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. 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.
Particle counting in pharmaceutical applications can be clearly segregated into one of three categories which can affect how to monitor:
- Certification is measuring a cleanroom for a standard. The only standard recognized worldwide is ISO 14644-1, “Classification of air cleanliness by particle concentration”, which defines how a cleanroom performs and its ability to show uniformity across the entire space. This is done irrespective of the activities performed in it.
- Qualification is the process of analyzing risk assessment for the activities in the room. Qualification follows grid methodology testing methods. Particle counts are measured in both operational and at-rest states; however, the operational data is the most valid.
- Monitoring is the ongoing sampling of the cleanroom on a frequency relative to the degree of control required to prove management over risk to the finished product. The number of sample points and their location is determined by risk assessment, and the qualification and certification process.
Tomorrow’s blog will discuss where to monitor for certification. Or, if you want to learn more now, download this paper on Choosing the Most Suitable Particle Sample Point Locations in the Cleanroom.