Nelson Labs, a Sotera Health company, now performs product-sterility testing through rapid microbiological methods (RMMs) at three laboratory sites located in the United States and Europe. Nelson Labs’ testing solution is unique in that 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 .
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 utilizes 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 .
“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,” states Nina Moreno, Global Segment Director of Sterility Assurance at Nelson Labs .
For 40 years Nelson Labs has been committed to quality, customer focus, and testing excellence. 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 .
Furthermore, Nelson Labs’ team of expert advisors and regulatory-compliance consultants at its affiliated company, Regulatory Compliance Associates, Inc., can guide customers who want support with any validations and regulatory submissions related to Rapid Sterility Testing .
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