As environmental system designers, we are often asked where to place sample points for particle monitoring, whether it be performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.).
The answer is not always straightforward. When particle counting in pharmaceutical applications can be clearly segregated into one of three categories: certification, qualification and monitoring. Each category requires a different approach. There are several guidance documents that offer advice on what processes need to be monitored, along with advice on suitable distances from the process being monitored.
The goal of this article is to identify the considerations, establish the most suitable location for monitoring a process, and build a scientific rationale for that decision.
Interested in learning more? Download a free copy of Choosing the Most Suitable Particle Sample Point Locations in the Cleanroom.