Understand the need to perform extractable and leachable evaluations for lyophilized drug products from a scientific perspective.

Lyophilized drug product containers and administration devices consist of the primary packaging (typically a glass vial and a rubber stopper), the reconstitution solution container (typically a vial or a prefilled syringe system), and the drug administration set (such as a disposable syringe, an intravenous bag, or a pump system with administration tubing) as shown in the Whitepaper.