In March, Dr Michael Miller published a case study of a "New Growth-based Rapid Microbiological Method (RMM) that Detects the Presence of Specific Organisms and Provides an Estimation of Viable Cell Count". This case study was issued in the American Pharmaceutical Review.
In this study the growth based method has been compared with the conventional pharmacopoeial methods. It is supposed to show the specificity (inclusivity and exclusivity), the precision and the ability to detect levels of microorganisms that are equivalent or better than the conventional plate count method.
In the summary, Michael outlines:
"The system is able to adapt to many different microbiological applications, including, but not limited to, raw material assessments, in-process analysis and finished product testing, but especially for the compendial testing of non sterile products.
Finally, the ability of this novel RMM technology to provide both an estimation of cell count as well as testing for the presence or absence of specified microorganisms is a benefit not available with most other rapid methods that are commercially available. The system has already been successfully used within the food, beverage, cosmetic, nutraceutical and dietary supplement sectors, and is now positioned to support the needs of the pharmaceutical industry as well."
Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)