PT - JOURNAL ARTICLE AU - Ljungqvist, Bengt AU - ReinmÜller, Berit TI - People as a Contamination Source in Pharmaceutical Clean Rooms—Source Strengths and Calculated Concentrations of Airborne Contaminants AID - 10.5731/pdajpst.2020.012054 DP - 2021 Mar 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 119--127 VI - 75 IP - 2 4099 - http://journal.pda.org/content/75/2/119.short 4100 - http://journal.pda.org/content/75/2/119.full SO - PDA J Pharm Sci Technol2021 Mar 01; 75 AB - 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.