Davinia Brouckaert

Laboratory of Pharmaceutical Process Analytical Technology

Ottergemsesteenweg 460
B-9000 Gent (Belgium)
Tel.: +32-9-264.80.60
Fax: +32-9-222.82.36
E-mail: Davinia.Brouckaert@UGent.be
Education: Pharmacist (Master in Drug Development)

Implementation of PAT systems in manufacturing processes of liquid formulations

Companies can only release products when their quality is guaranteed. Since the publication of the Process Analytical Technology (PAT) guidance by the FDA (2004), product quality should be built into the products already during production process design.

Theoretically, physical and phenomenological modeling of the production processes is required and advanced control systems are to be implemented. The process models should help to increase process understanding (processes should not be a black box) and to simulate processes. Process simulations should allow predicting the input material behavior during processing and should contribute significantly to guaranteeing the end product quality. Furthermore, the developed models should help to determine how input material variability can be managed by the process without losing product quality. The ultimate goal is to develop processes that are continuously under control and hence allow real-time release.

This PhD project aims at developing and validating Process Analytical Technology (PAT) systems for manufacturing processes of liquid formulations, and to exploit those systems in the development of advanced process control systems. The research is conducted in close cooperation with the company Procter & Gamble.