The USP <62> requires that prior to or in concert with routine specified microorganism testing (Microbial Limits), a one-time suitability of recovery test must be performed. This suitability test demonstrates the ability of the methods used to recover and detect the defined microorganisms if they are present in the sample. A suitability test, to show usage of an adequate neutralizer inactivates the preservative in the product being tested. This demonstrates that if organisms (bacteria yeast or molds) are in fact present they will be able to grow and be detected. The suitability test can be performed very simply and quickly with the BioLumix system.
As shown in the figure, in the BioLumix instrument, if the detection time (DT) of the media without product is within a couple of hours of the product containing media it means that enough neutralization is achieved. If there is a DT without the product in the positive control; but the sample containing vial does not have a DT it means that the product prevents the growth of bacteria and a different neutralization scheme needs to be employed.
What are the advantages of the BioLumix system?
Time Saving: The results are available much faster, for example, the results of the Yeast and Mold vials occurred in less than 48 hours, instead of five days for countable colonies. All products tested with bacteria using the automated BioLumix assay yielded results typically within 10-18 hours, instead of 48 hours for the plate count methodology. The advantage using the BioLumix system is that you can see results an entire day earlier if the product is exhibiting any sort of inhibition.
Labor Saving: The setup of the assay can be done much faster using the BioLumix system as opposed to traditional plating methods, saving significant hands-on labor due to its automation and simplicity of use.
High Correlation with USP: The BioLumix System showed a high correlation between the instrument results and the USP methodology.