STE Tecpharm is working on the commissioning of a new complete wet granulation line for the largest pharmaceutical production plant in Kazakhstan. This plant produces more than 113 generic drug items available in the form of sterile antibiotic powder capsules, ampoule injection solutions, infusion solutions, tablets, capsules, sachet powders, and syrups.
The granulation line manufactured by STE Tecpharm is the perfect combination for the development of wet granules since it integrates all the production process options in a single frame and in a single control panel:
■ Mixing and Granulation: High Shear Mixer Granulator.
■ Drying and Granulation: Fluidized Bed Granulator Dryer.
■ Calibration: Wet and dry Mill Calibrators.
■ Vacuum system for product loading, transfer, and discharge.
■ WIP cleaning system.
It minimizes the requested space in the cleanroom, reduces the risks of cross-contamination and provides maximum versatility for process development and scalability studies.
The High Shear Mixer Granulator has been designed to optimize the wet granulation process. Used to transform a heterogeneous mixture of fine powder into a uniform granulation, with higher particle size and density, offering an appropriate flow and optimum compaction, within a process of short duration and repetition.
The Fluidized Bed Dryer has been designed for three different applications: Drying of wet granules, Top Drive granulation, and Bottom Spray coating.
WET GRANULATION PROCESS
Granulation refers to the process in which primary dust particles are made to adhere to form larger entities of multiple particles called granules. In this process of wet granulation, the granules are formed by adding an agglutinative solution. The granulation solution contains a solvent or carrier material that must be volatile so that it can be removed by drying and not being toxic. Typical fluids include water, ethanol, and isopropanol alone or in combination. The liquid solution can be aqueous or solvent-based. Aqueous solutions have the advantage of being safer to treat than other solvents. The granulation process combines one or more dust particles and forms a granule that will allow the formation of tablets within the required limits.
FLUIDIZATION DRYING PROCESS
The fluidization process is widely used in the pharmaceutical industry to reduce the moisture content of pharmaceutical powder and granules. In this process, hot air is introduced through a perforated bed of wet solid particles at a defined pressure and flow rate. The wet solids rise from the bottom and are suspended in a stream of air (fluidized state). Heat transfer is done by direct contact between the wet solid and the hot gases. The vaporized liquid is carried by the drying gases.
In this way a predictable and repeatable process is possible and quality granules can be produced using the STE TECPHARM technology.