Our customer needed to replace an existing HE-leak test method for lyophilized vials due to the lack of method robustness and logistical demands that were caused by the outsourced testing process. The goal was to develop an alternative test method with the same sensitivity as the existing one, meaning that a leak rate of 10-6 mbar*l/sec had to be reached.

Our first stage was for our technical experts to perform a series of lab tests on the customer`s product samples with existing technologies inhouse. Headspace Analysis was the method of choice as it could reach the required leak rates by detecting the oxygen ingress. However, it was not possible to use the conventional HSA method as there was no light transmission on the product due to fogging on the vial sidewalls.

We have further enhanced the laser technology so that it can also be used to test non transparent packaging, as in the explained case.

A proof of concept study was performed. The result was a concept for a new Headspace Analysis system which was then used to create the method development for the customer`s specific application.

A manually operated Headspace Analysis lab system was developed that allowed the customer to perform a non-destructive measurement of oxygen ingress by which they could replace their previous helium leak test method. The system allows the CCI testing of multiple format sizes and can also be used for difficult to inspect containers such as vials with labels, condensation or fog caused by lyophilzation and cryo environments.

Due to the holistic approach, including method and system development, our customer was able to reduce the reoccurring costs for outsourced testing while improving results with a robust method.