In the most recent issue (2015 Volume 20, Number 3) of the European Journal of Parenteral & Pharmaceutical Sciences, Kham Nguyen, Anna Mills, Andrew Sage and David Jones published the article, “Validation of the Growth Direct™ System to perform pharmaceutical water bioburden analysis." The peer-reviewed article describes the, “Validation of the Growth Direct System…for the automated incubation and counting of microbial colonies on R2A media plates derived from a water bioburden test.” The paper outlines the validation strategy as well as the sample data generated to establish that the Growth Direct System is accurate and equivalent to the current traditional water test.
The paper introduces the Growth Direct technology and its similarity to the traditional test, noting that the test can be, “…Viewed as a rapid micro method rather than an alternative method.” As such, the authors point out that, “The key functional parts are…only the qualification of the incubators and the qualification of the counting technology.”
The article then dives into the validation steps of the technology, dividing the steps into 5 sections
- Installation/Operational Qualification
- Performance Qualification
- Time to Result Qualification
- Method Suitability
- Verification of Equivalence
The authors describe the various steps with supporting data to demonstrate comparable or expected results for each step. The data shows that the technology, “…Accurately enumerate(s) the microorganism colonies on the membrane surface and that the R2A media recovers organisms from both standard diluents and real world samples at equivalent levels to the standard method.” In addition, the article notes the faster time to result.
To read the article, visit the European Journal of Parenteral & Pharmaceutical Sciences (membership required.)
To learn more about the Growth Direct™ System for rapid detection of bioburden, visit our bioburden testing page.