1、CC ASEPTIC LINE L667北京汇源集团公司 PET 工厂灌装工序关键控制手册北京汇源集团 PET 工厂无菌冷灌装线关键控制手册 第 2 页，共 16页HACCP PLAN DEFINITIONS 定义：CRITICAL CONTROL POINT: Point of the process whose control is essential either to prevent or remove any possible risk for the safety of the product or in order to reduce it to an acceptable va
2、lue.关键控制点：即指对这些点进行控制能够预防或排除任何危及产品安全的因素，或者将其降低至可接受的范围。SPECIFICATION: Criteria which delimits the acceptability or the unacceptability of the process parameters subject to control.规范：即指给所需控制的过程参数划定可接受和不可接受的界限的标准。CONTROL: Activity, manual or automatic, control of the critical points to ensure they obse
3、rve the specifications.控制：即指手动或自动的行为，用以控制关键点，确保其遵守规范。AUTOMATIC ACTION: Automatic control system action, in the event that a specification is not observed.自动动作：即指自动控制系统的动作， 在不遵守规范的事件发生时执行。RECORDING SYSTEM: Activity, manual or automatic, monitoring of the critical control points.记录系统：即指手动或自动的行为，用以监测关键
4、控制点。VISUAL CONTROL: Visualization of the process parameters subject to automatic control.视觉控制：使可观察到的过程参数受自动控制。COUNTERMEASURES: This has to be performed when the monitoring system of a critical control point indicates that the specification has not been observed.对策：在关键控制点监测系统显示有违反规范的事件发生时执行。PERSON IN
5、 CHARGE: Person in charge of controlling and monitoring activities and of carrying out the countermeasures :负责人员：指负责控制和监测的行为并执行对策的人员。QA = Quality Assurance 质量保证员（即品控员）OP = Operator 操作员北京汇源集团 PET 工厂无菌冷灌装线关键控制手册 第 3 页，共 16页C. b. display = Control board display 主控制板显示器L. A. = low acid products 低酸产品H. A
6、. = high acid products 高酸产品Nr.序号CRITICAL CONTROLPOINT关键控制点SPECIFICATIONS规范CONTROL控制AUTOMATICACTION自动动作MONITORING SYSTEM监测系统VISUAL CHECK视觉检查COUNTERMEASURES对策PERSON IN CHARGE负责人员1 OXONIA PREPARATION - PRODUCTION UNIDOX Ref. Draw. 4-40672/20 rev. 1UNIDOX生产过程杀菌液制备1.1 Peracetic acid concentration 过氧乙酸浓度M
7、in. 最低 1400 ppm AT-02 Titrator自动滴定仪PAA concentrate product adding添加浓杀菌液Laboratory notebook(every 15 min.)检测记录(每 15 分钟)AT-02 TitratorDisplay自动滴定仪显示屏Concentration recovery to start自动调节浓度到设定值QA/OP品控员 /操作员1.2 Minimum delivery temperature最低泵送温度MIN.最低H.A.高酸 50CL.A.低酸 63CTemperature transmitter温度传感器TT 04Fi
8、ller on stand by灌装机处于等待状态Oxonia re-circulation杀菌液打循环C. b. alarm list主控制板报警列表Unit display单元显示屏C. b. display主控制板显示屏Specified temperaturerecovery to start自动调节温度到设定值OP操作员1.3 Minimum delivery pressure最低泵送压力Min.最低 4,5 bar Pressure switch压力开关PT 12Filler on stand by灌装机处于等待状态Oxonia re-circulation杀菌液打循环None无U
9、nit display单元显示屏C. b. display主控制板显示屏Specified pressure recovery to start自动调节压力到设定值OP操作员1.4 Oxonia filters differential pressure杀菌液过滤器压差Max.最大 1 bar Pressure transmitter压力传感器PT 10 / PT 12Alarm + Oxonia unit stop报警UNIDOX 停机None无Unit display单元显示屏C. b. display主控制板显示屏Filters cleaning清洗过滤器OP操作员2 WATER STE
10、RILIZATION PRODUCTION WATER UNITHERM Ref. Draw. 4-54739/3 rev. 2UNITHERM生产过程 水杀菌2.1 Holding tube exit Temperature保温管出口温度MIN.最低1nd Alarm 报警温度 136CTemperature transmitters温度传感器TT 141st Immediate system separation立即将系统分离2nd Loss of sterility失去无菌状态Data logging数据记录Unit display单元显示屏C. b. display主控制板显示屏1st
11、 Automatic water re-circulation自动进行水循环2nd UHT unit re-sterilization重新进行管道杀菌OP操作员2.2 Water flow rate水流量Max. flow rate最大流量33.000 L/hFlow transmitter流量传感器FT 12Immediate stop立即停止Lost sterility of the unit 失去无菌状态Re-sterilization重新杀菌Data logging数据记录Unit display单元显示屏C. b. display主控制板显示屏UHT unit re-steriliz
12、ation重新进行管道杀菌OP操作员北京汇源集团 PET 工厂无菌冷灌装线关键控制手册 第 4 页，共 16页Nr.序号CRITICAL CONTROLPOINT关键控制点SPECIFICATIONS规范CONTROL控制AUTOMATICACTION自动动作MONITORING SYSTEM显示系统VISUAL CHECK视觉检查COUNTERMEASURES对策PERSON IN CHARGE负责人员3 WATER STERILIZATION STERILIZATION WATER UNITHERM Ref. Draw. 4-54739/3 rev. 2UNITHERM杀菌过程 水杀菌3.
13、1 Sterilization temperature杀菌温度MIN.最低1nd Alarm 报警 136CTemperature transmitter温度传感器TT 161st Reset of the timer重新计时2nd Cooling and re-sterilization冷却后重新杀菌Data logging数据记录Unit display单元显示屏C. b. display主控制板显示屏Temperature recovery to start自动调节温度到设定值OP操作员4 NITROGEN STERILE FILTRATION - PRODUCTION UNIFLUX
14、Ref. Draw. 4-55604 rev. 5UNIFLUX生产过程氮气的无菌过滤4.1 Sterile nitrogen pressure无菌氮气压力Min.最低 0,5 bar Pressure switch压力开关PS 367Immediate stop立即停机Alarm list报警列表None无-Replace filters-更换过滤器- Re-sterilization-重新杀菌OP操作员5 AIR STERILE FILTRATION PRODUCTION UNIFLUX Ref. Draw. 4-55604 rev. 5UNIFLUX生产过程压缩空气的无菌过滤5.1 St
15、erile air pressure无菌空气压力Min.最低 1 bar Pressure switch压力开关PS 274Immediate stop立即停机Alarm list报警列表None无-Replace filters-更换过滤器- Re-sterilization-重新杀菌OP操作员6 NITROGEN STERILE FILTRATION / AIR STERILE FILTRATION - STERILIZATION UNIFLUX Ref. Draw. 4-55604 rev. 5UNIFLUX杀菌过程氮气、压缩空气过滤器6.1 Air filters sterilizat
16、ion temperature空气过滤器杀菌温度Min 最低 129C Temperature transmitter温度传感器TT 278Immediate stop立即停机Alarm list报警列表C. b. display主控制板显示屏Specified temperaturerecovery to start自动调节温度至设定值OP操作员6.2 Steam inlet pressure蒸汽进口压力Min.最低 2,5 bar Pressure switch压力开关PS 166Immediate stop立即停机Alarm list报警列表C. b. display主控制板显示屏Spe
17、cified pressure recovery to start自动调节压力至设定值OP操作员7 BOTTLE STERILIZATION - PRODUCTION - GRIPSTAR STERILIZER Ref. Draw. 4-55604 rev. 5瓶杀菌机生产过程瓶杀菌7.1 Machine output机器产量Max.最高 36.000 bph fed scroll rotation旋转轴反馈信号Limit to the speed adjuster受限于速度调节器Supervision data logging管理器数据记录C. b. display主控制板显示屏None无O
18、P操作员北京汇源集团 PET 工厂无菌冷灌装线关键控制手册 第 5 页，共 16页Nr.序号CRITICAL CONTROLPOINT关键控制点SPECIFICATIONS规范CONTROL控制AUTOMATICACTION自动动作MONITORING SYSTEM显示系统VISUAL CHECK视觉检查COUNTERMEASURES对策PERSON IN CHARGE负责人员7.2 PA based disinfectant temperature杀菌液温度MIN.最低H.A.高酸 50CL.A.低酸 63CTemperature transmitter温度传感器TT 861Stand by
19、 等待Oxonia re-circulation杀菌液再循环Data logging数据记录Temperature indicator温度指示器C. b. display主控制板显示屏Specified temperaturerecovery to start自动调节温度至设定值OP操作员7.3 PA based disinfectant pressure杀菌液压力Min.最低 2,5 bar Pressure switch压力开关PS 878Immediate stop立即停机Alarm list报警列表None无Specified pressurerecovery to start自动调节
20、压力至设定值OP操作员7.4 PA based disinfectant flow rate杀菌液流量Set 设定 41.000 L/hAlarm 报警 36.900 L/hMagnetic flow-meter电磁流量计FT 862Immediate stop立即停机Alarm list报警列表C. b. display主控制板显示屏Flow meter display流量表显示Specified flow raterecovery to start自动调节流量至设定值OP操作员7.5 Environment contamination control环境污染控制Door closed门关闭
21、Door sensor门传感器Immediate stop立即停机Alarm list报警列表C. b. display主控制板显示屏None无OP操作员7.6 Manipulation gloves手套Integrity完好性No damage to the feel无可感知的损坏None无Production notebook(end of production)生产记录（生产结束）None无Replace the glove更换手套OP操作员7.7 Verify nozzle spraying喷嘴喷洒状况Nozzles working correctly喷嘴工作的正常性1st Warni
22、ng 提示2nd Alarm 报警Smart sensor精确传感器1st Warning to the operator给操作员提示信息2nd Immediate stop立即停机Alarm list报警列表C. b. display主控制板显示屏Replace the nozzle andre-sterilize更换喷嘴并重新杀菌(hold product up until that time)（可以保持产品至更换完成）OP操作员7.8 Verify nozzle spraying 喷嘴喷洒状况Nozzles working correctly喷嘴工作的正常性Visual inspecti
23、on目测None无Production notebook(once a shift)生产记录（每班一次）None无Replace the nozzle andre-sterilize更换喷嘴并重新杀菌(hold product up until that time) （可以保持产品至更换完成）OP操作员7.9 Nozzle filters check喷嘴过滤器检查Cleaning and integrity清洁性及完好性Visual inspection目测None无Production notebook(once a month)生产记录（每月一次）None无Filters cleaning
24、清洁过滤器OP操作员8 BOTTLE RINSING - PRODUCTION - GRIPSTAR RINSER Ref. Draw. 4-55604 rev. 5冲瓶机生产过程瓶冲洗8.1 Rotating manifold steam barrier temperature旋转歧管的蒸汽障蔽温度Min.最低 80C Temperature transducer温度传感器TT 061Immediate stop立即停机Lost sterilityData logging数据记录C. b. display主控制板显示屏Complete sterilization of the system对
25、系统进行彻底杀菌OP操作员北京汇源集团 PET 工厂无菌冷灌装线关键控制手册 第 6 页，共 16页失去无菌状态Nr.序号CRITICAL CONTROLPOINT关键控制点SPECIFICATIONS规范CONTROL控制AUTOMATICACTION自动动作MONITORING SYSTEM显示系统VISUAL CHECK视觉检查COUNTERMEASURES对策PERSON IN CHARGE负责人员8.2 Sterile water temperature无菌水温度Min.最低 50C Temperature transmitter温度传感器TT 864Stand by等待状态Data
26、 logging数据记录Temperature indicator温度指示器C. b. display主控制板显示屏Specified temperature recovery to start自动调节温度至设定值OP操作员8.3 Sterile water pressure无菌水压力Min.最低 2,5 bar Pressure switch压力开关PS 881Immediate stop立即停机Alarm list报警列表C. b. display主控制板显示屏Specified pressure recovery to start自动调节压力至设定值OP操作员8.4 Sterile wa
27、ter flow rate无菌水流量Set 设定 14.500 L/hAlarm 报警 13.000L/hMagnetic flow-meter电磁流量计FT 865Immediate stop立即停机Alarm list报警列表C. b. display主控制板显示屏Flow meter display流量表显示屏Specified flow rate recovery to start自动调节流量至设定值OP操作员8.5 Verify nozzle spraying 喷嘴喷洒状况Nozzles working correctly喷嘴工作的正常性1st Warning 警示2nd Alarm
28、 报警Smart sensor精确传感器1st Warning to the operator给操作员以提示信息2nd Immediate stop立即停机Alarm list报警列表C. b. display主控制板显示屏Replace the nozzle andre-sterilize更换喷嘴并重新杀菌(hold product up until that time)（可以保持产品至更换完成）OP操作员8.6 Verify nozzle spraying 喷嘴喷洒状况Nozzles working correctly喷嘴工作正常Visual inspection目测None无Produc
29、tion notebook(once a shift)生产记录（每班一次）None无Replace the nozzle andre-sterilize更换喷嘴并重新杀菌(hold product up until that time)（可以保持产品至更换完成）OP操作员8.7 Environment contamination control环境污染控制Min. 0,2 mmH2O overpressure正压最低 0.2 毫米水柱Pressure gauge压力表Immediate stop立即停机Alarm list报警列表C. b. display主控制板显示屏At alarm res
30、et discharge the bottles inside the block将灌装区瓶子排出Automatic short sterilization/rinse cycle自动执行短杀菌循环OP操作员8.8 Environment contamination control环境污染控制Door closed门关闭Door sensor门传感器Immediate stop立即停机After reset discharge the bottlesShort Oxonia cycle瓶子排出后做短杀菌循环Alarm list报警列表C. b. display主控制板显示屏At alarm r
31、eset discharge the bottles inside the block报警复位后将灌装区内瓶子排出Automatic short sterilization/rinse cycle自动进行短杀菌循环OP操作员北京汇源集团 PET 工厂无菌冷灌装线关键控制手册 第 7 页，共 16页Nr.序号CRITICAL CONTROLPOINT关键控制点SPECIFICATIONS规范CONTROL控制AUTOMATICACTION自动动作MONITORING SYSTEM显示系统VISUAL CHECK视觉检查COUNTERMEASURES对策PERSON IN CHARGE负责人员8.
32、9 Mainframe contamination control主框架污染控制RS7 position 12BRS9 position 13B（检测点请参照微生物取样与分析指南，下同）Sterility无菌性Microbiological(swabs)微生物（表面涂抹实验）None无Laboratory notebook(end of production)检测记录（生产结束后）None无Verify the efficiency of the HEPA filter检验高效过滤器有效性Verify the sterilization system检验杀菌系统Verify the PA ba
33、sed disinfectant concentration检验杀菌液浓度QA品控员8.10 Rinser inlet star-wheel冲瓶机进口星轮RS6 position 12ASterility无菌性Microbiological(swab) 微生物（表面涂抹实验）None无Laboratory notebook(end of production) 检测记录（生产结束后）None无Verify the efficiency of the HEPA filter检验高效过滤器有效性Verify the sterilization system检验杀菌系统Verify the PA b
34、ased disinfectant concentration检验杀菌液浓度QA品控员8.11 Rinser exit star-wheel冲瓶机出口星轮RS8 position 13ASterility无菌性Microbiological(swab) 微生物（表面涂抹实验）None无Laboratory notebook(end of production) 检测记录（生产结束后）None无Verify the efficiency of the HEPA filter检验高效过滤器有效性Verify the sterilization system检验杀菌系统Verify the PA b
35、ased disinfectant concentration检验杀菌液浓度QA品控员8.12 Environment contamination control环境污染控制RA2 position 4RA1 position 3Sterility无菌性MicrobiologicalTC, M & Y(OPEN PLATES)微生物，霉菌及酵母菌（空气暴露实验）None无Laboratory notebook(end of production)检测记录（生产结束后）None无Verify the efficiency of the HEPA filters检验高效过滤器有效性Verify t
36、he microbiological isolator检验微生物隔离层QA品控员8.13 Environment contamination control环境污染控制M3,5 Class(FS 209E)洁净等级为百级Manual control with particle counter(under HEPA filters)粒子计数器（在高效过滤器下方）None无Laboratory notebook(end of production, when the machines have been at a standstill for at least 30 min.)检测记录(生产结束，
37、且设备停止至少 30 分钟后)None无Verify the efficiency of the HEPA filters检验高效过滤器有效性Verify the microbiological isolator检验微生物隔离层QA品控员北京汇源集团 PET 工厂无菌冷灌装线关键控制手册 第 8 页，共 16页Nr.序号CRITICAL CONTROLPOINT关键控制点SPECIFICATIONS规范CONTROL控制AUTOMATICACTION自动动作MONITORING SYSTEM显示系统VISUAL CHECK视觉检查COUNTERMEASURES对策PERSON IN CHARG
38、E负责人员8.14 Mainframe contamination control主框架污染控制Sterility无菌性WaterTC, M & Y(250 ml in double from a nozzle opened in manual mode)水，霉菌及酵母菌（手动打开一个喷嘴，取 250ml 样品两瓶）None无Laboratory notebook(end of production)检测记录（结束生产后）None无Verify the efficiency of the HEPA filter检验高效过滤器有效性Verify the sterilization system检
39、验杀菌系统Verify the PA based disinfectant concentration检验杀菌液浓度QA品控员8.15 Nozzle filters check喷嘴过滤器检查Cleaning and integrity清洁性及完好性Visual inspection目测None无Production notebook(once a month)生产记录（每月一次）None无Filters cleaning清洁过滤器OP操作员9 BOTTLE RINSE STERILIZATION GRIPSTAR RINSER Ref. Draw. 4-55604 rev. 5冲瓶机杀菌过程瓶
40、冲洗9.1 Manipulation gloves手套Integrity完好性No damage to the feel无可感知的损坏None无Production notebook(before starting the sterilization process)生产记录（开始杀菌程序前）None无Replace before launching the cycle在循环开始前更换OP操作员9.2 PA based disinfectant temperature杀菌液温度Min.最低 63C Temperature transmitter温度传感器TT 04(Ref. draw.4-40
41、672/20 rev.1)Stand by等待状态Water flushingRestarting重新开始水冲洗Alarm list报警列表C. b. display主控制板显示屏Specified temperature recovery to start自动调节温度至设定值OP操作员9.3 PA based disinfectant pressure杀菌液压力Min.最低 4,5 bar Pressure switch压力开关PT 12(Ref. draw.4-40672/20 rev.1)Immediate stop立即停机Alarm list报警列表None无Specified pre
42、ssure recovery to start自动调节压力至设定值OP操作员9.4 Verify external sterilization nozzles spraying外部杀菌喷嘴的喷洒状况Nozzles working correctly喷嘴工作的正常性Visual inspection目测None无Production notebook(every cycle)生产记录（每个循环）None无Replace the nozzle andre-sterilize更换喷嘴并重新杀菌OP操作员9.5 Environment contamination control环境污染控制Door c
43、losed门关闭Door sensor门传感器Immediate stop立即停机Alarm list报警列表C. b. display主控制板显示屏Automatic sterilization/rinse cycle at alarm reset报警复位后自动执行杀菌/冲洗循环 OP操作员北京汇源集团 PET 工厂无菌冷灌装线关键控制手册 第 9 页，共 16页Nr.序号CRITICAL CONTROLPOINT关键控制点SPECIFICATIONS规范CONTROL控制AUTOMATICACTION自动动作MONITORING SYSTEM显示系统VISUAL CHECK视觉检查COUN
44、TERMEASURES对策PERSON IN CHARGE负责人员9.6 Environment contamination control环境污染控制Min. 0,2 mmH2O overpressure正压最低 0.2mm 水柱Pressure gauge压力表Immediate stop立即停机Alarm list报警列表C. b. display主控制板显示屏Automatic sterilization/rinse cycle at alarm reset报警复位后自动执行杀菌/冲洗循环OP操作员9.7 Sterile water无菌水Sterility无菌性Rinse water冲
45、洗水TC, M & Y(250 ml in double from a nozzle on the base frame)（从底座喷嘴处取两瓶250ml 样品）None无Laboratory notebook(every cycle)检测记录（每次循环）None无Verify rinsing line检查冲洗管路QA品控员10 FILLING / CAPPING PRODUCTION FILLSTAR FX Ref. Draw. 4-55604 rev. 5灌装机生产过程灌装/旋盖10.1 Rotating manifold steam barrier temperature旋转歧管蒸汽障蔽温
46、度Min.最低 80C Temperature transducer温度传感器TT 065Immediate stop立即停机Lost sterility失去无菌状态Data logging数据记录C. b. display主控制板显示屏Complete sterilization of the system对系统进行彻底杀菌OP操作员10.2 Fix feeding piping steam barrier temperature进料管蒸汽障蔽温度Min.最低 80C Temperature transducer温度传感器TT 067Immediate stop立即停机Lost steril
47、ity失去无菌状态Data logging数据记录C. b. display主控制板显示屏Complete sterilization of the system对系统进行彻底杀菌OP操作员10.3 Aseptic tank pressure无菌罐压力Min.最低 20 mbar Pressure transducer压力传感器PT 662Immediate stop立即停机Lost sterility失去无菌性Data logging数据记录C. b. display主控制板显示屏Complete sterilization of the system对系统进行彻底杀菌OP操作员10.4 E
48、nvironment contamination control环境污染控制Door closed门关闭，保持正压Door sensor门传感器Immediate stop立即停机Alarm list报警列表C. b. display主控制板显示屏At alarm reset discharge the bottles inside the block报警复位后将灌装区内瓶子排空Automatic short sterilization/rinse cycle自动执行短杀菌循环OP操作员10.5 Environment contamination control环境污染控制Min. 0,2 m
49、mH2OOverpressure正压最低 0,2 mm 水柱Pressure gauge压力表Immediate stop立即停机Alarm list报警列表C. b. display主控制板显示屏At alarm reset discharge the bottles inside the block报警复位后将灌装区内瓶子排空Automatic short sterilization/rinse cycle自动执行短杀菌循环OP操作员北京汇源集团 PET 工厂无菌冷灌装线关键控制手册 第 10 页，共 16页Nr.序号CRITICAL CONTROLPOINT关键控制点SPECIFICATIONS规范CONTROL控制AUTOMATICACTION自动动作MONITORING SYSTEM显示系统VISUAL CHECK视觉检查COUNTERMEASURES对策PERSON IN CHARGE负责人员10.6 Mainframe contamination control主框架污染控制FS3 position 3ASter
