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Ann Pharm Fr


Title:Effects of electron beam sterilization on polyethylene terephthalate: Physico-chemical modifications and formation of non-volatile organic extractables
Author(s):Caire-Maurisier F; Aymes-Chodur C; Jandard V; Bourrel A; Yagoubi N;
Address:"TSA 30004, departement laboratoire, pharmacie centrale des armees, 45404 Fleury-les-Aubrais cedex, France. EA 401, IFR 141, laboratoire materiaux et sante, faculte de pharmacie, universite Paris-Sud 11, 5, rue J. B-Clement, 92296 Chatenay-Malabry, France; Equipe synthese de molecules et de macromolecules bioactives (SM2B), UMR 8182, CNRS, Institut de chimie moleculaire et des materiaux d'Orsay (ICMMO), universite Paris-Sud, universite Paris-Saclay, 91405 Orsay cedex, France. Electronic address: caroline.aymes-chodur@u-psud.fr. EA 401, IFR 141, laboratoire materiaux et sante, faculte de pharmacie, universite Paris-Sud 11, 5, rue J. B-Clement, 92296 Chatenay-Malabry, France"
Journal Title:Ann Pharm Fr
Year:2019
Volume:20190423
Issue:4
Page Number:276 - 285
DOI: 10.1016/j.pharma.2019.02.001
ISSN/ISBN:0003-4509 (Print) 0003-4509 (Linking)
Abstract:"Our investigations hereby involve the effects of ionizing radiation as a sterilization method, and especially electron beams, on a medical grade Polyethylene Terephthalate (PET). Ionizing radiations are known to induce free radicals formation in the polymer that will then either degrade or crosslink, depending on its chemical nature, ionizing type and irradiation atmosphere (Charlesby, 1967; Dole, 1972 and Dole, 1973). The evaluation of packaging material modifications under radiation sterilization is of great interest and the objective of our paper is to focus on both PET volume modifications and extractable analyses after electron beam sterilization. As regards the polymeric matrix and after sterilization, we did not observe by means of spectral analyses, any single chemical modification whatsoever, whereas by thermal techniques we evidenced polymer chain scissions. As for the non-volatile organic extractables, we further substantiate the presence of numerous compounds, namely oligomers and trimers especially, along with benzoic and terephthalic acids in particular. With respect to pharmaceutical stakes however, we claim herein that the 25kGy sterilization dose used, triggers oligomers and extractables formation, a result which is promising for further risk analysis"
Keywords:"Calorimetry, Differential Scanning Chromatography, Gel Chromatography, High Pressure Liquid Cross-Linking Reagents *Electrons Free Radicals Polyethylene Terephthalates/*chemistry/*radiation effects Spectroscopy, Fourier Transform Infrared Sterilization/*m;"
Notes:"MedlineCaire-Maurisier, F Aymes-Chodur, C Jandard, V Bourrel, A Yagoubi, N eng France 2019/04/28 Ann Pharm Fr. 2019 Jul; 77(4):276-285. doi: 10.1016/j.pharma.2019.02.001. Epub 2019 Apr 23"

 
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