Abstract
Chemically and biologically safe storage of solutions for medical uses is a daily concern for industry since decades and it appeared even more dramatic during the last two years of pandemia. Biological safety is readily reached by sterilization using γ-irradiation process. However, such a type of irradiation induces the degradation and the release of chemicals able to spoil the biological solutions. Surprisingly, there are no investigations on multi-layer films combining multi-technique and multi-method approaches to unveil the events occurring during γ-irradiation. Furthermore, our investigations are focuses on properties/events occurring at product, macromolecular, and molecular levels.
Highlights
Single-use systems are more and more frequently used in the biopharmaceutical and biotechnological industries
Plastic bags provide a single-use alternative to traditional containers made of glass, stainless steel, and rigid plastic, avoiding difficult cleaning and potential cross-contamination between several successive uses. These single-use bioprocessing bags are flexible containers manufactured from multilayer films, like polyethylene (PE), ethylene vinyl acetate (EVA), and ethylene vinyl alcohol (EVOH), and are designed for the preparation, storage, and transport of biopharmaceutical solutions, intermediates, and final bulk products [1,2,3]
Taking into account the lack of multi-technique approach, we developed a multilevel approach for the investigation of EVA/EVOH/EVA multi-layer films: (i) analysis of the properties at the product level, focusing on those material properties of the utmost importance for the end-users, e.g., the integrity of the materials and the quality of the stored solutions; (ii) analysis at the macromolecular level to get insights into the chemical changes leading to deterioration of material integrity; and (iii) analysis at the molecular level to understand all chemical processes leading to the observations done in (i) and (ii)
Summary
Single-use systems are more and more frequently used in the biopharmaceutical and biotechnological industries. Taking into account the lack of multi-technique approach, we developed a multilevel approach for the investigation of EVA/EVOH/EVA multi-layer films: (i) analysis of the properties at the product level, focusing on those material properties of the utmost importance for the end-users, e.g., the integrity of the materials and the quality of the stored solutions; (ii) analysis at the macromolecular level to get insights into the chemical changes leading to deterioration of material integrity; and (iii) analysis at the molecular level to understand all chemical processes leading to the observations done in (i) and (ii). The results obtained from the multi-level and multi-level technique approach are straightforwardly applicable by the end-users
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