A vial is a small, sealed container — typically made of borosilicate glass or cyclic olefin polymer (COP) — used as the primary packaging for injectable biopharmaceutical products, including drug substances, drug products, viral vectors, cell therapies, and vaccines. Vials are filled and sealed under strict aseptic conditions during the fill and finish stage of drug product manufacturing, and must meet rigorous quality standards for dimensional tolerances, chemical compatibility, extractables and leachables, container closure integrity (CCI), and sterility in compliance with Ph. Eur., USP, and applicable regulatory guidelines. Their selection, qualification, and compatibility testing with the drug product formulation are critical components of drug product development and regulatory submissions.
