Monday, 2 June 2014

Monitoring cleanrooms using a rapid micro method

A new paper of interest has been published.

In the paper, the researchers assessed the different operational states within a biopharmaceutical grade clean room, using a rapid microbiological method. The method was a novel system, based on spectrometry, designed for sampling, discriminating, and enumerating airborne particles (a BioVigilant IMD-A® System).

Central to the study was the aim to determine the microbiological levels as a clean room went from standard use through maintenance and shutdown, disinfection, and then back to standard use. The objective was to evaluate whether a rapid method could replace conventional environmental monitoring using growth-based media.

The paper concludes that the optical instrument can be used to process sufficient information, so that clean rooms can be returned to use following a period of unexpected downtime or following maintenance without the need to wait for the results from growth-based methods. As such, this type of rapid microbiological method is worth exploring further for clean room air monitoring.

Sandle, T., Leavy, C., Jindal, H. and Rhodes, R. (2014) Application of rapid microbiological methods for the risk assessment of controlled biopharmaceutical environments, Journal of Applied Microbiology, 116 (6): 1495-1505

Posted by Tim Sandle