PET无菌灌装和包装技术.ppt

1、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,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,500ml Product Cost/500ml饮料成本,Aseptic filling ca

2、n save nearly 0.1 RMB per 500ml bottle. 无菌灌装可节省0.1元瓶,Machine & Equipment 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

3、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 0.5p

4、pm 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

5、高速灌装机需要伺伏电机旋盖机 UHT: Turbular heat exchange with pressure 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

6、 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 filte

7、red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,Clean Room Standard 洁净室的标准,Beverage饮料,Beverage for aseptic filling无菌灌装的饮料 All most all non-carbonated

8、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 tank

9、s 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 contam

10、ination 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,

11、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

12、, 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 & H2O2 两种消毒剂的比较,Bacillus subtilis 枯草芽孢杆菌 Bacillus cereus 蜡状芽孢杆菌

13、 Bacillus polymyxa 多粘芽孢杆菌 Bacillus i 巨大芽孢杆菌 Aspergillus niger 黑霉菌,H2O2,PAA,Sterilization effect消毒效果：or more,Bottle Sterilization with H2O2 用消毒的设备,Bottle Sterilization with PAA 用过氧乙酸消毒的设备,High temperature sterilization will make bottle shrink 消毒温度高将使瓶收缩 65 sterilization temperature is safety for non-

14、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 Pac

15、kage 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 checking 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, pressureUHT的温度，压力 Stea

16、m 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

17、 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 m

18、achine 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 as