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  • Claeys-Bruno, Magalie  (3)
  • Marque, Sylvain R. A.  (3)
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  • 1
    Online Resource
    Online Resource
    DataSheet1.docx
    Frontiers Media SA ; 2022
    In:  Frontiers in Chemistry Vol. 10 ( 2022-5-11)
    Details
    In: Frontiers in Chemistry, Frontiers Media SA, Vol. 10 ( 2022-5-11)
    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.
    Type of Medium: Online Resource
    ISSN: 2296-2646
    URL: Article
    URL: Article
    DOI: 10.3389/fchem.2022.888285
    DOI: 10.3389/fchem.2022.888285.s001
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2022
    detail.hit.zdb_id: 2711776-5
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  • 2
    Online Resource
    Online Resource
    Effects of X-ray, electron beam and gamma irradiation on PE/EVOH/PE multilayer film properties
    Royal Society of Chemistry (RSC) ; 2021
    In:  Chemical Communications Vol. 57, No. 84 ( 2021), p. 11049-11051
    Details
    In: Chemical Communications, Royal Society of Chemistry (RSC), Vol. 57, No. 84 ( 2021), p. 11049-11051
    Abstract: To increase sterilization capacity, X-ray and e-beam irradiation modalities are more and more attractive for the indutrial sterilization of heathcare products (medical devices and biopharmaceutical goods). However, no study comparing these different techniques are available concerning multi-layer films. Thus, with the PE/EVOH/PE multilayer film as a model, we show that, whatever the modality of irradiation, the thermal properties are not significantly changed as shown by DSC, and, as such, the physical and mechanical properties of this material are also expected to behave similarly. On the other hand, chemical properties such as oxidation ability are strikingly modified, i.e. , the same oxidation level for X-ray and γ-irradiation and twice weaker for e-beam irradiation.
    Type of Medium: Online Resource
    ISSN: 1359-7345 , 1364-548X
    URL: Article
    DOI: 10.1039/D1CC02871E
    Language: English
    Publisher: Royal Society of Chemistry (RSC)
    Publication Date: 2021
    detail.hit.zdb_id: 1472881-3
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  • 3
    Online Resource
    Online Resource
    Monitoring of Peroxide in Gamma Irradiated EVA Multilayer Film Using Methionine Probe
    MDPI AG ; 2020
    In:  Polymers Vol. 12, No. 12 ( 2020-12-17), p. 3024-
    Details
    In: Polymers, MDPI AG, Vol. 12, No. 12 ( 2020-12-17), p. 3024-
    Abstract: In this study, the oxidation of methionine is used as a proxy to model the gamma radiation-induced changes in single-use bags; these changes lead to the formation of acids, radicals, and hydroperoxides. The mechanisms of formation of these reactive species and of methionine oxidation are discussed. With the help of reaction kinetics, the optimal conditions for the use of these single-use bags minimizing the impact of radical chemistry are highlighted. Biopharmaceutical bags gamma irradiated from 0 kGy to 260 kGy and aged from 0 to 36 months were filled with a methionine solution to follow the oxidation of the methionine. The methionine sulfoxide was measured with HPLC after different storage times (0, 3, 10, 14, 17, and 21 days). Three main results were analyzed through a design of experiments: the oxidative induction time, the methionine sulfoxide formation rate, and the maximum methionine sulfoxide concentration detected. A key aspect of the study is that it highlights that methionine is oxidized not necessarily directly by hydro(gen) peroxide but throughperacid, and likely peracetic acid. The answers to the design of experiments were considered to obtain the desirability domain for the optimization of the conditions of use for the single-use bags limiting the oxidation of methionine as well as the release of reactive species thereof.
    Type of Medium: Online Resource
    ISSN: 2073-4360
    URL: Article
    DOI: 10.3390/polym12123024
    Language: English
    Publisher: MDPI AG
    Publication Date: 2020
    detail.hit.zdb_id: 2527146-5
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