In vitro degradation of 3D-printed polycaprolactone\biomimetic hydroxyapatite scaffolds: Impact of the sterilization method

In the transition from the laboratory to the clinic, the sterilization of medical devices becomes a fundamental and mandatory step to ensure patient safety. This work evaluates the impact of three different sterilization methods - autoclave, ethylene oxide and gamma irradiation - on the physicochemical properties and degradation kinetics of 3D-printed polycaprolactone\calcium deficient hydroxyapatite (PCL\CDHA) scaffolds for bone regeneration. The in vitro degradation test was performed in phosphate buffer saline solution at 47 °C for 18 weeks by recording the evolution of pH, scaffold morphology, swelling degree, mass loss as well as polymer content, molecular weight and crystallinity. The results showed that under thermally accelerated degradation, the scaffolds underwent hydrolytic bulk degradation without altering the pH of the soaking medium nor compromising the morphology and integrity of the constructs. Although the structural integrity of the scaffolds was maintained, autoclaving severely deteriorated the properties of the polymer, resulting in a faster degradation pattern, confirming that it is not an appropriate sterilization method for PCL\CDHA scaffolds. While ethylene oxide had no significant effect on degradation, gamma irradiation slightly accelerated hydrolysis by chain scission. However, due to the porous nature of the scaffolds, the use of ethylene oxide is inadvisable due to the risk of gas trapping in the pores. Therefore, gamma irradiation, a non-toxic, effective, predictable and reproducible sterilization method, is considered the most appropriate. • The effect of sterilization method on the polymer phase of a composite bone scaffold is analysed. • The in vitro degradation of the PCL phase depends on the sterilization method. • Despite structural integrity preservation, steam sterilization degrades the PCL phase. • Gamma irradiation slightly accelerates the hydrolysis due to chain scission.