Insights into Terminal Sterilization Processes of Nanoparticles for Biomedical Applications
Sergio A. Bernal-Chávez,
María Luisa Del Prado-Audelo,
Isaac H. Caballero-Florán,
David M. Giraldo-Gomez,
Gabriela Figueroa-Gonzalez,
Octavio D. Reyes-Hernandez,
Manuel González-Del Carmen,
Maykel González-Torres,
Hernán Cortés,
Gerardo Leyva-Gómez
Affiliations
Sergio A. Bernal-Chávez
Departamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Ciudad de México 04510, Mexico
María Luisa Del Prado-Audelo
Departamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Ciudad de México 04510, Mexico
Isaac H. Caballero-Florán
Departamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Ciudad de México 04510, Mexico
David M. Giraldo-Gomez
Departamento de Biología Celular y Tisular, Facultad de Medicina, Universidad Nacional Autónoma de México, Ciudad de México 04510, Mexico
Gabriela Figueroa-Gonzalez
Laboratorio de Farmacogenética, UMIEZ, Facultad de Estudios Superiores Zaragoza, Universidad Nacional Autónoma de México, Ciudad de Mexico 09230, Mexico
Octavio D. Reyes-Hernandez
Laboratorio de Biología Molecular del Cáncer, UMIEZ, Facultad de Estudios Superiores Zaragoza, Universidad Nacional Autónoma de México, Ciudad de México 09230, Mexico
Manuel González-Del Carmen
Facultad de Medicina, Universidad Veracruzana, Mendoza 94740, VER, Mexico
Maykel González-Torres
CONACyT-Laboratorio de Biotecnología, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Ciudad de México 14389, Mexico
Hernán Cortés
Laboratorio de Medicina Genómica, Departamento de Genética, Instituto Nacional de Rehabilitación-Luis Guillermo Ibarra Ibarra, Ciudad de México 14389, Mexico
Gerardo Leyva-Gómez
Departamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Ciudad de México 04510, Mexico
Nanoparticles possess a huge potential to be employed in numerous biomedical purposes; their applications may include drug delivery systems, gene therapy, and tissue engineering. However, the in vivo use in biomedical applications requires that nanoparticles exhibit sterility. Thus, diverse sterilization techniques have been developed to remove or destroy microbial contamination. The main sterilization methods include sterile filtration, autoclaving, ionizing radiation, and nonionizing radiation. Nonetheless, the sterilization processes can alter the stability, zeta potential, average particle size, and polydispersity index of diverse types of nanoparticles, depending on their composition. Thus, these methods may produce unwanted effects on the nanoparticles’ characteristics, affecting their safety and efficacy. Moreover, each sterilization method possesses advantages and drawbacks; thus, the suitable method’s choice depends on diverse factors such as the formulation’s characteristics, batch volume, available methods, and desired application. In this article, we describe the current sterilization methods of nanoparticles. Moreover, we discuss the advantages and drawbacks of these methods, pointing out the changes in nanoparticles’ biological and physicochemical characteristics after sterilization. Our main objective was to offer a comprehensive overview of terminal sterilization processes of nanoparticles for biomedical applications.