Extractables and Leachables - Characterization of Drug Products, Packaging, Manufacturing and Delivery Systems, and Medical Device

Learn to address the safety aspects of packaged drug products and medical devices

Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards.

Extractables and leachables are derived from the drug product-s packaging, manufacturing systems and/or delivery systems or from the medical device-s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumul