Rapid Sterility

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.

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Qualification and Certification Support 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

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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