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.

The most universally applied method for cleanroom classification is the one suggested in 1963 by Federal Standard 209 of the USA. In this standard the number of particles equal to and greater than 0.5 µm is measured in one cubic foot of air. This count is then used to classify the room (1 particle = class 1; 10 particles = class 10…). In the same period, scientific publications concerning healthcare facilities suggested that airborne particles carrying micro-organisms associated with human disease were usually found in the 4-20 µm equivalent diameter range. This contamination can be detected by settle plates.

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 will discusses the using active air sampling versus passive air settle plate monitoring in routine environmental monitoring.

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Ready to upgrade your contamination control strategy to include active air sampling? Particle Measuring Systems (PMS) has complete cleanroom contamination control solutions for you including:

  • Our Contamination Control Advisory Services who can conduct a Risk Assessment for your pharmaceutical processes and provide a variety of support.
  • Active air samplers including:
    • portable/mobile
    • fixed/remote
    • single use
  • Data management software from Particle Measuring Systems

Particle Measuring Systems is direct in every major market and able to ensure the same ongoing support no matter where you are located. Contact us today for a quote.

Settle plate collection efficiency Particle size target

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.