castile soap towelettesQSCKL03B-SJ-69-B0肥皂水湿巾(新)配液、加液封包有效维持时间验证报告1.docVIP

Taizhou Kanglin Health Protection Products Co.,Ltd. Document name： castile soap towelettes ( 1304、AM5600) Validation report for effective maintain time of preparation solution,liquid adding/packing Unit type： 150L preparation solution tank (E)、DXD-ZB-Ⅲ towelettes machine Document no.：QS/CKL03B-SJ-69-B/0 Drafted by Preparation solution Date prep pad machine Date Verified by equipment Date Quality inspection department Approved by Quality control department Date List I. Verification Overview … process of verification overview data of confirmation requirement of confirmation II. purpose of verification III. institutional framework of verification and duty 1. institutional framework and duty 2. action team of verification IV. time plan V. content of verification equipment confirmation 1.1、1.2、1.3、 working confirmation 2.1、2.2 valid length of time confirmation of solution preparation,transport,liquid adding,bagging 2.2.1 length of time for the first time:24hours 2.2.2 length of time for the second time: 48hours 2.2.3 length of time for the third time:72 hours 3、3.1 the various elements confirmation of verification process 3.2 processing program of abnormal condition variance analysis of verification and control change VII. training of verification scheme VIII. verification period IX. conclusion of verification I. verification overview process of verification This verification target is valid length of time confirmation of sterile towelettes preparation process ,move storage tank ,liquid adding ,bagging of DXD-ZB-Ⅲ machine and castile soap towelettes solution for solution preparation workshop. 1.1 main equipment as followed： Name Specification Material quality Solution perparation(E) 150L 304 stainless steel sanitary pump YS-7144 304 stainless steel microporous membrane cartridge filter 20×1 core 0.45um、0.22um 304 stainless steel filter element： polyether sulfone membrabe move solutio