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KMID : 1142220230180020143
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Regulatory Research on Food, Drug & Cosmetic
2023 Volume.18 No. 2 p.143 ~ p.150
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A Study on the Evaluation of Changes in Characteristics of Implantable 3D Printed Medical Devices made of Biodegradable Polymers According to Sterilization
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Lee Eung-Tae
Seong Yeon-Guk
Jeong Ji-Hee
Eom Joon-Ho
Ko Yong-Seok
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Abstract
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With the development of 3D printer technology, research and development of human implantable 3D printing medical devices to replace damaged parts of human tissues or to be used with cell therapy are being actively carried out. The raw material used at this time mainly uses synthetic polymers with biocompatibility and biodegradation properties. Implantable medical devices must be sterilized and may affect the physical and chemical properties of medical devices depending on the sterilization method. In particular, in the case of medical devices made of polymers, sterilization treatment can affect the characteristics of medical devices. Therefore, this study compared and analyzed the characteristics before and after gamma and ethylene oxide sterilization of 3Dprinted medical devices(Barrier, intra oral, resorbable) using polycaprolactone to evaluate changes in the characteristics of polymer medical devices following sterilization treatment. As a result, the tensile load and molecular weight of gamma-sterilized medical devices decreased statistically significantly by about 5.9% and 4.2%, respectively, compared to before sterilization. Through this, it was confirmed that gamma sterilization affects the mechanical and chemical properties of polymer medical devices. Therefore, biodegradable polymer implantable medical devices should consider changes in characteristics due to sterilization when verifying performance, especially medical devices applying gamma sterilization, and performance and quality should be managed by reflecting changes in characteristics due to sterilization treatment in product design and development.
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KEYWORD
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3D printing, Biodegradable, Polymer, Implantable medical device, Sterilization, Property change
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