Alcami Corporation is now providing 5-day turnaround rapid sterility testing from its North Carolina advanced analytical testing technology centre. Alcami is performing these tests using the Milliflex® Rapid System, which uses ATP bioluminescence technology, to detect viable organisms.  This service, which keeps Alcami at the frontline of contract laboratory services, is predicted to improve batch release times from its South Carolina clinical and commercial-scale sterile manufacturing facility. 

Rapid sterility is an alternative test method to the traditional United States Pharmacopeia (USP) General Chapter <71> sterility test that allows for shorter incubation periods and faster results to clients. Typical sterility tests require 14 days of incubation and use analyst observations to generate results, whereas rapid sterility tests need only five days of incubation, a 64% reduction in processing time. Rapid sterility is scientifically demonstrated to have a comparable recovery to the harmonised USP <71> reference method. Like the reference method, microorganisms detected using the Milliflex Rapid System can later be identified to the species level. The technology also incorporates more sophisticated, computer-generated results, which eliminate observation bias.