Influence of sterilisation methods on collagen-based devices stability and properties

Delgado, Luis M.; Pandit, Abhay; Zeugolis, Dimitrios I.

doi:10.1586/17434440.2014.900436

Cited by 59 publications

(48 citation statements)

References 86 publications

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“…Autoclaving is no option for the sterilization of collagen-based biomaterials since collagen is easily denaturized by elevated temperatures. Sterilization using gamma irradiation and EO are superior to steam sterilization, although there are still changes in physical properties caused by non-thermal sterilization techniques [4]. In the present study, the influence of scCO 2 sterilization on the mechanical parameters of two different collagen-based materials was analyzed in comparison to other sterilization methods.…”

Section: Discussionmentioning

confidence: 99%

“…Low temperature sterilization methods like gamma irradiation and electron beam treatment, as well as ethylene oxide gas (EO) and low-temperature formaldehyde/steam exposure have been shown to alter morphology, structure, and surface properties of different organic polymers [1–4]. An alternative method for the inactivation of microorganisms is the application of dense phase and supercritical carbon dioxide (scCO 2 ) [5–7].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2015

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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 CO2 (scCO2) treatment is a promising strategy for the terminal sterilization of sensitive biomaterials at low temperature. In combination with low amounts of additives scCO2 treatment effectively inactivates microorganisms including bacterial spores. We established a scCO2 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 scCO2 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 scCO2 treatment. Human mesenchymal stem cell viability and proliferation were not compromised by scCO2 treatment of these materials and scaffolds. We conclude that scCO2 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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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2015

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“…All the characterization studies were performed after sterilization with γ-irradiation (15 kGγ) [40]. The study of the scaffolds’ stability was carried out by incubation in culture medium during 14 days at 37 °C.…”

Section: Methodsmentioning

confidence: 99%

Marine Collagen/Apatite Composite Scaffolds Envisaging Hard Tissue Applications

et al. 2018

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The high prevalence of bone defects has become a worldwide problem. Despite the significant amount of research on the subject, the available therapeutic solutions lack efficiency. Autografts, the most commonly used approaches to treat bone defects, have limitations such as donor site morbidity, pain and lack of donor site. Marine resources emerge as an attractive alternative to extract bioactive compounds for further use in bone tissue-engineering approaches. On one hand they can be isolated from by-products, at low cost, creating value from products that are considered waste for the fish transformation industry. One the other hand, religious constraints will be avoided. We isolated two marine origin materials, collagen from shark skin (Prionace glauca) and calcium phosphates from the teeth of two different shark species (Prionace glauca and Isurus oxyrinchus), and further proposed to mix them to produce 3D composite structures for hard tissue applications. Two crosslinking agents, 1-[3-(dimethylamino)propyl]-3-ethylcarbodiimide hydrochloride/N-Hydroxysuccinimide (EDC/NHS) and hexamethylene diisocyanate (HMDI), were tested to enhance the scaffolds’ properties, with EDC/NHS resulting in better properties. The characterization of the structures showed that the developed composites could support attachment and proliferation of osteoblast-like cells. A promising scaffold for the engineering of bone tissue is thus proposed, based on a strategy of marine by-products valorisation.

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“…Specifically to tendon repair, such materials have shown improved mechanical properties, improved functionality and minimal inflammatory response in small animal studies over 40 days implantation in an Achilles defect model [389]. The batch-to-batch variability of natural biomaterials and their susceptibility to various sterilisation methods [390] have triggered investigation into the potential of synthetic biomaterials for tendon repair and regeneration.…”

Section: Bottom-up Approached For Tendon Repair Based On Natural In Omentioning

confidence: 99%

The past, present and future in scaffold-based tendon treatments

Lomas

Ryan

Sorushanova

et al. 2015

Advanced Drug Delivery Reviews

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Influence of sterilisation methods on collagen-based devices stability and properties

Cited by 59 publications

References 86 publications

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

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

Marine Collagen/Apatite Composite Scaffolds Envisaging Hard Tissue Applications

The past, present and future in scaffold-based tendon treatments

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