Rediguieri Carolina Fracalossi, De Bank Paul A, Zanin Maria Helena Ambrosio, Leo Patrícia, Cerize Natalia Neto Pereira, de Oliveira Adriano Marim, Pinto Terezinha de Jesus Andreoli
a Departamento de Farmácia, Faculdade de Ciências Farmacêuticas , Universidade de São Paulo , São Paulo , Brazil.
b Agência Nacional de Vigilância Sanitária , Brasília , Brazil.
J Biomater Sci Polym Ed. 2017 Nov;28(16):1918-1934. doi: 10.1080/09205063.2017.1358549. Epub 2017 Jul 30.
The growing area of tissue engineering has the potential to alleviate the shortage of tissues and organs for transplantation, and electrospun biomaterial scaffolds are extremely promising devices for translating engineered tissues into a clinical setting. However, to be utilized in this capacity, these medical devices need to be sterile. Traditional methods of sterilization are not always suitable for biomaterials, especially as many commonly used biomedical polymers are sensitive to chemical-, thermal- or radiation-induced damage. Therefore, the objective of this study was to evaluate the suitability of ozone gas for sterilizing electrospun scaffolds of polycaprolactone (PCL), a polymer widely utilized in tissue engineering and regenerative medicine applications, by evaluating if scaffolds composed of either nanofibres or microfibres were differently affected by the sterilization method. The sterility, morphology, mechanical properties, physicochemical properties, and response of cells to nanofibrous and microfibrous PCL scaffolds were assessed after ozone gas sterilization. The sterilization process successfully sterilized the scaffolds and preserved most of their initial attributes, except for mechanical properties. However, although the scaffolds became weaker after sterilization, they were still robust enough to use as tissue engineering scaffolds and this treatment increased the proliferation of L929 fibroblasts while maintaining cell viability, suggesting that ozone gas treatment may be a suitable technique for the sterilization of polymer scaffolds which are significantly damaged by other methods.
组织工程学这一不断发展的领域有潜力缓解移植用组织和器官的短缺问题，而电纺生物材料支架是将工程化组织转化为临床应用极具前景的装置。然而，要以这种能力被利用，这些医疗器械需要是无菌的。传统的灭菌方法并不总是适用于生物材料，特别是因为许多常用的生物医学聚合物对化学、热或辐射引起的损伤敏感。因此，本研究的目的是通过评估由纳米纤维或微纤维组成的支架是否受到灭菌方法的不同影响，来评估臭氧气体对聚己内酯（PCL）电纺支架灭菌的适用性，PCL是一种广泛应用于组织工程和再生医学应用的聚合物。在臭氧气体灭菌后，评估了纳米纤维和微纤维PCL支架的无菌性、形态、力学性能、物理化学性质以及细胞反应。灭菌过程成功地对支架进行了灭菌，并保留了其大部分初始属性，但力学性能除外。然而，尽管灭菌后支架变弱了，但它们仍然足够坚固，可以用作组织工程支架，并且这种处理增加了L929成纤维细胞的增殖，同时保持了细胞活力，这表明臭氧气体处理可能是一种适合对被其他方法严重损坏的聚合物支架进行灭菌的技术。
