A Quasi-Continuous Granulation and Drying Process QCGDP to Avoid Scale-Up Problems

A QUASI-CONTINUOUS GRANULATION AND DRYING PROCESS (QCGDP) TO AVOID SCALE-UP PROBLEMS 

In the food and chemical industry, continuous production lines play an important role, whereas the pharmaceutical industry production is mainly based on a batch type procedure. Concerning the safety of a dosage form 

In the case of a continuous process, a batch has to be defined somehow artificially, i.e., the amount of product—the amount of granules produced within six to eight hours. On the other hand, continuous processes offer two important advantages (1) there is no difficult scale-up exercise necessary for larger batches, and (2) a 24-hour automatic production line should be possible. 

Development of the Quasi-Continuous Production Line for Granules 

In order to combine the advantages of a batch type and continuous production, a prototype for a quasi-continuous production line was developed (15-18,33-35). The principle of this quasi-continuous production line is based on a semi-continuous production of mini-batches in a specially designed high-shear mixer/granulator which is connected to a continuous multicell-fiuidized (Glatt Multicell ) bed dryer (Fig. 10). 

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