Validation of cross-contamination control in biological safety cabinet for biotech/pharmaceutical manufacturing process

Environ Sci Pollut Res Int. 2015 Dec;22(23):19264-72. doi: 10.1007/s11356-015-5091-5. Epub 2015 Aug 11.

Abstract

For class II, type A2 biological safety cabinets (BSC), NSF/ANSI Standard 49 should be conformed in cabinet airflow velocity derivation, particle contamination, and aerodynamic flow properties. However, there exists a potential problem. It has been built that the cabinet air flow stabilize is influenced by the quantity of downflow of air and the height above the cabinet exhaust opening. Three air downflow quantities were compared as an operating apparatus was placed from 20 to 40 cm above the bench of the cabinet. The results show that the BSC air downflow velocity is a function of increased sampling height, displaying that containment is improvingly permitted over product protection as the sampling height decreases. This study investigated the concentration gradient of particles at various heights and downflow air quantity from the bench of the BSC. Experiment results indicate that performance near the bench was better than in the rest of the BSC. In terms of height, the best cleanliness was measured at a height of 10 cm over the bench; it reduced actually with add in height. The empirical curves accommodate, founded on the concentration gradient of particle created was elaborated for evaluating the particle concentration at different heights and downflow air quantity from the source of the bench of the BSC. The particle image velocimetry system applied for BSC airflow research to fix amount of airflow patterns and air distribution measurement and results of measurements show how obstructions can greatly influence the airflow and contaminant transportation in a BSC.

Keywords: Biological safety cabinet; Cleanroom airflow pattern; Cross-contamination; Particle image velocimetry.

Publication types

  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Air Pollution, Indoor / analysis
  • Biotechnology / instrumentation
  • Containment of Biohazards / instrumentation*
  • Drug Industry / instrumentation
  • Environmental Monitoring
  • Equipment Contamination / prevention & control*
  • Filtration
  • Hazardous Substances / analysis
  • Particulate Matter / analysis

Substances

  • Hazardous Substances
  • Particulate Matter