NOVA Biologicals Expands GMP Pharmaceutical Microbiology Capabilities with USP 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 program. 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 in building sterility testing programs 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.

About NOVA Biologicals

Founded in 1993, NOVA Biologicals is a Tentamus company based in Conroe, Texas. The laboratory specializes in microbiological testing for pharmaceutical, medical device, food, water, and antimicrobial applications. NOVA brings a quality-oriented, customer-focused approach and rapid response to clients’ testing needs. The laboratory is FDA-registered, ISO-accredited, and NELAP-accredited.

About Tentamus North America

Tentamus North America brings together specialized laboratories across the United States, Canada, and Mexico, combining local scientific expertise with the resources of the global Tentamus Group. The network provides analytical testing, method development, validation, and scientific support for the pharmaceutical, medical device, food, dietary supplement, cosmetics, agriculture, and environmental industries. Through comprehensive capabilities, dedicated support, and proactive communication, Tentamus helps clients protect their brands, address regulatory requirements, and bring safe, high-quality products to market.

To discuss USP <72> Rapid Sterility Testing or other pharmaceutical microbiology services, contact NOVA Biologicals at 888-503-1020 or hello.americas@tentamus.com