Laboratory Services

Rapid Sterility Testing

Drug Product Manufacturing
Laboratory Services
Routing & Custom Testing

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. It requires shorter incubation periods and provides 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.

  • Qualification & Certification Support Benefits of Rapid Sterility Testing

  • 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

Related Topics
Best Practices in Steam Quality Testing
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Summary

Alcami offers rapid sterility testing as an alternative to traditional methods. This accelerated process reduces testing time, allowing for faster product release and improved decision-making. By utilizing advanced technology, Alcami ensures comparable results while enhancing efficiency and reducing costs.

Related Topics
Best Practices in Steam Quality Testing
Contact Alcami
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