Process Scale-Up

Current interest in the industry toward continuous processing with the smaller footprint withstanding, commercial products being developed and scaled up represent major processing challenges for processing professionals. Scale-up in the pharmaceutical industry is unique in that experiments at laboratory and pilot scale are also required to produce products of desired specifications for different stages of clinical trials. The appropriate quality management principles can be helpful in prioritizing pharmaceutical development studies to collect knowledge of process performance. The fluid bed agglomeration process is a combination of three steps, namely, dry mixing, spray agglomeration, and drying to a desired moisture level. Granule size is directly proportional to the bed humidity during granulation; hence, control of this humidity during scale-up is essential.

[1]  Koen Dewettinck,et al.  Modeling the steady-state thermodynamic operation point of top-spray fluidized bed processing , 1999 .

[2]  K. Dewettinck,et al.  Combined population balance and thermodynamic modelling of the batch top-spray fluidised bed coating process. Part I—Model development and validation , 2007 .

[3]  K. Dewettinck,et al.  Modelling side-effect spray drying in top-spray fluidised bed coating processes , 2008 .

[4]  Stefan Heinrich,et al.  Fluidized bed spray granulation: analysis of heat and mass transfers and dynamic particle populations , 2005 .

[5]  L. R. Glicksman,et al.  Dynamic similarity in fluidization , 1994 .

[6]  D L Massart,et al.  Scaling up of the fluidized bed granulation process. , 2003, International journal of pharmaceutics.

[7]  Anker Degn Jensen,et al.  Batch top-spray fluid bed coating: Scale-up insight using dynamic heat- and mass-transfer modelling , 2009 .

[8]  Piotr Wnukowski,et al.  Modelling of the three-domain fluidized-bed particulate coating process , 1997 .

[9]  Anker Degn Jensen,et al.  Top-spray fluid bed coating: Scale-up in terms of relative droplet size and drying force , 2008 .

[10]  Akira Nonaka,et al.  A new similarity rule for fluidized bed scale‐up , 1986 .

[11]  Poul Bertelsen,et al.  A new process control strategy for aqueous film coating of pellets in fluidised bed. , 2003, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[12]  J. Baeyens,et al.  Spray-agglomeration of NPK-fertilizer in a rotating drum granulator , 2006 .

[13]  John F. Davidson,et al.  Slug flow in fluidised beds , 1967 .

[14]  Lian X. Liu,et al.  Scale-Up Considerations in Granulation , 2005, Handbook of Pharmaceutical Granulation Technology.

[15]  A. Nienow,et al.  STUDIES OF SEGREGATION/MIXING IN FLUIDISED BEDS OF DIFFERENT SIZE PARTICLES , 1987 .

[16]  Mehrdji Hemati,et al.  Experimental study and modeling of fluidized bed coating and agglomeration , 2003 .

[17]  K. Dewettinck,et al.  Combined population balance and thermodynamic modelling of the batch top-spray fluidised bed coating process. Part II—Model and process analysis , 2007 .