Nelson Laboratories, LLC, a business unit of Sotera Health Company and provider of outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries, has launched RapidCert™, a rapid biological indicator (BI) sterility testing service using a combination of traditional BIs and rapid microbiological methods (RMMs). Nelson Labs says it 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,” says 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.
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, contact a Nelson Labs sales representative at
