Performance Comparability of Commercial Preparations of Test Organisms Used in the Validation of RMMs: Not All Bugs are Created Equal

 

Study by Andrew Sage, Nadine Timas, David Jones

 

Microbial validation and release testing in the manufacturing industry often uses commercially prepared stocks of standard test organisms. These preparations exhibit acceptable performance when used with the compendial test method.

 

Performance Comparability of Commercial Preparations of Test Organisms Used in the Validation of RMMs: Not All Bugs are Created Equal

 But with the emergence of rapid microbial testing systems that drastically reduce the time to result for analysis, the relative performance of these products can impact the potential time savings that rapid methods can provide. 

 

This revealing study examines the relative growth performance of three vendor preparations vs. freshly grown in-house cultures. Comparison of the preparations was performed using Growth Direct.

 

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