Dear Sir,
I have some doubt about airborne particulate concentration during qualification (PQ) and routine monitoring. Let me explain my understanding about them.
For cleanliness classification test in PQ, the number of sampling point and sampling volume should follow ISO 14644-1. The sampling point should be located at the center of a grid of room area that divided by number of sampling point. Otherwise it should be determined based on risk assessment. Together with the microbial result, the PQ will reflect effectiveness of HVAC system and operation, cleaning procedure, gowning procedure including personnel practice and equipment operation within cleanroom.
But for the routine monitoring, many guidelines said that the sampling plan, sampling location and volume should be determined based on risk-based analysis. Then the question is it necessary to perform test with same no. of sampling point? Can we reduce no. of sampling point and select only location that is significant?
I know that this concept is applicable for the microbial test but I’m not sure for particle.
Thanks in advance
Sunya