γ射线、电子束和X射线对PE/EVOH/PE多层薄膜的辐照：关于对机械性能影响的工业视角

Girard-Perier Nina, Marque Sylvain R A, Dupuy Nathalie, Krieguer Blanche, Dorey Samuel

Sartorius Stedim FMT S.A.S, Z.I. Les Paluds, Avenue de Jouques CS91051, CEDEX, 13781 Aubagne, France.

Aix Marseille Univ, CNRS, ICR, Case 551, 13397 Marseille, France.

Polymers (Basel). 2023 Jun 24;15(13):2799. doi: 10.3390/polym15132799.

X-ray and electron-beam (E-beam) sterilization technologies were assessed to supplement gamma sterilization, the most common radiation technology used today for biopharmaceutical product sterilization. The mechanical properties of a PE/EVOH/PE film were studied using tensile tests and dynamical mechanical analysis after each irradiation technology (i.e., gamma, electron beam and X-ray irradiations). The effects of each irradiation were compared using two statistical methods. The results indicate that the three irradiation technologies induce no difference in mechanical properties in the investigated dose range for this material.

对X射线和电子束（E束）灭菌技术进行了评估，以补充伽马灭菌，伽马灭菌是目前生物制药产品灭菌最常用的辐射技术。在每种辐照技术（即伽马、电子束和X射线辐照）后，使用拉伸试验和动态力学分析研究了PE/EVOH/PE薄膜的机械性能。使用两种统计方法比较了每种辐照的效果。结果表明，在所研究的该材料剂量范围内，三种辐照技术在机械性能方面没有差异。