Compatibility of ethylene vinyl acetate (EVA)/ethylene vinyl alcohol (EVOH)/EVA films with gamma, electron-beam, and X-ray irradiation

Yelin Ni , Tucker T Bisel , Md Kamrul Hasan , Donghui Li , Witold K Fuchs , Scott K Cooley , Larry Nichols , Matt Pharr , Nathalie Dupuy (1) , Sylvain R A Marque (2) , Mark K Murphy , Suresh D Pillai , Samuel Dorey , Leonard S Fifield

1 IMBE - Institut méditerranéen de biodiversité et d'écologie marine et continentale
2 ICR - Institut de Chimie Radicalaire

Many polymer-based medical devices are sterilized by gamma irradiation. To reduce the use of cobalt-60 gamma-ray sources, transition from gamma ray to alternative irradiation technologies was proposed, namely electron beam (e-beam) and X-ray. A major impediment for such a transition is the knowledge gap in material compatibility with the different radiation sources. In this study, multi-layer films consisting of ethylene vinyl acetate (EVA) and ethylene vinyl alcohol (EVOH) components were irradiated to target doses of 30, 45, and 60 kGy by gamma-ray, e-beam, and X-ray sources. Effects of irradiation were evaluated on 12 material properties, and statistical comparisons between gamma irradiation and alternative technologies were conducted using the two one-sided t-test (or "equivalence test") and classic t-test. Melting temperature and UV absorbance below 300 nm showed dose dependencies, while other investigated properties such as discoloration and mechanical durability did not change with dose up to 60 kGy. Based on these results, there is no material compatibility issue associated with the transition from gamma to e-beam or to X-ray as source of sterilization radiation of the studied multi-layer film.

Keywords: Characterization and analytical techniques; Polymers

Domains: Chemical Sciences

Yelin Ni, Tucker T Bisel, Md Kamrul Hasan, Donghui Li, Witold K Fuchs, et al.. Compatibility of ethylene vinyl acetate (EVA)/ethylene vinyl alcohol (EVOH)/EVA films with gamma, electron-beam, and X-ray irradiation. npj Materials Degradation, 2023, 7, ⟨10.1038/s41529-023-00413-x⟩. ⟨hal-04424140⟩