The Wrong Container Choice – A Threat to Patient Safety and Time-To-Market

A common situation is that pharma companies select a certain primary packaging container and in first short term studies, everything is fine… Later, issues could occur during development or after launch – maybe even years after the launch. These issues could be the presence of glass particles due to delamination or a shift in pH because of elevated leachables. From a patient safety perspective, this is disastrous, with a threat of blocked blood vessels, adverse reactions, or unavailability due to market recall respectively drug shortage.

One example is a case from 2010. The drug had been on the market for roughly ten years before suddenly, certain vials showed the presence of particles. A big recall followed, and all containers were retrieved from the market. Glass particles were found in only 0.03 % of the analysed vials. This demonstrates that appearance of glass delamination is driven by production outliers, which makes it very difficult to address.

Pharma companies can also face unpleasant surprises in the early stages of development when specific formulations are not stable in conventional vials. This can lead to a restriction in packaging options or even product re-formulations that can take many months, resulting in lost time and money.