FAQ - Pharmaceutical/Life Sciences Particle Counting

Lasair II Particle Counter for Cleanroom Validation

Question
Regarding GMP annex 1."For routine testing the total sample volume should not be less than 1 m3 for grade A and B areas and preferably also in grade C areas", 1) What iss the meaning of the word "Areas"? Is it for the cleanroom area or the sampling point? 2) If we have grade B class and it is 16m2 in surface, we will have 4 sample location. How much sample volume do we have for each location?

Answer

First, we need to define "routine testing."

This is note (a) second statement which supports the EU GMP table for room Certification. So routine testing is therefore the recertification of that room , as done in accordance with ISO14644-1.

Now, we have identified that this is certification and not monitoring the next answers become clearer.

1. Areas. The cleanroom under consideration must have a total sample volume of 1m3. This was originally intended to mean 1m3 at each of the sample points defined in ISO14644, so in your example below you have a 16m2 area which is 4 sample points (all equidistant and at work height - ISO14644) you will need to take 4 m3, 1m3 at each point. It has however also been misinterpreted as meaning the whole room is an area and as such one could take a 1/4 m3 at each location giving 1m3 for the room. This second stance, although valid and meets the letter of the rule, does not meet the intent of the rule. My advice is 1m3 at each location - for certification only - and that is once per year or once per 6 months - in accordance with ISO14644-2.
2. See answer above.