An Alternative Medium to Support Sterility Testing using the Growth Direct® Rapid Sterility System

Recently, it has been shown that there are other media that perform equivalently or better than the compendial sterility test media, TSB and FTM1. The results presented here demonstrate that a new single medium, Rapid Sterility Medium (RSM) Broth, performs as well as or better for the growth promotion of test organisms compared to compendial sterility test media. In side-by-side tests of aerobic bacteria, yeast and molds and anaerobic organisms, RSM broth supported growth promotion comparable to TSB or FTM for a panel of microorganisms relevant to the pharmaceutical market. These results demonstrate that RSM broth can serve as a valid alternative for both TSB and FTM for sterility testing being performed by the Growth Direct® Rapid Sterility System. Keywords: Sterility test, Alternative media, Rapid Microbial Method, Growth Direct System®