There is no longer need for conventional thief sampling and laboratory analysis which retard manufacturing processes and therewith raise production costs. This makes a PAT solution to a very valueable tool in process and formulation development, up-scaling, and routine use. Fully implemented and applied the online monitoring of blend uniformity is a key element for real-time release. Blend curve 250 Many different approaches to monitor this unit operation and to detect the end point of the mixing process are realized. The selection of the best suited one is very strong depending on the product or range of products the NIR is applied to. The most commonly used methods are: Simple spectral statistics such as Standard Deviation in a certain wavelength range oreven small absorbance rangeAdvanced statistical calculation using Moving Block Standard Deviation and Moving Block FTest both in combination with mathematical pretreatmentsCalculation and monitoring of area values for absorbance bands of activesQualitative analysis based on Principal Component Analysis (PCA)Quantitative monitoring of API or functional ingredients based on chemometric models, e.g. PLSCombination of different approaches listed above, e.g. statistics such as RSDapplied to quantitative values
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Sanjay Miglani (MK Teknology1 Pvt. Ltd.)
GG- 1, 139- C, PVR Road, Vikaspuri, Vikas Puri, Delhi - 110018, India
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