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Peer-reviewedCC BY-NC-NDEuropean Journal of Pharmaceutical Sciences

Compatibility of PVC after irradiation: spectroscopic evaluation

Abstract

Polyvinyl chloride (PVC) is extensively used in advanced therapies due to its flexibility, chemical resistance, and biocompatibility. This study investigates the equivalency of three ionizing radiation sterilization technologies (gamma rays, X-rays, and electron beam) at 50 and 100 kGy on three medical-grade PVC formulations. A comprehensive analytical approach combining Electron Spin Resonance (ESR), Fourier Transform Infrared Spectroscopy (FTIR), colorimetry, and High-Performance Liquid Chromatography (HPLC) was employed. ESR revealed persistent polyenyl radicals (up to 60 days) influenced by ageing rather than irradiation technology or dose. FTIR-PCA demonstrated dose-dependent carbonyl growth (1708 cm⁻¹) from additive oxidation whereas PVC backbone signatures remained stable. Statistical analysis established that differences among technologies remain within acceptable equivalence margins. These findings confirm that gamma, X-ray, and e-beam irradiation preserve the chemical integrity of PVC formulations for medical device applications.

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BibTeX
@article{dorey2026compatibility,
  title = {{Compatibility of PVC after irradiation: spectroscopic evaluation}},
  author = {Samuel Dorey and Fabien Girard and Nathalie Dupuy and Celine Huart and Sylvain R.A. Marque and Blanche Krieguer},
  journal = {European Journal of Pharmaceutical Sciences},
  year = {2026},
  month = oct,
  doi = {10.1016/j.ejps.2026.107687},
  url = {https://hal.science/hal-05808155v1},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - Compatibility of PVC after irradiation: spectroscopic evaluation
AU  - Samuel Dorey
AU  - Fabien Girard
AU  - Nathalie Dupuy
AU  - Celine Huart
AU  - Sylvain R.A. Marque
AU  - Blanche Krieguer
PY  - 2026
DA  - 2026/10/19
JO  - European Journal of Pharmaceutical Sciences
DO  - 10.1016/j.ejps.2026.107687
UR  - https://hal.science/hal-05808155v1
AB  - Polyvinyl chloride (PVC) is extensively used in advanced therapies due to its flexibility, chemical resistance, and biocompatibility. This study investigates the equivalency of three ionizing radiation sterilization technologies (gamma rays, X-rays, and electron beam) at 50 and 100 kGy on three medical-grade PVC formulations. A comprehensive analytical approach combining Electron Spin Resonance (ESR), Fourier Transform Infrared Spectroscopy (FTIR), colorimetry, and High-Performance Liquid Chromatography (HPLC) was employed. ESR revealed persistent polyenyl radicals (up to 60 days) influenced by ageing rather than irradiation technology or dose. FTIR-PCA demonstrated dose-dependent carbonyl growth (1708 cm⁻¹) from additive oxidation whereas PVC backbone signatures remained stable. Statistical analysis established that differences among technologies remain within acceptable equivalence margins. These findings confirm that gamma, X-ray, and e-beam irradiation preserve the chemical integrity of PVC formulations for medical device applications.
SN  - 0928-0987
SN  - 1879-0720
ER  -