The potential changes of single‐use plastic materials (EVA/EVOH/EVA multilayer film in this study) used in biopharmaceutical and food‐packaging industries are investigated after several gamma irradiation doses: 30, 50, 115, and 270 kGy, and for nonsterilized samples (0 kGy) from a point of view of mechanical properties, thermal properties and permeability properties. Tensile tests, differential scanning calorimetry (DSC), oxygen transmission rate (OTR) and water vapor transmission rate (WVTR) are performed on the multilayer film. For irradiation doses below 50 kGy, thermal and water vapor barrier properties are not altered. For higher doses (50 to 270 kGy), mechanical, thermal and water vapor barrier properties are slightly altered whereas oxygen barrier property decreases from 13 to 27 cm3.m−2.day−1. This slight change is shown not to happen due to chain entanglement or chain mobility loss in the amorphous phase of the different polymers. It rather comes from a change of the chemical environment of the EVOH layer.
Polymers such as polyethylene (PE) and ethylene vinyl alcohol (EVOH) are primary constituents of multilayer films used in the food and biopharmaceutical packaging. In order to explore the film behavior after gamma-sterilization, several tests are performed (tensile tests, differential scanning calorimetry (DSC), oxygen transmission rate (OTR) and water vapor transmission rate (WVTR). The investigation of the PE/EVOH/PE multilayer film is done at several gamma-irradiation doses up to 270 kGy. For irradiation dose up to 50 kGy, mechanical properties are not altered. Whatever the irradiation dose, water barrier in PE/ EVOH/PE multilayer film is not altered whereas the oxygen barrier property is increased by 300%. This enhancement is shown not to occur due to reorientation, closer chain packaging and restriction of chain mobility of polymer chains in the amorphous phase of the different polymers. This enhancement rather comes from a change of the chemical environment of the EVOH layer.
With the increasing use of γ-irradiated containers made of multilayer polymeric flexible films for food and biopharmaceutical applications, the possible migration of degradation products of the polymers and their additives is becoming a topic of concern. This article aims at highly reliably identifying the degradation products generated after gamma irradiation and their origin to later on assess their potential harmfulness in single-use containers. In this study, GC-MS is used to identify by-products created by γ-irradiation of primary and secondary antioxidants usually present in polyolefin-based biotechnological single-use materials and to confirm identification relevancy based on the literature survey or standard when available. Degradation pathways are proposed to account for the formation of by-products identified during the study and to list intermediates and other by-products present in too small amounts to be detected and identified accurately in all extractable studies.
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