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1、1. SCOPE范围1.1. To ensure correct maintenance of water preparation systems and continuous production of PW/WFI quality water.保证水制备系统的正常维护，持续生产符合PW/WFI要求的水。2. DEFINITIONS定义2.1. PW USP Purified WaterPW符合美国药典的纯水2.2. WFI USP Water for InjectionWFI符合美国药典的注射用水3. REFERENCES参考3.1.United States Pharmacopeia ，
2、 current revision美国药典，当前版本3.2 PW/WFI System Manual PW/WFI系统使用手册4. RESPONSIBILITY - Maintenance/Engineering， QA职责维护、工程、QA人员5. ATTACHMENTS附录5.1. MF-01-0001-01: PW/WFI System Daily Maintenance Check MF-01-0001-01: PW/WFI 系统日常维护检查5.2. MF-01-0001-02: Maintenance Record of PW System MF-01-0001-02: PW 系统维护
3、记录5.3. MF-01-0001-03: Maintenance Record of WFI System MF-01-0001-03: WFI 系统维护记录6.PROCEDURES程序6.1. Maintenance of Pumps泵的维护6.1.1. The radiator of the pump motor， the cover and the shaft of cooling fan shall be checked daily. Please replace when any damage occurs.泵电机散热片，冷却风扇盖板和叶片应保持完整，如有损坏应立即更换。6.1.2
4、. The pump shall be cleaned daily.泵应每日保持清洁。6.1.3. The operation of motor bearing and shaft shall be checked by rob every day. Any abnormity shall be treated immediately. 泵的电机轴及轴承应每天用听棒检查运行声响，任何异常情况都应及时处理。6.1.4. The oiling point shall be lubricated with high temperature grease once a year.各加油点应定期（每年）
5、补充高温润滑油脂。6.2. Contamination and Cleaning of RO Film反渗透膜的使用及清洗6.2.1. First Use of RO Film:新反渗透膜的初次使用The RO Film is kept in sealed plastic bags with storage mixture of 1% sodium bisulflate and 20% hydroxy-pyruvate. The bags shall have no damage before it is opened in time of installation. The film sha
6、ll be put into film tube as soon as it is opened and could be used after cleaning.反渗透膜保存在密封的塑料袋中，袋内为1%亚硫酸氢钠和20%羟基丙脂的混合液。在安装前袋子应完整无损。拆封后应马上放入膜管内，清洗后即可使用。6.2.2. There may be some Residual material on the RO film after long time operation of pure water. The reasons could be ineffective pre-treatment， i
7、mproper control， polluted inlet water or wrong chemicals. The RO film must be cleaned in the following procedures:由于净水长时间在RO膜上运行，RO膜上会结垢。结垢的原因有:预处理系统失效，控制不当，进水污染或使用错误的化学品。RO膜按下列程序清洗:6.2.2.1. Prepare suitable cleaning solution with correct pH value per section 6.2.5. Be sure that all chemicals in the
8、 solution have been fully dissolved and evenly mixed to be transparent and clear solution before it is filled into the film.准备适当的清洗液，准确的PH值依照6.2.5节.在加入清洗液之前，确认所有的化学品已完全溶解混合均匀。6.2.2.2. The solution is filled into the film tube by low pressure and flow of pump. The pressure shall be low enough that no
9、 osmosis happens. The cleaning solution shall be first discharged and then circulated.用泵的低压流量打入膜管，低压控制在无渗透液产生.清洗液先排放后循环。6.2.2.3. The acid will be consumed when it dissolves the inorganic sediment and its pH value shall rise by 0.5 unit. Add acid at that time until the pH value drops by 0.5.当酸溶解无机物沉淀
10、时酸会消耗，PH值升高0.5个单位时，需加酸直到PH值下降0.5个单位。6.2.2.4. Dipping: Shut off the pump. Dip the components in the solution for 1 hour or longer for dirt difficult to dissolve.浸泡:关掉泵.将元件浸泡在溶液中1小时，如有难溶污垢可延长浸泡时间。6.2.2.5. High-speed Flushing: High-speed water flow in about 30 to 40 minutes will clear the dirt on the s
11、urface of the film.高速冲洗:用高速水流冲洗30到40分钟，将膜表面污垢冲洗出去。6.2.2.6. The used solution will be discharged and sampled to compare with pure solution for analysis of the cleaning effect.排除清洗液，取样与原液分析比较，确认清洗效果。6.2.2.7. The flushing water shall be purified water in temperature of at least 20C. The cleaning soluti
12、on in the film must be cleared before normal operation of the system. 用不低于20C的纯化水冲洗，在正常操作之前必须把膜内清洗液冲掉。6.2.2.8. Clean Again: The film shall be flushed by purified water in at least 10 minutes. Normal production can begin only after it is rinsed clean.再清洗:用纯化水冲洗膜至少10分钟.冲洗干净后才能开始正常的生产。6.2.3. Contaminat
13、ion of Reverse Osmosis Film Module反渗透膜污染6.2.3.1. After a period of normal operation， the complex polyamide reverse osmosis film module could be contaminated by some suspends or matters difficult to dissolve in water supply such as calcium carbonate， calcium sulfate， metal oxide， silicon sediment， or
14、ganic or inorganic sediments.运行一段时期后，复合反渗透膜会受到水中悬浮物和难溶物的污染，如碳酸钙，硫酸钙，金属氧化物，硅沉积，无机物和有机物沉积物。The character of pollutant and contaminating speed depends on the quality of the water supply. The contamination can happen quickly and needs to be monitored because the film module can be damaged in a short per
15、iod of time. 污染物的性质及污染速度与给水有关.污染发生很快需监控，因为污染会在很短的一段时间损坏膜。6.2.4. Elimination of Pollutant污染物的去除The pollutant can be eliminated either chemically or physically. Therefore， the RO system shall be cleaned after daily operation in physical way of low pressure operation for 15 minutes in order to get rid of the surface dirt. But chemical cleaning must be done if any of the following happens:污染物能够用化学或物理的方法去除.因此，RO系统每天运行后可以用物理冲洗的方法去除膜表面的沉积物。6.2.4.1. The flow reduces
