How Many Particles? How Much Sample Volume?

How 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.

 

In order to provide complete functionality, this web site needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site including but not limited to: log in, buy products, see personalized content, switch between site cultures. It is recommended that you allow all cookies.