In a collaborative project with researchers from the University Of Dusseldorf, Germany, the UK contract manufacturing organisation (CMO) developed techniques to measure humidity across the entire active pharmaceutical ingredient (API) granulation process.
The resulting techniques and information were then used as a process analytical technology (PAT) tool to determine the optimum endpoint of the granulation process and to further streamline in-process operations.
Sean Marett, managing director of NextPharma’s product development services team, told Outsourcing-pharma about the project and its implications for the firm’s manufacturing operations.
He explained that: “The work was coordinated by the University of Düsseldorf; NextPharma was responsible for carrying out the experiments and collecting and jointly interpreting the humidity data using our existing Glatt fluid bed granulator at our plant in Waltrop, Germany.
“The experiments were conducted using "real-life products" thereby demonstrating the practical application of the results of the research to improved quality of manufacture of pharmaceutical products. Glatt and Advanced Microwaves Systems provided the rest of the equipment required for the research.”
Marett added that, aside from the new monitoring techniques which are being applied across NextPharma’s fluid bed granulation platforms, the project also underlined the importance of controlling humidity levels during granulation.
“The findings were that we can measure humidity on line and determine the optimum time when the end point is reached. We also learned that if humidity exceeds a certain level that the system will not work and that this point requires further research.”