BFS环境监测

陈成成

Jaffray磊 发表于 2021-11-24 10:44
个人人为可以不监测，但是要对关键区域动态粒子控制进行评估，比如烟雾实验

或气流流型

王成

你那个是风淋装置，严格意义上来讲应该是A级送风不是A级，因为你只需要满足静态A级而不需要满足动态A级。在线监测可以有，但不一定要附在批记录里。

fywl1983

你说的是背景环境的排风不够吗？还是设备排风不够？

CRUSH。.

陈成成 发表于 2021-11-24 20:10
你说的烟雾试验是指自净时间？

气流流型，灌装区域单向流，灌针出口处

CRUSH。.

8.103. For shuttle type equipment used for aseptic filling, the area between parison cutting and mould sealing should be covered by a flow of filtered air to provide Grade A conditions at the critical zone. The equipment should be installed in at least a Grade C environment, provided that Grade A/B clothing is used. The filling environment should meet Grade A for viable and non viable limits at rest and the viable limit only when in operation. （EUGMP附录一）

小金库

谢谢分享。