EUGMP

9.23 Viable particle monitoring should also be performed within the cleanrooms when normal manufacturing operations are not occurring (e.g. post disinfection, prior to start of manufacturing, on completion of the batch and after a shutdown period), and in associated rooms that have not been used, in order to detect potential incidents of contamination which may affect the controls within the cleanrooms. In case of an incident, additional sample locations may be used as a verification of the effectiveness of a corrective action (e.g. cleaning and disinfection).

9.23 未进行正常生产操作的洁净室（例如，消毒后，生产开始前，批完成时和停产后）以及未使用的相关房间，也应进行活性粒子监测，以发现可能影响洁净室内控制的潜在污染事件。如果发生污染事件，可使用额外的采样位置以核实纠正措施（例如清洁和消毒）的有效性。

这里从实践的角度说，暂可以认定时AB级区域这样搞，其他的区域定期这样搞。