Blend Monitor intends to support the FDA’s Process Analytical Technology (PAT) Initiative, which attempts to encourage the application of analytical instrumentation to pharmaceutical manufacturing processes for the purpose of advancing in-process quality control, by offering an in-process chemical imaging solution for monitoring pharmaceutical ingredient blending processes.
The solution aims to anticipate and prevent downstream quality issues associated with pressed pharmaceutical tablets by chemically imaging pharmaceutical ingredients prior to their tabletization, which ensures that pharmaceutical ingredients are optimally blended.
Spectral Dimensions Blend Monitor images particles in a manufacturing blender in a near-line configuration and the blend in process at periodic interruptions of the process. It is expected to quickly provide both images and quantitative data to support continuing or ending a blending process, without requiring removal of samples from the blender and without requiring destructive analysis.
The goal of the FDA’s PAT initiative is to advance pharmaceutical manufacturing quality by increasing reliance on optical instrumentation such as chemical imaging systems, for monitoring and measuring adherence to process standards in the actual course of production. Spectral Dimension offers the first industry solution for employing chemical imaging to meet PAT goals.
