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




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