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
Header Artwork
Header Artwork

PUBLISHED ARTICLE

How to Avoid Costly E&L Testing Mistakes, According to an Expert

Ahead of her MEDevice Silicon Valley talk, Nelson Labs’ Alexa McLean breaks down how manufacturers can design defensible extractables and leachables studies—from selecting representative materials to troubleshooting unexpected findings.

Read the Full Article in MD+DI

 

22706

Alexa McLean

Expert Technical Consultant

Alexa McLean has been a member of the Analytical Chemistry team at Nelson Labs for the past 17 years. After earning her degree in Microbiology, she began her career in the Chemistry laboratory at Nelson Labs, where she has played an integral role in the development and growth of the company’s Extractables and Leachables (E&L) testing program since its inception. Alexa served as an E&L Study Director for more than 10 years and currently works closely with Sponsors to design and develop testing strategies for E&L projects at Nelson Labs’ Salt Lake City facility. She also provides support to Sponsors throughout the regulatory submission process. Alexa is an active member of AAMI BE-WG14, the working group responsible for standards related to Chemical Characterization testing.