RAPID ACCELERATION OF DIAGNOSTICS (RADX) TECH PROJECT NO. 7453: HIGH VOLUME INJECTION MOLDED SWAB

快速诊断加速 (RADX) 技术项目编号

• 批准号: 10506002
• 负责人: RENUKA SIRIGIRI
• 金额: $ 675.63万
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-18 至 2021-12-17
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10506002
• 关键词: Dialysis procedure; Ensure; Individual; Injections; Knowledge; Medical Device; Molds; Process; Production; RADx Tech; Sterilization; Swab; in vitro testing; nasopharyngeal swab; seal

Our solution is an injection molded nasopharyngeal swab that does not require flocking of the swab end and is individually packaged and sterilized. We have completed in vitro testing and found it to be substantially equivalent to flocked swabs. This product is a perfect fit for our knowledge and expertise in the manufacturing of disposable medical devices. Our supply chain is perfect for this project as we have our primary partners in injection molding, packaging, and sterilization with solutions immediately available.  For example, our injection molding partner and 50% owner in our company specializes in high volume production of medical device components, primarily in IV therapy and dialysis. They have one injection mold capable of producing over 1 billion single injection molded components per year. Our packaging partner had a validated form-fill-seal package that is a perfect fit for the swab and a validated sterilization cycle that we were able to leverage to get the product to market efficiently. We are also experts in establishing the necessary process controls to ensure a consistently high quality product.

我们的解决方案是注射成型的鼻咽拭子，它不需要棉签末端的植绒，并且是单独包装和消毒的。我们已经完成了体外测试，发现它基本上相当于绒毛拭子。这款产品非常适合我们在一次性医疗器械制造方面的知识和专业知识。我们的供应链非常适合这个项目，因为我们在注塑、包装和杀菌方面有我们的主要合作伙伴，并立即提供解决方案。例如，我们的注塑合作伙伴和我们公司50%的所有者专门从事医疗器械零部件的大批量生产，主要是静脉注射治疗和透析。他们有一个注塑模具，每年能够生产超过10亿个单次注塑零件。我们的包装合作伙伴有一个经过验证的表格-填充-密封包装，非常适合拭子和经过验证的灭菌周期，我们能够利用它将产品高效地推向市场。我们也是建立必要的过程控制以确保持续高质量产品的专家。