title: Ozone Gas as a Benign Sterilization Treatment for PLGA Nanofiber Scaffolds.
abstract: The use of electrospun nanofibers for tissue engineering and regenerative medicine applications is a growing trend as they provide improved support for cell proliferation and survival due, in part, to their morphology mimicking that of the extracellular matrix. Sterilization is a critical step in the fabrication process of implantable biomaterial scaffolds for clinical use, but many of the existing methods used to date can negatively affect scaffold properties and performance. Poly(lactic-co-glycolic acid) (PLGA) has been widely used as a biodegradable polymer for 3D scaffolds and can be significantly affected by current sterilization techniques. The aim of this study was to investigate pulsed ozone gas as an alternative method for sterilizing PLGA nanofibers. The morphology, mechanical properties, physicochemical properties, and response of cells to PLGA nanofiber scaffolds were assessed following different degrees of ozone gas sterilization. This treatment killed Geobacillus stearothermophilus spores, the most common biological indicator used for validation of sterilization processes. In addition, the method preserved all of the characteristics of nonsterilized PLGA nanofibers at all degrees of sterilization tested. These findings suggest that ozone gas can be applied as an alternative method for sterilizing electrospun PLGA nanofiber scaffolds without detrimental effects.
authors.affiliation: 1 Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo , São Paulo, Brasil .|2 Agência Nacional de Vigilância Sanitária , Brasília, Brasil .
authors.forename: Carolina Fracalossi
authors.initials: CF
authors.lastname: Rediguieri
authors.affiliation: 1 Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo , São Paulo, Brasil .
authors.forename: Terezinha de Jesus Andreoli
authors.initials: Tde J
authors.lastname: Pinto
authors.affiliation: 1 Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo , São Paulo, Brasil .
authors.forename: Nadia Araci
authors.initials: NA
authors.lastname: Bou-Chacra
authors.affiliation: 1 Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo , São Paulo, Brasil .|3 Centro de Química Estrutural, Instituto Superior Técnico, Universidade de Lisboa , Lisboa, Portugal .
authors.forename: Raquel
authors.initials: R
authors.lastname: Galante
authors.affiliation: 1 Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo , São Paulo, Brasil .
authors.forename: Gabriel Lima Barros
authors.initials: GL
authors.lastname: de Araújo
authors.affiliation: 4 Departamento de Análises Clínicas e Toxicológicas, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo , São Paulo, Brasil .
authors.forename: Tatiana do Nascimento
authors.initials: Tdo N
authors.lastname: Pedrosa
authors.affiliation: 4 Departamento de Análises Clínicas e Toxicológicas, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo , São Paulo, Brasil .
authors.forename: Silvya Stuchi
authors.initials: SS
authors.lastname: Maria-Engler
authors.affiliation: 5 Department of Pharmacy & Pharmacology and Centre for Regenerative Medicine, University of Bath , Bath, United Kingdom .
authors.forename: Paul A
authors.initials: PA
authors.lastname: De Bank
mesh_terms: D004203:Disinfection / Q000379:methods*; D001411:Geobacillus stearothermophilus / Q000502:physiology*; D019344:Lactic Acid; D057139:Nanofibers / Q000382:microbiology*; D010126:Ozone / Q000737:chemistry*; D011100:Polyglycolic Acid; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D013171:Spores, Bacterial / Q000254:growth & development*; D054457:Tissue Scaffolds / Q000737:chemistry / Q000382:microbiology*
chemical_list: D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid; D010126:Ozone