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IsoAir Particle Sensor
Question

Per ISO, statistical analysis is required if the number of locations to be measured is(as the area calculated) > 2 and < 9. If, based on my area, the number of locations to be sampled is 7, can I perform counting at extra locations (up to 10) and avoid the statistical analysis?

Answer

The question here is "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 ISO 14644-1 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 that, in your opinion, the size of the room requires 10 sample points. The best rational would be that the "room is turbulent and additional points are needed to determine full coverage." The 10 samples then need to be spaced equidistant and at work height.

There are changes proposed to the ISO standard that would remove the 95% limits, 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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