The FDA's PAT (Process Analytical Technology) Initiative encourages the application of novel analytical instrumentation to pharmaceutical manufacturing processes for the purpose of advancing in-process quality control. In support of pharmaceutical companies developing PAT strategies, Spectral Dimensions is pleased to introduce its Blend Monitor, an in-process chemical imaging solution for monitoring pharmaceutical ingredient blending processes. Downstream quality issues associated with pressed pharmaceutical tablets can now be anticipated and prevented through chemically imaging pharmaceutical ingredients prior to their tabletization – chemical imaging can be used to ensure that pharmaceutical ingredients are optimally blended.
Inadequate process control of the pharmaceutical blending process can lead to final tablet quality problems such as undesirable dissolution characteristics, poor hardness, inconsistent appearance, etc. Over-blending as well as under-blending can ruin batches of ingredients and the tablets produced from them. Only in-process monitoring of ingredient blending can ensure optimal blending.
While standard NIR spectroscopy can measure the constituents and average blending characteristics of a pharmaceutical formulation, a Chemical Imaging System can provide additional information through spectral images and quickly assess both the identities and the relative arrangements and sizes of component particles for a more complete understanding and characterization of the mixture. This additional information can become a key parameter in optimizing the blending process, particularly for complex or ‘difficult' formulations. Chemically imaging a blend can support both scale-up testing of optimal blending time, and subsequent, routine, noninvasive monitoring of every production blending batch.
Spectral Dimensions Blend Monitor is a Chemical Imaging system that can image the particles in a manufacturing blender in a "near-line" configuration. Through a quartz window integrated into a blender, Spectral Dimensions Blend Monitor can image the blend in process at periodic interruptions of the process. Essentially, Spectral Dimensions Blend Monitor can quickly provide both images and quantitative data to support continuing or ending a blending process. Furthermore Spectral Dimensions Blend Monitor can do this 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. PAT seeks to break dependence on post-production analysis of finished goods as the only way to measure quality or adherence to production standards. In offering a chemical imaging system for monitoring pharmaceutical ingredient blending in the course of manufacturing, Spectral Dimensions offers the first industry solution for employing chemical imaging to meet PAT goals.