Near-line Chemical Imaging Tested for Blend Optimization

01/26/2005

Spectral Dimensions (Olney, Md.) has developed its first Blend Monitor, a chemical imaging solution for blend analysis, in accordance with FDA’s PAT initiative. The monitoring system was developed in collaboration with, and is being tested by, Pfizer under that firm’s Cooperative Research and Development Agreement (CRADA) with FDA.

Chemical imaging of ingredients during the blending process will allow operators to anticipate and prevent downstream quality issues due to under- or overblending. While standard NIR spectroscopy can measure the constituents and average blending characteristics of a pharmaceutical formulation, a chemical imaging system can provide additional information, particularly for complex or ‘difficult’ formulations.

Spectral Dimensions’ Blend Monitor images particles in a “near-line” configuration. The system relies on a fiber-optic sensor to record images through a sapphire window integrated into a blender, says company president Neil Lewis. The images provide spatial and chemical information—regarding mean drug load, purity, particle size, blend uniformity and more.

While the blender must be stopped for imaging, the data can be analyzed in a matter of seconds using a version of Spectral Dimensions’ ISys software. Ultimately, Lewis envisions a system in which the sensor is attached permanently to the blender, and in which data is transmitted wirelessly.

Lewis says the system is a work in progress. With Pfizer yet to release the final results of its studies, he says the “jury is out” as to how extensively the system will be used, and how firms will adapt it for their production processes.

For more information regarding Spectral Dimensions’ Blend Monitor, contact Glenn Bloom, Director of Sales & Marketing, Spectral Dimensions, 301-260-0290 x115 or gbloom@spectraldimensions.com.