People as a Contamination Source in Pharmaceutical Clean Rooms-Source Strengths and Calculated Concentrations of Airborne Contaminants

PDA J Pharm Sci Technol. 2021 Mar-Apr;75(2):119-127. doi: 10.5731/pdajpst.2020.012054. Epub 2020 Sep 30.

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.

Keywords: airborne contaminants; pharmaceutical cleanrooms; predicted contamination levels; source strengths; test chamber.

MeSH terms

  • Air Microbiology*
  • Drug Contamination / prevention & control
  • Environment, Controlled
  • Humans
  • Pharmaceutical Preparations*

Substances

  • Pharmaceutical Preparations