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Updated: Dec 7, 2025

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
People as a Contamination Source in Pharmaceutical Clean Rooms-Source Strengths and Calculated Concentrations of
Bengt Ljungqvist1, Berit ReinmÜller2
1Building Services Engineering, Chalmers University of Technology, Göteborg, Sweden.
Abstract:
Results are presented from studies performed in a test chamber on clean room garments used, laundered, and sterilized (autoclaved 20 min at 121°C), 50, 60, and 70 times, and garments used, laundered, and sterilized with a prolonged autoclave cycle 50 times. The source strength is described as the mean value of the number per second of airborne particles and aerobic colony-forming units (CFUs), respectively, emitted from one person dressed in the system to be evaluated. Results from body-box tests have been used to calculate theoretical expected concentrations of airborne aerobic CFUs and particles (≥0.5 µm) in clean rooms with different numbers of people present and at different airflows (m3/s). Theoretical expected concentrations of airborne aerobic CFUs are often below the detection level of traditional measuring equipment.
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