A state-of-the-art guide to the sterilization of thermoplastic polymers and resin materials used in the additive manufacturing of medical devices

3D Printing Applications for Craniomaxillofacial Reconstruction: A Sweeping Review

“…Due to its high melting point and Young’s modulus, a 3DMD made from titanium is sterilizable by irradiation or autoclaving without risk of deformation . Similarly, PEEK 3DMD can be sterilized by autoclave without significant changes to its dimensional accuracy. ,, By contrast, PMMA devices should not be sterilized by autoclave as conflicting data exists regarding structural compromise. , The remaining thermoplastic materials, PLA, PGA, PLGA, PE and PCL, are not survivable by autoclave, dry heat, or EO sterilization without altering their final structure or mechanical properties. , H 2 O 2 plasma vapor sterilization, ethanol, and electron beam irradiation have been found to be the safest sterilization techniques for PGA/PLGA and polycaprolactone. , Steam sterilization by autoclave (121 °C for 40 min) has been found to alter the physiochemical properties and pH of porous bioceramics with a concern that this would affect their osteoinductivity/osteoconductivity in vivo …”

“…107,168 The remaining thermoplastic materials, PLA, PGA, PLGA, PE and PCL, are not survivable by autoclave, dry heat, or EO sterilization without altering their final structure or mechanical properties. 169,170 H 2 O 2 plasma vapor sterilization, ethanol, and electron beam irradiation have been found to be the safest sterilization techniques for PGA/PLGA and polycaprolactone. 169,171 Steam sterilization by autoclave (121 °C for 40 min) has been found to alter the physiochemical properties and pH of porous bioceramics with a concern that this would affect their osteoinductivity/osteoconductivity in vivo.…”

“…169,170 H 2 O 2 plasma vapor sterilization, ethanol, and electron beam irradiation have been found to be the safest sterilization techniques for PGA/PLGA and polycaprolactone. 169,171 Steam sterilization by autoclave (121 °C for 40 min) has been found to alter the physiochemical properties and pH of porous bioceramics with a concern that this would affect their osteoinductivity/osteoconductivity in vivo. 172…”

3D Printing in Regenerative Medicine: Technologies and Resources Utilized

“…Told et al, describe the use of various materials and techniques in order to achieve the desirable sterilization and disinfection degrees. These ranged from the use of ethanol in 70% (V/V) concentration, chlorine in the form of chlorine-based tablets containing sodium-dichloroisocyanurate-dihydrat, and techniques such as gas plasma dehydration, autoclaving, and dry-heat sterilization [ 73 ]. In addition, Rynio et al, also used heat (105 °C and 121 °C), hydrogen peroxide plasma, and ethylene oxide gas as sterilization and disinfection methods in the case of three-dimensionally printed aortic templates [ 74 ].…”