Manufacturing Scale Implementation of MicroNIRTM PAT for Blend Monitoring of Solid Dose Formulations

For many years now, the pharmaceutical industry has adopted Near Infrared Spectroscopy
(NIRS) for various applications, particularly raw material identification and qualification.
When the US FDA released its PAT Framework document in 2004, many of the larger
innovator companies dedicated much time and effort into the development of NIRS
for real time monitoring and control applications in solid dose manufacturing.
One of the key processes targeted was Fluid Bed Drying (FBD) because of the static nature
of the process and its criticality to downstream manufacturing operations. Many of these
companies also used dynamic blenders for their blending operations, however, during the
early 2000’s the availability of reliable and robust NIR instrumentation for monitoring
blend uniformity was not readily available.

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