COMPLETE WET GRANULATION PROCESS
COMPLETE WET GRANULATION PROCESS
The Granulation Line integrates into a single frame and control panel all options for pharmaceutical wet granulation process:
■ Mixing and Granulation: High Shear Granulator.
■ Drying, Granulatin, Coating: Fluidized Bed Dryer.
■ Calibration: Conical and Cylindrical Calibrators.
It minimizes the space requested in clean-room, reduces the risks of cross-contamination, and gives maximum versatility to process development and scalability studies.
HIGH SHEAR MIXER GRANULATOR
The High Shear Mixer Granulator is designed to optimize the wet granulation process. Used to turn a fine-powder heterogeneous mixture into a uniform granulation, with increased particle size and higher density, offering proper flow and compactness properties, in a short time process and with repeatability.
■ Standard equipment with capacities ranging from 25 L to 1.400 L. [Other dimensions on request].
■ In-wall design to be integrated in the clean room.
■ Manufactured in AISI 316L.
■ Mirror polished Ra < 0,5. ■ No contact top cover without supports in the container.
■ Bottom impeller and side chopper to guarantee the intensive mixing in a very short time period.
■ Control of endpoint by time or by Torque.
■ PLC + HMI for the controlin manual and automatic mode, with recipe editing.
■ Automatic impeller lift during cleaning phase.
■ Working platform adapted to the client room.
FLUIDIZED BED DRYER
Designed for 3 different processes: Drying of wet granulate (dryer), Top drive granulation (granulator), and Bottom spray coating (coater).
■ From 30 L to 1.540 L. [Other dimensions on request].
■ In-wall design concept.
■ Built-in AISI 316L, mirror polished Ra < 0,5. ■ PCL + HMI in manual and automatic mode, with recipe editing.
■ 12 bar pressure-shock resistance.
STE TECPHARM offers all range of services: installation “turnkey concept” in the client facilities, start-up, qualification, training and production support.
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 fluidization process is used extensively in the pharmaceutical industry to reduce the moisture content of powder and granules in a drying process.
In this process, hot air is introduced at defined pressure and flow rate through a perforated bed of moist solid particles.
The wet solids are lifted from the bottom and suspended in a stream of air (fluidized state).
Heat transfer is accomplished by direct contact between the wetted solid and hot gases.
The vaporized liquid is carried away by the drying gasses.
STE Tecpharm delivers a new 50L granulation line for pharmaceutical products in Algeria. This installation, designed for small productions, is composed of different integrated pieces of equipment with an in-wall design and managed from the same Siemens PC control panel.
STE Tecpharm is working on the commissioning of a new complete wet granulation line for the largest pharmaceutical production plant in Kazakhstan.
Commissioning of a new 1,100L fluidized bed dryer for a major Italian pharmaceutical company. This company has 16 production plants worldwide and is present in more than 130 countries.