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.
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
