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
On this episode of SPOT radio, Charlie Webb speaks with Wendy Mach with Nelson Labs about their Packaging Validation 101 Webinar. This online event will cover topics such as: determining the appropriate sample size for testing, writing the validation protocol, developing...
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)...
Medical device reprocessing, and the scientific validation of reprocessing instructions, are critical steps to ensuring devices are safe and effective for patient use. The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for COVID-19, as...
Each year medical device packagers, engineers, directors, managers and quality teams meet to discuss upcoming industry trends, regulatory updates, and issues associated with common packaging ordeals and this year’s event in Charlotte, North Carolina was no exception. Due to current...
With the beginning of the New Year comes the responsibility of reviewing your present radiation sterilization process. One of the most commonly overlooked parts of this assessment is the annual review of product family groupings. After four (4) quarters of...
