对生产车间地漏的微生物监测有什么要求

2024-02-14

对生产车间地漏的微生物监测有什么要求吗?

There are no direct specifications for the inspection within the framework of microbiological monitoring, but it is expected to be carried out based on risk. This involves evaluating the sources of contamination in terms of their potential impact.

微生物监测框架内的检查没有直接规范，但预计将根据风险进行检测。这包括根据污染源的潜在影响对其进行评估。

Checking the drains may be useful to verify the effectiveness of the disinfection process. In the outer area (on the room side on the floor above the closures), this could be considered as a potential "worst case" by sampling the surface. In this case, frequency and limit values depend on the risk of the processed dosage form and thus the cleanroom class (monitoring programme).

检查地漏口可能有助于确认消毒过程的有效性。在外部区域(在房间内、排污口封口处上方的地板)，通过对表面进行采样，可以将其视为潜在的“最差条件”。在这种情况下，频率和微生物限度取决于加工剂型的风险，以及取决于洁净室级别(监测程序)。

An inspection inside the drainage system can certainly be carried out with the aim of checking the effectiveness of the disinfection step. This also raises the question of the limit value that would have to be set for this. If the drain construction is not suitable due to design or damage (closability, backflow, ventilation, disinfectability), this should be corrected if possible. Open drains should be avoided per se. Otherwise, this risk point would have to be taken into account in the monitoring, accordingly.

当然可以在排污系统内部进行检查，以检查消毒步骤的有效性。这也提出了必须为此设定的微生物限度的问题。如果由于设计或损坏(密封性、回流性、通风性、消毒性)导致排水管结构不适合，则应尽可能纠正。明渠本身应避免。否则，在监控中就必须相应地考虑到这个风险点。

Floor areas are in any case rather rarely the subject of monitoring due to their indirect potential influence. The risk assessment for determining the monitoring programme should take this into account. Examination of the inner sides of (closed) drains is normally not necessary. However, it can be helpful for root cause investigation in the context of investigations of OOS results on batches or in the case of deviating/abnormal monitoring results.

由于其间接的潜在影响，地板区域在任何情况下都很少成为监测的对象。确定监测方案的风险评估应考虑到这一点。通常不需要检查(封闭的)地漏的内侧。然而，在对批次OOS结果进行调查或监测结果偏离/异常的情况下，它可以帮助进行根本原因调查。

撰稿人 | Pharma之路

责任编辑 | 邵丽竹

审核人 | 何发