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The SpectRx® Near Infrared High Speed
Production System is Compliant with FDA CFR-21-Part 11
The SpectRx Near Infrared System acquires and analyzes
the spectrum of each tablet or capsule and determines its acceptability
with respect to certain production control limits. The chemical compositions
of each tablet/capsule/caplet, that passes under the probe are analyzed
and measured. Also, the SpectRx NIR system measures
the hardness and disintegration of each tablet/caplet at a rate of 160
objects per second using a dual-probe system or 80 sans per second using
a single-probe system.
The SpectRx Near Infrared System measures the hardness,
the disintegration, the active ingredients, the moisture content, and
plots the spectrum of the acceptable tablet. The system also stores
the data using an electronic time stamp throughout the entire production
run.
A production screen is developed to illustrate acceptable tablets passing
under the NIR probe. The required data are displayed on the same screen
and can be continuously stored in a peripheral storage media.
Two tablets were analyzed, the acceptable one is displayed in green spectrum,
the other tablet is a reject tablet and displayed in red spectrum.
A foreign or unacceptable capsules/tablets/caplets are automatically
rejected by using an electro-pneumatic rejection
mechanism.
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