无菌干预操作后人员表面菌采样问题
QA

在参与关键干预操作后以及离开B级洁净室时应进行人员表面菌采样,离开B级洁净室采样没有疑问,如果生产过程中发生了关键干预如何采样:

1、如果是打开RABS门进行的干预,人员表面菌应该如何采样?

2、如果没有打开RABS门,是通过手套箱手套进行的干预,人员表面菌应该如何采样?


欧盟附录一 9.25 

2023-12-05 14:33 知守     
2个回答

我的理解,这人取样是基于无菌风险考虑的:

1. 如果是打开RABS门进行干预,只是手和胳膊进入门内,操作完成后,应退至更衣室对手套和胳膊的相关部位取样。(人可能要退出去或更换洁净服)

2. 如果是通过手套箱进行的干预,则这个干预是否需要定义为关键干预可能要讨论一下,这种情况下,我认为不需要对人取样,而是应在生产结束后对RABS手套内表面取样。

2023-12-06 10:33 任刁刁     

原文是这样说的,注意标红的部分。

9.25   A risk assessment should evaluate the locations, type and frequency of personnel monitoring based on the activities performed and the proximity to critical zones. Monitoring should include sampling of personnel at periodic intervals during the process. Sampling of personnel should be performed in such a way that it will not compromise the process. Particular consideration should be given to monitoring personnel following involvement in critical interventions (at a minimum gloves, but may require monitoring of areas of gown as applicable to the process) and on each exit from the grade B cleanroom (gloves and gown). Where monitoring of gloves is performed after critical interventions, the outer gloves should be replaced prior to continuation of activity. Where monitoring of gowns is required after critical interventions, the gown should be replaced before further activity in the cleanroom.

原文的理解,最少是手套。

2023-12-05 20:15 亦心