FAQ - 气体悬浮物粒子监测
发送新问题- 问题
根据ISO的规定，当监测地点的数量大于2、小于9时，就必须进行统计分析。假如我们取样地点数为7，我们能否对额外的地点（不超过10）进行监测而无需进行统计分析？ - 答案
The question is in respect to can I add sample points to remove the need for statistical compliance. The answer is yes, if you refer to section B.4.1.2 of the standard it allows additional points providing that they have been deemed additional due to a risk analysis. A document may need to be generated defining the size of the room to require 10 points, in your opinion, the best rational would be that the "room is turbulent and additional points are to determine full coverage". The 10 samples then need to be spaced equidistant and at work height.
There are changes proposed to ISO that would removed the 95% limits and so this philosophy is certainly in keeping with current process.
For additional information read our paper Particle Monitoring Requirements in Pharmaceutical Cleanrooms.
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