Pharmaceutical Manufacturing Quality Control

Hyperspectral imaging, or chemical imaging, is ideal for analyzing solid form pharmaceutical products such as films, blends, and tablets either during on-line manufacturing or in laboratory formulation development. By collecting spatial and spectral (chemical) information simultaneously, one can rapidly image a sample or product line. Hyperspectral imaging provides information about the spatial distribution of chemical components within the sample. The homogeneity or patterned dispersion of chemical components is often critical in the end effect of the pharmaceutical product, and hyperspectral imaging provides precisely this information without contacting or destroying the sample or product, and without requiring a high heat load from illumination.

How it works: The hyperspectral camera collects both spatial and spectral (chemical) information by employing a push-broom imaging method. As opposed to a staring array, the camera images one line of the product at a time and as the sample tray or product moves underneath the camera (or as the camera is moved over the sample), the whole image is collected. A full spectrum of each point is saved, resulting in a "hypercube" of data that can be analyzed to identify chemically distinct components and their spatial distribution within the product. This process is relatively quick and because only one line of the sample is imaged at a time, a high prolonged heat load from the illumination is not necessary.

Middleton Research offers complete hyperspectral workstations for in-lab use (see SisuCHEMA and Via-Spec system product brochures below). In addition, we can work with you to develop a hyperspectral system that is optimized for your specific application. We provide individual system components and consulting to integrate a specific system complete with a camera, illumination source, and software to meet your needs.

---

imMix™ Micromixing Hyperspectral Imager

Micromixing is a process in which ingredient particles rearrange to form a blend. Development of pharmaceutical formulations requires understanding how the ingredients blend with each other and how the blending progresses through different stages. It is also important to establish in a scientific manner when the blending is considered complete, establishing the margins of blending performance, so that in production the blending is complete before the blending process stops.

In order to achieve optimal blending, the micromixing process must be studied to determine mixing parameters such as blending time, blending speed, type and size of blender, choice of materials, and particle size grades of ingredients. When blending is performed too long, overblending may occur, with particles re-aggregating, resulting in segregation of the previously ideal blend.

The imMix system is a near-infrared hyperspectral imaging tool that can be used to optimize the blending process without needing to pull samples from the blend or run time-consuming laboratory analyses, as is the case in current destructive analytical methods. Hyperspectral data is collected through an optical window on the blender, and composition maps (spatial dispersion) of all of the blend ingredients are created from the spectra throughout the blending process. The very large amount of imaging data is condensed to a limited number of useful micromixing parameters.

Please see the brochures below or contact us for further information.

Check out a Pittcon 2009 interview with Dr. Gabor Kemeny on Hyperspectral Imaging

Hyperspectral Imager Systems for Pharmaceutical Analysis

SisuCHEMA™ Hyperspectral Imaging Systems

Via-Spec™ Hyperspectral Transmission System

imMix™ Micromixing Hyperspectral Imager

imMix™ Software

Hyperspectral Thin Film Measurement System Product Sheet

Hyperspectral Prediction Engine

Hyperspectral Imaging for Pharmaceutical Applications

SisuCHEMA™ in Pharmaceutical Applications

Monitoring of Continuous Manufacturing

High Speed Hyperspectral Chemical Imaging (Technical Paper)