Choosing the Most Suitable Cleanroom Particle Sample Point Locations for Certification, Qualification and Monitoring Activities

As environmental monitoring 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. 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 locations for monitoring a process, and build a scientific rationale for that decision.

Particle counting in pharmaceutical applications can be clearly segregated into one of three categories: certification, qualification, and monitoring. Additionally, this paper covers considerations for sample point placement for each of these activities to achieve the most representative results for your process.