Modeling the Permeation Rates of Organic Migrants through a Fluoropolymer Film

Polymer films were widely used as barriers for blocking certain organic molecules (such as leachables and extrables) in both food and parenteral pharmaceutical packaging applications. However, a good understanding of the barrier properties of those polymer films is still lacking for combination drug product manufacturers to make practical risk-based assessment regarding the effectiveness of the barrier films against potential leachables. The present work addressed this issue by a combined theoretical/experimental approach: a new mathematical model based on Hansen Solubility Parameters, the size, and the shape of organic molecules was developed to quantitatively estimate the Steady State Permeation Rate (SSPR) of organic migrants through a model ETFE fluoropolymer film, by considering contributions from both solubility and diffusivity. This model facilitates expedited screening of potential leachables, allowing for experimental focus on higher-risk leachables and ultimately enabling more rapid combination drug product development.