Nelson Labs launches rapid sterility testing to three labs across the US and Europe

Nelson Labs, a US-based testing and advisory firm specialising in microbiology and analytical chemistry, has launched a product sterility testing service that uses rapid microbiological methods (RMMs) at three laboratory sites in the US and Europe.

The company, part of Sotera Health, claims its solution is unique because it supports a broad range of both medical devices and pharmaceutical products. 

This innovative approach broadens the scope of rapid sterility testing—a field that has primarily focused on products with biological components or short shelf life—by providing a versatile solution that is suitable for a wider array of applications, according to Nelson Labs.

This cutting-edge technology significantly reduces testing times, allowing for faster product release while maintaining the highest standards of quality and safety

Product-sterility testing has traditionally been performed according to the United States Pharmacopeia (USP) General Chapter 71, which entails a 14-day incubation period in growth media to allow any contaminants to grow, after which the test samples are inspected visually.

Nelson Labs’ Rapid Sterility Testing offering reduces the incubation time to as little as 6 days, depending on product-specific validation. 

Additionally, this method’s instrumentation utilises quantitative data to automate test results, reducing the chance of human error. Rapid sterility testing complies with USP <71> and <1223> for validating alternative microbiological methods.

Rapid Sterility Testing can aid medical device and pharmaceutical drug manufacturers in achieving a faster release of their products to market, along with regulatory compliance and product safety.

Rapid Sterility Testing can aid medical device and pharmaceutical drug manufacturers in achieving a faster release of their products to market

However, Nelson Labs does state that it does not guarantee specific outcomes, as performance depends on many variables and compliance with Nelson Labs’ recommendations.

Nina Moreno, Global Segment Director of Sterility Assurance at Nelson Labs, said: “We’re thrilled to offer Rapid Sterility Testing as part of our sterility-testing solutions for our customers.

“This cutting-edge technology significantly reduces testing times, allowing for faster product release while maintaining the highest standards of quality and safety.”