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.
High Shear Mixer Granulator for wet granulation
Fluidized Bed Dryer for wet granulate drying
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.
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 has designed and manufactured a new complete 600L wet granulation line for the production of microencapsulated food, for an important Spanish food group.
Microencapsulation is a process by which bioactive substances from food are introduced into a matrix to prevent them from being lost, to protect them from reaction with other compounds or to stop oxidation reactions. It is also used for the controlled release of nutrients and to transform flavors.
It is one of the most demanded techniques in the food industry.
The installation designed by STE Tecpharm is composed of a set of:
– High Shear Mixer Granulator.
– Fluidized Bed Dryer.
– Mill Calibrators and Automatic Handling System.
– WIP cleaning.
Some utilities and applications of microencapsulation in food:
– Vitamin C: Ascorbic acid has been used because it is an antioxidant and as a vitamin supplement. The problem is that it oxidizes easily so it is convenient microencapsulation.
– Vitamin A: it is a fat-soluble vitamin, or encapsulation increases its stability, for example, in the storage of skimmed milk powder.
– Omega 3: it is a very beneficial product for our health but of short duration, microencapsulation would allow us to increase the duration and its use in baby food or in bakery products.
– Calcium: Soy milk contains little calcium but the calcium enrichment of soy milk presents a problem, it causes milk proteins to clot. This can be avoided by microencapsulation by keeping it stable for longer.
For all these reasons, this technique represents a great advance for the improvement of our diet and our goal is to improve it even more.
STE TECPHARM closes a new contract for the manufacture of a complete wet granulation line and a tablet coater with an Italian leading manufacturer of pharmaceutical, nutraceutical, cosmetic and food ingredients.
The turnkey project consists of:
600L High Shear Granulator with integrated wet granule calibrator.
660L Fluidized Bed Dryer Granulator with integrated dry granule calibrator.
Automatic vacuum loading and unloading systems.
200Kg Perforated Tablet Coater
WIP cleaning system
Installation and engineering services
The contract also includes the rental of a Laboratory Tablet Coater for testing and new developments.
All equipment supplied will be equipped with the SRS Remote Service, remote assistance system for technical support and assistance.
STE Tecpharm delivers a full range of laboratory process equipment for the production of solid dosage forms to a Mexican engineering company specialized in the design and management of pharmaceutical projects. The set consists of various pieces of equipment in its laboratory version used for the development and research of new products.
– Laboratory High Shear Granulator.
– Laboratory Fluidized Bed Dryer.
– Laboratory Mill Calibrator.
– Laboratory Solid Mixer.
– Laboratory Tablet Coater.
They are equipped with a technology that easily allows changing to pilot scale. And also provides useful information for industrial batches.
LAB HIGH SHEAR MIXER GRANULATOR
The Lab Scale High Shear Mixer Granulator has been designed to turn a fine-powder heterogeneous mixture into a uniform granulation, with increased particle size and higher density.
It has 3 interchangeable bowls of 2, 5 and 10 liters.
Equipped with Siemens PLC and touch panel, It allows us to optimize the process and take relevant parameters: Mixing speed, Binding liquid flow, Dispersion of droplets size, and Granulation endpoint by Time or by Torque.
LABORATORY FLUIDIZED BED DRYER
Lab Scale Fluidized Bed Dryer designed for 3 different laboratory processes: Drying of wet granulate, Top drive granulation, Bottom spray coating for micro granules.
It disposes of 2 interchangeable recipients: 4,5 L and 9 L capacity.
Allows setting up specific drying programs for each product, which are executed from the operator touch panel, through necessary commands and controllers, achieving that in the process development and program set-up we can eliminate characteristic problems, such as Formation of air channels, Lack of uniformity in the drying process, Localized overheating of the granulation, and Attrition of the granulation as it dries.
LABORATORY MILL CALIBRATOR
Equipped with an electronic speed variator, this equipment is intended to reduce the size of dry and wet granules and to prepare raw materials of actives and excipients.
LABORATORY SOLID MIXER
The Laboratory Mixer has been designed to perform a mixing process for solids and powders with different types of containers.
This model has been designed considering the three main mixing variables determining a mixture: equipment geometry (container), loading level of the equipment, and mixing speed.
It allows the exchange of recipients of different geometries, such as Double cone, Bin, “V” Shape, and Drum.
LABORATORY TABLET COATER
Laboratory Tablet Coater with perforated coating pan designed to produce the film coating of tablets or pellets, suitable in aqueous and organic coatings.
The standard equipment is suitable to work with interchangeable drums from 0,5 to 2 Kg.
The Laboratory Tablet Coater controls each critical variable which is decisive for the dynamic equilibrium, such as Applied liquid flow, Inlet airflow, Exhaust airflow, Inlet and exit air temperature, Tablet temperature during the process, and Turning the speed of the pan drum.
Laboratory High Shear Granulator
Laboratory Fluidized Bed Dryer
Laboratory Mill Calibrator
Laboratory Solid Mixer
Laboratory Tablet Coater