NOVA Biologicals, a Tentamus company, is expanding its GMP pharmaceutical microbiology capabilities with the addition of USP <72> Rapid Sterility Testing.
USP <72>, Respiration-Based Microbiological Methods for the Detection of Contamination in Short-Life Products, provides a compendial approach for validated rapid sterility testing when appropriate for the product and testing programme.
The new capability provides manufacturers with an alternative to traditional USP <71> sterility testing, which typically requires a 14-day incubation period.
For applicable products, NOVA anticipates results in approximately 3–7 days, depending on the product, method suitability and validated testing requirements.
The automated system continuously monitors samples for microbial growth, enabling earlier detection compared with traditional visual methods.
The reduced testing timeline can help manufacturers make more timely product-release decisions while maintaining applicable USP, validation and GMP requirements.
“Implementing USP <72> Rapid Sterility is an important expansion of NOVA Biologicals’ pharmaceutical microbiology capabilities,” said Karla Allred, General Manager of NOVA Biologicals.
“By offering a validated rapid sterility testing option, we can help clients significantly reduce turnaround time while maintaining the quality and compliance expectations required for GMP testing."
"This capability allows us to better support time-sensitive products and gives our clients greater flexibility when building sterility testing programmes that meet their specific needs.”
Potential applications include pharmaceutical and biopharmaceutical products, sterile drug products, compounded sterile preparations, cold radiopharmaceuticals and other short shelf-life products where faster sterility results can support timely release.
NOVA will work with each client to evaluate product suitability, testing requirements and applicable validation requirements before establishing the appropriate method and expected turnaround time.
