Thursday, 28 March 2013

Monitoring for psychrophilic bacteria in cleanrooms

Tim Sandle and Kerry Skinner have undertaken research into the presence of psychrophilic and psychrotolerant microorganisms in pharmaceutical facility cold rooms. The study has been published in the Journal of Applied Microbiology.

Here is a summary of the study:

Aims: To examine for psychrophilic or psychrotolerant micro-organisms in pharmaceutical cold rooms (in relation to numbers, incidents and species) and to determine, where such micro-organisms are present, whether standard microbiological environmental monitoring regimes require modification. This is presented as a case study.

Methods and results: Comparative environmental monitoring within different pharmaceutical facility cold rooms (using standard mesophilic and low temperature incubation). Data were collected over two periods, 5 years apart. The results indicated that psychrophilic micro-organisms were not present and that those micro-organisms deemed psychrotolerant, primarily pseudomonads, could be grown on standard media under mesophilic conditions.

Conclusions: Psychrophilic micro-organisms were not detected and those considered to be psychrotolerant were only found in low numbers. Pyschrotolerant organisms were recovered under both low temperature incubation conditions and under standard conditions (between 20 and 35°C). Further evaluation may be required, using alternative agar, and microbiologists should regularly review the species recovered to note differences between different environments.

Sandle, T. and Skinner, K. (2013). Study of psychrophilic and psychrotolerant microorganisms isolated in cold rooms used for pharmaceutical processing, Journal of Applied Microbiology, 114 (4), 1166—1174

Posted by Tim Sandle