September 2, 2022
In the early 1980s, Dr. Jerry Nelson, founder of Nelson Laboratories, began developing a whole-package aerosol-challenge test. The original intent of the test method was to simulate real-time shelf life using a high-challenge microbial-spore load. In essence, this involved...
See BlogMay 24, 2022
This eBook addresses common challenges and best practices for medical-device manufacturers with questions about testing their products. Table of Contents: EO Optimization and Potential Effects on Sterile-Barrier Packaging Patient-Specific Implants Often Require More Testing Extractable Chemical Characterization and Risk Assessment:...
See BlogMarch 3, 2022
In this article Jennifer Gygi, Expert Technical Consultant at Nelson Labs, discusses how EO-optimization efforts can affect a manufacturer’s packaging validation. Read Full Story
See BlogNovember 18, 2021
Particulate testing is required for medical devices to ensure patient safety, but there isn’t a lot of guidance available. Here are four important things you need to know about particulate testing on medical devices. First, while there are some device-specific...
See BlogApril 22, 2021
It’s not over just yet. Eclipsed for the past year by COVID-19, medtech’s long-simmering ethylene oxide (EO) controversy could soon flare up (again) as the industry grapples with alternative sterilization methods for its products. The U.S. Environmental Protection Agency (EPA)...
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