The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
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...
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:...
In this article Jennifer Gygi, Expert Technical Consultant at Nelson Labs, discusses how EO-optimization efforts can affect a manufacturer’s packaging validation. Read the Full Story in MPO
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...
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)...
