Pharmaceuticals
Rapid Sterility Testing
Ensuring product sterility is critical to patient health and safety, so a fast turnaround time is essential to delivering critical medicines to the patients who depend on them. But the standard USP <71> sterility test, essential to sterile compounders, outsourcing facilities and manufacturers, has a 14-day incubation time and can result in a manufacturing bottleneck. Product release cannot happen until all QC testing, particularly sterility testing, is complete. Our rapid sterility comparability study and test use BacT/ALERT® 3D Dual-T, the first fully automated, growth-based, dual-temperature microbial detection system. Results are available in 7 days, half the time of the standard USP <71> test.