water systems水系统知识专题讲座.pptVIP

Water systems design水系统设计 Check Why? How Not “reactive, 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 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 recontamination 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 and transport 样品储存和转移 Arrival at the laboratory 到达实验室 Start of test 开始测试 Sampling (2) 取样（二） Testing - setting specifications for purified water or WFI测试 – 规定纯化水或注射用水标准 Purified Water纯化水 Ph. Eur. 中国药典（2005） USP Nitrates硝酸盐 ≤ 0.2ppm ≤ 0.06ppm - Conductivity电导率 ≤ 5.1μS/cm@25oC - ≤ 1.3μS/cm@25oC TOC ≤ 0.5mg/l - ≤ 0.5mg/l Heavy metals重金属 ≤ 0.1ppm ≤ 0.5ppm - Microbia微生物 100cfu/ml 100cfu/ml 100cfu/ml Test