A pharmaceutical company was running a 3 day water test using PCA (Plate Count Agar) media. Following an audit, they were required to change to an R2A agar media test with a 5 day incubation. The increased time associated with requirement drove the need for a faster release test.
Samples were run using R2A on the Growth DirectTM System with a 68 hour read and compared to the traditional 5-7 day read.
The graph below illustrates the correlation was seen across the Colony Forming Unit range seen between the traditional method and the Growth Direct result (obtained in half the time).
A second test for validation of the water system includes parallel testing over 3 weeks with daily sampling. The traditional R2A method with a 7-8 day incubation at 30-35°C was run in parallel to the Growth Direct method using R2A media with a 66 hour incubation at 30-35°C. The trending of the 2 methods (graphed below) clearly illustrates the successful validation of water testing with Growth Direct.
