Laboratory of Pharmaceutical Process Analytical Technology

Ottergemsesteenweg 460
B-9000 Gent (Belgium)
Tel.: +32-9-264.80.68
Fax: +32-9-222.82.36
E-mail: Fien.DeLeersnyder@UGent.be
Education: Pharmacist (Master in Pharmaceutical Care)

Design Space Approach for the Validation of a Continuous Pharmaceutical Production Process

This study focuses on the optimisation and the validation of the most important steps in the production line of the ConsiGma™: the continuous high-shear granulator, the multicell dryer and the mill. The aim is to define the combination of process parameters leading to the product expected specifications with a very high probability, based on data collected by the process sensors. This combination is the design space.

In first instance, using implemented process sensors, quantitative methods are developed and pre-validated to accurately evaluate in real-time the critical quality attributes of the continuously produced granules. Secondly, it is investigated which process parameters have the most impact on the critical quality attributes of the granules. Thirdly, the selected critical process parameters are optimized to define the design space leading to (the desired) robust product performance. Fourthly, based on the normal operating conditions, the quantitative methods developed on the process analyzers are thoroughly validated. Finally, possibilities to implement the design space in the manufacturing environment are investigated.

The present study is the first step to optimize and validate the continuous granulator, dryer and mill step of the full continuous pharmaceutical from-powder-to-tablet process, meeting the new requirements of the regulatory authorities.