Evaluation of High-Temperature Sterilization Processes: Their Influence on the Mechanical Integrity of Additively Manufactured Polymeric Biomaterials.

Abstract

The continuous advancement of medical technologies and the increasing demand for high-performance medical devices have driven the search for innovative solutions in biomaterials engineering. However, ensuring the sterility of polymeric biomaterials while maintaining their mechanical integrity remains a significant challenge. This research examines how steam sterilization impacts the mechanical properties of four polymeric biomaterials frequently utilized in medical applications: MED610, PEEK, PET-G HT100, and RGD720. Samples were produced using additive manufacturing (AM), specifically Material Jetting (MJT) and Material Extrusion (MEX) processes, and exposed to steam sterilization at 121 °C and 134 °C. A comprehensive verification process was conducted to ensure the effectiveness of sterilization, including pre-sterilization cleaning, disinfection procedures, and the use of process indicators such as the Bowie-Dick test. Mechanical evaluation included bending tests and Rockwell hardness measurements to assess changes in structural integrity and mechanical strength after sterilization. The results revealed that, while some materials exhibited significant alterations in mechanical properties, others demonstrated high resistance to thermal and humidity exposure during sterilization. These findings provide critical insights into the selection and optimization of polymeric biomaterials for sterilizable medical applications, ensuring their durability and safety in clinical use.