WaterSystems水系统知识专题讲座.pptxVIP

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Objectives目的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 VVURS用户需求URS ¤FDS ¤DQ¤SAT ¤IQ ¤OQWater 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Water system design (1)水系统设计（一）DFlow direction arrows on pipes are important管道中的流向很重要Deadleg section死角部分X3DIf D=25mm distance X isgreater than 75mm, we havea dead leg that is too long.如果D=25mm，X大于75mm，则有较长的死角Sanitary Valve洁净阀Water scours deadlegThere should be no dead legs不应有死角Water system design (2)水系统设计（二） 1. Ball valves are unacceptable 不可使用球阀2. Bacteria can grow when the valve is closed 当阀门关闭时，会生长细菌3. The water is contaminated as it passes through the valve当水通过阀门时，被污染Stagnant water inside valve阀门中的死水Water system design (3)水系统设计（三）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Low pressure低压Reverse osmosis (RO) theory反渗透（RO）原理High pressure高压Semi-permeableMembrane半渗透膜Feed water Under pressure加压进水Purified water纯化水raw water原水RejectWater不合格水PermeateWater渗透水drain or recycle排放或循环Typical de-ionizer schematic典型的去离子示意图665544332211from water softener软水机HClNaOHWater must be kept circulatingAnionic columnCartridgefilter 5 μmCartridgefilter 1 μmCationic columnUV lightEluates toneutralizationplantOzone generatorHygienic pump卫生泵Return to de-