Companies using commercially prepared organisms as part of their validation process should be aware of the differences as they plan their validations
The Parenteral Drug Association's Pharmaceutical Microbiology Conference was held in Berlin in March 2015, bringing the pharmaceutical and biopharmaceutical community together to promote scientific advances, as well as regulatory and educational information. Rapid Micro Biosystems’ Andrew Sage presented a poster titled 'Performance Comparability of Commercial Preparations of Test Organisms Used in the Validation of RMMs: Not All Bugs are Created Equal'.
The poster illustrated the results of a study that examined the relative growth performance of three vendor preparations of standard USP organisms versus freshly grown in-house cultures from Rapid Micro Biosystems. Comparison of the preparations was performed using the Growth Direct System.
Validation and release testing often rely on the use of commercially prepared stocks of standard test organisms. For compendial methods, these stocks display acceptable results; however, with rapid microbial testing systems that reduce the time to results for detection and enumeration, the relative performance of commercially prepared stocks can affect the potential time savings of the rapid method.
The study measured the mean detection rate of the test populations, the mean time point of first colony detection, and the time point at which 85% of the final count of the colonies was detected. The study revealed measurable differences in growth and detection as determined by the Growth Direct System.
Companies using commercially prepared organisms as part of their validation process should be aware of the differences as they plan their validations.