What are extractables and leachables and how should they be considered during validation?
Drug developers and regulators are concerned about potentially adverse impact on drug product quality or safety by chemicals that may migrate into the drug product from fluid contact process equipment (including Single-Use systems), final drug product containers or secondary packaging.Extractables are chemicals that migrate from fluid contact materials under exaggerated conditions (e.g. solvent, time, temperature) and represent a “worst case” library of chemicals that could potentially contaminate or interact with drug product. Leachables are chemicals that can be found in final drug product and typically include some extractables from process equipment as well as from the final container/closures or packaging along with any reaction or degradation products of those extractables and the active drug.The BPSA Guide—Recommendations for Extractables and Leachables Testing—Parts 1 and 2 (part 3 pending) provides a risk-based approach for determination of extractables and leachables from Sin
