New RapidCert™ expedites results for lot release and sterilization validations by reducing incubation time to 48 hours versus seven days with a traditional compendial method.
Salt Lake City, UT, September 30, 2025 – Nelson Laboratories, LLC, a business unit of Sotera Health Company and a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries, announces the launch of RapidCert™, a new and innovative rapid biological indicator (BI) sterility testing service using a combination of traditional BIs and rapid microbiological methods (RMMs). Nelson Labs is the first to offer this unique rapid method for BI sterility testing of medical device and pharmaceutical products, which is intended to confirm sterility for lot release and sterilization validations in as little as three days.
According to the traditional compendial method, BIs must be incubated for seven days after they are removed from a sterilization cycle. After the incubation period, the BIs are examined visually to check for microbial growth. The new rapid BI sterility testing from Nelson Labs leverages RMMs and modern instrumentation to reduce incubation time to 48 hours and provide objective, instrument-based results.
“RapidCert™ BI sterility testing reflects Nelson Labs’ legacy of innovation, science and quality, designed to meet applicable regulatory expectations, while overcoming challenges and mitigating risk. It is the result of Nelson Labs’ desire to push the boundaries of traditional microbiological methods and to provide accurate and early detection of spore-forming microorganisms on biological indicators utilized in manufacturer-validated sterilization cycles. This solution exemplifies our commitment to advancing testing methodologies to support our partners in delivering safe, effective healthcare solutions,” states Scott Dimond, Principal Scientist at Nelson Labs.
Nelson Labs now offers both rapid product sterility testing and rapid BI sterility testing, in addition to sterility testing using traditional compendial methods.
“We understand that our customers need testing solutions that can best support their production and process needs, so we have developed a range of options that ensure the speed, quality and flexibility they can rely on,” says Nina Moreno, Global Segment Director of Sterility Assurance at Nelson Labs.
For over 40 years, Nelson Labs has been committed to quality, customer focus and testing excellence. These values have motivated Nelson Labs to continuously innovate to offer faster test results without compromising data integrity. RapidCert™ BI testing is intended to help medical device and pharmaceutical drug manufacturers release their products to market more quickly, while supporting regulatory compliance and product safety goals. Nelson Labs also offers expert advisory services and regulatory consulting to guide customers through validations and regulatory submissions related to rapid testing.
To learn more about the suitability of RapidCert™ BI sterility testing for your product, contact a Nelson Labs sales representative at [email protected] or learn more at www.nelsonlabs.com/testing/biological-indicator-rapid-sterility-testing.
About Nelson Labs: Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. We serve approximately 3,000 customers across 12 facilities in the United States, Mexico, Asia and Europe. With a comprehensive array of over 900 laboratory tests and the expertise of Regulatory Compliance Associates, a recognized leader in life science consulting, we support our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety and quality assurance. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.
Safeguarding Global Health® – with every test completed. Learn more: nelsonlabs.com.
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Media Contact:
Kristin Gibbs
Chief Marketing Officer, Sotera Health
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