When the sterility or integrity of a container closure system is compromised, even the most promising therapy is at risk. Whether you're developing parenteral drugs, biologics, or sensitive formulations, the ability to identify leaks or weaknesses in your packaging, and to characterise materials and chemicals with potential to migrate through barriers of a packaging component or system, is vital - not just for patient safety, but also for compliance with USP <1207>, European Pharmacopeia (EP), and FDA requirements.

For drug developers, especially those navigating complex regulatory pathways or short development timelines, identifying leaks or packaging failures late in the process can disrupt progress, increase costs, and put patient safety at risk. For many small to medium manufacturers, knowing exactly when and how to involve a testing partner can be just as challenging.

The Eurofins Medical Device Services network of laboratories offers a full suite of Container Closure Integrity Testing (CCIT) services designed to meet these challenges. Our experts support clients at all stages, from method development to ongoing batch release,  with both deterministic and probabilistic testing approaches to provide regulatory confidence and operational clarity.

Our testing services ensure your packaging maintains a sterile barrier throughout the product’s shelf life, aligns with regulatory expectations, and protects the efficacy and safety of your drug product. We evaluate elemental and biological compositions of materials and testing of various shapes, sizes, thicknesses, and compositions for plastics, and test a wide range of packaging formats, including vials, syringes, screw-cap bottles, and auto-injectors using state-of-the-art instruments and validated protocols.

Whether you're facing pressure from regulatory timelines or need clarity on test selection, Eurofins Medical Device Services can help. Our global reach and local support put expert advice, rapid turnaround, and unmatched technical capability within reach.