04.07.21 -- Technologies To Ensure Container Closure Integrity

The COVID-19 pandemic has highlighted many of the challenges facing the pharmaceutical industry, among them the importance of distribution logistics. Vaccines and other large-molecule products require unique storage conditions, especially during the cold chain. Helium detection technology can improve the quality of drug delivery system and container design.

This article explores the need for sensitive, reliable, and automated container closure integrity (CCI) testing technologies, and how existing deterministic solutions can help achieve optimum quality assurance goals in CCI for pharmaceutical manufacturers.

Due to their complexity, combination products, specifically autoinjection systems, present unique challenges in implementing a container closure integrity (CCI) testing strategy. This is further complicated by a pervasive, though diminishing, tendency for companies to consider CCI only at the final product-package life cycle stage, an approach where combination products will highlight the pitfalls.

Parenteral delivery systems are the highest risk packaging application concerning container closure integrity. Leaks that register in the single micron range can introduce a threat of bacterial ingress. To manage this risk, the industry has continued to pursue leak detection methods that are more sensitive and reliable for vials, ampoules, cartridges and syringes.

The dye ingress test method continues to be a widely used test method for container closure integrity (CCI) within the pharmaceutical industry. Even with recent research attempting to support its use, this paper explains why the dye ingress test method is not a suitable approach.