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.
High Shear Mixer Granulator. It has automatic lifting of the central agitator, peristaltic dosing pump and integrated conical calibrator. Fluidized Bed Dryer Granulator. With inlet and outlet air treatment systems, vacuum loading system from the in-line granulator, sampling valve, top spray granulation system and vacuum discharge system with integrated calibrator.
The entire installation has been validated with the ATEX II 3GD certificate.
The end result is complete granulation and drying equipment, fully automated to minimize production times, product loss and the risk of cross-contamination.
Now we begin the installation works at the customer’s manufacturing plant and the subsequent technical training.
The confidence in STE Tecpharm is renewed with this new project since, in 2017, this client already acquired an 880L Fluidized Bed Dryer-Granulator, large equipment of optimum performance.
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.
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. The equipment has been successfully installed and commissioned in the Spanish production plant.
The customer already had a high shear mixer granulator, to which has been added a wet conical mill calibrator, the 1,100L fluidized bed dryer with its inlet and outlet air treatment units, and a dry mill calibrator.
The loading and unloading of the product are carried out by means of a vacuum system, avoiding the loss of the product and reducing the risks of cross-contamination.
It incorporates a WIP cleaning system.
The entire installation has been adapted to ATEX II 2G / D regulations.
Before contracting the equipment, the client was able to carry out product tests in the STE Tecpharm pilot plant, being able to previously check the performance and obtain scalable results.
FLUID BED DRYING PROCESS
In the Fluidized Bed Dryer, the drying process is carried out to reduce the humidity in the granule. Hot air is introduced through a vacuum generated inside the equipment. The wet solids rise from the bottom and are suspended in a current of air, remaining in a fluidized state. The heat transfer and the low humidity of the air in direct contact with the wet granule allow the evaporation of the water or solvents, reducing their humidity.
STE Tecpharm completes the delivery of a complete wet granulation line for a pilot plant for the production of solid pharmaceutical forms, located in Spain.
The granulation line consists of different equipment, integrated into a single frame and managed from within the same control panel.
– 50L High-Shear Granulator.
– Calibrator mill for sieving the wet granule.
– Fluidized Bed Dryer 60L.
– Calibrator mill for sieving the dry granule.
– Fully automated loading, transport and unloading systems to avoid cross-contamination and ensuring optimal product transfer.
The entire installation has been validated with the ATEX II certificate.
Once installed in the cleanroom, this set minimizes the space required and provides maximum versatility for development studies and process scalability.
STE Tecpharm delivers wet granulation equipment to a well-known Spanish laboratory specializing in the manufacture of pharmaceutical and nutraceutical solid forms.
This set consists of a High Shear Granulator with a capacity of 200L and a mill calibrator installed at the product outlet of the granulator. The installation was carried out with the ATEX II certificate.
The high shear mixer granulator has been designed to optimize the wet granulation process, transforming a heterogeneous mixture of fine powder into a uniform granulation, with particle size and a higher density, offering an appropriate flow and optimum compatibility, within of a process of short duration and repetition.
It has been fully designed and built by STE in Europe according to the legal requirements and pharmaceutical standards of good manufacturing practices (GMP), with integrated design inside the cleanroom.
Granulation refers to the process in which the primary dust particles are adhered to form larger entities of multiple particles called granules. In this wet granulation process, the granules are formed by the addition of a binder 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 liquids include water, ethanol, and isopropanol alone or in combination. The liquid solution may 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 STE TECPHARM technology.
STE TECPHARM closes the contract for the manufacture of an OPTIMA tablet coater with a major German pharmaceutical company. The machine will be located in a subsidiary factory in Chile.
The requested equipment is a tablet coating machine with our patented OPTIMA technology. It is based on the perforated pan system, with a variable capacity of between 30Kg and 300Kg. Our patented system detects the volume of product introduced into the drum and automatically adjusts all process parameters for optimal coating:
– Position of spray nozzles.
– The applied liquid flow
– The inlet and exhaust air flow and temperature.
The equipment meets all the requirements of GMP regulations and the high quality standards of our customers and is adapted to comply with the ATEX zone 2/22 regulations.