Date/TimeJanuary 11, 2023
Performing an exhaustive extraction as defined by ISO 10993-18:2020 is a common regulatory expectation for medical device Extractable & Leachable (E&L) studies that has a crucial impact on study design and corresponding results. Since there is no standardized procedure for determining the exhaustive endpoint, various approaches for this purpose are in use in the industry.
Join NAMSA for this webinar where we will discuss the most common approaches used for determining the exhaustive endpoint, their advantages and disadvantages and their influence on study design and results. We will also outline how regulatory requirements and laboratory execution diverge, as well as other challenges of an E&L study that are influenced by a lack of standardized procedures (e.g. mass balance, toxicological assessment).
Participants of this webinar can expect to learn how to:
- Define and determine regulatory framework for exhaustive extraction
- Understand common industry approaches for exhaustive endpoint determination including:
- Chromatographic determination based on the iterative extracts results
- Gravimetric determination based on the Non-Volatile Residue (NVR)
- Other possible procedures
- Understand the advantages and disadvantages of the different procedures and impact on the study design
- Understand NVR determination
- Utilize mass balance – match of NVR and instrumental results
- Use Electronic Data Capture (EDC) to your benefit
- Understand toxicological evaluation based on daily exposure vs. exhaustive extraction
Tim PetermannPrincipal Chemist
Tim Petermann graduated as a Food Chemist at the University of Würzburg in June 2012 and became a State Certified Food Chemist in June 2013 at the Landesamt für Gesundheit und Lebensmittelsicherheit Bayern (State Office for Health and Food Safety Bavaria). Tim has experience as a Study Director and HPLC Systems’ Owner for a Contract Laboratory in the field of food supplements, dietetic food, pharmaceuticals and water. He joined NAMSA in September 2017 and has served as a Study Director and UPLC-MS responsible at NAMSA Obernburg in the field of chemical characterization and E&L Studies of Medical Devices. Since August 2021 he has served as a Principal Chemist responsible for technical and scientific questions and projects.