Nelson Labs, a Sotera Health company, launched its Innovative Rapid Sterility Testing solution, now available at three laboratory sites in the United States and Europe. This new offering significantly expedites product sterility results, reducing incubation time to as little as six days, depending on product-specific validation.
Traditionally, product-sterility testing, performed according to USP general chapter 71, requires a 14-day incubation period. Nelson Labs' rapid method broadens the scope of such testing beyond products with biological components or short shelf life, making it suitable for a wider array of medical devices and pharmaceutical products. The method also utilizes quantitative data and automation to reduce human error.
This cutting-edge technology complies with USP <71> and <1223> for validating alternative microbiological methods. The faster turnaround times enable medical device and pharmaceutical manufacturers to achieve quicker product release to market, ensuring regulatory compliance and product safety. Nelson Labs' expert advisors are available to guide customers through validation and regulatory submissions related to this new testing method.
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