pw和wfi系统维护

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1、SCOPEl.L范围ToensurecorrectmaintenanceofwaterpreparationsystemsandconlinuousproductionofPW/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•UnitedStatesPharmacopeia,currentrevision美国药典，当前版本PW

2、/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:MaintenanceRecordofPWSystemMF-01-0001-02:PW系统维护记录5.3.MF-01-0001-03:MaintenanceRecordofWFISystemMF-

3、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・Theoperationofmotorbearingandshaftshal

4、lbecheckedbyrobeveryday.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。6.1.4.Theoilingpointshallbelubricatedwithhightemperaturegreaseonceayear・6.1.ContaminationandCleaningofROFilm反渗透膜的使用及清洗FirstUseofROFilm:新反渗透膜的初次使用TheROFilmiskeptinsealedplasticbagswithstoragemixtureo

5、f1%sodiumbisulflateand20%hydroxy-pyruvate・Thebagsshallhavenodamagebeforeitisopenedintimeofinstallation.Thefilmshallbepulintofilmlubeassoonasitisopenedandcouldbeusedaftercleaning・反渗透膜保存在密封的塑料袋屮，袋内为1%业硫酸氢钠和20%疑基丙脂的混合液。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。TheremaybesomeResidualmaterialontheROfilmafter

6、longtimeoperationofpurewater.Thereasonscouldbeineffectiveprc-trcatmcnt>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：PreparesuitablecleaningsolutionwithcorrectpHvaluepersecti

7、on6.2.5.Besurethatallchemicalsinthesolutionhavebeenfullydissolvedandevenlymixedtobetransparentandclearsolutionbeforeitisfilledintothefilm.准备适当的清洗液，准确的PH值依照625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。Thesolutionisfilledintothefilmtubebylowpressurean