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.