Nelson Labs Expedites Product Sterility Results with Innovative Rapid Sterility Testing

Nelson Labs, a global leader in microbiological and analytical chemistry testing, has unveiled its cutting-edge Rapid Sterility Testing, an innovation poised to potentially expedite product release timelines for pharmaceutical and medical device manufacturers. By leveraging rapid microbiological methods (RMMs), Nelson Labs has reduced sterility testing turnaround times to as little as six days*—less than half the industry-standard 14-day incubation period dictated by United States Pharmacopeia (USP) <71>. This breakthrough represents a pivotal advancement for manufacturers operating under stringent regulatory timelines and underscores the critical need for advanced cleanroom facilities, sterile processing equipment, and contamination-controlled environments.

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

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 testing solution not only accelerates the timeline but also enhances reliability through automated quantitative analysis. The method adheres to USP <71> and <1223> validation requirements for alternative microbiological approaches, reinforcing compliance while expediting production cycles.

“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.

Source: Nelson Labs