HIGH SHEAR MIXER GRANULATOR

PHARMACEUTICAL WET GRANULATION PROCESS

HIGH SHEAR MIXER GRANULATOR

PHARMACEUTICAL ​WET GRANULATION PROCESS

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.

Innovative high-quality equipment certified by accredited entities.
Fully designed and built in Europe following regulatory requirements and the GMP´s normative.

MAIN FEATURES

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.

OPTIONALS

Binder reactor with peristaltic pump.
Heating/cooling jacket.
ATEX version.
Product automatic charge and discharge by vacuum.
Integrated wet conic mill calibrator.
Automatic cleaning system (WIP).
21CFR part 11 compliance module: Batch report & Audit Trail.
Explosion proof 12 bar.
Containment execution (until OEB 5).
Dust free loading system.

STE TECPHARM offers all range of services from installation “turnkey concept” in the client facilities, start-up, qualification, training, and production support.

WET GRANULATION
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. In this way a predictable and repeatable process is possible and quality tablets can be produced using the STE TECPHARM technology.

High Shear Mixer Granulator for wet granulation process | STE Tecpharm

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