Effect of different sterilization methods on the properties of commercial biodegradable polyesters for single-use, disposable medical devices
Effect of different sterilization methods on the properties of commercial biodegradable polyesters for single-use, disposable medical devices
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不同灭菌方法对一次性医疗器械用商业可生物降解聚酯性能的影响
DOI：
10.1016/j.msec.2019.110041
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发表时间：
2019
期刊：
影响因子：
--
通讯作者：
Shen Changyu
中科院分区：
文献类型：
--
作者：
Zhao Yuping;Zhu Bo;Wang Yaming;Liu Chuntai;Shen Changyu
基于不可降解聚合物的一次性医疗器械的使用不断增加，导致了巨大的环境压力。用可生物降解的替代品取代不可降解的聚合物可能是一种解决办法。由于最终灭菌是医疗器械消除感染的必要步骤，本文研究了灭菌对可生物降解聚乳酸（PLA）、聚己二酸丁二醇酯-对苯二甲酸丁二醇酯（PBAT）及其共混物的透明性、黄色指数、尺寸稳定性和力学性能的影响。通过压缩成型制备样品，并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具有用于透明医疗器械（如注射器筒或微流控芯片）的潜力，而PBAT和PLA/PBAT共混物用于其他非透明医疗包装应用。
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.