Effects of X-Rays, Electron Beam, and Gamma Irradiation on Chemical and Physical Properties of EVA Multilayer Films

Nina Girard-Perier; Sylvain R A Marque; Nathalie Dupuy; Magalie Claeys-Bruno; Fanny Gaston; Samuel Dorey; Leonard S Fifield; Yelin Ni; Donghui Li; Witold K Fuchs; Mark K Murphy; Suresh D Pillai; Matt Pharr; Larry Nichols

doi:10.3389/fchem.2022.888285

Effects of X-Rays, Electron Beam, and Gamma Irradiation on Chemical and Physical Properties of EVA Multilayer Films

Front Chem. 2022 May 11:10:888285. doi: 10.3389/fchem.2022.888285. eCollection 2022.

Authors

Affiliations

¹ Sartorius Stedim FMT S. A. S., Aubagne, France.
² Case 551, CNRS, ICR, Aix Marseille University, Marseille, France.
³ CNRS, IRD, IMBE, Aix Marseille University, Avignon Université, Marseille, France.
⁴ Pacific Northwest National Laboratory, Richland, WA, United States.
⁵ National Center for Electron Beam Research, Texas A&M University, College Station, TX, United States.
⁶ Department of Mechanical Engineering, Texas A&M University, College Station, TX, United States.
⁷ Steri-Tek, Fremont, CA, United States.

Abstract

Gamma-ray irradiation, using the cobalt-60 isotope, is the most common radiation modality used for medical device and biopharmaceutical products sterilization. Although X-ray and electron-beam (e-beam) sterilization technologies are mature and have been in use for decades, impediments remain to switching to these sterilization modalities because of lack of data on the resulting radiation effects for the associated polymers, as well as a lack of education for manufacturers and regulators on the viability of these sterilization alternatives. For this study, the compatibility of ethylene vinyl acetate (EVA) multilayer films with different ionizing radiation sterilization (X-ray, e-beam, and gamma irradiation) is determined by measuring chemical and physical film properties using high performance liquid chromatography, differential scanning calorimetry, Fourier-Transform InfraRed spectroscopy (FTIR), surface energy measurement, and electron spin resonance techniques. The results indicate that the three irradiation modalities induce no differences in thermal properties in the investigated dose range. Gamma and X-Ray irradiations generate the same level of reactive species in the EVA multilayer film, whereas e-beam generates a reduced quantity of reactive species.

Keywords: differential scanning calorimetry; e-beam irradiation; electron spin resonance; gamma; liquid chromatography; methionine oxidation; x-ray.