PW和WFI系统维护.doc

《PW和WFI系统维护.doc》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

1、***COMPANYSTANDARDOPERATINGPROCEDURE标准操作程序CONFIDENTIAL保密文件SUBJECT:PW/WFISYSTEMPREVENTIVEMAINTENANCEEffectiveDate生效日:SOPNumber:SOP号PM-01-0001PW/WFI系统预维护Page:Page11of15SupersedesDate:更换日期Dec.05,20011.SCOPE范围1.1.Toensurecorrectmaintenanceofwaterpreparationsystemsandcontinuousproductionof

2、PW/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.UnitedStatesPharmacopeia，currentrevision美国药典，当前版本3.2PW/WFISystemManualPW/WFI系统使用手册4.RESPONSIBILITY-Maintenance/Engineering，QA

3、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-01-0001-03:WFI系统维护记录6.PROCEDURES程序6.1.MaintenanceofPumpsQARevi

4、ewBy:QA审核人Date:日期IssuedBy:发行人Date:日期***COMPANYSTANDARDOPERATINGPROCEDURE标准操作程序CONFIDENTIAL保密文件SUBJECT:PW/WFISYSTEMPREVENTIVEMAINTENANCEEffectiveDate生效日:SOPNumber:SOP号PM-01-0001PW/WFI系统预维护Page:Page11of15SupersedesDate:更换日期Dec.05,2001泵的维护6.1.1.Theradiatorofthepumpmotor，thecoverandthesha

5、ftofcoolingfanshallbecheckeddaily.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.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.

6、4.Theoilingpointshallbelubricatedwithhightemperaturegreaseonceayear.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.Thebagsshallhavenodamag

7、ebeforeitisopenedintimeofinstallation.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.Thereasonscouldbeinef

8、fecti