biotactical introduces a rapid sterility testing platform for pharmaceutical QC microbiology, reducing sterility release timelines from weeks to 48 hours. The platform addresses a core QC bottleneck by shortening batch quarantine while maintaining regulatory alignment.
The solution is designed for GMP environments and aligns with USP <71>, USP <73>, USP <1223> and Ph. Eur. 2.6 and 5.1.6. It combines ATP bioluminescence with accelerated growth media and supports complex, short-shelf-life products, including ATMPs, where traditional sterility testing creates release risk and lost treatment windows.
Key benefits for QC teams include:
- Sterility results in 48 hours instead of 14 to 21 days
- Faster batch release with reduced quarantine and inventory burden
- Lower handling time and fewer opportunities for contamination
- Designed to support method suitability and regulatory validation
Learn how biotactical can be evaluated within your QC workflow
