PET无菌灌装和包装技术.ppt

Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,Classified-Internal Use OnlySCMC BOARD MEETING JAN.23,rd,2003,*,PET,无菌灌装和包装技术,2,灌装技术发展,含汽饮料,铝罐热灌装,PET,热灌装,PET,超洁净热灌装,PET,无菌灌装,1960,1970,1980,1990,2000,杀菌釜,风险和,技术难度,2002,铝瓶,罐无菌灌装,Comparison of,Aseptic,vs Hot Filling,无菌灌装和热灌装的比较,Hot Fill,热灌装,Aseptic Fill,无菌灌装,What can be filled,可灌装产品,Juice,Green/Black/Olong Tea,Black Coffee,Sports Drink,果汁，绿,/,红,/,乌龙茶，黑咖啡，运动饮料,Juice,Green/Black/Olong Tea,Barley Tea,Black Coffee,Sports,Drink,Milk containing Coffee&Tea,Flavor/White Milk,果汁，绿,/,红,/,乌龙茶，大麦茶，黑咖啡，运动饮料，奶茶,/,咖啡，纯,/,风味牛奶,Key Manufacturing,Equipment,关键生产设备,UHT/HTST,Hot Filler,Clean Room,Closure,Pasteurizer,超高温,/,高温瞬时杀菌机，热灌装机，洁净室，倒瓶杀菌机,UHT&Aseptic Tank,Aseptic Filler(including Bottle Sterilizer,Closure Sterilizer,NASA 100 Clean Room),超高温和无菌罐，无菌灌装（瓶和盖杀菌，洁净室）,Dissolved Oxygen,溶解氧,Very few,很少,More,较多,Critical Points,关键控制点,Filling Temperature,Filling Environment,灌装温度，罐装环境,Beverage Sterilization,Package Sterilization,Sterilization&,Maintenance of Manufacturing Equipment and Environment,饮料杀菌，包装杀菌，生产设备和环境的杀菌及维护,Operation,运营管理,Focus on Filling Temperature,控制灌装温度,Total Process Management,全流程管理,Labor Skill,操作者技能,Low,较低,Higher operation skill,较高的操作技能,4,无菌灌装系统,无菌灌装系统,空气，水,杀菌,杀菌,隔离,环境,操作人员,包装,饮料,设备,杀菌,Cost of,Aseptic,vs Hot Filling,无菌灌装和热灌装的成本,Hot Fill,热灌装,Aseptic,无菌灌装,Bottle Weight,瓶重,26,20.5,PET Resin Cost,树脂成本,0.26,0.205,Preform Injection cost,注塑成本,0.084,0.045,Closure,盖,0.06,0.06,Label,标签,0.02,0.02,Blowing&Filling Cost,吹瓶和灌装,成本,0.15,0.15,Amount,合计,0.574,0.48,Cost Saving,成本节省,0.094,500ml Product Cost/500ml,饮料成本,Aseptic filling can save nearly 0.1 RMB per 500ml bottle.,无菌灌装可节省,0.1,元瓶,Machine,&,E,quipment,机器设备,Most effective aseptic design,有效的无菌设计,Simple structure,简单结构,Smooth surface,表面光滑,No dead space,没有死角,Airtight,sealed,隔绝空气密封,All surface to be washed and sterilized,所有表面容易清洗消毒,Materials/structure durable to chemicals and heat,材料耐腐蚀，耐热,Automatic COP/CIP/SIP,自动内外清洗消毒,Critical points to be checked and recorded,关键控制点的监测和记录,Critical equipment to be visually checked,关键设备的人工目检,Isolated from non-aseptic area,materials,conveyors,与非无菌区域的隔离,Design criteria,设计标准,Filling system:6D reduction,杀菌能力,log 6,灌装系统,Residue of,H2O2,-less than 0.5ppm,杀菌剂残余量小于,0.5ppm,Isolation:air,water,conveyor,rotary part,旋转部件的隔离,Easy to wash and sterilize all surface,表面易清洗消毒,Neck handling,吊瓶口,Check and record critical conditions,关键状况的监测和记录,Non-touch filling valve,非接触式灌装阀,Negative pressure in capper machine room,旋盖机保持相对负压,Servo capper for high-speed,filler,高速灌装机需要伺伏电机旋盖机,UHT:,Turbular heat exchange with p,ressure balance,压力平蘅的管式热交换器,Piping:Easy to visually check,便于目检,Aseptic tank:Steam barrier for,mechanical seal,机械密封有蒸汽杀菌,Hygiene,agitator,无菌搅拌器,Environment Control,环境控制,Isolated from microbe contamination,隔绝微生物污染,Zone control,区域控制,Filling/capping under highest positive pressure,灌装区域保持正压,Isolated from operator,人员隔离,Human being the most contamination source,人是最大的污染源,Cleaning and disinfection on all surface,清洗消毒所有表面,Periodical cleaning/disinfection,周期性清洗消毒,Organized program and verification,按程序验证消毒结果,Air,quality,control,空气质量控制,Not sterilized,but filtered,不需要消毒，但要过滤,Double filter system,双过滤系统,Periodically change filters,周期性更换过滤网,Integrity test for sterilized filter,检测无菌过滤网的完整性,Particle count,使用尘埃颗粒记数器,Ventilation System for Production Area,生产区域的通风系统,Area,区域,Cleanness,洁净度,Ventilation Cycle Time(time/hr),循环次数,Temperature(),温度,Relative Humidity(%),相对湿度,Fresh Air Rate(%),新风量,Positive Pressure,正压,Process,调配,MEPA Filtation,中效过滤网,30,to be determined,待定,to be determined,待定,local code,暖通标准,N/A,Blow Machine,吹瓶,MEPA Filtation,中效过滤网,1425,2,030,5010,3060,Yes,Filling Room,灌装间,NASA Class 10,000,25,50,1530,5010,20100,Yes,Packing,包装区,N/A,3,to be determined,待定,to be determined,待定,local code,暖通标准,N/A,Clean Room Standard,洁净室的标准,NASA Class,Partical Size,尘埃颗粒尺寸,0.1m,0.2m,0.3m,0.5m,1m,5m,100,2,841,673,290,100,24,1,1,000,28,409,6,733,2,898,1,000,236,8,10,000,N/A,N/A,N/A,10,000,2,364,82,100,000,N/A,N/A,N/A,100,000,23,636,824,Beverage,饮料,Beverage for aseptic filling,无菌灌装的饮料,All most all non-carbonated beverage can be filled except:,所有非碳酸饮料除了：,Juice sac containing products,含果粒的饮料,High viscosity products.,高粘度产品,Oxygen control,溶氧控制,Usually oxygen more in aseptic-fill product than in hot-fill product,无菌灌装产品溶氧量高于热灌装产品,Oxygen reduction technology to be applied for sensitive products,Head space air in tanks and bottles is replaced with N2 gas.,对明感产品应用氮气置换罐和瓶口的空气,Beverage processing,饮料工艺,Minimize initial contamination,减少内部污染,Low temperature,short storage,温度低，保存时间短,Appropriate beverage sterilization,适当的饮料消毒,Time,temperature,时间，温度,Pressure balance,压力平衡,Package,包装,Package quality:,包装质量,Minimize initial contamination,减少瓶和盖的内部污染,Bottle,closure,Package design:,包装设计,Material:,包装材料要耐腐蚀，耐温,Durable to chemical and heat treatment,Shape:,包装形状能与消毒剂充分接触，易于清洗消毒,Full contact with chemicals,Easy to wash and sterilize,Challenge test/Durability test,测试,6D reduction with target microbes,微生物消毒能力,log6,Durability in taste,adhesion of printing,没有异味，印刷没有剥落,Supplier,transportation/storage,GMP,供应商的,GMP,，运输，储存,Package,Sterilization Agency,包装消毒剂,PAA is mixture of peroxyacetic acid,hydrogen peroxide,acetic acid and water,过氧乙酸是过氧化氢，乙酸和水的混合物，消毒温度为,55-65,CH3COOH+H2O2CH3COOOH+H2O,Normally sterilizing temperature of PAA is 55-65,Hydrogen peroxide is another sterilant,双氧水是另一种消毒剂，消毒时吹热空气使过氧化氢蒸发，瓶的温度将达,70,以上,2H2O2 2H2O+O2,Sterilizing temperature would be more than 70 because of utilization of hot air more than 100 to evaporate hydrogen peroxide,Comparison of PAA&H,2,O,2,两种消毒剂的比较,Bacillus,subtilis,枯草芽孢杆菌,Bacillus cereus,蜡状,芽孢杆菌,Bacillus polymyxa,多粘芽孢杆菌,Bacillus,i,巨大芽孢杆菌,Aspergillus niger,黑霉菌,H,2,O,2,PAA,Sterilization effect,消毒效果,：,：,：,or more,Bottle Sterilization with H2O2,用消毒的设备,Shibuya,SIG/,Asbofill,Ampack,KHS/Alfill,Stock,Bosch,Tetra-Pak,Combibloc,International Paper,H,2,O,2,Inject Temperature(),H,2,O,2,喷射温度,65,7090,7090,52,70,60,70,90,70,Hot Air Active Temperature(),热风温度,120,140,110,110,144,110,90,130,140,110,Rinsing Method,冲瓶方式,hot water,hot air,hot air,hot air,hot air,hot air,hot air,hot air,hot air,Rinsing Temperature(),冲瓶温度,65,7090,7090,72,80,60,90,90,80,Holding Time(sec),保持时间,13,20,20,17,10,20,7,10,10,Log Reduction,消毒效果,6,6,6,6,4,4,6,6,4,Bottle Sterilization with PAA,用过氧乙酸消毒的设备,Krones,MHI,Procomac,Serac,Sidel,SIG,Sterilent Temperature for Bottle Sterilization,消毒温度,60,6065,65,50,5,5,56,60,PA,A,Concentration for Bottle Sterilization,过氧乙酸浓度,2000ppm,15002000ppm,16002000,ppm,1800,ppm,2000 ppm,1800ppm,Contact Time for Bottle Sterilization(sec),消毒时间,17.5,13,1012,20,16,35,Method of Sterilization,消毒方式,Spray ambient PA with steam to inject into bottle,Rinsing,Rinsing,Soaking,Rinsing,Soaking&Rinsing,Sterilent Recycling System,消毒剂循环,N/A,Yes,Yes,Yes,Yes,Yes,High temperature sterilization will make bottle shrink,消毒温度高将使瓶收缩,65 sterilization temperature is safety for non-crystalized PET.,65,对非结晶,PET,瓶是安全的,When sterilization temperature is more than 70,PET bottle is better to be crystalized,消毒温度超过,70,PET,瓶最好要结晶,If sterilization temperature is more than 90,PET is not applicable.HDPE or PP will be replacement,消毒温度超过,90,PET,瓶不适用，可以用,HDPE,或,PP,材料,Sterilization Influence on Package,消毒对包装的影响,Operation,运营管理,Total process control assures quality,全程质量控制,Follow QA manual and SOP,跟踪品控手册和标准操作程序,Automatic c,hecking for critical conditions,自动检测关键点,COP,SIP:temperature,清洗温度,Package sterilization:temperature,flow-rate,concentration,包装消毒的温度，流量，浓度,UHT:temperature,pressure,UHT,的温度，压力,Steam barrier:temperature,蒸汽温度,Visual check still essential,人工目检依然重要,Leakage of beverage,CIP detergent,饮料泄漏，,CIP,消毒剂,Rinsing nozzle conditions,冲瓶头的状态,Quality tests not make quality,监控并不能创造质量,Operators sensitivity and managers knowledge/leadership help prevent trouble,操作人员的敏感性和管理人员的领导能力的知识水平将有助于防止事故,People skill and education,is,important,人员的教育和技能很重要,Understanding of aseptic system and microbiology,充分理解无菌系统和微生物知识,Trouble information among aseptic plants,工厂之间的信息共享,Quality of product,影响产品质量的因素,Aseptic system capability,无菌系统的能力,Structure/design of machine and environment,机器和环境的设计和结构,Sterilization of machine and environment,机器和环境的消毒,Package sterilization conditions,包装的消毒,Maintenance of aseptic conditions,无菌状态的维护,Operation,运营管理,Package quality,包装质量,Process control,过程控制,Preventive maintenance,预防性维护,Quality test,品控检测,Sensitivity to unusual conditions,对非正常情况的敏感性,Improvement in facility and operation,设备和操作的改进,Key to success aseptic operation,成功运营的关键,Appropriate aseptic system/supplier,合适的无菌系统,/,供应商,Understanding of aseptic system,对无菌系统的理解,Leadership of management,管理者的领导能力,Good operators and supervisors,好的操作人员,Organized training,组织培训,Operation Manuals/SOPs,操作手册和标准操作过程,Preventive maintenance program,预防性维护程序,