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1、2019年8月27日,Water Systems 水系统 知识讲座 九新药业国际认证部经理 高级工程师 徐影,To examine the basic technology and requirements for: 检查以下方面的基本技术和要求： 1) Water treatment systems 水处理系统 2) Storage requirements 贮存要求 3) Sampling and testing 取样和检测 4) Different types of water used in pharmaceuticals 制药用水的不同类型 5) Microbial limits,
2、disinfection 微生物限度、消毒,Objectives 目的,C&Q -V-Model V V,URS 用户需求,URS FDS DQSAT IQ OQ,Water system design 水系统的设计 1) Pipes sloped so water does not pool and can drain easily 管道要有斜度，以防止积水，易于排空 2) Sanitary fittings & connections 洁净配件和接口 3) Constructed of suitable materials such as stainless steel 建造材料适合，如不
3、锈钢 4) Circulate the water 水要循环,Further water treatment purification stages downstream of the pre-treatment system 预处理系统后水的进一步纯化 1) Filtration 过滤 2) Disinfection 消毒 3) Reverse osmosis or de-ionization 反渗透或去离子 4) Distillation or ultra-filtration 蒸馏或超滤,There should be no dead legs 不应有死角,Water system de
4、sign (1) 水系统设计（一）,3. The water is contaminated as it passes through the valve 当水通过阀门时，被污染,2. Bacteria can grow when the valve is closed 当阀门关闭时，会生长细菌,1. Ball valves are unacceptable 不可使用球阀,Stagnant water inside valve 阀门中的死水,Water system design (2) 水系统设计（二）,1) Sanitary pumps 洁净泵 2) Clamps and O rings
5、versus threaded fittings 卡箍和O环，不用螺纹配件 3) Heat exchangers 换热器 4) Side arm level measuring devices are unacceptable 不可使用边侧 臂状水位测量装置,Water system design (3) 水系统设计（三）,Reverse osmosis (RO) theory 反渗透（RO）原理,Branch,Branch,Cartridge filter 1 m,Second stage RO cartridge,First stage filtrate feeds second stag
6、e RO with excess back to 1st stage buffer tank,.,1st stage reject concentrate,Air break to sewer,Second stage reject water goes back to first stage buffer tank,Second stage RO water meets Pharmacopoeia standards,Water from softener or de-ioniser,Typical 2-stage RO schematic 典型二级反渗透示意图,Hygienic pump,
7、High pressure pump,Advantages 优点 Disadvantages 缺点 Many uses 应用领域 purified water 纯化水 feeding of distillation units or ultra-filtration units 蒸馏器或超滤器的进水 Water for Final Rinse 最终冲洗用水 Water for Injections (if permissible) 注射用水（如许可）,Use of reverse osmosis 反渗透的应用,Can be used for WFI or for Water For Final
8、 Rinsing for parenteral manufacturing (if permitted) 可用作注射用水或生产注射剂的最终冲洗用水（如许可） Removes organic contaminants, such as endotoxins 去除有机污染物，如内毒素 Operation at 65 - 80C, and sterilization at 121C 在65 - 80C下运行，在121C进行灭菌,Ultra-filtration 超滤,Single-effect distillation 单效蒸馏 simple distillation, single effect
9、简单蒸馏，单效 vapour compression, thermo compression 蒸汽压缩，热压缩 Multi effect distillation 多效蒸馏 multiple effect stills 多效蒸馏机,Distillation 蒸馏,Still,Storage tank,Pump,Ball valves,0.22um filter,Plate heat exchanger,KEY,Still,Storage tank,Pumps,T,C,TOC,Diaphragm valves,T - Temp probe C- Conductivity TOC - Total
10、Organic Carbon,Double tube sheet heat exchanger,KEY,Spray ball,Back Pressure Regulator,Water systems design水系统设计,Check检查,Why?,How,Feed Water Quality 进水质量,Subsequent treatment stages cannot cope with unrestricted microbial and endotoxin load 其后的处理阶段无法处置未受限制的微生物和内毒素负荷,Connections 连接,Sampling 取样,Minima
11、l crevices 最小裂缝,Inspection 检查,Water systems design水系统设计,Check检查,Why?,How,Finishes 抛光,Reduce bacterial adhesion 减少细菌粘着,Pipe slopes 管道倾斜度,Certification证书,Drain ability especially of condensate after steam sanitising 排水性,尤其是蒸汽消毒后的冷凝水,Inspection检查 spirit level水平仪 Isometrics等容法,Water systems design水系统设计,
12、Check检查,Why?,How,To produce unfavourable conditions for microbial growth and attachment 制造不利于微生物生长和附着的条件,Sanitisation 消毒,Flow meter 流速计,Records记录,Velocity in loop 回路中流速,For control of microbial proliferation and in response to problems 控制微生物繁殖,解决问题,Water systems design水系统设计,Check,Why?,How,Not “react
13、ive, additive or absorptive” 不“产生反应,添加或吸附“,Instruments 仪器,Certificates 证书,Certificates证书 Inspection检查,Materials of construction材质,Calibrated已校正 Sanitary清洁,Water systems design水系统设计,Check,Why?,How,Minimal crevices 最小裂缝,Passivation 钝化,Documentation (Welders Qualification, weld logs) Sample welds,Weld
14、inspection 文件 (焊接工资质确认,焊接日志) 焊接取样, 焊接检查,Documentation (Procedures, Passivation log) 文件 (规程,钝化日志),Welding 焊接,Maximum corrosion resistance 最大耐受腐蚀 性,Water Systems design,Check,Why?,How,Demonstration of consistent ability to produce water of right quality 证实有持续产生高品质水的能力,Master Plan, 验证主计划 Protocols, 验证方
15、案 summary reports 总结报告,Validation 验证,Heat 热 - One of the most reliable methods of disinfection of water systems 最可靠的消毒水系统的方法之一 Ozone 臭氧 - Produced easily 容易制备 - Leaves no residue 没有残留,Disinfection (1) 消毒（一）,UV 紫外 - UV does not “sterilize” 紫外不可灭菌 - Flow rate critical 流速很关键 - Post-irradiation recontam
16、ination may be an issue 后放射再污染可能是个问题 - Lamps have finite life 灯的寿命有限 Other chemicals 其他化学法 - XO2 - Halogen 卤素 - Formaldehyde 甲醛,Disinfection (2) 消毒（二）,There must be a sampling procedure 必须有取样规程 Sample integrity must be assured 必须保证样品的完整性 Sampler training 取样人培训 Sample point 取样点 Sample size 取样多少,Sampling (1) 取样（一）,Sample container 取样容器 Sample label 样品标签 Sample storage
