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Design space approach for the validation of an innovative continuous pharmaceutical production process. (FWOAL620)

Nowadays, there exists the intention within the pharmaceutical industry to move from traditional batch processing to continuous processing. The latter can be defined as a manufacturing process that continuously receives raw materials and continuously processes them through all manufacturing stages until the final product is obtained. Continuous production offers many advantages such as flexible batch size, reduced batch variability and no time-consuming and expensive scale up issues. Within the scope a continuous oral solid dosage manufacturing line, "from-powder-to-tablet", the present project will focus on the optimization and validation of a main unit (process step) of this continuous production line: the continuous high shear granulator. Based on the identified critical process parameters and the critical quality attributes related to the product, the aim will be to translate data collected from process analyzers (e.g., near infrared and Raman spectroscopy, particle size analyzers) into a space of process parameters, displaying the probability to meet the product targeted performance. This will allow the prediction of the process parameters leading to the expected product specifications with a very high probability: the Design Space. Finally, from the calculated Design Space, the process Normal Operating Conditions will be implemented and validated in a real industrial environment.
Date:1 Jan 2012  →  31 Dec 2015
Keywords:Drug Analysis, Chemometrics, Analytical Chemistry, Chromatography, Artificial Intelligence, Food Analysis
Disciplines:Pharmaceutical sciences, Chemical sciences