Container Closure Integrity Testing: the Importance of Leak Detection and how to Approach it

Tommaso Taroni, Project Leader E&L and packaging testing division, Eurofins BioPharma Product Testing Italy, Vimodrone, Italy (TommasoTancrediAlessandroTaroni@eurofins.com)

The integrity of packaging systems is a fundamental pre-requisite for the safety and sterility of drug products. The ability to assess whether a container closure system (CCS) is able to maintain a sterile barrier against microorganisms or prevent the escape and ingress of substances, leading to contamination or loss of the drug product, is of utmost importance to evaluate its biological safety and suitability.

To fulfil these requirements, Container Closure Integrity Testing (CCIT) has the purpose of developing and applying suitable testing procedures to apply during all product life cycle phases, from the qualification of the packaging system, to the manufacture, release, storage and shipment of the drug product, until the end of shelf life. Over the course of the last few years, requests by regulatory authorities about this kind of testing have become more and more demanding.

Since Container Closure Integrity is influenced by both the package and the drug product, testing methods are numerous and vary greatly depending on the specific combination of the two. They can be based either on a probabilistic or a deterministic approach and this contributes to defining their statistical relevance and sensitivity, among other key parameters.

Starting from the regulatory requests of the USP <1207> chapter, the presentation will show the rationale behind the choice of the most proper analytical technique to be applied depending on the product-CCS coupling. Real case studies as Microbial Ingress Testing on large bags (500L) for drug manufacturing and Pressure Decay Testing for Biologics, will be presented and discussed.

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Short Biography of Presenting Author

Tommaso taroni

After graduating in Chemical Sciences in 2017, I received a PhD fellowship from the University of Milan and deepened my knowledge of physical chemistry and material sciences, with a focus on nanotechnology.

During the years, I gathered theoretical and practical understanding of numerous advanced materials, such as magnetic particles and photoactive thin films, with applications ranging from diagnostics to sensors.

After achieving the Chemistry PhD title in 2021, in 2022 I started working at Eurofins Biolab as Project Leader in the CCIT & Packaging department, where I learned the importance of Container Closure Integrity Testing and gained experience with many different testing techniques.