OXYGEN SENSOR FOR MODIFIED-ATMOSPHERE MEDICAL PACKAGING

该项目开发了一种创新的传感器方法，使用不损害密封包装完整性的非侵入性光学传感技术来测量医疗产品包装内的氧气。总体目标是提供一种无损测量工具，以确保所有对氧敏感的产品都经过适当的包装，并保持在所需的低氧状态。该技术将使更高质量的交付成果成为可能，同时降低降级产品到达患者手中的风险。第一阶段的研究致力于将该技术应用于医用氧敏感包装材料的制造。将准备、表征和评估用于测量氧气的各种感官胶片的再现。此外，还将调查候选材料在耐受工业灭菌过程和生物兼容性方面是否符合医疗应用的要求。在第二阶段，将准备包装薄膜的高级副本。根据感官膜特性的需要，对读氧仪进行改进。原型技术将在中试应用试验中进行现场测试。拟议的商业应用：氧气敏感药品和设备的制造商将通过以下方式将传感技术用于包装：-作为生产过程控制的辅助手段，在包装点对QC生产线进行使用，以最大限度地确保达到低氧-在最终用户或使用点验证产品质量(氧含量)，确保包装完整性和可交付产品的质量-为气调包装开发改进的材料和工艺-设计产品斑点包装并验证其制造工艺-调查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