Fluid bed processes are long-lasting and energy-intensive manufacturing techniques commonly applied in pharmaceutical manufacturing. Because of their ubiquity, the potential energy savings by decreasing the process time are immense.
When a pharmaceutical dosage form is traditionally approved by the authorities, a set of defined process parameters is approved as well. These parameters have to be used, even though they are not chosen because of energy consumption considerations – but based on risk assessments aiming to minimize the number of off-specification batches.
The idea of this project is based on the principles of Quality by Design (QbD) according to the ICH guideline Q8. When the manufacturing process is approved according to QbD, the process parameters can be varied in a specific Design Space. Therefore, parameters resulting in decreased process time can be chosen.
In order to decrease the process time without increasing the risk of off-specification batches, a feedback control will be developed in this project. The Parsum® probe will monitor the critical quality attribute particle size inline and compare the actual particle size with a predefined one. When they do not match, the process control will automatically adjust the process parameters. Thereby, the energy consumption is minimized.
Project Operation:
Dr. Julian Quodbach (stellv. Projektkoordinator)
Institut für Pharmazeutische Technologie und Biopharmazie
Heinrich-Heine-Universität Düsseldorf
Universitätsstraße 1
40225 Düsseldorf
www.pharmazie.hhu.de/institute/ptb
Lilia Sprich
Glatt GmbH
Werner-Glatt-Straße 1
79589 Binzen
www.glatt.com
Stefan Dietrich
Parsum Gesellschaft für Partikel-, Strömungs- und Umweltmesstechnik GmbH
Reichenhainer Straße 34-36
09126 Chemnitz
www.parsum.de
Dr. Peter Stöckel
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Straße 173
55216 Ingelheim am Rhein
www.boehringer-ingelheim.de
Ref. 31829
