Introduction  1   2
 



The SpectRx Near Infrared System is being used for medical Stent devices. The SpectRx NIR System identifies and measures 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 automatically conducts the analysis by acquiring several spectra of the presented Stent and 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.



Figure 3   Side View of Medical Coated Stent


Figure 4  Coated Bridges and Struts of Medical Coated Stent

The SpectRx Near Infrared System acquires spectra between 4000 to 12000 Wave Numbers, or 830 to 2500 nanometers. The spectra illustrated below were taken from five different Stents of the same production lot. The acquired data indicate that the five Stents are in good conformity with the acceptable limits set for production run. The presence of each chemical composition for each Stent is represented by a range of wave-numbers. The quantitative values of the chemical composition are measured by the energy level reflected or absorbed as illustrated

The SpectRx Near Infrared System acquires Stent spectra between 4000 to 1200 Wave Numbers C 830 to 2500 nanometer. The spectra were taken from 5 different Stents within the same production lot.

The SpectRx NIR system is integrated with peripheral equipment such as an automated indexer, a PLC, and several sensors to enable seamless inspection operation conducted in a fully-automated mode 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 in secure files stamped electronically with date, and time of operation. The records are made permanent, and cannot be deleted and provide an accurate history of product performance for any inspected batch.

 Production Interface Screen describing the upper control and lower control limits. The SpectRxNIR system acquires the spectra of a presented sample. A viable and acceptable product must fall between these two limits to deem the presented sample acceptable.

The selection of the upper and lower control limits are usually achieved by the Quality Assurance personnel. A hierarchical password level is required to enter the secure domains. Password authority levels are assigned by the IT department.