Exhaustive Extractions in E&L Studies – Endpoint Determination Challenges, Expectations and Reality

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