RAPID STERILITY TESTING

  • Rapid Sterility Testing
Looking for a Micro Rapid Sterility Testing Solution? 

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.

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.

Learn More About Rapid Sterility


icon for rapid sterility

Ready to Get Started?

Connect with an Expert