The ability of an instantaneous microbial detection system (IMD-A) to monitor microbial populations in environmental air was evaluated. The IMD-A results were compared with results from conventional environmental air monitoring methods. The comparisons were carried out in controlled microbial barrier test chambers and in cleanroom environments. Additionally, microbial populations in environmental air in an unclassified environment were evaluated using the IMD-A and the all-gas impingement (AGI) method coupled with ScanRDI. In 1-m3 and 150-m3 controlled-barrier test chamber studies the mean recoveries with the IMD-A were equal to or greater than the mean recoveries obtained with the Anderson air sampler at various concentrations. The mean microbial recoveries obtained using the AGI were higher, but in the same order of magnitude, as those recovered by IMD-A. In classified environments, microbial recoveries from the SAS air sampler were substantially lower than microbial counts detected by the IMD-A. There were reasonable correlations of microbial recoveries between the IMD-A and the SAS air sampler results in cleanroom environments. Mean microbial recoveries from environmental air in an unclassified environment were similar in the IMD-A and AGI methods coupled with ScanRDI analysis. These results suggest that the IMD-A has the potential to reliably and instantaneously evaluate microbial populations in environmental air to provide a valuable technique for biopharmaceutical manufacturing.
Evaluation of an Instantaneous Microbial Detection System in Controlled and Cleanroom Environments
BioPharm International, September 2007
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