RT Journal Article
SR Electronic
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
FD Parenteral Drug Association (PDA)
SP 119
OP 127
DO 10.5731/pdajpst.2020.012054
VO 75
IS 2
A1 Ljungqvist, Bengt
A1 ReinmÜller, Berit
YR 2021
UL http://journal.pda.org/content/75/2/119.abstract
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.