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1、this module serves as a guide to the auditor in completing an audit of the microbiological monitoring processes. the auditor will determine whether or not the facility is complying with the specifications and requirements of the cocacola company by completing this module.此模块作为审核员审核微生物监测过程的指南。审核员通过完成
2、此模块将确定工厂是否符合可口可乐公司的规范和要求。plant 工厂:date:日期 auditor(s)审核员:1) questionnaire 调查表yesdivno1is a microbiological monitoring program, in line with company requirements, in place?线上微生物检测程序是否有符合公司要求?2did the division approve all microbiological sampling points? 所有微生物取样点是否得到确认?3is appropriate record review in
3、place?是否启合适的反馈记录?4is the plant following the required testing on water? 工厂是否按照水质要求进行检测?5is the plant following the required testing on sweeteners? 工厂是否按照测试白砂糖检测要求?6is the plant following the required testing on syrup / finished product?工厂是否按照糖浆及产品的检测要求?7is the plant following the required testing on
4、 process equipment and others?工厂是否按照在生产设备及其它方面的检测要求?8is an adequate microbiological monitoring program in use to validate the effectiveness of the cleaning & sanitation? 是否使用适当的微生物监测计划来评价清洗消毒效果?9is the plant using company specified microbiological monitoring methods?工厂是否使用指定的微生物监测方法?10is the pla
5、nt properly conducting the membrane filtration technique where applicable?工厂是否正确使用膜过滤?11is the plant properly conducting the pour plate technique where applicable?工厂是否正确使用倾倒平板法?12is the plant properly conducting other microbiological methods? (if applicable)工厂是否适当采用其它的微生物检验方法?13are correct media use
6、d?培乔基是否使用止确?14are correct incubation temperatures used?:温度是否止确?15are correct incubation times applied?:时 1 可是否止确的?2) reference standards list参考标准清单:beverage operationsbo-rq-434microbiological requirements 一 cleaning & sanitation 微生物要求一清洗和消毒manual饮料操作手册bo-rq- microbiological monitoring435 require
7、ments微生物监控要求standards methods manual -micro微生物检测方法标准手册sm-pr- 660sm-pr- 605microbiological methods 检测方法commercially available microbiological methods 商业无菌检测方法微生物sm-pr- 625sm-pr- 655membrane filtration 膜过滤法pour plate 倾倒平板法3) specifications and requirements summary:标准和要求概要specifications / requirements
8、标准 / 要求1is a microbiological monitoring program, in line with company requirements, in place?线上微生物监控程序是否符合公司要求?bo-rq-435 all microbiological sample points are identified in each process,每个过程的所有微生物采样点都须得到 确认。 sop s available on sampling and testing sofw准操作程序适用于取样及检测 microbio. testing by trained perso
9、nnel with correct equipment 受过设备正确操作培训的人才甫9进行微 生物检测2did the division approve all microbiological sampling points?所有微生物取样点是否得到确认?bo-rq-435 division must approve microbiological sampling points区域公司必须认可所有微生物取样点3is appropriate record review in place?是否启合适的反馈记录?bo-rq-435 maintain all test records. 保留所有的检
10、测记录 routinely review results and identify problems and trends.每日反馈结果来确认问题及趋势。4is the plant following the required testing on water?工厂是否按照水质要求进行检测?sampling points:取样点:raw water:原水:每个来源treated water: each carbon purifier / each proportioner / syrup room 处理水:每个碳滤净化器/每个混比器/糖浆房carbonated water:each f川er.
11、(only if carbonated water is usedas a process step.)碳酸水:每个充填阀。(生产步骤只有使用到 碳酸水)final rinse water (after washing / rinsing): each washer / rinser 最后冲洗水(洗瓶/冲瓶后)每台洗瓶机/冲瓶 机final rinse water (after sanitation):each piece of process equipment最后冲洗水(杀菌后):每台生产设备final rinse water (after sanitation):each filler,
12、 2 samples最后冲洗水(杀菌后):每个充填阀取两个取 样点。cooling water for ncb: each cooling station用于非碳酸饮料的冷却水bo-rq-435sample test frequency samplespecification样品名检测频率样品量标准ea raw watercoliformweekly100 ml0 / 100 ml 原水大肠菌群每周 total count1 ml <500 / ml 总菌 treated watercoliformweekly100 ml0 / 100 ml 处理水大肠菌群每周total count10
13、 ml <25 / ml总 菌 carbonatedcoliformweekly100 ml0 / 100 ml 碳酸化水大肠菌群每周total count10 ml <25 / ml总菌 yeast/mold20 ml 0/ 20 ml酵 母/毒菌 final rinsecoliform- 一100 ml0 / 100 ml最后冲洗水大肠菌群total count10 ml <25 / ml总菌 final rinse ciptotal countweekly 1 ml < 25 / ml cip最后冲洗水总菌每周coliform100 ml0 / 100ml 大肠菌
14、群 final rinse cipyeast/moldweekly 100 ml< 10 / 100 ml cip最后冲洗水醉母/霉菌每周 cooling watercoliformweekly100 ml0 / 100 ml 冷却水大肠菌群每周total count10 ml <25 / ml总菌5is the plant following the required testing on sweeteners?工厂是否按照测试白砂糖检测要求?sampling points:检测点granulated sucrose: receiving container白砂糖袋包装liqui
15、d sucrose: receiving container袋包装液体糖 targets are: < 25 for total count / < 5 for yeast and mold.对象为:总菌霉而口 xhfss 42 or 55: receiving container.袋包装mis (medium invert sugar) : receiving container还原转化糖袋包装bo-rq-435sample test frequency samplespecification样品名检测频率样品量标准 gran. sucrose total bact. every
16、 5th10 g < 200 / 10 g*白砂糖总菌deliveryyeast10 g < 10 /10 g酵 母 5 批1次mold10 g < 10 /10 g霉菌 liquid sucrose total bact. each del.10 g < 200 / 10 g液体糖总菌每批target < 25 / 10 g目标 yeast10 g < 10 /10 gxtarget < 5 / 10 g目标 mold10 g < 10 /10 g霉菌target < 5 / 10 g目标 hfsstotal bact.each del.
17、10 g < 200 / 10 g 果匍糖浆总菌每批 yeast10 g < 10 /10 g酵母mold10 g < 10 /10 g 霉菌 mistotal bact.each del.10 g < 100 / 10 还原转化糖总菌每批yeast10 g < 10 /10 g酵母mold10 g < 10 /10 g霉菌6is the plant following the required testing on syrup / finished product?工厂是否按照糖浆及产品的要求进行检测?sampling points:取样点bo-rq-43
18、5sample test frequency samplespecification样品名检测频率样品量标准simple syrup: before each filter / after each filter单糖浆:每个过滤器前/后final syrup: each proportioner后糖缸:每个混比缸finished product (csd): each lines; 3 samples.最终广品(cs国碳酸产品)每条生产线3个样 simple syrup yeast &weekly5 ml < 5 / 5 ml 简单糖浆酵母每周mold霉 菌 final syru
19、pyeast &weekly5 ml < 5 / 5 ml 最后糖浆酵母每周mold霉 菌 finished prod. yeast &weekly20 ml < 10 / 20 ml 最终产品酵母每周(csd非碳酸产品!)mold霉菌7is the plant following the required testing on process equipment and others? 工厂是否按照在生产设备及其它方面的要求进 行检测?sampling points:取样点filler valve: each f川er, 2 samples充填阀:每个充填阀取2个
20、filler valve snift: each f川er, 2samples充填阀夹口每台充填机2个样empty container: 5 samples空罐:5个can warmer solution: each warmer罐暖瓶机:每台暖瓶机filler valve and filler snift swab tests are performed after sanitation to determine its effectiveness充填阀和充填阀夹口表面擦拭检查以评估清洗消毒效果。bo-rq-435sample test frequency samplespecificati
21、on样品名检测频率样品量标准 filler valve total count weeklyswab < 10 / valve 充填阀总菌每周擦拭阀yeast/mold swab < 10 / valve 酵母/霉 国擦拭阀 filler valve snift total countweeklyswab < 10 / snift 充填阀夹口 总菌每周擦拭夹口yeast/moldswab <10 / snift酵母/毒菌擦拭夹口empty container. total count troubleshooting< 50 / each空罐总菌故障排除后次 yea
22、st/mold < 25/ each醉母/霉菌 次warmer solutio total count weekly暖瓶水总菌每周8is an adequate microbiological monitoring program in use to validate the effectiveness of the cleaning & sanitation?是否使用适当的微生物监控计划来评估清洗消 毒效果? equipments are: mix tanks / storage tanks / fillers / etc.设备有:混比缸/储藏缸/充填机/等等see also
23、cleaning & sanitation module 也可参考“清洗消毒模块”micro results of the reference treated water can also be used to monitor the sanitary condition of the treated water pipe work.处理水的微生物检测结果参考值也常用来评估 水处理管道的消毒状况.bo-rq-434 sop s available on sampling and testing (final rinse water). sop标准操作程序)适用取样及测试(如 最后冲洗水
24、) use approved analytical procedures specified by division 使用经可乐公司认可的程序 roles and responsibilities for the monitoring are defined 监控任务和职责需明确. random, periodic sampling of all process equipment 随机和定期对生产设备进行取样 specify which process equipment , required daily or weekly, for sampling and testing 明确那些生产设
25、备需要每天或每周采样 测试. special frequency for equipment used in the production of microbiologically sensitive products 对微生物敏感的产品时的设备需制订特 别的采样检测频率 final rinse water only sampled when below 40 0 c 最后冲洗水只能在水温低于40。c时取 样 use swab test if sampling of final rinse water is not possible 在最后冲洗水不容易取就采用擦拭法检测 use final r
26、inse water reference samples( just before inlet) 使用最后冲洗水作参考样(刚好在入 口处) use a sterile water control sample with each batch of samples.使用无菌水来处理每批样品9is the plant using company specified microbiological monitoring methods? 工厂是否使用指定的微生物监测方法?sm-pr-660 / sm-pr-605 membrane filtration: generally applicable,膜
27、过滤法普遍使用 pour plate technique: generally applicable平板法 普遍使用 colilert:to determinecoliform in water 发酵法检测水中大肠菌群millipore 55+ monitors: totalcount / yeast & mold / coliformmillipore 膜过滤法总菌/醉母和霉菌/大肠菌群 atp biolumininescence:todetermine san. cond. of surfaces atp (三磷酸腺酊)评估物体表面清洁状况 redigel:tot. count /
28、 yeast& mold / coliform总菌/醉母和霉菌/大肠菌群* m-air-t:to determine moldand yeast in air测试空气中醉母和霉菌的量 rcs:to determinemold and yeast in air测试空气中醉母和霉菌的量10is the plant properly conducting the membrane filtration technique where applicable?工厂是否正确使用膜过滤?sm-pr-625 good microbiological practices are in use良好的微生物
29、操作note: juices might require largerfilter sizes (e.g. 1,2仙 m)注:过滤果汁可能需要更大孔径的滤膜(例如1,2 n) the plant uses the correct membrane filters工厂使用止确的滤膜- 0,45 n m for total count / coliform-0,45以好1径用于才测总菌/大肠菌 群-0,65 or 0,80 n m for yeast and mold0,65小联0,80以好1径用于检测酵 母和与困11is the plant properly conducting the pou
30、r plate technique where applicable?工厂是否正确使用倾倒平板法?sm-pr-655 technique is only used if membrane filtration is not possible (when sample can not be filtered, or high reading is expected)平板法仅用于膜过滤法无法进行时(当 样品无法过滤或菌量估计较大时). good microbiological practices are in use 使用良好的微生物操作 plates are inverted during in
31、cubation培亦时平皿必须倒放12is the plant properly conducting other microbiological methods? (if applicable) 工厂是否适当采用其它微生物检验方法?standards methods manual - microbiological testing section 标准方法手册一微生物检测部分 see manual for bioburden, direct microscopic examination, heat-resistant mold, howard mold count, listeria su
32、rveillance, plate contact, swab contact, spot test and thermophilic acidophilic bacteria. 参考 bioburden检测手册、 “耐热霉菌检测”、“霍华德霉菌计数”、“李斯特监测法”、“平板 法”、“擦拭法”、“现场检测法”和 “嗜热嗜酸菌检测”13are correct media used? 是否使用合适的培养基?sm-pr-660media (培养基) total count:m-tger2a总菌 yeast & mold:m-green y&mschaufus-pottinger 酵母困/毒菌 coliform:m-endo大肠菌群exceptions:例外 total count r2amedia not for: co2, n2, hfss, granular and liquid sucrose, equipment surfaces, juice containing beverages, washed & rinsed containers 总菌检测r2a培乔基不适于:二氧化 碳、氮气、果匍糖浆、颗粒状和液态
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