A sampler that detects and counts ‘viable’ airborne particles in real-time was evaluated for potential use in cleanrooms used for aseptic manufacture. When tested within an environment deliberately enhanced with high numbers of microbe-carrying particles (MCPs), the sampler reported 4.8 times higher numbers of airborne ‘viables’ compared to the number of CFUs recovered by a traditional microbial air sampler and it is considered that this increased level may not be overly unrealistic. However, for similar testing within an environment enhanced with a high concentration of inanimate particles, but with extremely low levels of viable MCPs, the sampler reported 197 times higher numbers of airborne ‘viables’ compared to the number of recovered CFUs but it is considered that many of these were actually sourced from inanimate materials which intrinsically fluoresce and are therefore recorded as ‘viables’. If such a sampler is to be considered for cleanroom monitoring, comprehensive investigative work should be completed to determine the likely increase in the concentrations of reported ‘viables’ and the impact to the manufacturing operation, with the possibility of the introduction of scientifically justified limits, based upon the technology associated with real-time samplers, that, would need to be agreed with the relevant regulatory authority. For critical workstations, where the expectation is that no microbial contamination is recovered, investigative work to identify those inanimate materials that are reported to be ‘viables’ would need to be completed to provide a full understanding, so they can be eliminated or minimised. In these situations, real-time alert may be beneficial if the proportion of any implicated product could be immediately segregated, rather than waiting for the delayed reporting of any conventional CFUs, in which case, all of the manufactured product may have to be discarded. Key words: Cleanroom; real-time microbial air sampler; ‘viables’, fluorescence; microbe-carrying particles (MCPs); airborne microbial contamination

Tim Eaton

Karen Capper

Evaluation of a Real Time Airborne ‘Viables’ Particle Counter

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