Replacing Settle Plates With Active Air Sampling

Settle plates were adequate in the past to meet regulations, but the new approach requires active air sampling.

Historically, cGMP guidelines highlighted their expectations concerning a microbiological 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. Unfortunately, settle plates are a non-validatable method as it is simply based on the physical principle of the downfall of a particle on a surface. We discuss the using active air sampling versus passive air settle plate monitoring in routine environmental monitoring.