Key Laboratory of Materials Processing & Mold (Zhengzhou University), Ministry of Education, National Engineering Research Center for Advanced Polymer Processing Technology, Zhengzhou University, Zhengzhou 450002, China; Center for Applied Polymer Research, Henan Tuoren Medical Device Co., Ltd., Weiyuan Industrial Park, Changyuan 453400, China.
Key Laboratory of Materials Processing & Mold (Zhengzhou University), Ministry of Education, National Engineering Research Center for Advanced Polymer Processing Technology, Zhengzhou University, Zhengzhou 450002, China.
Mater Sci Eng C Mater Biol Appl. 2019 Dec;105:110041. doi: 10.1016/j.msec.2019.110041. Epub 2019 Jul 31.
The increasing employment of non-degradable polymers based single-use, disposable medical devices have led to huge environmental pressure. Replacement of non-degradable polymers with biodegradable alternatives could be one solution. Since terminal sterilization is a necessary procedure for medical devices to eliminate infections, in this paper, the modifications of sterilization on the transparency, yellow index, dimensional stability and mechanical properties of commercial biodegradable poly(lactic acid) (PLA), poly(butylenes adipate-co-terephthalate) (PBAT) and their blends were investigated. The samples were prepared by compression molding and exposed to four sterilization treatments including ethylene oxide gas (EtO), saturated steam (SS), electron beam (EB), and hydrogen peroxide gas plasma (HPGP). It is concluded that EB can be applied for the sterilization of all the materials investigated, while SS and EtO are not recommended for PLA, and HPGP is not for PBAT and PLA/PBAT blends. This study demonstrates that, when a suitable sterilization process is chosen, PLA has potential to be used for transparent medical devices such as the barrel of syringes or microfluidic chips, while PBAT and PLA/PBAT blends for other non-transparent medical packaging applications.
越来越多的不可降解聚合物基一次性使用的医疗器械的使用给环境带来了巨大的压力。用可生物降解的替代品替代不可降解聚合物可能是一种解决方案。由于终端灭菌是医疗器械消除感染的必要程序，因此在本文中，研究了商业可生物降解聚乳酸（PLA）、聚丁二酸丁二醇酯-对苯二甲酸酯（PBAT）及其共混物的灭菌处理对透明度、黄色指数、尺寸稳定性和力学性能的影响。样品通过压缩成型制备，并分别暴露于四种灭菌处理，包括环氧乙烷气体（EtO）、饱和蒸汽（SS）、电子束（EB）和过氧化氢气体等离子体（HPGP）。结果表明，EB 可用于所有被研究材料的灭菌，而 SS 和 EtO 不推荐用于 PLA，HPGP 不推荐用于 PBAT 和 PLA/PBAT 共混物。本研究表明，当选择合适的灭菌工艺时，PLA 有可能用于透明医疗器械，如注射器筒或微流控芯片，而 PBAT 和 PLA/PBAT 共混物则可用于其他非透明医疗器械包装应用。
