PW与WFI系统维护.docVIP

SCOPE 范围 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。 DEFINITIONS 定义 PW – USP Purified Water PW–符合美国药典的纯水 WFI – USP Water for Injection WFI–符合美国药典的注射用水 REFERENCES 参考 3.1. United States Pharmacopeia ， current revision 美国药典，当前版本 3.2 PW/WFI System Manual PW/WFI系统使用手册 RESPONSIBILITY - Maintenance/Engineering， QA 职责–维护、工程、QA人员 ATTACHMENTS 附录 MF-01-0001-01: PW/WFI System Daily Maintenance Check MF-01-0001-01: PW/WFI 系统日常维护检查 MF-01-0001-02: Maintenance Record of PW System MF-01-0001-02: PW 系统维护记录 MF-01-0001-03: Maintenance Record of WFI System MF-01-0001-03: WFI 系统维护记录 6. PROCEDURES 程序 Maintenance of Pumps 泵的维护 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。 The pump shall be cleaned daily. 泵应每日保持清洁。 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。 The oiling point shall be lubricated with high temperature grease once a year. 各加油点应定期（每年）补充高温润滑油脂。 Contamination and Cleaning of RO Film 反渗透膜的使用及清洗 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 shall 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。 There may be some Residual material on the RO film after long time operation of pure water. The reasons could be ineffective pre-treatment， improper 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: Prepare suitable cleaning solution with corre