Sobi

Purpose and goal

Leakage in pre-filled syringes is today an industrial problem in the pharmaceutical sector that results in recalled product or failed batches. The purpose of the project has been to deeper understand the causes and mechanisms of leakage. A major challenge in the past has been that leakage inside a needle guard could not be observed without affecting the system. In this project, neutron radiography has been successfully used to study leakage in the needle . The technology may be implemented industrially in connection with the manufacture of syringes and filling.

Expected results and effects

the project has provided an experimental method for studying syringes and leaks without affecting them. We can now a) detect leakage without removing needle protection and b) do mechanistic studies on the cause of leakage.

Planned approach and implementation

The project was carried out in collaboration between SOBI AB and RISE together with participants from suppliers of large-scale research structure in France. Sobi has developed samples and mechanistic issues and RISE has provided important expertise in experimental neutron radiography. Two series of trials have been conducted at LLB, one initial and one confirmation. The results have been presented at several scientific / industrial conferences and received great interest.