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Improved Sterilization of Sensitive Biomaterials with Supercritical Carbon Dioxide at Low Temperature

The development of bio-resorbable implant materials is rapidly going on. Sterilization of those materials is inevitable to assure the hygienic requirements for critical medical devices according to the medical device directive (MDD, 93/42/EG). Biopolymer-containing biomaterials are often highly sens...

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Autores principales: Bernhardt, Anne, Wehrl, Markus, Paul, Birgit, Hochmuth, Thomas, Schumacher, Matthias, Schütz, Kathleen, Gelinsky, Michael
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4466598/
https://www.ncbi.nlm.nih.gov/pubmed/26067982
http://dx.doi.org/10.1371/journal.pone.0129205
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author Bernhardt, Anne
Wehrl, Markus
Paul, Birgit
Hochmuth, Thomas
Schumacher, Matthias
Schütz, Kathleen
Gelinsky, Michael
author_facet Bernhardt, Anne
Wehrl, Markus
Paul, Birgit
Hochmuth, Thomas
Schumacher, Matthias
Schütz, Kathleen
Gelinsky, Michael
author_sort Bernhardt, Anne
collection PubMed
description The development of bio-resorbable implant materials is rapidly going on. Sterilization of those materials is inevitable to assure the hygienic requirements for critical medical devices according to the medical device directive (MDD, 93/42/EG). Biopolymer-containing biomaterials are often highly sensitive towards classical sterilization procedures like steam, ethylene oxide treatment or gamma irradiation. Supercritical CO(2) (scCO(2)) treatment is a promising strategy for the terminal sterilization of sensitive biomaterials at low temperature. In combination with low amounts of additives scCO(2) treatment effectively inactivates microorganisms including bacterial spores. We established a scCO(2) sterilization procedure under addition of 0.25% water, 0.15% hydrogen peroxide and 0.5% acetic anhydride. The procedure was successfully tested for the inactivation of a wide panel of microorganisms including endospores of different bacterial species, vegetative cells of gram positive and negative bacteria including mycobacteria, fungi including yeast, and bacteriophages. For robust testing of the sterilization effect with regard to later application of implant materials sterilization all microorganisms were embedded in alginate/agarose cylinders that were used as Process Challenge Devices (PCD). These PCD served as surrogate models for bioresorbable 3D scaffolds. Furthermore, the impact of scCO(2) sterilization on mechanical properties of polysaccharide-based hydrogels and collagen-based scaffolds was analyzed. The procedure was shown to be less compromising on mechanical and rheological properties compared to established low-temperature sterilization methods like gamma irradiation and ethylene oxide exposure as well as conventional steam sterilization. Cytocompatibility of alginate gels and scaffolds from mineralized collagen was compared after sterilization with ethylene oxide, gamma irradiation, steam sterilization and scCO(2) treatment. Human mesenchymal stem cell viability and proliferation were not compromised by scCO(2) treatment of these materials and scaffolds. We conclude that scCO(2) sterilization under addition of water, hydrogen peroxide and acetic anhydride is a very effective, gentle, non-cytotoxic and thus a promising alternative sterilization method especially for biomaterials.
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spelling pubmed-44665982015-06-22 Improved Sterilization of Sensitive Biomaterials with Supercritical Carbon Dioxide at Low Temperature Bernhardt, Anne Wehrl, Markus Paul, Birgit Hochmuth, Thomas Schumacher, Matthias Schütz, Kathleen Gelinsky, Michael PLoS One Research Article The development of bio-resorbable implant materials is rapidly going on. Sterilization of those materials is inevitable to assure the hygienic requirements for critical medical devices according to the medical device directive (MDD, 93/42/EG). Biopolymer-containing biomaterials are often highly sensitive towards classical sterilization procedures like steam, ethylene oxide treatment or gamma irradiation. Supercritical CO(2) (scCO(2)) treatment is a promising strategy for the terminal sterilization of sensitive biomaterials at low temperature. In combination with low amounts of additives scCO(2) treatment effectively inactivates microorganisms including bacterial spores. We established a scCO(2) sterilization procedure under addition of 0.25% water, 0.15% hydrogen peroxide and 0.5% acetic anhydride. The procedure was successfully tested for the inactivation of a wide panel of microorganisms including endospores of different bacterial species, vegetative cells of gram positive and negative bacteria including mycobacteria, fungi including yeast, and bacteriophages. For robust testing of the sterilization effect with regard to later application of implant materials sterilization all microorganisms were embedded in alginate/agarose cylinders that were used as Process Challenge Devices (PCD). These PCD served as surrogate models for bioresorbable 3D scaffolds. Furthermore, the impact of scCO(2) sterilization on mechanical properties of polysaccharide-based hydrogels and collagen-based scaffolds was analyzed. The procedure was shown to be less compromising on mechanical and rheological properties compared to established low-temperature sterilization methods like gamma irradiation and ethylene oxide exposure as well as conventional steam sterilization. Cytocompatibility of alginate gels and scaffolds from mineralized collagen was compared after sterilization with ethylene oxide, gamma irradiation, steam sterilization and scCO(2) treatment. Human mesenchymal stem cell viability and proliferation were not compromised by scCO(2) treatment of these materials and scaffolds. We conclude that scCO(2) sterilization under addition of water, hydrogen peroxide and acetic anhydride is a very effective, gentle, non-cytotoxic and thus a promising alternative sterilization method especially for biomaterials. Public Library of Science 2015-06-12 /pmc/articles/PMC4466598/ /pubmed/26067982 http://dx.doi.org/10.1371/journal.pone.0129205 Text en © 2015 Bernhardt et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Bernhardt, Anne
Wehrl, Markus
Paul, Birgit
Hochmuth, Thomas
Schumacher, Matthias
Schütz, Kathleen
Gelinsky, Michael
Improved Sterilization of Sensitive Biomaterials with Supercritical Carbon Dioxide at Low Temperature
title Improved Sterilization of Sensitive Biomaterials with Supercritical Carbon Dioxide at Low Temperature
title_full Improved Sterilization of Sensitive Biomaterials with Supercritical Carbon Dioxide at Low Temperature
title_fullStr Improved Sterilization of Sensitive Biomaterials with Supercritical Carbon Dioxide at Low Temperature
title_full_unstemmed Improved Sterilization of Sensitive Biomaterials with Supercritical Carbon Dioxide at Low Temperature
title_short Improved Sterilization of Sensitive Biomaterials with Supercritical Carbon Dioxide at Low Temperature
title_sort improved sterilization of sensitive biomaterials with supercritical carbon dioxide at low temperature
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4466598/
https://www.ncbi.nlm.nih.gov/pubmed/26067982
http://dx.doi.org/10.1371/journal.pone.0129205
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