RT Journal Article
SR Electronic
T1 People as a Contamination Source in Pharmaceutical Cleanrooms –Source Strengths and Calculated Concentrations of Airborne Contaminants
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2020.012054
DO 10.5731/pdajpst.2020.012054
A1 Bengt Ljungqvist
A1 Berit Reinmüller
YR 2020
UL http://journal.pda.org/content/early/2020/09/30/pdajpst.2020.012054.abstract
AB People as a Contamination Source in Pharmaceutical Cleanrooms −Source Strengths and Calculated Concentrations of Airborne Contaminants BENGT LJUNGQVIST AND BERIT REINMÜLLER Building Services Engineering, Chalmers University of Technology, Göteborg, Sweden Corresponding author: Berit Reinmüller, Building Services Engineering, Architecture and Civil Engineering, Chalmers University of Technology, SE SE-41296 Göteborg, Sweden e-mail: beritr@chalmers.se ABSTRACT Results are presented from studies performed in a test chamber on cleanroom garments used, laundered, and sterilized (autoclaved 20 minutes 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 CFU, 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 CFU and particles (≥0.5µm) in cleanrooms with different number of people present, and at different airflows (m3/s.). Theoretical expected concentrations of airborne aerobic CFU are often below the detection level of traditional measuring equipment. .