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

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

doi:10.1038/s41529-023-00413-x

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

Journal Article · Fri Dec 01 00:00:00 EST 2023 · npj Materials Degradation

DOI:https://doi.org/10.1038/s41529-023-00413-x· OSTI ID:2229366

^[1]; Bisel, Tucker T. ^[2]; Hasan, Md Kamrul ^[3]; Li, Donghui ^[1]; Fuchs, Witold K. ^[4]; Cooley, Scott K. ^[1]; Nichols, Larry ^[5]; Pharr, Matt ^[6];

^[7]; Marque, Sylvain R. A. ^[8]; Murphy, Mark K. ^[1]; Pillai, Suresh D. ^[6]; Dorey, Samuel ^[9];

^[1]

Pacific Northwest National Laboratory (PNNL), Richland, WA (United States)
Washington River Protection Solutions, Richland, WA (United States); Pacific Northwest National Laboratory (PNNL), Richland, WA (United States)
Pacific Northwest National Laboratory (PNNL), Richland, WA (United States); Texas A & M University, College Station, TX (United States)
Pacific Northwest National Laboratory (PNNL), Richland, WA (United States); NASA Lewis Research Center, Cleveland, OH (United States)
Steri-Tek, Fremont, CA (United States)
Texas A & M University, College Station, TX (United States)
Aix Marseille Université, Avignon Université, CNRS, IRD, IMBE (France)
Aix Marseille Université, Case 551, CNRS, ICR (France)
Sartorius Stedim FMT S.A.S., Aubagne (France)

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.

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Research Organization:: Pacific Northwest National Laboratory (PNNL), Richland, WA (United States)

Sponsoring Organization:: USDOE National Nuclear Security Administration (NNSA)

Grant/Contract Number:: AC05-76RL01830

OSTI ID:: 2229366

Report Number(s):: PNNL-SA-184492

Journal Information:: npj Materials Degradation, Vol. 7, Issue 1; ISSN 2397-2106

Publisher:: SpringerCopyright Statement

Country of Publication:: United States

Language:: English

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46 INSTRUMENTATION RELATED TO NUCLEAR SCIENCE AND TECHNOLOGY
radiation effects
sterlization
ethylene copolymer
multilayer film
single-use biopharmaceutical products

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

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