Elaboração de um mapeamento de boas práticas de fabricação para manufatura aditiva no laboratório de tecnologias 3D do núcleo de tecnologias estratégicas em saúde da UEPB

Abstract

This work seeks to perform a mapping of the production process for Good Manufacturing Practices in Additive Manufacturing in the Laboratory of Three Dimensional Technologies of the Nucleus of Technology for Health of the State University of Paraíba based on chapter five of RDC 16/13, in order to Possible future preparation of a manual of good manufacturing practices of this laboratory. This is a theoretical work in order to guarantee methodologies to extract the maximum quality of the process in question, aiming to provide guarantees of reliability, reproducibility and predictability of the biomodels produced, through standards, manuals, methods and resolutions when manufacturing medical products Such as surgical guides, temporary or permanent prostheses and orthoses. This work is justified on the assumption that biomodels are already being manufactured, but that they do not follow the necessary method in order to optimize the manufacturing process, thus spending too much time and financial resources. With this, it was possible to guarantee that the process is carried out following a layout for the laboratory that will facilitate the manufacture of the biomodel, and the creation of a flow chart proper to good manufacturing practices, allowing each agent to have its own function.