Rapid sterility is an alternative microbiological test method to the US Pharmacopeia (USP) <71>, Ph. Eur. 2.6.1, and JP 4.06 sterility tests that allows for shorter incubation periods and faster results. Alcami utilizes the Milliflex® Rapid System for the rapid sterility test, which uses adenosine triphosphate (ATP) bioluminescence for detection of microorganisms after five days.

Rapid Sterility Services Offered at Alcami

Benefits of Rapid Sterility
  • Faster release of drug product, especially valuable in the case of market shortage products
  • Corrective action can be implemented sooner if the product does not meet specification
  • Scientifically demonstrated to have comparable recovery to the harmonized USP <71> reference method
  • Like the reference method, microorganisms detected using the Milliflex® Rapid System can later be identified to the species level
  • Reduced observation bias

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Limitations of Traditional Sterility Testing
  • Lengthy incubation time results in increased holding/inventory costs
  • Requires multiple manual reads based on analyst observation
  • Longer time to product release, delaying time to market
  • Not ideal for products with short shelf lives and beyond use dates (BUDs)
  • Limits facility throughput

Alcami’s Milliflex® Rapid Sterility System is an ideal rapid method that has proven comparability to USP <71>. Alcami can meet your tight timelines and provide an alternative to rush sterility tests.

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