无菌操作人员灌装设备安装完后，要做接触皿测试吗

水手波波

无菌操作人员灌装设备安装完后，要做接触皿测试吗？一般是提前一天安装吗？接触皿采样标准是按A级还是B级

椒陵小小兵

这个要评估的，看最新的欧盟法规里面有讲到
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.
根据员工所执行的活动和与关键区域的接近程度，风险评估中应评估对人员监测的位置、类型和频率。监测应包括在工艺中以适当时间间隔对人员进行采样。人员采样的方式不应影响
工艺。对人员的监测应特别关注，需在参与关键干预后（至少进行取样手套，可能需要对洁净服适当的区域进行取样）以及每次退出B 级洁净室时（手套和洁净服）进行取样。当在关键干预后进行了手套监测，则应在继续操作之前更换外层手套。如果在关键干预后需要进行洁净服取样监测，则应在进一步活动之前更换洁净服。

wsn

当天安装当天灌，B级

kikilalala

提前灭菌，当天组装，每次退出时采取人员表面皿，采取操作台面以上的人员区域即可。

AlieZookii

验证干嘛用的。