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
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.