Nelson Labs Launches Rapid Sterility Testing, Cutting Incubation Times

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Nelson Labs, headquartered in Salt Lake City, Utah under the umbrella of Ohio-based Sotera Health, announced on March 4, 2025 that its rapid sterility testing approach, a way of performing product-sterility testing through rapid microbiological methods (RMMs), is now being offered at three of its laboratory sites: in Salt Lake City and Itasca, Ill. in the United States and in Europe at a site in Wiesbaden, Germany (1,2).

In a press release, Nelson Labs said its testing solution is unique because it supports a wide range of both pharmaceutical products and medical devices, broadening the scope of sterility testing using RMMs, which until now, according to the company, has mostly focused on those products that have biological components or a short shelf life (1). Rapid sterility testing can further expand capabilities to testing products that require prompt release to market or are manufactured in small batches (2).

Sterility testing ensures product safety by detecting microbial contamination, according to Nelson Labs (2). United States Pharmacopeia (USP) General Chapter <71>, which the company said has guided previous product-sterility testing, specifies a customary 14-day incubation period in growth media to allow contaminants to grow, followed by a visual inspection (1,3). This length of time can expand to 18 to 20 days with a sub-culture (2). Nelson Labs’ rapid sterility testing—depending on product-specific validation—is designed to reduce the incubation time to as little as six days, although the company said it cannot guarantee specific outcomes (1). The testing complies with USP <71> as well as <1223>, for validating alternative microbiological methods, according to Nelson Labs (1,4).

“We’re thrilled to offer rapid sterility testing as part of our sterility-testing solutions for our customers,” Nina Moreno, global segment director of sterility assurance at Nelson Labs, said in the press release (1). “This cutting-edge technology significantly reduces testing times, allowing for faster product release while maintaining the highest standards of quality and safety.”

Information provided on Nelson Labs’ website details the process of rapid sterility testing, using advanced bioluminescence technology to detect microbial adenosine triphosphate—in this case, light being produced at levels elevated enough to indicate contamination (2). The instrumentation used, according to the company, replaces subjective visual inspections for turbidity, or the presence of contamination, with quantitative results, in addition to having a high capacity for throughput and being easy to perform. In practice, this has reduced testing time by at least half, Nelson Labs said (2).

Nelson Labs said it is offering its team of experts at an affiliated company, Regulatory Compliance Associates, to assist customers in the medical device and pharmaceutical drug manufacturing fields with validation and regulatory submission support, in the interest of bringing products to market in an expedited manner (1).

Click here for the latest Pharmaceutical Technology® Drug Digest video, which features Ask the Expert columnist Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

References

1. Nelson Labs. Nelson Labs Launches Innovative Rapid Sterility Testing to Significantly Expedite Product Sterility Results. Press Release. March 4, 2025.
2. Nelson Labs. Product Sterility–Rapid. NelsonLabs.com (accessed March 4, 2025).
3. USP, USP General Chapter <71>, “Sterility Tests,” USP 26–NF 21, 933–940 (Rockville, MD, 2003).
4. USP, USP General Chapter <1123>, “Validation of Alternative Microbiological Methods,” USP 32–NF 27, 731 (Rockville, MD, 2009).