NIR Spectroscopy for Real-Time, In-Line Measurement of API Concentration in a Continuous Blending Process

Solid dose and powder dose pharma products contain multiple ingredients. These include an Active Pharmaceutical Ingredient (API) and numerous excipients which include fillers, binders, lubricants or disintegrants to name a few. Blending is a process which mixes the API and excipients to ensure there is a homogeneous mixture of the all ingredients for each manufacturing process. Blending is a process that can be carried out numerous times within a manufacturing process when new excipients need to be added to the blend.

The blending process critical process parameters are identified as blender speed and blend time. To ensure a homogeneous mixture from a blending process the incorporation of process analytical technologies such as the Multieye, a multi-point NIR system, which can monitor blend uniformity may be necessary as excessive blending can lead to electrostatic build-up, attrition and over lubrication.

Measurement of the concentration of the API in a continuous blending process is critical to ensure the quality of the end product material. See how Multieye2 NIR spectrophotometer can be implemented to track the API concentration of the powder being outputted from a continuous blender - capable of monitoring multiple SKUs and detecting process variations.

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