The SpectRx™ Near Infrared System is being used for medical “Stent” devices by identifying the drug contents placed between several layers of different polymers in a “Stent”. The quantitative analysis of the drug combined with the surrounding polymers are measured and analyzed in each “Stent.” The SpectRx™ system conducts the analysis automatically by acquiring several spectra of the presented “Stent,” then stores them automatically in the database. The SpectRx™ system compares the acquired spectra of the presented “Stent” with a cluster of well defined standards. “Stents” that are within the allowable tolerances are deemed acceptable. Unacceptable “Stents” are automatically directed to a quarantined chamber for further analysis.
The SpectRx™ system incorporates one, or two “Fiber Optic Probes” placed above each stream of objects to meet the production demands. The objects, which are flowing in a single file under the probe, are analyzed at a rate of 80 scans per second per probe.
The detection of unacceptable chemical concentration in any presented sample of various organic products will force the system to pneumatically reject it. A quarantine chute is developed for further analysis and error accountability. Foreign objects may also force the production line to shut down when deemed necessary.
Analysis of Stents of Same Polymers with Different Active Concentrations
Stents of Different Polymers with same Constant of Active Layer
The SpectRx™ NIR system is currently used in clean room environment to analyze the polymer composition of each Stent including the micro-composition of drug contents deposited between polymer layers.
The SpectRx™ NIR system is capable of inspecting the chemical composition of each component without operator’s interference. The data are uploaded automatically and stored in the database. Unacceptable units are rejected and sent to a quarantined location for further analysis.
The SpectRx™ NIR system complies with the safety requirements. It is equipped with operator’s interface devices to override the automation mode and transfer the functions into manual interface mode.
The SpectRx™ NIR system is integrated with peripheral equipment such as an automated indexer, a PLC, and several sensors to enable the operation to be conducted in a fully automated mode, and in a clean room environment.
Once the product is selected, the SpectRx™ NIR system achieves its functions without further interference. It analyzes, and displays the output data, then stores the results at secure files stamped electronically with date and time of operation. The records are permanent and cannot be deleted, as it provides accurate history of product performance for a certain batch.
Production Interface Screen” describing the upper control and the lower control limits. The SpectRx™ NIR system acquires the spectra of a presented sample. A viable product must fall between these two limits to deem the sample acceptable.