Department of Research, LifeCell Corporation, Branchburg, New Jersey 08876.
J Biomed Mater Res B Appl Biomater. 2009 Nov;91(2):572-578. doi: 10.1002/jbm.b.31431.
The purpose of this study was to validate supercritical carbon dioxide (SC-CO(2)) as a terminal sterilization method for biological materials, specifically acellular dermal matrix. In this study, bacterial spores, Bacillus atrophaeus, were inoculated onto porcine acellular dermal matrix to serve as a "worst case" challenge device. The inactivation of the spores by SC-CO(2) with peracetic acid (PAA) sterilant was analyzed as a function of exposure times ranging from 1 to 30 min. A linear inactivation profile for the Bacillus atrophaeus spores was observed, and a SC-CO(2) exposure time of 27 min was determined to achieve a sterility assurance level of 10(-6). The inactivation of viruses was also studied using Encephalomyocarditis (EMC) viruses. After 15 min of exposure to SC-CO(2) with PAA sterilant, more than a 6 log(10) reduction was observed for EMC viruses. Biochemical and biomechanical evaluations showed that the SC-CO(2) treatment with PAA sterilant did not cause significant changes in porcine acellular matrix's susceptibility to collagenase digestion, tensile or tear strength, indicating limited alteration of the tissue structure following SC-CO(2) sterilization.
本研究旨在验证超临界二氧化碳（SC-CO₂）作为生物材料（特别是脱细胞真皮基质）的终端灭菌方法的有效性。在这项研究中，细菌芽孢杆菌萎缩亚种被接种到猪脱细胞真皮基质上，作为“最坏情况”的挑战装置。用过氧乙酸（PAA）灭菌剂的 SC-CO₂对孢子的灭活作用随暴露时间从 1 分钟到 30 分钟的变化进行了分析。观察到芽孢杆菌萎缩亚种孢子的线性灭活曲线，并且确定 SC-CO₂暴露 27 分钟可实现 10⁻⁶的无菌保证水平。还使用脑炎心肌炎（EMC）病毒研究了病毒的灭活。在用 PAA 灭菌剂的 SC-CO₂暴露 15 分钟后，观察到 EMC 病毒的减少超过 6 个对数（10）。生化和生物力学评估表明，PAA 灭菌剂的 SC-CO₂处理不会导致猪脱细胞基质对胶原酶消化的敏感性发生显著变化，拉伸或撕裂强度也没有变化，表明 SC-CO₂ 灭菌后组织结构的改变有限。
