Nelson Labs will be attending and presenting at PharmaEd Resources’ Extractables & Leachables West 2026, November 4–5 in La Jolla, California.
The summit brings together experts from across the pharmaceutical, biologics, and medical device industries to discuss evolving approaches to extractables and leachables, chemical characterization, biocompatibility, toxicological risk assessment, and regulatory compliance.
Join Our Presentation
Speaker: Kristin Treece, PhD, Principal Scientist, Nelson Labs
Co-authors: Caitlin Keller, Sr. Developmental Chemist, Nelson Labs, and Sarah C. Campbell, Principal Toxicologist, Nelson Labs
When: Wednesday, November 4 | 1:55 PM
Title: Exploration of Medical Device Extract Stability: What Is an Acceptable Loss of Extractables?
About the Presentation
Holding times for medical device extracts intended for chemical characterization are not formally established in ISO 10993-18, creating practical challenges when regulatory expectations reference the ≤24-hour holding times outlined in ISO 10993-12 for biological testing.
Kristin will share results from a stability study designed to better understand potential loss of organic extractables over time. The study evaluated semi-volatile and non-volatile compounds across multiple solvent types and storage conditions over approximately 40 days.
The presentation will explore the stability observed across these holding periods, the importance of storage conditions such as amber vial use for UV-sensitive compounds, and the potential combined impact of holding time from extraction through sample preparation and instrumental analysis.
November 4–5, 2026
Sheraton La Jolla | La Jolla, CA
For more information on the conference, visit PharmaEd Resources.
About the presenter:
Kristin Treece
Principal Scientist
Kristin Treece, PhD, is an analytical chemist specializing in extractables and leachables (E&L) and chemical characterization of medical devices. She earned her doctorate in Applied Analytical Chemistry from West Virginia University, where her research focused on advanced mass spectrometric analysis. Following her PhD, Kristin completed a post doctoral research associateship at Los Alamos National Laboratory. Her work included targeted and untargeted screening of high explosive formulations and structural elucidation of trace impurities, leveraging high resolution mass spectrometry and advanced chromatographic techniques. Kristin has spent the past seven years in the E&L industry, supporting both pharmaceutical and medical device programs. She is currently the Principal Scientist at Nelson Labs – Salt Lake City, where she leads chemical characterization efforts in accordance with ISO 10993 18, guiding study design, analytical strategy, and data interpretation for complex materials and devices.
