Nelson Labs, a Sotera Health company and provider of outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharma industries, has launched RapidCert, a new rapid biological indicator (RBI) sterility service using a combination of traditional BIs and rapid microbiological methods (RMMs).

The company claims it’s the first to provide this rapid method for BI sterility testing of medical device and pharma products. The method aims to confirm sterility for lot release and sterilization validations in as short as three days.

According to the traditional compendial method, BIs must be incubated for a week after they’re 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 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,” said Scott Dimond, Principal Scientist at Nelson Labs. “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.”

The company now offers both rapid product sterility testing and rapid BI sterility testing, in addition to sterility testing with 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,” said Nina Moreno, global segment director of sterility assurance at Nelson Labs.

In August, the company announced it had expanded its laboratory space at its Wiesbaden, Germany facility.