Particle Measuring Systems

http://www.pharmtech.com/pt_w/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 webcast will discuss current scientific knowledge around active air/automated vs. passive air/settle plate microbial monitoring as part of a routine environmental monitoring procedure.

		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

Dr. Frank Panofen, Business Development Director (EMEA), Particle Measuring Systems

	Heather Mason, Microbial Product Sales Specialist, Particle Measuring Systems

 Wednesday, Nov.13, 2019 at 10am EST | 9am CST | 3pm GMT | 4pm CET

	On demand available after airing until Nov. 13, 2020 

Webcasts

Join this discussion with experts about implementing active air microbial monitoring in sterile cleanrooms. Learn about changes that can save time and money and reduce the risk of product contamination.
Live: Wednesday, Nov.13, 2019 at 10am EST | 9am CST | 3pm GMT | 4pm CET

On demand available after airing until Nov. 13, 2020
Register free

Particle Measuring Systems

Articles