Biocompatibility testing and cleaning validation on custom implants based on risk analysis

• Grant number: 21/14129-1
• Support Opportunities: Regular Research Grants
• Duration: May 01, 2022 - April 30, 2024
• Field of knowledge: Health Sciences - Pharmacy
• Principal Investigator: Terezinha de Jesus Andreoli Pinto
• Grantee: Terezinha de Jesus Andreoli Pinto
• Host Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Associated researchers: Adir José Moreira ; Adriana Bugno ; Daniela Dal Molim Ghisleni ; Kamal Dua ; Natália Neto Pereira Cerize ; Patrícia Léo ; Ronaldo Domingues Mansano

Abstract

Among medical devices, implants encompass a wide and complex variety of technologies that have been developed over decades and that are continually evolving and getting better. The complexity of implants increases as they remain in the patient's body for many years, unlike most other medical devices that only come into contact with the body once or a few times. In order to ensure the safety and efficacy of these products for patients before their availability on the market, it is essential to evaluate and validate the design of an orthopedic implant through the execution of numerous pre-clinical tests, including biocompatibility tests between the implant and the human body and the evaluation of contaminants that can be released or remain on its surface through cleaning validation. The interest in the development and use of customized implants by Additive Manufacturing (3D printing) increases the complexity of discussions regarding the choice of test materials and the applicability of these tests, as a single piece is developed for the specific need of a patient. Furthermore, there is still no consensus on the biocompatibility characteristics of raw materials to be maintained after going through the Additive Manufacturing process. Currently, the literature is scarce regarding this type of assessment. In this context, this study aims to develop a risk-based approach and perform biocompatibility tests and cleaning validation, in accordance with applicable standards, in order to ensure the safety and effectiveness in the use of customized orthopedic implants manufactured by an implant manufacturing company located in the state of São Paulo. With the development of this project, it is expected to contribute to scientific research with technical bases in the field of construction and evaluation of customized implants, increasing the safety of their use, and accelerating the delivery of these products to patients awaiting this therapy in the hope of improved quality of life. (AU)