Sterilization Efficacy of a Below 40°C Plasma Processes Assessed by a Biological Indicator

Abstract

Biodegradable biopolymers have been widely used in biomaterials for tissue engineering. Sterilization is a process by which a product can be made free of contamination from microorganisms such as bacteria, yeasts, and viruses. When sterilizing biodegradable scaffolds, the sterilization technique chosen must maintain the structural and biochemical properties of the scaffolds to ensure that the scaffolds can fulfill their intended purposes post-sterilization. In addition, in response to the development of customized, rapid and accurate medical devices via 3D printed biomaterials, sterilization of such devices by low-temperature hydrogen peroxide (H2O2) gas plasma (HPGP) will provide new capabilities not only for rapidly manufacturing customized medical devices but also for producing sterile end-use parts. This device uses a below 40°C temperature plasma with H2O2 activated by ultraviolet light irradiation processes to evaluate the sterilization efficacy with a biological indicator. The results demonstrated several parameter combinations for HPGP that can achieve sterilization at temperatures below 40°C. Therefore, the parameters associated with this HPGP device have the potential to provide a sterilization process applicable for future development of biopolymer devices manufactured by 3D printing. This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License .