Chemical Characterization: The Starting Point for Biological Evaluations
Hannah S. Tims, Ph.D.
Senior Chemist, Eurofins Medical Device Testing
The safety assessment of any medical device is predicated on the biological assays and chemical characterization of the device. Guidance for the performance and assessment of the chemical characterization for medical devices is described in ISO 10993, which includes recommendations for the temperature, surface area to volume ratios, and solvents to be used for the extraction.
This presentation will provide a framework for the chemical characterization of medical devices with an emphasis on extractables and leachables assessments as an important part of this process, including several case studies presenting details of extractables and leachables set-up, evaluation and implications for medical device risk assessment.
Dr. Hannah Tims is a Senior Chemist for Eurofins Lancaster Laboratories’ Extractables and Leachables group where she specializes in GC/MS and LC/MS-TOF analysis for extractables and leachables testing. During her 12-year academic career, Dr. Tims held multiple positions in academia, including Assistant Professor of Chemistry and Biochemistry for Messiah College and Visiting Instructor at the College of Wooster. In this role, she directed research on biochemical and biophysical characterization of protein structures. Dr. Tims earned a Ph. D. in Biological Sciences from Northwestern University and a B.S. in Biochemistry and Molecular Biology from Bethel College.