Feasibility of Supercritical Carbon Dioxide Sterilization for Absorbable Suture M

描述(申请人提供)：在过去的几十年里，医疗器械灭菌领域的创新相对较少。环氧乙烷(ETO)和伽马辐照(3-辐照)是目前可用于医疗设备的唯一技术。特别是，由于伽马辐射引起的不良化学降解和/或机械变化，合成聚合物医疗设备几乎完全由ETO灭菌。伽马辐照需要钴-60，这些设施通常设在大型工业或研究机构，可能会导致与这项技术相关的高昂运营成本。由于灭菌产品中残留的ETO的短期和长期影响、它是公认的致癌物质以及绕过ETO的毒性和爆炸性所需的预防措施，缝合线制造商已表示有兴趣放弃这一过程。最近，环境保护局和其他政府机构已经开始监测ETO，以应对个人和环境问题。因此，开发能够达到经过验证的10-6(SAL6)无菌保证水平的替代灭菌工艺是非常重要的，该无菌保证水平是医疗器械的基准，而不使用危险的ETO或破坏性的3-辐射。目前提议的努力旨在推进NovaSterilis的超临界二氧化碳灭菌技术，并生产一种可行的方法，在保持缝合机械性能的同时对缝合材料进行灭菌。NovaSterilis的过程是环保的，只使用二氧化碳和一种化学消毒剂，在这个过程中会分解成无害的化合物。拟议的项目将使用超临界二氧化碳灭菌技术建立最佳条件，以保持SAL6灭菌缝合线的基线机械性能。根据ISO指南，我们将演示使用超临界二氧化碳对SAL6进行灭菌。我们还将展示其在体外对细胞毒性的影响。第一阶段的资金将使我们能够展示超临界二氧化碳作为一种方法的可行性，以克服目前用于缝合的灭菌选择的当前限制。使用我们的超临界二氧化碳工艺的终端灭菌有可能为缝合制造商和分销商增加一步验证的终端灭菌工艺，同时降低与当前环氧乙烷灭菌工艺相关的成本和负担。 与公共健康相关：商业缝合材料的超临界二氧化碳灭菌提供了一种环境安全的技术，不需要缝合行业目前使用的苛刻条件。伤口愈合的未来受到先进的合成伤口封闭材料的发展的影响，这些材料经不起当前的消毒方案。卫生保健行业显然需要新材料和安全、创新的材料灭菌方法，以消除任何疾病传播的机会。

DESCRIPTION (provided by applicant): Over the past several decades there has been relatively little innovation in the arena of medical device sterilization. Ethylene oxide (ETO) and gamma irradiation (3-irradiation) are the only technologies currently available for medical devices. In particular, synthetic polymeric medical devices are sterilized almost exclusively by ETO due to undesirable chemical degradation and/or mechanical changes caused by gamma-irradiation. Gamma-irradiation requires cobalt-60 and these facilities are generally housed in large industrial or research institutions that can high operating costs associated with this technology. Suture manufacturers have expressed interest in moving from this process due to the short- and long-term effects of residual ETO in sterilized products, the fact that it is a recognized carcinogen, and the precautionary measures needed to operate around the toxic and explosive nature of ETO. Recently the EPA and other government agencies have started to monitor ETO in response to personal and environmental issues. Thus, development of alternative sterilization processes that are capable of achieving validated sterility assurance levels of 10-6 (SAL6) - the benchmark for medical devices - without the use of dangerous ETO or damaging 3-irradiation is of great importance. The current proposed effort aims to advance NovaSterilis' supercritical carbon dioxide sterilization technology and produce a viable method to sterilize suture materials while maintaining suture mechanical properties. The NovaSterilis process is environmentally friendly and uses only carbon dioxide and a chemical sterilant that breaks down into benign compounds during the process. The proposed project will establish the optimal conditions using supercritical carbon dioxide sterilization technology that will maintain the baseline mechanical properties of sutures sterilized to SAL6. We will demonstrate SAL6 sterilization using supercritical carbon dioxide under ISO guidelines. We will also show the effects on cytotoxicity in vitro. Funding of Phase I will allow us to show feasibility of supercritical carbon dioxide as a method of overcoming the current limitations on sterilization options currently used for sutures. Terminal sterilization using our supercritical carbon dioxide process has the potential to add a one step validated terminal sterilization process to suture manufacturers and distributors while decreasing the costs and burdens associated with current ethylene oxide sterilization processes. PUBLIC HEALTH RELEVANCE: Supercritical carbon dioxide sterilization of commercial suture materials presents an environmentally safe technique that does not require harsh conditions currently in use by the suture industry. The future of wound healing is affected by the development of advanced synthetic wound closure materials that will not stand up to current sterilization regimens. There is a clear need in the health care industry for both new materials and safe, innovative approaches to materials sterilization that will eliminate any opportunity for disease transmission.