title: Use of a real-time microbial air sampler for operational cleanroom monitoring.
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.
  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.
authors.affiliation: Sterile Manufacturing Specialist, AstraZeneca, Macclesfield, UK.
authors.forename: T
authors.initials: T
authors.lastname: Eaton
authors.forename: C
authors.initials: C
authors.lastname: Wardle
authors.forename: W
authors.initials: W
authors.lastname: Whyte
mesh_terms: D000391:Air Microbiology; D004780:Environment, Controlled; D004784:Environmental Monitoring / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D005189:False Positive Reactions; D008828:Microbiological Techniques / Q000295:instrumentation*; D010316:Particle Size; D052638:Particulate Matter / Q000032:analysis*; D015203:Reproducibility of Results; D013997:Time Factors
chemical_list: D052638:Particulate Matter
keywords: Airborne microbial contamination; Andersen sampler; Cleanroom; Real-time microbial air sampler