Application of a dense gas technique for sterilizing soft biomaterials.
Application of a dense gas technique for sterilizing soft biomaterials.
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DOI：
10.1002/bit.23105
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发表时间：
2011-07
影响因子：
3.8
通讯作者：
Foster NR
中科院分区：
文献类型：
--
作者：
Karajanagi SS;Yoganathan R;Mammucari R;Park H;Cox J;Zeitels SM;Langer R;Foster NR
水凝胶等软生物材料的灭菌具有挑战性，因为现有的方法（例如伽马射线照射、蒸汽灭菌或环氧乙烷灭菌）虽然可以有效实现高无菌保证水平（SAL），但可能会损害其理化性质和生物相容性。因此，需要有效地对软生物材料进行灭菌而不损害其特性的新方法。在本报告中，采用基于致密二氧化碳（CO2）的技术对基于软聚乙二醇（PEG）的水凝胶进行灭菌，同时保留其结构和理化性质。伽马射线照射和蒸汽灭菌等传统灭菌方法严重损害了水凝胶的结构。具有高含水量和低弹性剪切模量（刚度的衡量标准）的 PEG 水凝胶被故意接种细菌和孢子，然后暴露在浓密的 CO2 中。基于浓密 CO2 的方法有效地对水凝胶进行了灭菌，实现了 10−7 的 SAL，而不影响凝胶的粘弹性、pH 值、含水量和结构。此外，经二氧化碳处理的致密凝胶在皮下植入雪貂体内时具有生物相容性且无毒。应用新型高密度二氧化碳方法对软生物材料进行灭菌对于开发软生物医学植入物（如真皮填充剂和粘性补充剂）的安全灭菌方法具有重要意义。
Sterilization of soft biomaterials such as hydrogels is challenging because existing methods such as gamma irradiation, steam sterilization, or ethylene oxide sterilization, while effective at achieving high sterility assurance levels (SAL), may compromise their physicochemical properties and biocompatibility. New methods that effectively sterilize soft biomaterials without compromising their properties are therefore required. In this report, a dense-carbon dioxide (CO2)-based technique was used to sterilize soft polyethylene glycol (PEG)-based hydrogels while retaining their structure and physicochemical properties. Conventional sterilization methods such as gamma irradiation and steam sterilization severely compromised the structure of the hydrogels. PEG hydrogels with high water content and low elastic shear modulus (a measure of stiffness) were deliberately inoculated with bacteria and spores and then subjected to dense CO2. The dense CO2-based methods effectively sterilized the hydrogels achieving a SAL of 10−7 without compromising the viscoelastic properties, pH, water-content, and structure of the gels. Furthermore, dense CO2-treated gels were biocompatible and non-toxic when implanted subcutaneously in ferrets. The application of novel dense CO2-based methods to sterilize soft biomaterials has implications in developing safe sterilization methods for soft biomedical implants such as dermal fillers and viscosupplements.