Nelson Labs

Articles

Extractables and leachables (E&L) testing for packaging-related impurities is essential to ensure cGMP compliance and, most importantly, patient safety. 

E&L Testing to Ensure Compliance & Patient Safety

Sterility testing is commonly the first test we think of to determine if something is “sterile”, but in most cases it is not the appropriate test. In this webinar, experts from Nelson Labs review the accepted approach for determining sterility assurance through sterilization and packaging validations.

https://www.pharmtech.com/pt_w/sterility-testing

Sterility testing is commonly the first test we think of to determine if something is “sterile”, but in most cases it is not the appropriate test. In this webinar, experts from Nelson Labs review the accepted approach for determining sterility assurance through sterilization and packaging validations. They will examine sterility testing, including the pros and cons of the methods, to understand when and how testing should be applied. Common case studies where sterility testing is often used will also be presented and better approaches will be suggested.


Learn when sterility testing is and is not appropriate

Understand Test of Sterility versus Test for Sterility

Identify approaches to navigate through specific case scenarios


Expert Technical Consultant
Nelson Laboratories, LLC

 is a recognized authority and industry leader on Radiation Sterilization, Bioburden, Microbiology, and Tissue Processing. He has over 15 years of experience working in laboratory functions in research, test design, media formulation, medical device, and tissue industries. Bryce works with clients in all areas of the world to speak, train, and consult on failure investigations, bioburden issues, establishing bioburden alert and action levels, product family grouping, product adoption, radiation sterilization, and tissue validations.


Bryce has worked with Nelson Laboratories representatives as well as with the Association for the Advancement of Medical Instrumentation (AAMI) and the International Organization for Standardization (ISO). He has worked and supported updates for ISO 11737-1 and 11737-2. He has served as the document owner of multiple Nelson Laboratories Standard Testing Protocols (STP), Work Instructions (WI), and Standard Works (SW). He acts as one of the Nelson Laboratories Bioburden, Microbiology, and Radiation Sterilization subject matter experts.


Webcasts

Webinar Date/Time: Wed, Mar 6, 2024 2:00 PM EST





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Videos

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Updated Lab Testing Methods to Safeguard Global Health

 is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Nelson Labs serves over 3,500 customers across 15 facilities in the United States, Mexico, Asia, and Europe. 

We have a comprehensive array of over 800 laboratory tests supporting 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 we complete.

Nelson Labs offers a comprehensive approach toward Extractables & Leachables testing for the pharmaceutical industry. Our approach combines technical and analytical expertise, polymer knowledge and understanding of regulatory requirements, all combined in a tailored approach for our customers.