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蒲公英 - 制药技术的传播者 GMP理论的实践者»蒲公英論壇 › 設備工程 › 設備設施 › 手動SIP

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樓主

发表于 2023-5-22 09:53:30 | 只看該作者回帖奖励

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公司改造了一批上游多功能罐，增加了手動SIP功能，請问增加手動SIP是否需要进行验证？

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沙發

发表于 2023-5-22 10:12:34 | 只看該作者

不管什麽動都需要驗證

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板凳

樓主| 发表于 2023-5-22 10:39:24 | 只看該作者

九五二七发表于 2023-5-22 10:12
不管什麽動都需要驗證

设备改造需要进行IOQ，那SIP的温度分布需要验证吗？是需要制定出手動SIP操作规程，规定灭菌时间和温度以及操作方式吗？有没有老师做过，能帮忙介绍下过程吗？

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偉大的毛神1

地板

发表于 2023-5-22 11:02:17 | 只看該作者

王西超发表于 2023-5-22 10:39
设备改造需要进行IOQ，那SIP的温度分布需要验证吗？是需要制定出手動SIP操作规程，规定灭菌时间和温度以 ...

如果是改造的話，建議形成sop升版的初稿後，再進行驗證，驗證通過後，新版文件生效

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制藥設備學習

5^#

发表于 2023-5-22 11:12:33 | 只看該作者

评估一下改造的程度如果改造的范围和内容比较大一般IOPQ都需要做

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