Nelson Labs introduces Rapid Sterility Testing, reducing incubation time to 6 days for diverse medical and pharmaceutical products.
Quiver AI Summary
Nelson Labs, a Sotera Health company and leader in microbiological testing, has expanded its rapid microbiological methods (RMMs) for product-sterility testing at three laboratory sites in the U.S. and Europe. Their innovative testing solution enables a broader application for both medical devices and pharmaceutical products, significantly reducing the traditional 14-day testing incubation period to as little as 6 days, depending on validation. This method enhances accuracy by automating results and complies with USP standards. Nina Moreno, Global Segment Director of Sterility Assurance, emphasized that this technology allows for quicker product release while ensuring quality and safety. Nelson Labs has been dedicated to testing excellence for 40 years and offers support in regulatory compliance through their affiliated consultants. For more information, customers can reach out to Nelson Labs directly.
Potential Positives
- Nelson Labs expands its Rapid Sterility Testing capabilities, now available at three laboratory sites in the U.S. and Europe, ensuring broader geographic access to their customers.
- The new testing solution significantly reduces the incubation time for product-sterility testing from 14 days to as little as 6 days, facilitating faster product release for clients in the medical device and pharmaceutical industries.
- Rapid Sterility Testing provides a versatile solution suitable for a wide range of products, enhancing its applicability in the market compared to traditional methods.
- This innovative testing method complies with established USP standards, supporting customers in achieving regulatory compliance and maintaining high standards of quality and safety.
Potential Negatives
- Despite the claims of improved testing times, the reliance on product-specific validation and external factors may lead to inconsistent results, potentially undermining customer confidence.
- The disclaimer stating that Nelson Labs does not guarantee specific outcomes introduces uncertainty regarding the reliability of their new Rapid Sterility Testing method.
- Since the press release highlights adherence to existing USP standards, any future regulatory changes could challenge the validity of their testing methods and require additional adjustments.
FAQ
What is Rapid Sterility Testing offered by Nelson Labs?
Rapid Sterility Testing is a method that reduces incubation time for sterility testing to as little as 6 days.
How does Rapid Sterility Testing benefit medical device manufacturers?
This testing method allows for faster product release while ensuring quality and regulatory compliance.
What is the traditional sterility testing incubation period?
Traditional sterility testing typically involves a 14-day incubation period as per the USP standards.
Where are Nelson Labs' Rapid Sterility Testing facilities located?
Nelson Labs performs Rapid Sterility Testing at three facilities in the United States and Europe.
Who can assist with validations related to Rapid Sterility Testing?
The team at Regulatory Compliance Associates can guide customers with validations and regulatory submissions.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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 [email protected] 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
