Chemical Characterization of Medical Device Materials According to ISO 10993-18:2020
Chemical characterization is an important component of biocompatibility testing for medical devices. Therefore, before conducting medical device extractable and leachable (E&L) studies, it’s crucial that you keep in mind all necessary analytical considerations.
But are you up-to-speed with the latest recommendations set out in ISO 10993-18?
If not, or if you’re looking for more guidance on how to remain ISO-compliant moving forward, then you’ve come to the right place.
Objective
This presentation will focus on the analytical considerations of medical device extractable and leachable (E&L) studies as per the new ISO 10993-18 chapter. It will also explore common regulatory deficiency points on medical device E&L studies.
Agenda
- Extraction strategy and solvent selection
- Analytical evaluation threshold (AET) calculation and analytical uncertainty factor considerations
- Testing methodologies and method qualification
- E&L compound identification strategies during GC-MS and LC-MS analysis
- Q&A
Presenter: Dujuan Lu (Ph.D. E&L Manager/Global Lead, SGS)
Dr. Lu serves as the manager for the extractables and leachables (E&L) team at the SGS Fairfield New Jersey facility as well as the global leader amongst the three centers of excellence for E&L testing. Before joining SGS, she worked at Fresenius Kabi as a research scientist, leading E&L projects to support transfusion and infusion medical device and parenteral products. She has extensive pharmaceutical industry experience with more than 400 E&L projects on a broad range of packaging systems, including process materials, pharmaceutical finished packaging, and medical device. As a subject matter expert in the E&L field, she is frequently presenting at various conferences as invited speakers and technical session chairs. She was named one of the 60 most influential people working in the pharmaceutical industry in the Medicine Maker’s 2020 power list.
Dr. Lu obtained her PhD in analytical chemistry from the University of Pittsburgh and BS in chemistry from Nanjing University. She has 15 years of experience in pharmaceutical analysis, specialized in trace analysis by LC/MS and GC/MS. She has authored more than 15 high-impart journal publications with more than 300 citations. She is serving as an expert reviewer for more than 10 prestigious journals in the field of analytical chemistry and pharmaceutical science.
