Modelling of drying process in Pharmaceutical continuous operation

Modelling of drying process in Pharmaceutal continuous operation

Nowadays, the pharmaceutical industry relies mostly on batch processing. However, this production method has several disadvantages; upscaling from lab or pilot to production scale is not straightforward, lack of process understanding, limited control of essential reactor variables… The shift to a continuous process with more on-line monitoring and control, which would make the process easier to operate and more cost-effective, has for a long time been hindered by the regulatory uncertainty, i.e. the vision of the regulatory authorities on such innovative production methods was unclear. That has all changed with the publication of the PAT guidance in 2004.

In order to control the quality of the final product, advanced quality control systems should be implemented. These control systems should rely on in-line measurements and real-time adjustment of the most significant process variables. However detailed knowledge of the process and the effect of essential process variables on the product quality is required to develop these control systems. When mapping the available process knowledge, the behavior of the raw materials during processing can be modeled using a mechanistic modelling approach. Once such a mechanistic model has been established, it has to be validated by several experiments.

The validated mechanistic models help to gain insight in the process, and can be used to simulate the process for a range of settings of the different process inputs. These simulations can predict the outcome of the process, and thereby help to map and interpret the influence of changing input variables on the final product quality.

This research project will focus on the continuous tabletting process, and more specifically on the drying of the wet granules that are produced by the granulator. The goal is to develop a combined CFD-PBM model to describe the drying process in a fluid bed dryer, and to achieve an online and real time adaptation of the drying process on the basis of the available process measurements. CFD is a mathematical tool to study the flow pattern of the granules in the gas phase, whereas a PBM-approach is interesting for the description of the change of the moisture content of the granules during the drying process.

Project duration: 2010-08-01 - 2014-07-31

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Severine Mortier
Department of Applied Mathematics, Biometrics and Process Control
Coupure Links 653
9000 Gent
Tel: +32 9 264 61 96
Fax: +32 9 264 62 20

Last update: 01 december 2008,

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