Nelson Labs Launches Innovative Rapid Sterility Testing to Significantly Expedite Product Sterility Results
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.
Nelson Labs, una società di Sotera Health, ha lanciato i servizi di Test di Sterilità Rapidi in tre laboratori situati negli Stati Uniti e in Europa. Questo metodo innovativo riduce il tempo per i risultati dei test di sterilità dei prodotti dal tradizionale periodo di 14 giorni a soli 6 giorni, mantenendo la conformità agli standard USP <71> e <1223>.
La nuova soluzione di test supporta in modo unico sia i dispositivi medici che i prodotti farmaceutici, espandendosi oltre il tipico focus sui componenti biologici o sui prodotti a breve scadenza. Il metodo utilizza strumenti di dati quantitativi per automatizzare i risultati dei test, riducendo il potenziale errore umano. Questo progresso consente un rilascio più rapido dei prodotti, mantenendo al contempo gli standard di qualità e sicurezza.
Nelson Labs, una empresa de Sotera Health, ha lanzado servicios de Pruebas de Esterilidad Rápidas en tres sitios de laboratorio en los Estados Unidos y Europa. Este método de prueba innovador reduce el tiempo de resultados de pruebas de esterilidad de productos del tradicional período de 14 días a tan solo 6 días, manteniendo el cumplimiento de los estándares USP <71> y <1223>.
La nueva solución de prueba apoya de manera única tanto a los dispositivos médicos como a los productos farmacéuticos, ampliándose más allá del enfoque típico en componentes biológicos o productos de corta vida útil. El método emplea instrumentación de datos cuantitativos para automatizar los resultados de las pruebas, reduciendo el potencial de error humano. Este avance permite un lanzamiento más rápido de productos, manteniendo al mismo tiempo los estándares de calidad y seguridad.
넬슨랩스(Nelson Labs)는 소테라 헬스(Sotera Health) 회사로서 미국과 유럽의 세 개 실험실 사이트에서 신속 멸균 테스트 서비스를 출시했습니다. 이 혁신적인 테스트 방법은 전통적인 14일 기간에서 6일로 제품 멸균 테스트 결과 시간을 단축하면서 USP <71> 및 <1223> 표준 준수를 유지합니다.
새로운 테스트 솔루션은 의료기기와 제약 제품 모두를 독특하게 지원하며, 생물학적 구성 요소나 짧은 유통기한 제품에 대한 전형적인 초점을 넘어섭니다. 이 방법은 테스트 결과를 자동화하기 위해 정량적 데이터 장비를 사용하여 인적 오류 가능성을 줄입니다. 이 발전은 품질 및 안전 기준을 유지하면서 더 빠른 제품 출시를 가능하게 합니다.
Nelson Labs, une société de Sotera Health, a lancé des services de Tests de Stérilité Rapides sur trois sites de laboratoire aux États-Unis et en Europe. Cette méthode de test innovante réduit le temps des résultats de test de stérilité des produits de la période traditionnelle de 14 jours à seulement 6 jours, tout en maintenant la conformité avec les normes USP <71> et <1223>.
La nouvelle solution de test soutient de manière unique à la fois les dispositifs médicaux et les produits pharmaceutiques, s'élargissant au-delà de l'accent habituel sur les composants biologiques ou les produits à courte durée de vie. La méthode utilise des instruments de données quantitatives pour automatiser les résultats des tests, réduisant ainsi le potentiel d'erreur humaine. Cette avancée permet un lancement de produit plus rapide tout en maintenant les normes de qualité et de sécurité.
Nelson Labs, ein Unternehmen von Sotera Health, hat Rapid Sterility Testing-Dienstleistungen an drei Laborstandorten in den Vereinigten Staaten und Europa eingeführt. Diese innovative Testmethode reduziert die Zeit für die Ergebnisse der Sterilitätstests von den traditionellen 14 Tagen auf nur 6 Tage und bleibt dabei konform mit den USP-Standards <71> und <1223>.
Die neue Testlösung unterstützt auf einzigartige Weise sowohl Medizinprodukte als auch pharmazeutische Produkte und erweitert sich über den typischen Fokus auf biologische Komponenten oder Produkte mit kurzer Haltbarkeit hinaus. Die Methode verwendet quantitative Datentechnologie zur Automatisierung der Testergebnisse und reduziert das Potenzial menschlicher Fehler. Dieser Fortschritt ermöglicht eine schnellere Produktfreigabe und hält gleichzeitig die Qualitäts- und Sicherheitsstandards ein.
- 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
- Results timing may vary based on product-specific validation
- No guaranteed specific outcomes
Insights
Nelson Labs' launch of Rapid Sterility Testing represents a meaningful operational advancement for parent company Sotera Health (SHC). By reducing testing timeframes from 14 days to as little as 6 days, this innovation delivers significant value to medical device and pharmaceutical manufacturers needing to validate product sterility before market release.
This technology enhancement strengthens Sotera's competitive positioning in the laboratory testing services market by addressing a critical industry bottleneck. For manufacturers, accelerated testing translates directly to faster revenue recognition and improved cash flow cycles - particularly valuable in high-margin medical product segments where time-to-market is crucial.
The expanded application across both medical devices and pharmaceuticals (previously primarily to biological products) substantially broadens the addressable market for this service. Additionally, the automation component reduces human error risk while potentially improving operational efficiency at Nelson Labs' facilities.
This development aligns with Sotera Health's long-term strategy of maintaining technological leadership in testing services while expanding higher-margin specialty offerings. The cross-selling opportunity with their affiliated Regulatory Compliance Associates creates additional revenue potential beyond the core testing service.
While the financial impact isn't quantified, this represents a positive operational development that enhances Sotera's value proposition to clients in competitive testing markets.
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
FAQ
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