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Whitepaper

WHITEPAPER

Comprehensive Chemical Characterization of Extractables and Leachables (E&L) in Medical Devices with Mass Spectrometry

The following poster was presented at the extractables & leachables session of the annual conference of American Society for Mass Spectrometry (ASMS) in Minneapolis.

Read the following abstract to learn more:

Medical device testing is a significant part of a present-day healthcare system established to support preclinical product safety. In recent years, the quality of medical device testing methods has been strictly regulated by government agencies through different protocols and guidelines such as ISO-10993 and ISO-14971. A vital part of the biological evaluation of medical devices is their chemical characterization by mass spectrometric analysis. We present our comprehensive chemical characterization platform consisting of volatile organic compounds (VOCs) analysis by headspace gas chromatography mass spectrometry (HS-GC-MS), semi-volatile organic compounds (SVOCs) analysis by gas chromatography–mass spectrometry (GC-MS), non-volatile organic compounds (NVOCs) analysis by UHPLC-HRMS, and metals analysis by ICP-MS with the case study of a chemical profiling of a metallic implantable device.

The authors employed by Nelson Labs are listed below. The other authors are Ghazanfar Ali, Robert Mueller, and Benjamin Hunt.

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Manoj Ghaste

Senior Development Scientist

Manoj Ghaste received his Ph.D. in Bioanalytical Chemistry and Metabolomics (2015) from the Centre of the Department of Cellular, Computational and Integrative Biology (CIBIO), University of Trento, Italy. He joined Nelson Labs, Salt Lake City in 2021 as a Senior Development Scientist in Analytical Chemistry Department. Prior to coming to Nelson Labs, he worked as Postdoctoral Fellow at Purdue University & University of North Texas. During his career, over the last 14 years, he has worked extensively in the field of development and applications of advanced mass spectrometry platforms for different types of chemical analyses, and published 13 peer-reviewed publications with over 600 citations. In addition, he is an active member of several professional organizations, such as the Royal Society of Chemistry (MRSC), the American Society for Mass Spectrometry (ASMS), the Association of Official Analytical Chemists (AOAC International), and the Metabolomics Association of North America (MANA).

Patrick Finnegan

Senior Laboratory Operations Manager

Caitlin Keller

Senior Developmental Chemist

Kimberly Mitchell

Lab Analyst II

Patrick Odea

Lab Analyst II

Amelia Turley

Amelia Turley

Lab Analyst I

Manasa Venkatesh

Lab Analyst I

Corbin Hartig

Lab Analyst I

Krystine Osumo

Lab Analyst I

Melanie Millham

Chemist II

Sarah Curlee

Chemist II

Toree Fitzgerald

Chemist II

Phillip McKinney

Chemist I

Lilian Reyes

Chemist I

Adam Michaud

Study Director III

Courtney Willis

Service Coordinator II

Jennifer Coons

Quality Auditor II

Alexa McLean

Lab Operations Manager

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