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Research ArticleTechnology/Application

Use of a Real-Time Microbial Air Sampler for Operational Cleanroom Monitoring

T. Eaton, C. Wardle and W. Whyte
PDA Journal of Pharmaceutical Science and Technology March 2014, 68 (2) 172-184; DOI: https://doi.org/10.5731/pdajpst.2014.00952
T. Eaton
1Sterile Manufacturing Specialist, AstraZeneca, Macclesfield, UK;
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  • For correspondence: timeaton@astrazeneca.com
C. Wardle
2Technical Officer, Microbiology Laboratory, AstraZeneca, Macclesfield, UK; and
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W. Whyte
3Honorary Research Fellow, University of Glasgow, Glasgow, UK
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Abstract

A sampler that detects and counts viable particles in the air of cleanrooms in real-time was studied. It was found that when the sampler was used to monitor airborne particles dispersed from a number of materials used in cleanrooms, including garments, gloves, and skin, the number of viable particles dispersed from these materials was greater than anticipated. It was concluded that a substantial proportion of these viables were of a non-microbiological origin. When the sampler was used to monitor a non-unidirectional airflow cleanroom occupied by personnel wearing cleanroom garments, it was found that the airborne viable concentrations were unrealistically high and variable in comparison to microbe-carrying particles simultaneously measured with efficient microbial air samplers. These results confirmed previously reported ones obtained from a different real-time sampler. When the real-time sampler was used in a workstation within the same cleanroom, the recorded viables gave results that suggest that the sampler may provide an effective airborne monitoring method, but more investigations are required.

LAY ABSTRACT: The airborne concentrations measured by a real-time microbial air sampler within an operational, non-unidirectional airflow cleanroom were found to be unrealistically high due to a substantial numbers of particles of non-microbiological origin. These particles, which resulted in false-positive microbial counts, were found to be associated with a number of materials used in cleanrooms. When the sampler was used within a cleanroom workstation, the counts appeared to be more realistic and suggest that this type of real-time airborne microbial counter may provide a useful monitoring method in such workstations, but further investigations are required.

  • Cleanroom
  • Real-time microbial air sampler
  • Andersen sampler
  • Airborne microbial contamination
  • © PDA, Inc. 2014
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PDA Journal of Pharmaceutical Science and Technology: 68 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 2
March/April 2014
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Use of a Real-Time Microbial Air Sampler for Operational Cleanroom Monitoring
T. Eaton, C. Wardle, W. Whyte
PDA Journal of Pharmaceutical Science and Technology Mar 2014, 68 (2) 172-184; DOI: 10.5731/pdajpst.2014.00952

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Use of a Real-Time Microbial Air Sampler for Operational Cleanroom Monitoring
T. Eaton, C. Wardle, W. Whyte
PDA Journal of Pharmaceutical Science and Technology Mar 2014, 68 (2) 172-184; DOI: 10.5731/pdajpst.2014.00952
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Keywords

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  • Andersen sampler
  • Airborne microbial contamination

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