Alcami Corp. has launched its new rapid sterility offering, a service that leverages cutting-edge microbiological testing technology to deliver faster testing results. Alcami invested in the Milliflex Rapid System for the rapid sterility test, which uses adenosine triphosphate (ATP) bioluminescence for detection of microorganisms after five days.

Rapid sterility is an alternative test method to the traditional United States Pharmacopeia (USP) General Chapter sterility test that allows for shorter incubation periods and faster results. 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 has demonstrated comparable recovery to the harmonized USP 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.

The new Milliflex Rapid System is housed in Alcami’s Wilmington, NC advanced analytical testing technology center, and its capabilities are expected to generate efficiencies across the organization, including faster batch releases from the company’s Charleston, SC clinical and commercial scale sterile manufacturing facility.

“Our modern rapid sterility solution prominently positions Alcami on the frontline of contract laboratory services and aligns with our strategy to help reduce our customers’ project timelines, from concept through commercialization,” said Alcami chief commercial officer Chad Telgenhof. “Few of our competitors offer rapid sterility capabilities, and even fewer use ATP-bioluminescence technology. We are pleased to introduce rapid sterility as an ideal way to meet our clients’ tight timelines, and reduce or eliminate the need to pay rush fees for sterility tests.”