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Author: Jennifer Gygi





September 2, 2022

Aerosol Challenge Exposure: A Retrospective Review

  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...

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May 24, 2022

Lessons from the Lab eBook

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:...

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March 3, 2022

EO Optimization and Potential Effects on Sterile Barrier Packaging

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

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November 18, 2021

Four Important Things to Know About Particulate Testing and Medical Devices

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...

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April 22, 2021

Custom Packaging Typically Required for Orthopedic Devices

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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