OXYGEN SENSOR FOR MODIFIED-ATMOSPHERE MEDICAL PACKAGING

该项目开发了一种创新的传感器方法，用于测量医疗产品包装内的氧气，使用非侵入式光学传感技术，不会损害密封包装的完整性。总体目标是提供一种非破坏性测量工具，以确保所有对氧敏感的产品都得到适当包装并保持在所需的低氧状态。该技术将实现更高质量的可交付成果，降低产品到达患者的风险。第一阶段的研究致力于实施该技术，以制造氧传感医疗级包装材料。将准备各种感官膜的再现，表征和性能评估用于测量氧气。此外，还将研究候选材料在耐受暴露于工业灭菌过程和生物相容性方面是否符合医疗应用要求。在第二阶段，将准备包装薄膜的先进版本。雅阁感测膜的性质所指示的需要，将对氧阅读仪器进行改进。原型技术将在试点应用试验中进行实地测试。拟议的商业应用：传感技术将被氧敏感药物和器械的制造商以下列方式用于包装：- 在包装点对生产线进行质量控制，作为生产过程控制的辅助手段，以最大限度地确保达到低氧（氧含量）在最终用户水平或使用点，确保包装完整性和交付物的质量-开发改进的气调包装材料和工艺-设计产品-斑点包装并验证其制造工艺-研究产品在低氧条件下的使用寿命

This project develops an innovative sensor method for measuring oxygen inside packages of medical-products using a non-invasive optical sensing technique that does not compromise the sealed packages' integrity. The overall objective is to provide a non-destructive measurement tool for insuring that all oxygen-sensitive products are properly packaged and maintained in their required low-oxygen state. The technology will enable higher quality deliverables with lower risk of degraded product reaching patients. Phase I research addresses the implementation of the technology towards fabrication of oxygen-sensing medical-grade packaging materials. Various renditions of sensory films will be prepared, characterized, and performance evaluated for measuring oxygen. In addition, compliance of candidate materials with requirements for medical applications in terms of withstanding exposure to industrial sterilization processes and being biocompatible will be investigated. In Phase II advanced renditions of the packaging films will be prepared. Improvements will be made in the in the oxygen reading instrumentation in accord with needs dictated by the sensory films' properties. The prototypic technology will be field tested in pilot application trials. PROPOSED COMMERCIAL APPLICATIONS: The sensing technology will be utilized by manufacturers of oxygen- sensitive drugs and devices towards packaging in the following manners: - To QC manufacturing lines at the point of packaging, as an adjunct to production process controls, for maximum assurance that low oxygen is attained - To verify product quality (oxygen-content) at the end-user level or point of use, to ensure package integrity and quality of the deliverable - To develop improved materials and processes for modified-atmosphere packaging - To design product- speck packaging and to validate their manufacturing processes- To investigate product use-life under low oxygen conditions