Nelson Labs Unveils Rapid Sterility Testing to Speed Up Results
Nelson Labs, a Sotera Health company, has launched an innovative solution for product-sterility testing through rapid microbiological methods (RMMs) at three of its laboratory sites in the United States and Europe. This cutting-edge technology expands the scope of Rapid Sterility Testing (RST), which has typically been limited to products with biological components or short shelf lives. Nelson Labs’ solution is unique because it is adaptable to a broad range of both medical devices and pharmaceutical products, providing a versatile testing method that can meet various industry needs.
Traditionally, sterility testing has been performed in accordance with the United States Pharmacopeia (USP) general chapter 71. This method involves a 14-day incubation period in growth media, allowing any potential contaminants to grow, followed by a visual inspection of the test samples. While effective, this approach can delay the time-to-market for products, which is a significant concern for manufacturers. However, Nelson Labs’ Rapid Sterility Testing reduces the incubation time to as little as 6 days*, depending on product-specific validation. This accelerated testing process helps manufacturers achieve faster product release, without compromising on safety or regulatory standards.
One of the key advantages of Nelson Labs’ Rapid Sterility Testing is its ability to utilize advanced instrumentation that automates test results, using quantitative data to minimize human error. This automation ensures greater consistency and accuracy in the results. Additionally, the method complies with both USP <71> and <1223>, ensuring that the testing meets regulatory standards for validating alternative microbiological methods.
“We’re thrilled to offer Rapid Sterility Testing as part of our sterility-testing solutions for our customers,” said Nina Moreno, Global Segment Director of Sterility Assurance at Nelson Labs. “This cutting-edge technology significantly reduces testing times, allowing for faster product release while maintaining the highest standards of quality and safety.”
Nelson Labs has been a leader in quality and customer service for over 40 years, making it a trusted partner for medical device and pharmaceutical manufacturers. The company’s Rapid Sterility Testing solution provides a quicker pathway for products to enter the market while ensuring compliance with stringent safety and regulatory requirements.
With the backing of its expert team, Nelson Labs also offers regulatory-compliance consulting through its affiliated company, Regulatory Compliance Associates, Inc., to support customers with validation processes and regulatory submissions related to Rapid Sterility Testing.
The ability to release products to market faster while maintaining rigorous sterility standards is essential in industries like medical devices and pharmaceuticals, where patient safety is paramount. Nelson Labs’ Rapid Sterility Testing solution helps manufacturers streamline their operations, enabling them to meet tight timelines and stay ahead of the competition. Additionally, the company’s global presence, with laboratory facilities across 12 locations in the United States, Mexico, Asia, and Europe, ensures that its solutions can be implemented across a wide range of markets and product types.
To further assist customers, Nelson Labs provides personalized guidance from its team of advisors and regulatory experts. Whether customers are looking for assistance with validating their product or ensuring that their sterility testing methods comply with international regulations, Nelson Labs’ support offers peace of mind that their products are in safe hands.
In addition to Rapid Sterility Testing, Nelson Labs offers an extensive range of testing services, including over 900 laboratory tests for sterility, safety, and quality assurance. These services cover all stages of the product lifecycle—from initial development and sterilization validation to ongoing testing after regulatory approval.
“By integrating innovative testing methods like Rapid Sterility Testing into our service offering, we continue to provide our customers with the highest level of expertise and reliability,” said Moreno. “Our commitment to excellence and customer focus sets us apart in the industry and ensures that manufacturers can trust us with their most critical testing needs.”
*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. The company serves approximately 3,000 customers across 12 facilities worldwide, providing over 900 laboratory tests and offering expertise in regulatory compliance through its affiliated company, Regulatory Compliance Associates, Inc. Nelson Labs supports customers from product development and sterilization validation to regulatory approval and ongoing testing for sterility, safety, and quality assurance. The company is known for collaborating with customers to solve complex issues and delivering trusted, best-in-class testing solutions.
