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Neutron radiography for detection of leakage in prefilled syringes

Reference number
Coordinator RISE Research Institutes of Sweden AB - RISE Research Institutes of Sweden, Göteborg
Funding from Vinnova SEK 500 000
Project duration October 2018 - November 2019
Status Completed
Venture Research infrastructure - utilisation and collaboration
Call Research infrastructure - utilisation and collaboration: Industrial pilot projects for neutron and photon experiments at large scale research infrastructures - 2018
End-of-project report 2018-03261_Swedish_Orphan_Biovitrum.pdf (pdf, 512 kB)

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.

The project description has been provided by the project members themselves and the text has not been looked at by our editors.

Last updated 2 July 2020

Reference number 2018-03261

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