Bryan J. McEntire, Ramaswamy Lakshminarayanan, Prabhakar Thirugnanasambandam, Jacob Seitz-Sampson, Ryan Bock, David O’Brien
As a relatively new biomaterial, silicon nitride (Si3N4) is currently used as an arthrodesis device in the cervical and thoracolumbar spine, and it is under consideration as a bearing material in total joint arthroplasty. In this paper, the development and validation of the manufacturing processes used in the production of Si3N4 biomedical implants are presented and discussed. Manufacturing was conducted in a facility specifically dedicated for this purpose using processes designed to yield net shape intervertebral spinal spacers by conventional dry-pressing, CNC machining of components in the green state, sintering, and hot isostatic pressing. These manufacturing methods were industrialized using Taguchi fractional factorial experimental designs, followed by implementation of statistical process controls. The roles of various processing parameters including raw materials, pressing, and firing conditions (i.e., time, temperature, and pressure) are elucidated. For these devices, it was demonstrated that acceptable physical, mechanical, and dimensional properties were consistently obtained from carefully designed and statistically controlled processes.
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