Validation and Successful Implementation of SCANRDI®

While rapid microbiological methods (RMM) have been in common use by the food, health, and beauty aid industries for decades, the more highly regulated pharmaceutical industry has been slower to adopt them. The FDA supports RMMs for drug testing, as long as these alternative methods are validated to demonstrate their equivalency to the compendial methods. Compounded sterile preparations, with their inherently short shelf lives, are a perfect fit for sterility testing by rapid microbiology methods.

This case study outlines the qualification and validation process conducted at Atlas Analytical to sterility test and release customers’ compounded drug products. Atlas Analytical is a contract testing laboratory which supports sterile compounding pharmacies with cGMP compliant microbiological and analytical testing.