The effect of process parameters on audible acoustic emissions from high-shear granulation

Drug Development and Industrial Pharmacy
Erin M HansuldJoe A B McCann

Abstract

Product quality in high-shear granulation is easily compromised by minor changes in raw material properties or process conditions. It is desired to develop a process analytical technology (PAT) that can monitor the process in real-time and provide feedback for quality control. In this work, the application of audible acoustic emissions (AAEs) as a PAT tool was investigated. A condenser microphone was placed at the top of the air exhaust on a PMA-10 high-shear granulator to collect AAEs for a design of experiment (DOE) varying impeller speed, total binder volume and spray rate. The results showed the 10 Hz total power spectral densities (TPSDs) between 20 and 250 Hz were significantly affected by the changes in process conditions. Impeller speed and spray rate were shown to have statistically significant effects on granulation wetting, and impeller speed and total binder volume were significant in terms of process end-point. The DOE results were confirmed by a multivariate PLS model of the TPSDs. The scores plot showed separation based on impeller speed in the first component and spray rate in the second component. The findings support the use of AAEs to monitor changes in process conditions in real-time and achieve consistent p...Continue Reading

References

May 30, 2009·International Journal of Pharmaceutics·Erin M HansuldAmyn Sayani
Jun 13, 2009·Pharmaceutical Development and Technology·John F GambleMike Tobyn
Aug 12, 2009·International Journal of Pharmaceutics·Jun HuangArwinder Nagi

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Citations

May 23, 2015·Drug Development and Industrial Pharmacy·Naoto UeharaKozo Takayama
Feb 14, 2015·Drug Development and Industrial Pharmacy·Allison Crouter, Lauren Briens
Oct 10, 2013·Drug Development and Industrial Pharmacy·Ayeshah Fateemah Beebee FauzeeRoderick Bryan Walker
Jun 21, 2014·International Journal of Pharmaceutics·E M Hansuld, L Briens

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