Replacing Settle Plates with Active Air Sampling

The most universally applied method for cleanroom classification is one suggested in 1963 by US Federal Standard 209. In this standard, the number of particles ≥0.5 µm is measured in one cubic foot of air. This count is then used to classify the room (e.g., 1 particle for Class 1; 10 particles for Class 10, etc.). In the same period, scientific publications regarding healthcare facilities suggested that airborne micro-organisms associated with human disease were typically found in the 4–20µm diameter range. This microbial contamination can be detected by settle plates.

Historically, cGMP guidelines highlighted their expectations around microbial continuous process monitoring in A and B grades (FDA guideline_2004 and Annex 1_2008) by referring to settle plates, because no other technology was easily available. Regrettably, settle plates are a non-validatable method. This webcastwill discuss current scientific knowledge around active air/automated vs. passive air/settle plate microbial monitoring as part of a routine environmental monitoring procedure.

Key Learning Objectives:

• Review of current scientific literature influencing microbial cleanroom monitoring
• Comparison of the effectiveness of settle plates vs. active air sampling
• How to replace settle plates with active air monitoring; acceptance and validation
• Microbial active air sampling as it pertains to Quality Risk Management (QRM) and contamination control strategy