Container-Closure Integrity Testing for Drug Delivery Devices
Manager, Chemistry & Container Testing, Eurofins Medical Device Testing
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.
As Manager of Chemistry and Container Testing, Ms. Roark oversees testing to support the container and package testing needs of both pharmaceutical and medical device clients.
With more than 23 years of analytical testing experience, Ms. Roark serves as one of Eurofins’ leading subject matter experts for Container Closure Integrity and Extractables and Leachables Testing. She is a member of multiple ASTM Committees and subcommittees, including E55 on the Manufacture of Pharmaceutical and Biopharmaceutical Products, E55.04 General Biopharmaceutical Standards, F02 on Primary Barrier Packaging, and F02.40 on Package Integrity. Ms. Roark is also leading efforts to draft standard WK43945—New Practice for Determining and Characterizing BioProcess Extractables from Components, Subassemblies, and Assemblies Used in Single-Use Applications: Part 1-Preparation of Extractables Test Solutions and has co-published a series of articles on method validation. Ms. Roark currently sits on the USP Expert Panel for <660> Containers – Glass and <1660> Evaluation of Inner Surface Durability of Glass Containers. She has co-instructed three Container Closure Integrity Workshops for the Parenteral Drug Association in Europe.