requirements of Part 113) OR3.SET ASIDE THE PRODUCT FOR A PUBLIC HEALTH EVALUATION30如果留下產(chǎn)品做公共健康評價評價應(yīng)由有資質(zhì)的殺菌主管當(dāng)局進(jìn)行.并且2. 應(yīng)該與主管當(dāng)局認(rèn)可的程序保持一致以便探測任何潛在的最公共健康的危害.31IF YOU SET ASIDE THE PRODUCT FOR AN EVALUATIONTHE EVALUATION SHALL BE MADE BY A COMPETENT PROCESS AUTHORITYAND2. SHALL BE IN AC

15、CORDANCE WITH PROCEDURES RECOGNIZED BY COMPETENT PROCESS AUTHORITIES AS BEING ADEQUATE TO DETECT ANY POTENTIAL HAZARD TO PUBLIC HEALTH.32如果留下產(chǎn)品做公共健康評價除非評價證明食品經(jīng)過了使之安全的殺菌, 留下的食品將: 1.完全重新殺菌使之安全 或者 2. 銷毀33IF YOU SET ASIDE THE PRODUCT FOR AN EVALUATIONUNLESS THE EVALUATION DEMONSTRATES THAT THE FOOD HAS

16、UNDERGONE A PROCESS THAT HAS RENDERED IT SAFE, THE FOOD SET ASIDE SHALL BE: 1.FULLY REPROCESSED TO RENDER IT SAFE OR 2. DESTROYED3421 CFR 114.89 and 114.100記錄記錄應(yīng)由以下組成:1. 偏差2. 識別出的產(chǎn)品受影響的部分 3. 使用的評價程序4. 結(jié)果以及 5. 最終采取的行動 (處理). 記錄必須保留在一套獨立的偏差文件中.35 RECORDS 21 CFR 114.89 and 114.100A RECORD SHALL BE MADE

17、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.36最終處理經(jīng)過全部的再殺菌或者主管當(dāng)局用認(rèn)可方法證明不存在公共健康危害 產(chǎn)品可以正常銷售運輸.否則產(chǎn)品必須銷毀.37FINAL DISPOSTIONAFTER FULL RE

18、PROCESSING OR A DETERMINATION THAT NO PUBLIC HEALTH HAZARD EXISTS BY A COMPETENT PROCESSING AUTHORITY USING RECOGNIZED PROCEDURESTHE PRODUCT MAY BE SHIPPED IN NORMAL DISTRIBUTION.IF NOT, THE PRODUCT MUST BE DESTROYED.38當(dāng)你遇到偏差時你還能夠做什么?108.35(d)當(dāng)偏差本質(zhì)存在潛在公共健康顯著性危害，且這種食品任一批次已經(jīng)整體或部分進(jìn)入商業(yè)銷售時，受雇于低酸密封包裝食品熱殺菌

19、工藝的商業(yè)殺菌員應(yīng)該迅速向FDA匯報任何腐敗例證或者殺菌偏差。39SO WHAT ELSE DO YOU DO WHEN YOU HAVE A DEVIATION?108.35(d) A commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers shall promptly report to the Food and Drug Administration any instance of spoilage or proc

20、ess deviation the nature of which indicates potential health significance, where any lot of such food has in whole or in part entered distribution in commerce.40當(dāng)你遇到偏差時你還能夠做什么?108.35(e)當(dāng)其中任一批次受微生物污染可能危及健康的該產(chǎn)品已經(jīng)整體或部分進(jìn)入銷售時.受雇于低酸密封包裝食品熱殺菌工藝的商業(yè)殺菌員應(yīng)該迅速向FDA匯報任何事例。41SO WHAT ELSE DO YOU DO WHEN YOU HAVE A D

21、EVIATION?108.35(e) A commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers shall promptly report to the Food and Drug Administration any instance wherein any lot of such food, which may be injurious to health by reason of contamination wi

22、th microorganisms, has in whole or in part entered distribution.42當(dāng)你遇到偏差時你還能夠做什么?108.25(d) 受雇于酸化食品殺菌的商業(yè)殺菌人員應(yīng)迅速向FDA匯報 腐敗, 殺菌偏差, 或者微生物污染, 其實質(zhì)是可能潛在的顯著性健康危害，且任何批次該產(chǎn)品已整體或部分進(jìn)入商業(yè)銷售時.43SO WHAT ELSE DO YOU DO WHEN YOU HAVE A DEVIATION?108.25(d) A commercial processor engaged in the processing of acidified foods shall promptly report to the Food and Drug Administration any instance of spoilage, a process deviation, or contamination with microorganisms, the nature of which has potential health endangering significance, where an