In recent years, the regulatory landscape has encouraged the adoption of rapid microbiological methods as alternatives to traditional sterility compendial tests, which currently require a minimum incubation time of 14 days. General chapters 5.1.6 of the European Pharmacopoeia and <1223> of the USP provide clear guidelines on the implementation of alternative methods, emphasising the possibility of selecting the most suitable technology based on the product type, provided it is properly validated and demonstrated to be comparable to traditional methods.
In response to this regulatory evolution and the growing demand to reduce release times, benefiting both patient safety and manufacturing companies, Eurofins BioPharma Product Testing (BPT) Italy has adopted a multi-technological approach, integrating rapid and automated methods to support clients in choosing the most suitable solution.
In addition to the classic compendial sterility test Ph. Eur. 2.6.1/USP <71>, Eurofins BPT Italy now offers the following innovative technologies in compliance with 21 CFR Part 11 and data integrity:
- RedOne® by Redberry (based on Solid Phase Cytometry): sterility test in four days. With high sensitivity and automation, it supports early decision-making in batch release processes.
- Celsis® by Charles River (based on ATP bioluminescence): rapid detection through ATP bioluminescence. This allows product release in a minimum of six days with significant optimisations for large sets of samples.
- BacT/ALERT 3D: automated test for cellular products, validated according to the specific chapter of the pharmacopoeia EP 2.6.27. It’s suitable for cell-based preparations with high complexity or reduced shelf life.
The adoption of rapid and automated microbiological methods drastically reduces the time-to-results, prevents production blocks, optimises deviation management, and improves timely patient access to advanced therapies.
Eurofins BPT Italy is a strategic partner in the implementation of innovative solutions, in line with the principles of Quality by Design and Process Analytical Technology, promoted by the FDA and EMA.
Contact us or visit our rapid sterility webpage to learn more.