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The SpectRx® Near Infrared High Speed Production System is Compliant with FDA CFR-21-Part 11 SpectRx™ Clean Room Environment  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
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The SpectRx™ NIR system is capable of inspecting the
chemical composition of each component without operator
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 safety requirements.
It is equipped with operator interface devices to override
the automation mode and transfer the functions into manual interface
mode 
