TY - JOUR T1 - People as a Contamination Source in Pharmaceutical Clean Rooms—Source Strengths and Calculated Concentrations of Airborne Contaminants JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 119 LP - 127 DO - 10.5731/pdajpst.2020.012054 VL - 75 IS - 2 AU - Bengt Ljungqvist AU - Berit ReinmÜller Y1 - 2021/03/01 UR - http://journal.pda.org/content/75/2/119.abstract N2 - 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. ER -