FAQ - 気中微粒子

ISO Requirements for Sampling Points and Statistical Analysis

質問 ISOによると、監視箇所（場所）が2箇所以上9箇所以下の場合、統計分析を行わなければなりません。当社の場合、監視箇所は7箇所ですが、統計分析を行わずに他の箇所（最大10箇所）も測定して構いませんか？

回答

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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