On Demand

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 webinar will 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
Webinar Presented By:
Anna Campanella, PhD
Advisory Team Head, Particle Measuring Systems

Anna has vast industry experience which she uses to collaborate and consult with pharmaceutical companies. She is highly skilled in the development and implementation of science-based strategies, principles of contamination monitoring, and methods of controlling and improving the chemical, physical, and microbiological states of various production processes. Anna holds a PhD in Molecular Medicine and is an authority in many areas of pharmaceutical manufacturing; such as: QA & QC processes, validation of chemical and microbiological methods and the validation of sterile production processes. Additionally, she maintains expert-level knowledge of the microbiological aspects of aseptic production processes.

Paola Lazzeri
EMEA Field Application Specialist Sterility Assurance/Microbiology, Particle Measuring Systems

Paola has extensive professional experience over 14+ years supporting pharmaceutical companies in the application of regulatory requirements, with a specific focus on microbiological contamination control. She maintains this expertise through constant dialogue with Quality Officers, Production and Financial teams in the various industries she works with. She actively collaborates with the PMS Advisory Team on decontamination strategy using a Quality Risk Management approach and assists Pharma companies with the validation of sanitizing and decontaminating agents. Paola also regularly writes technical articles and participates as a speaker at national and international Pharma conferences.