Container-Closure Integrity Testing for Drug Delivery Devices

Container-closure integrity is evaluated during all phases of the product-package life cycle for a drug delivery device from package development, as part of the design verification study, to manufacturing, through commercial stability, and in many cases in lieu of sterility testing. So, what exactly is meant by the term container-closure integrity, and how can an appropriate leak testing technology be selected for a drug delivery device such as a pre-filled syringe, a cartridge, an auto-injector, or a pen injector? This presentation will compare various container-closure integrity testing technologies, will explore the applications of these technologies at different phases of the product-package life cycle, and will discuss method development and validation strategies to ensure the sterility and quality of the drug product while packaged in the drug delivery device through to expiry.