A novel approach for rapid risk assessment of targeted leachables in medical device polymers is proposed and validated. Risk evaluation involves understanding the potential of these additives to migrate out of the polymer, and comparing their exposure to a toxicological threshold value. In this study, we propose that a simple diffusive transport model can be used to provide conservative exposure estimates for phase separated color additives in device polymers. This model has been illustrated using a representative phthalocyanine color additive (manganese phthalocyanine, MnPC) and polymer (PEBAX 2533) system. Sorption experiments of MnPC into PEBAX were conducted in order to experimentally determine the diffusion coefficient, D = (1.6 ± 0.5) × 10−11 cm2/s, and matrix solubility limit, Cs = 0.089 wt.%, and model predicted exposure values were validated by extraction experiments. Exposure values for the color additive were compared to a toxicological threshold for a sample risk assessment. Results from this study indicate that a diffusion model-based approach to predict exposure has considerable potential for use as a rapid, screening-level tool to assess the risk of color additives and other small molecule additives in medical device polymers.
Bibliographical noteFunding Information:
The findings and conclusions in this paper have not been formally disseminated by the Food and Drug Administration, are the views of the authors, and should not be construed to represent any agency determination or policy. The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by Department of Health and Human Services. This research was funded by the CDRH Critical Path program, DBCMS program funding and the Oak Ridge Institute for Science and Education through an agreement between the U.S. Department of Energy and the U.S. Food and Drug Administration. The authors acknowledge FDA Advanced Characterization Facility (ACF) for instrument use. The authors thank Jennifer Goode, Yong Wu and Michael Ibrahim for helpful discussions.
© 2017, Biomedical Engineering Society (Outside the U.S.).
- Color additive
- Medical device
- Risk assessment