求问：关于人员更衣确认的周期有无指南规定啊？

asia85008500

如题，想知道有没有什么指南对人员更衣确认的周期进行过规定，就是最少多久一定要重新做一个更衣确认之类的，最好是国际法规，多谢了~~

jixia

An aseptic gowning qualification program should assess the ability of a cleanroom operator to maintain the quality of the gown after performance of gowning procedures. We recommend that this assessment include microbiological surface sampling of several locations on a gown (e.g., glove fingers, facemask, forearm, chest). Sampling sites should be justified. Following an initial assessment of gowning, periodic requalification will provide for the monitoring of various gowning locations over a suitable period to ensure consistent acceptability of aseptic gowning techniques. Annual requalification is normally sufficient for those automated operations where personnel involvement is minimized and monitoring data indicate environmental control. For any aseptic processing operation, if adverse conditions occur, additional or more frequent requalification could be indicated.--FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice

战斗的蟋蟀

我估计这些周期类的东西不会有法规

scslk0045

好像没有什么法规有规定

asia85008500

dingkaiwang 发表于 2016-11-21 16:40
An aseptic gowning qualification program should assess the ability of a cleanroom operator to mainta ...

谢谢大神~~

asia85008500

这份指南能不能发我一份啊，谢谢

jixia

asia85008500 发表于 2016-11-21 16:49
这份指南能不能发我一份啊，谢谢

论坛里面有，你搜索下

石头968

无菌区半年，跟着培养基模拟验证走呗
其它的，无关紧要了

静水蓝心

每年就OK吧