Effects of Sterilization Cycles on PEEK for Medical Device Application

The effects of the sterilization process have been studied on medical grade thermoplastic polyetheretherketone (PEEK). For a reusable medical device, material reliability is an important parameter to decide its lifetime, as it will be subjected to the continuous steam sterilization process. A spring nature, clip component was selected out of a newly designed medical device (patented) to perform this reliability study. This clip component was sterilized for a predetermined number of cycles (2, 4, 6, 8, 10, 20…100) at 121 °C for 30 min. A significant decrease of ~20% in the compression force of the spring was observed after 30 cycles, and a ~6% decrease in the lateral dimension of the clip was observed after 50 cycles. No further significant change in the compression force or dimension was observed for the subsequent sterilization cycles. Vickers hardness and differential scanning calorimetry (DSC) techniques were used to characterize the effects of sterilization. DSC results exhibited no significant change in the degree of cure and melting behavior of PEEK before and after the sterilization. Hardness measurement exhibited an increase of ~49% in hardness after just 20 cycles. When an unsterilized sample was heated for repetitive cycles without the presence of moisture (121 °C, 10 and 20 cycles), only ~7% of the maximum change in hardness was observed.