Webinar: Multiparticulates Part 8: Scale up considerations on the Wurster (bottomspray) fluidized bed process
Scale up of manufacturing processes is an important step in drug development – not to say: a big hurdle! The Wurster (bottomspray) fluidized bed process is based on a clear technical concept. For scale up, configuration of the process equipment, definition of batch size, thermodynamic parameters and droplet size of drug layering and coating liquids are scaled up following a well-understood and transparent concept.
In the end, scale up of the Wurster process is a straightforward activity which – to be successful – should always be based on sound scientific process development and optimization in the small scale.
Q1: If you want to adjust the throughput within the same equipment by adjusting the degree of filling. Which process parameters would you keep constant and which not? Would you just spray for longer to deliver the needed amount of coating?
Q2: After certain atomization air it seems the same droplet size e.g. 3 or 4 bar pressure
Q3: The diameter of the bottom plate is important for scale-up calculation. Is the outer diameter of the bottom plate relevant or the diameter of the outer holes within the plate?
Speaker: Dr. Norbert Pöllinger
Norbert Poellinger is heading the Technology Development unit. Until 2018, he was responsible for Development and Manufacturing Services Group at Glatt Pharmaceutical Services which included Pharmaceutical Development, Manufacturing, Quality Control, Quality Assurance and Plant Engineering. He studied pharmaceutical sciences at the University of Erlangen, Germany and received a PhD degree in Pharmaceutical Technology. Currently, the recently formed Glatt Pharmaceutical Services GmbH & Co.KG focuses on controlled release and taste masked multiparticulates including minitablets and tablets. Drug products for the paediatric and geriatric population are of particular interest. Logistic services have become a new service opportunity of Glatt