I am looking for some direction.  Regs or guidance information on minimum times and volumes required of each sample site for rountine EM for Viable and Non Viable particles.  ISO 7 and ISO 8 cleanrooms for used for nonsterile Pharmaceuticals.

The rooms have been Qualified to ISO 7 ansd ISO 8 per  ISO-14644 standards and the number of sites were determined by the typical method of square root of the area. 

Our QC group is now stating that for our weekly and daily routine monitoring program we still need to pull a cubic meter of air at [b]each sample site[/b] location for non viable and I am questioning this.  My under standing was that the offically no matter how large the area and how many sample sites you were required to test, you only had to pull 1 cubic meter of air per room, so then this could be done by dividing up the locations as long as the samples were taken keeping the minimum volume and time requirements ( 2L of Air and 1 min sample time).  Am I on track or off base?

You may refer to ISO14644 Part 1, Annex B4.2.1 for detailed computation of minimum single sample volume per location, (same as `sample site location' as mentioned in the question), 

Assuming your particle counter is with flowrate of 1cfm.

In your case, you need to refer to equation B2… Vs (as in the equation) is less than 1 litre per location. So sampling for 1 minute per location equivalent to 28.3 litre, more than sufficient. Also, this is fulfilling requirement as per para Annex B4.2.2

You may refer to Annex D1.5 for a detailed working example.

You do not have to sample for 1m3 per location, neither 1 m3 for 1 room.

Regards,
HCChong (NEBB Certified Supervisor)

Thanks for the info!