ok 濕熱水浴滅菌櫃驗證過程中熱分布狀態櫃內控制探頭是否要拔出來呢？-有問有答-蒲公英 - 制药技术的传播者 GMP理论的实践者

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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 › 特色＆熱點 › 有問有答 › 湿热水浴灭菌柜验证过程中热分布状态柜内控制探头是否要 ...

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[確認&驗證] 濕熱水浴滅菌櫃驗證過程中熱分布狀態櫃內控制探頭是否要拔出來呢？

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樓主

发表于 2019-1-24 16:51:02 | 只看該作者回帖奖励

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樓主公司主要是大容量生产输液的，灭菌柜用的是新华的水浴灭菌柜，温度控制是靠柜内的6根探头来控制。目前在做热分布状态验证时，和其他人有了不同的意见，一部分觉得分布时柜内控制探头应也是裸露状态，这样才能确认灭菌柜的均匀性是否符合要求；一部分觉得应与日常生产状态相符所以柜内控制探头要插入瓶子中，通过最终的验证数据来查看均匀性。后者做出来的数据通常保温时间长，在验证探头刚进入保温阶段温度冲高，比设定值高3度，但均匀性没问题。查了指南，好像也没说控制探头是否裸露还是插在瓶中，特来这里找老师咨询下。各位是怎么做的呢？

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发表于 2019-1-24 17:30:20 | 只看該作者

目的，一定要清楚你做確認的目的。目的是服務于工作需求，離開這個目的談確認與驗證，純粹時耍流氓。

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一般壞而已

板凳

发表于 2019-1-24 20:45:36 | 只看該作者

插入瓶中，插入瓶中，

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地板

发表于 2019-1-25 07:48:49 | 只看該作者

必須與生産保持一致啊

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5^#

发表于 2019-1-25 07:49:55 | 只看該作者

驗證最終目的是爲了生産，而不是驗證

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6^#

发表于 2019-1-25 08:00:52 | 只看該作者

和實際生産保持一致。
沖溫問題，還是要看你的産品性質決定，如果想要控制，看看PID的設置參數，升溫段的幾個開度是可以調整的，但是需要時間去摸索。

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zhiyaoluzhong11

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发表于 2019-1-25 08:36:41 | 只看該作者

熱分布分空載熱分布和負載熱分布，你要做的那種？很好辨別啊！另外如果你們對溫控要求較高，可以調節控制參數。

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8^#

发表于 2019-1-25 09:03:51 | 只看該作者

插在瓶子裏，如果你用正常生産的工藝參數取跑還拔了瓶子，那幾乎可以百分之百確定是不合格的。

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9^#

发表于 2019-1-25 09:08:23 | 只看該作者

需要查到藥液裏，因爲要驗證的是藥液能達到你設定的溫度和時間

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