PW和WFI系统日常维护情况

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1、\1.SCOPE范围1.1.ToensurecorrectmaintenanceofwaterpreparationsystemsandcontinuousproductionofPW/WFIqualitywater.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–USPPurifiedWaterPW–符合美国药典的纯水2.2.WFI–USPWaterforInjectionWFI–符合美国药典的注射用水3.REFERENCES参考3.1.UnitedState

2、sPharmacopeia，currentrevision美国药典，当前版本3.2PW/WFISystemManualPW/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/WFISystemDailyMaintenanceCheckMF-01-0001-01:PW/WFI系统日常维护检查5.2.MF-01-0001-02:MaintenanceRecordofPWSy

3、stemMF-01-0001-02:PW系统维护记录5.3.MF-01-0001-03:MaintenanceRecordofWFISystemMF-01-0001-03:WFI系统维护记录6.PROCEDURES程序6.1.MaintenanceofPumps泵的维护6.1.1.Theradiatorofthepumpmotor，thecoverandtheshaftofcoolingfanshallbecheckeddaily.Pleasereplacewhenanydamageoccurs.泵电机散热片，冷却风扇

4、盖板和叶片应保持完整，如有损坏应立即更换。6.1.2.Thepumpshallbecleaneddaily.泵应每日保持清洁。6.1.3.Theoperationofmotorbearingandshaftshallbecheckedbyrobeveryday.Anyabnormityshallbetreatedimmediately.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。\6.1.1.Theoilingpointshallbelubricatedwithhightemperatureg

5、reaseonceayear.各加油点应定期（每年）补充高温润滑油脂。6.2.ContaminationandCleaningofROFilm反渗透膜的使用及清洗6.2.1.FirstUseofROFilm:新反渗透膜的初次使用TheROFilmiskeptinsealedplasticbagswithstoragemixtureof1%sodiumbisulflateand20%hydroxy-pyruvate.Thebagsshallhavenodamagebeforeitisopenedintimeofinsta

6、llation.Thefilmshallbeputintofilmtubeassoonasitisopenedandcouldbeusedaftercleaning.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.TheremaybesomeResidualmaterialontheROfilmafterlongtimeoperationofpurewater.Thereasonscouldbeineffective

7、pre-treatment，impropercontrol，pollutedinletwaterorwrongchemicals.TheROfilmmustbecleanedinthefollowingprocedures: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.PreparesuitablecleaningsolutionwithcorrectpHvaluepersection6.2.5.Besuretha

8、tallchemicalsinthesolutionhavebeenfullydissolvedandevenlymixedtobetransparentandclearsolutionbeforeitisfilledintothefilm.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