Feasibility of Supercritical Carbon Dioxide Sterilization for Absorbable Suture M

描述（由申请人提供）：在过去几十年中，医疗器械灭菌竞技场的创新相对较少。环氧乙烷（ETO）和 伽马辐照（？辐照）是唯一可用于医疗器械的商业技术。特别地，合成聚合物医疗器械几乎完全通过ETO灭菌，这是由于伽马辐照引起的不期望的化学降解和/或机械变化。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，这些机构与这项技术有关的运营成本很高。由于灭菌产品中残留ETO的短期和长期负面影响、其是公认的致癌物的事实以及围绕ETO的毒性和爆炸性操作所需的预防措施，缝线制造商表示有兴趣放弃该工艺。最近，环保署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，开发能够实现10-6（SAL 6）（医疗器械的基准）的经验证无菌保证水平的替代灭菌工艺非常重要，而无需使用危险的ETO或破坏性辐照。目前提出的努力旨在推进NovaSterilis的超临界二氧化碳（scCO 2）灭菌技术，并产生一种可行的方法来对缝线材料进行灭菌，同时保持缝线的机械性能。NovaSterilis工艺是环保的，仅使用二氧化碳和一种化学灭菌剂，在工艺过程中分解为良性化合物。第I阶段工作已经确定了使用超临界二氧化碳（scCO 2）灭菌技术的最佳条件，该技术对根据ISO指南灭菌至SAL 6的缝线的机械性能无不良影响且无细胞毒性。因此，第一阶段使我们能够证明超临界二氧化碳作为克服目前缝线灭菌选择限制的方法的可行性。使用我们的超临界二氧化碳工艺进行的最终灭菌有可能为缝线制造商和分销商增加一步经验证的最终灭菌工艺，同时降低与当前环氧乙烷灭菌工艺相关的成本和负担。NovaSterilis已准备好开始II期体内和体外高级测试，以评估scCO 2灭菌缝线材料的商业就绪性，为医疗器械行业提供毒性更低、更温和的替代当前灭菌技术的方法。该项目的牵头公司NovaSterilis将与其经验丰富的工程师，化学家和生物学家团队合作，包括顾问 教授康奈尔大学的CC Chu是缝线开发竞技场公认的专家，其他专家则是动物毒性和有效性试验、放大和有效期试验。第一阶段的合作伙伴关系已被证明是非常成功的，商业化的逻辑下一步将在第二阶段完成。主要目标是通过体内和体外商业准备测试，确保使用NovaSterilis超临界二氧化碳技术灭菌的缝线的安全性和有效性。

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 (¿ irradiation) are the only technologies commercially 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 have high operating costs associated with this technology. Suture manufacturers have expressed interest in moving from this process due to the short- and long-term negative effects of residual ETO in sterilized products, the fact that it s 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 ¿-irradiation is of great importance. The current proposed effort aims to advance NovaSterilis' supercritical carbon dioxide (scCO2) 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 Phase I work has established the optimal conditions using supercritical carbon dioxide (scCO2) sterilization technology that have no adverse effects on the mechanical properties and no cytotoxicity of sutures sterilized to SAL6 under ISO guidelines. Thus, the Phase I has allowed 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. NovaSterilis is ready to begin Phase II in vivo and in vitro advanced testing to assess commercial- readiness of scCO2-sterilized suture materials to provide the medical device industry with a less toxic and more gentle alternative to current sterilization technologies. NovaSterilis, the lead company for this project, will pair its team of experienced engineers, chemists and biologists, including consultant Prof. CC Chu of Cornell University, a recognized expert in the arena of suture development, with additional experts in animal toxicity and efficacy testing, scale-up and shelf-life testing. Te Phase I partnership has proven highly successful, and the logical next steps towards commercialization will be accomplished in the Phase II. The primary goal is to ensure the safety and efficacy of sutures sterilized using NovaSterilis supercritical carbon dioxide technology through in vivo and in vitro commercial-readiness testing.