Sartorius Stedim FMT S.A.S, Z.I. Les Paluds, Avenue de Jouques CS91051, Aubagne Cedex 13781, France.
Aix Marseille Univ, Avignon Univ, CNRS, IRD, IMBE, Marseille, France.
Chem Commun (Camb). 2021 Oct 21;57(84):11049-11051. doi: 10.1039/d1cc02871e.
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, , the same oxidation level for X-ray and γ-irradiation and twice weaker for e-beam irradiation.
为了提高灭菌能力,射线和电子束辐照方式越来越受到医疗产品(医疗器械和生物制药产品)工业灭菌的青睐。然而,目前还没有关于这些不同技术的比较研究涉及多层薄膜。因此,我们以 PE/EVOH/PE 多层膜为模型,表明无论辐照方式如何,热性能都不会像 DSC 所显示的那样发生显著变化,因此,这种材料的物理和机械性能也有望表现出相似的行为。另一方面,氧化能力等化学性质则发生了显著的变化,射线和γ射线辐照的氧化水平相同,而电子束辐照的氧化水平则弱两倍。