关于欧盟附录中的报警压差报警延迟该如何论证？

隐月

4.16 Indicators of air pressure differences should be fitted between cleanrooms and/or between isolators and their
background. Set points and the criticality of air pressure differences should be considered within the CCS. Air pressure
differences identified as critical should be continuously monitored and recorded. A warning system should be in place to
instantly indicate and warn operators of any failure in the air supply or reduction of air pressure differences (below set
limits for those identified as critical). The warning signal should not be overridden without assessment and a procedure
should be available to outline the steps to be taken when a warning signal is given. Where alarm delays are set, these
should be assessed and justified within the CCS. Other air pressure differences should be monitored and recorded at regular
intervals.
应在洁净室之间和/或隔离器与其背景之间安装气压差指示器。 CCS 内应考虑设定点和气压差的临界值。应持续
监测和记录被确定为关键的气压差。应安装警告系统，以立即指示和警告操作员任何供气故障或气压差减小（低
于确定为关键的设定限值）。警告信号不应在未经评估的情况下被忽略，并且应该有一个程序来概述发出警告信
号时要采取的步骤。如果设置了警报延迟，则应在 CCS 内对其进行评估和论证。应定期监测和记录其他气压差。

请问如何评估和论证？

成慧潫

一般的，考虑人员物料进出所需要的开关门时间加上恢复开关门后恢复压差所需要的时间。

隐月

成慧潫 发表于 2022-11-4 13:26
一般的，考虑人员物料进出所需要的开关门时间加上恢复开关门后恢复压差所需要的时间。

感谢，是否需要证明开门情况下的气流方向？

成慧潫

隐月 发表于 2022-11-4 13:45
感谢，是否需要证明开门情况下的气流方向？

按照0825的EU GMP是要证明流向的（可视化的，即拍视频），不光是压差。