Nelson Labs Launches Innovative Rapid Sterility Testing to Significantly Expedite Product Sterility Results
Rhea-AI Summary
Nelson Labs, a Sotera Health company, has launched Rapid Sterility Testing services at three laboratory sites across the United States and Europe. This innovative testing method reduces product sterility test results time from the traditional 14-day period to as little as 6 days, while maintaining compliance with USP <71> and <1223> standards.
The new testing solution uniquely supports both medical device and pharmaceutical products, expanding beyond the typical focus on biological components or short shelf-life products. The method employs quantitative data instrumentation to automate test results, reducing human error potential. This advancement enables faster product release while maintaining quality and safety standards.
Positive
- Significant reduction in testing time from 14 to 6 days
- Automated testing process reduces human error
- Broader product application range than competitors
- Multi-site testing capability across US and Europe
Negative
- Results timing may vary based on product-specific validation
- No guaranteed specific outcomes
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Rapid Sterility Testing yields product sterility test results in as little as 6 days and can be used for broadscale medical device and pharmaceutical product application
SALT LAKE CITY, March 04, 2025 (GLOBE NEWSWIRE) -- Nelson Labs, a Sotera Health company and a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries, 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.
To learn more about the suitability of Rapid Sterility Testing for your product, contact a Nelson Labs sales representative at sales@nelsonlabs.com or learn more at www.nelsonlabs.com.
*Results may vary based on product-specific validation and external factors beyond our control. Nelson Labs does not guarantee specific outcomes, as performance depends on many variables and compliance with Nelson Labs’ recommendations.
About Nelson Labs: Nelson Labs is a global leader in 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.
Media Contact
Nelson Labs
Kate Corr, Senior Marketing Manager, Americas
801-290-9190
