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.