Feasibility of Supercritical Carbon Dioxide Sterilization for Absorbable Suture M

可吸收缝线M超临界二氧化碳灭菌的可行性

• 批准号: 8486452
• 负责人: Julien Fey
• 金额: $ 51.78万
• 依托单位: NOVASTERILIS, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-03-01 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8486452
• 关键词: Advanced Development; Adverse effects; Affect; Animal Model; Animal Testing; Animals; Benchmarking; Benign; Biocompatible Materials; Carbon Dioxide; Carcinogens; Chemicals; Cobalt 60; Collaborations; Development; Due Process; Engineering; Ensure; Ethylene Oxide; Future; Goals; Government Agencies; Guidelines; Health; Healthcare Industry; Housing; Hydrogen Peroxide; Impaired wound healing; In Vitro; Industry; Inflammation; Institution; Lead; Life; Maintenance; Manufacturer Name; Measures; Mechanics; Medical Device; Methodology; Methods; Monitor; Nature; One-Step dentin bonding system; Patients; Phase; Poison; Process; Property; Readiness; Regimen; Research; Residual state; Safety; Sterility; Sterilization; Surgeon; Surgical sutures; Techniques; Technology; Testing; Tissues; Toxic effect; Toxicity Tests; Universities; Work; Wound Healing; commercialization; cost; cytotoxicity; disease transmission; efficacy testing; experience; in vitro testing; in vivo; innovation; interest; irradiation; novel; response; scale up; wound

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.

描述（由应用程序提供）：在过去的几十年中，医疗设备灭菌的舞台上的创新相对较少。氧化乙烷（ETO）和 伽马射线（辐射）是医疗设备上唯一可用的技术。特别是，由于不良的化学降解和/或由γ-辐照引起的机械变化，ETO几乎完全由ETO刻板地定型合成聚合物。伽马射线需要钴60，这些设施通常位于与该技术相关的高运营成本的大型工业或研究机构中。由于残留ETO在灭菌产品中的短期和长期负面影响，这是公认的致癌物质以及围绕ETO的有毒和爆炸性的预防措施，因此缝合制造商对从这一过程的转变表示了兴趣。最近，EPA和其他政府机构已经开始监视ETO，以应对个人和环境问题。这是能够达到10-6（SAL6）的替代灭菌过程的开发 - 医疗设备的基准 - 无需使用危险的ETO或损坏``````````````''非常重要的。目前提出的努力旨在推进Novasterilis的超临界二氧化碳（SCCO2）灭菌技术，并在维持缝合力机械性能的同时，生成可行的刻板印象材料的可行方法。 Novasterilis工艺对环境友好，仅使用二氧化碳和在此过程中分解成良性化合物的化学灭菌剂。第一阶段的工作已经使用超临界二氧化碳（SCCO2）灭菌技术建立了最佳条件，这些抗性对机械性能没有不利影响，并且在ISO指南下未对SAL6进行灭菌的细胞毒性。这是I阶段使我们能够显示出超临界二氧化碳的可行性，作为克服当前用于成功的灭菌选项的当前限制的方法。使用我们的超临界二氧化碳工艺的末端灭菌有可能向缝合制造商和分销商添加一步验证的末端灭菌过程，同时降低与当前氧化乙烯氧化物灭菌过程相关的成本和燃烧。 Novasterilis准备开始在体内和体外高级测试中开始II阶段，以评估SCCO2-STERILIDIAD缝合材料的商业准备，以使医疗器械行业提供较少的毒性和更温和的替代方法，以替代当前的消毒技术。该项目的主要公司Novasterilis将配对其经验丰富的工程师，化学家和生物学家的团队，包括顾问 康奈尔大学（Cornell University）的CC Chu教授是缝合式开发领域的公认专家，在动物毒性和有效性测试，扩展和保质期测试方面拥有更多专家。事实证明，第一阶段的合作伙伴关系非常成功，并将在第二阶段实现逻辑上的商业化步骤。主要目的是通过体内和体外商业准备测试确保使用Novasterilis超二氧化碳技术对缝线的安全性和有效性进行灭菌。