We’re excited to announce that we’ll be exhibiting and presenting at the Extractables & Leachables Summit 2025.
Location: Philadelphia, Pennsylvania, USA.
For more information, please visit: https://www.pharmaedresources.com/event/extractables-leachables-summit-2025/.
Our Senior Technical Advisor Philippe Verlinde, PhD will present at this event “The use and value of FDA’s CLAP-list to support scientific quality in extractable testing.”
This presentation is scheduled Thursday April 24, at 10:05 PM.
The “Chemical List of Analytical Performance” (CLAP) published by the FDA (CDRH), represents an attempt to significantly improve and harmonize chemical analyses and Non-Target Analytical Methods (NTA-Methods) that are used for Biocompatibility assessment of medical devices. These methods inherently come with a high level of variance and uncertainty and henceforth the CLAP can be considered a large step forward to address these inter- and intra-lab variability issues. Although the list could be further expanded, it could set the basis for:
- Optimizing analytical methodologies to minimize gaps and addressing the uncertainty in detectability of a relevant set of compounds.
- Understanding variability of responses per technique
- Providing the basis to calculate Uncertainty Factors (UF) based on a reference set of compounds.
- Calculating the coverage for a methodology, using the derived UF.
- Providing the basis of a new way of generating Quantitative data: the RRF-approach.
- Minimizing inter-lab variability in Chemical Characterization results.
In the presentation we will show how a lab could make use of this CLAP list and what kind of conclusions can be drawn with respect to the above to support a higher level of scientific quality in extractable testing.
