STE PROCESS TECHNOLOGY – OUR PROCESSES
1. DEVELOPMENT EQUIPMENT
STE TECPHARM offers to their client a complete range of technologies for R&D and laboratory purposes.
- Fluid Bed drier
Designed to assist on the scalability and industrialization of different products, minimizing time and cost.
STE Pilot Plant:
- 250 sqm. to make all type of tests
- Wet granulation (from 20 to 50 L)
- Fluid bed dryer (from 5 to 10 L)/(with bottom spray for microgranules and top spray granulation).
- Blending system in different containers shape: Bi-cone/Bin/V/drum (from 5 to 75 L).
- Calibrator for wet and dry granules (conic and cylindrical).
- Perforated pan coating (from 2 to 5 kg).
Our in house Laboratory and our pharmacists, can assist to confirm the suitability of STE TECPHARM technologies to client and product requirements.
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 a 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.
The drying process is carried out in fluid-bed Dryers , is an equipment used extensively in the pharmaceutical industry to reduce moisture content of powder and granules.
The equipment works on a principle of fluidization of the feed materials.
In fluidization 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 offers a wide range from R&D to industrial sizes of Fluid Bed Dryers STE TPS with also the possibility of Granulation with Top Spray and Coating by means of Bottom Spray.
Calibration is the action of homogenizing particle size on wet or dry granulated products in order to improve efficiency on different process steps on Pharmaceutical applications.
The main application of in-line or standalone calibrators during wet and/or dry powder granulation is to obtain a homogeneously sized granules or powder to optimize performance in Vacuum transportation, drying process, tableting, etc…
In Pharmaceutical Industry the main use of calibrators is to disaggregate raw materials to improve and simplify the mixing and granulation process.
At STE TECPHARM we also install our calibrators in-line on the discharging point of our HIGH SHEAR MIXERS GRANULATORS (STE TP-G) to homogenize the wet granules size to avoid the transfer of large particles and lumps in to fluid bed Dryer (transfer carried out by vacuum) or tray dryers to obtain homogeneous drying processes.
Once the product is dry STE TECPHARM offers the possibility to install a Dry product Calibrator in-line on the discharging of our Fluid Bed Dryers (STE TP-S) to homogenize particle size, to ensure performance of the granulated product for Compression on tableting, or capsule filling.
5 . MIXING
Blending powders is one of the oldest unit-operations in the solids handling industries. For many decades powder blending has been used just to homogenize bulk materials.
Many different machines have been designed to handle materials with various bulk solids properties. On the basis of the practical experience gained with these different machines, engineering knowledge has been developed to construct reliable equipment and to predict scale-up and mixing behaviour.
Nowadays the same mixing technologies are used for many more applications: to improve product quality, to coat particles, to fuse materials, to wet, to disperse in liquid, to agglomerate, to alter functional material properties, etc.
This wide range of applications of mixing equipment requires a high level of knowledge, long time experience and extended test facilities to come to the optimal selection of equipment and processes.
Coating is a covering (film coating) that is applied to the surface of a particle or a tablet for different purposes.
The motivation for coating dosage forms range goes from:
- Colour and gloss)
- Improving the stability (light protection, moisture and gas barrier)
- Making it easier to swallow the tablet.
In addition, functional coatings can be used to modify the drug release behaviour from the dosage form. Depending on the polymers used it is possible either delay the release of the drug or use the coating to sustain the release of the drug from the dosage form over extended periods of time.
STE TECPHARM offers a wide range of systems for tablet or particle coating depending on it application
- STE TPR (Perforated Pan Coaters)
- STE TPS Fluid Bed Dryers with Bottom Spray System for coating pellets.
7. HANDLING SYSTEMS
Within the range of equipment and process used in Pharmaceutical Industry it is extremely important to minimize operator exposure to the products and the risks related to the process operations and handlings carried out in pharmaceutical plants. Within the range of equipment and process used in Pharmaceutical Industry it is extremely important to minimize operator exposure to the products and the risks related to the process operations and handlings carried out in pharmaceutical plants. STE TECPHARM is focussed in this matter and within the range of equipment supplied offers the supply of Handling solutions, from lifting columns to lift Bins, Drums, Big Bags to feed Capsule fillers, tablet presses, Mixers, etc… eliminating the risks of injuries related to repetitive movements and lifting of heavy weights. Also containment is priority that is why STE TECPHARM includes as option in most of its systems vacuum transferring:
- Bin/hopper/Drum to Machine
- Machine to Machine
- Machine to Bin / Hopper / Drum
These systems ensure the minimum exposure of the operator to the product and also minimizes the risk of contamination of the product due to open transferring systems.