Effect of electron beam radio-sterilization on cyclo olefin copolymers and its impact on the interactions with active molecules
type: Dataset
description: The aim of this work was to study the effect of electron beam radio-sterilization on cyclo olefins copolymers (COC) used as pharmaceutical storage materials, as well as to investigate its impact on the interaction with pharmaceuticals formulations. Due to the analytical methodology used which dealt with different techniques of characterization such as size exclusion chromatography, reversed phase high performance liquid chromatography, Fourier transformed infrared spectroscopy, atomic force microscopy and contact angle measurements, we have been able to put into evidence different kinds of modifications both in the bulk and on the surface of the sterilized material and also after ageing.The principal modification of material’s bulk, observed at the recommended dose for sterilization (25 kGy), was polymer chains scissions, accompanied with creation of low molecular weight compounds, that are potentials migrants that risk to affect the safe use of COC. Indeed, some of these compounds have been found with a relatively important concentration in the solutions where sterilized COC was stored, especially in aqueous solutions. However, the preliminary study of toxicity has shown the absence of cytotoxicity of the extractables obtained at the sterilization dose.Surface modifications of radio-sterilized COC are of two types: a physical one, with an increase of the surface’s roughness and a chemical one with the formation of polar oxidation products; these two modifications result in an increase of surface’s wettability that may be important. However, in some cases such as for aged samples, these modifications are relatively weak even at doses higher than the one recommended for sterilization, which can explain the absence of the effect of radiation on the behavior of COC towards drug solutions. Indeed, no variation of drug sorption has been observed between aged COC irradiated and none irradiated.
identifier: NNT: 2013PA114802
issued: 2026-05-07T06:25:29.144404
language: fr
modified: 2026-05-07T06:25:29.144408
contact point: Organization
  fn: CCSD
keyword: ageing
keyword: chromatographie-dexclusion-sterique
keyword: chromatographie-liquide-haute-performance-a-polarite-de-phases-inversee
keyword: compatibilite
keyword: compatibility
keyword: composes-de-faible-masse-molaire
keyword: copolymeres-dolefines-cyclique-coc
keyword: cyclo-olefins-copolymers-coc
keyword: electrons-acceleres
keyword: electrons-beam
keyword: fourier-transformed-infrared-spectroscopy
keyword: infoeu-reposemanticsdoctoralthesis
keyword: interactions
keyword: low-molecular-weight-compounds
keyword: migration
keyword: mouillabilite
keyword: oxydation
keyword: reversed-phase-high-performance-liquid-chromatography
keyword: rugosite-de-surface
keyword: scission
keyword: sdvmheplife-sciences-q-biohuman-health-and-pathology
keyword: size-exclusion-chromatography
keyword: sorption
keyword: spectroscopie-infra-rouge-a-transformee-de-fourier
keyword: sterilisation
keyword: sterilization
keyword: surface-roughness
keyword: theses
keyword: toxicite
keyword: toxicity
keyword: vieillissement
keyword: wettability
landing page: https://theses.hal.science/tel-00936342

Effect of electron beam radio-sterilization on cyclo olefin copolymers and its impact on the interactions with active molecules
type: Distribution
format: HTML
issued: 2026-05-07T06:25:29.147092
modified: 2026-05-07T06:25:29.108461
access URL: https://theses.hal.science/tel-00936342

test_moissonnage_selune
type: Agent