Rapid sterility testing methods have become increasingly valuable by demonstrating significant time savings in pharmaceutical and biopharmaceutical manufacturing, enabling faster product release, improved process control, and earlier detection of contamination events. However, regulatory authorities continue to require conventional sterility testing as the reference method for product release and validation of the alternative method.
Since traditional sterility testing is essential for rapid method performance, execution of the comparability studies relies on a means for sample taking without compromising either the traditional or rapid sterility test. Sterisart® canisters with septum are uniquely designed to support this need by enabling secure, closed-system sterility testing and seamless sample taking for rapid testing.
The integrated septum allows for:
- samples can be safely accessed for confirmatory testing, microbial identification, or rapid method correlation
- aseptic sampling, inoculation, and reagent addition without compromising system integrity
- reducing the risk of secondary contamination
When paired with the Sterisart® pump system, these canisters provide validated, reproducible workflows that align with regulatory expectations—helping laboratories confidently bridge traditional and rapid sterility testing while maintaining the highest standards of data integrity and product safety.
