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

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:
10554228
负责人:
RENUKA SIRIGIRI
金额:
$155.6万
依托单位:
--
依托单位国家:
美国
项目类别:
财政年份:
2020
资助国家:
美国
项目状态:
已结题
起止时间:
2020-12-18 至 2022-12-17

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中文摘要
翻译
我们的解决方案是一种注射成型的鼻咽拭子,不需要棉签末端的植绒,并且单独包装和消毒。我们已经完成了体外测试,发现它与蜂群拭子基本相同。这款产品非常适合我们在一次性医疗设备制造方面的知识和专业知识。我们的供应链对于这个项目来说是完美的,因为我们在注塑,包装和灭菌方面有我们的主要合作伙伴,可以立即提供解决方案。例如,我们的注塑合作伙伴和我们公司50%的股权专门从事医疗设备组件的大批量生产,主要是静脉注射治疗和透析。他们有一个注塑模具,能够每年生产超过10亿个单一注塑件。我们的包装合作伙伴有一个经过验证的表单-填充-密封包装,非常适合棉签和经过验证的灭菌周期,我们能够利用这一点将产品有效地推向市场。我们也是建立必要的过程控制方面的专家,以确保始终如一的高质量产品。
英文摘要
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.
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RAPID ACCELERATION OF DIAGNOSTICS (RADX) TECH PROJECT NO. 7453: HIGH VOLUME INJECTION MOLDED SWAB
  • 批准号:
    10506002
  • 项目类别:
  • 资助金额:
    $675.63万
  • 财政年份:
    2020
  • 负责人:
    RENUKA SIRIGIRI
  • 依托单位:
    --
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