How Many Particles, How Much Sample Volume

Abstract

TP46_HowManyParticles_041110How many particles are needed to demonstrate statistical confidence for cleanroom control and how much sample volume is required to see them? There is increasing confusion over the requirements for compliance with EC GMP Annex 1 limits on 5.0 μm particles, especially when compared with the ISO 14644-1 calculations recommended for establishing conditions for such testing.

The problem arises when using the ISO 14644-1 calculations. The minimum sampling volume required by this formula for EC GMP compliance is huge.

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