Water Systems水系统知识专题讲座.pptVIP

*;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, disinfection 微生物限度、消毒;CQ -V-Model VV;;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;;1) Sanitary pumps 洁净泵 2) Clamps and O rings 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;;;Branch;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）;Can be used for WFI or for Water For Final 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 - 80°C, and sterilization at 121°C 在65 - 80°C下运行，在121°C进行灭菌;Single-effect distillation 单效蒸馏 simple distillation, single effect 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 ??效蒸馏机;Typical water storage and distribution schematic 典型的水贮存和分配示意图 ;;;Water systems design水系统设计;Water s