A Continuous Fluidized Bed Process under GMP Conditions

Are you a drugmaker searching for a drying method for your slurries, solutions or emulsions? Your aim is a dust-free granule with excellent flow properties, continuously manufactured under GMP conditions? IPC Process-Center – a Glatt group company – can manufacture your products reliably, on-time and in consistent high quality.

For drying liquids, spray drying is the state-of-the-art process. They are sprayed into spray towers and dried to fine powders. By re-circulating dust particles into the atomized spray, porous agglomerates of up to about 200 microns can be produced.
Because the time in the spray dryer is limited by the height of the installation, the granules reach only a limited size.

Spray Granulation = Spray Drying + Agglomeration
The ProCell technology, a continuous fluidized bed process, combines spray drying and agglomeration in a single step. Fine particles produced by spray drying in a fluidized bed are wetted by spray droplets and form an agglomeration seed. With increasing time in the chamber the granules continue to build, become more spherical and grow, layer by layer, to form a dense, free-flowing product. The continuously withdrawn product stream is separated by a sieve into the desired fractions. The siftings are crushed by a mill and brought back into the process, together with the fine fraction. These continuously added seeds affect the bulk density and particle size of the granules. It is possible to achieve granules of low loose weight and porous structure, as well as dense, non-abrasive ones. The particular geometry of the ProCell technique allows it to produce dense, ball-shaped pellets of 100 microns up to a few millimeters in diameter.

The Benefits of a Continuous Process for GMP Products:
Continuous processes for manufacturing pharmaceutical products require a re-assessment of the batch concept and of product release. In a conventional batch process the release analyses are carried out after the process has ended, whereas a continuous process requires product properties and parameters to be recorded in real time. The European Medicines Agency has stipulated in its Guideline on Real Time Release Testing (RTRT) Revision 1 (29 March 2012, EMA/CHMP/QWP/811210/2009-Rev1, Committee for Medicinal Products for Human Use (CHMP)) measures for implementing real-time testing.

What needs to be done: In the development phase the relationship between product quality and the quality determining process parameters must be examined in detail on the basis of the Quality by Design (QbD) approach. After the important influencing factors have been found and evaluated, suitable sensors and analysis instruments are installed to monitor the process. Because the measured parameters and product properties must reproducibly represent the quality of the product, the validation of these measurement methods is of eminent importance within the validation of the entire process. The parameter limits of the process are set in a way that, if or whenever they are exceeded, action can be directly taken to adjust or correct the process. Production safety increases and the effort associated with analyses is reduced when compared with conventional release practices. There are also no storage times for intermediates and the entire process is accelerated.

We can let you take advantage of these benefits to manufacture your products, without investing in complex process engineering. We perform contract manufacturing using continuous agglomeration and spray granulation under GMP conditions for your drying necessities.