Theoretical and Practical Considerations When Selecting Solvents for Use in Extractables Studies of Polymeric Contact Materials in Single-Use Systems Applied in the Production of Biopharmaceuticals

Regulatory authorities require the biopharmaceutical industry to demonstrate that extractables that may migrate from production systems do not alter the safety, efficacy, potency, or purity of drug products. Extractables studies of polymeric materials used in production systems and in particular single-use systems are designed to show material safety and should support the users to perform risk-based toxicological assessment of leachables that could potentially enter into the final product under process conditions. In this paper, we intend to improve the understanding of solvent–polymer interactions and thereby allow the prediction of extractables from a range of fluids based on their chemical properties. The possibility to predict solvent–polymer interactions and polymer swelling in biopharmaceutical applications based on solubility parameters is introduced.