There are two types of Granulation Lines employed in the production of solid dosage forms in the Pharmaceutical Industry;
- Wet Granulation
- Dry Granulation
In essence, a granulator is a multipurpose processor that is suitable for the high-speed dispersion of dry powders, aqueous or solvent granulations and effervescent products as well as wet and melt pelletisation.
The Standard Group of Companies has developed and supplied Barrier Isolator equipment solutions for both Dry Granulation and Wet Granulation and has a vast amount of experience servicing both types of Granulation production Lines.
Wet Granulation Line
Standard group provides machines, equipment and barrier isolators for the wet granulation line including the Feed Station, Milling, Sieving, High Shear Mixing, Fluid Bed Processing and Blending. The Standard Group has also fully integrated barrier isolator solutions for the Tablet Press Machine and Coating Machine and can supply turnkey solutions for Vacuum powder transfer systems powder and CIP / WIP systems.
The process of wet granulation involves the addition of a liquid solution to a powder mixture and the massing of the mix to produce granules. Typical liquids include water, ethanol and isopropanol and once the powders have formed into a dense mass and the granulation fluid has been evaporated then the granules are milled to an appropriate size for compression.
The extact process depends on the characteristics of the powders and the final dosage form. Organic solvents are used when water sensitive drugs are processed, as an alternative to dry granulation, or when a rapid drying time is required.
As direct compression is not the best technology for many active substances, wet granulation is still a preferred method. Even if the active substance is sensitive to hydrolysis, modern equipment such as a fluidized bed eliminates the problems associated with wet granulation. Products including anti-neoplastic agents/Hormones(OEB3) may be produced using wet granulation. Below shows an example of a 2kg Granulation Line Barrier Isolator including Rapid Mix Granulator (RMG), a Fluid Bed Dryer (FBD) and Multi-mill blender workstations, designed and manufactured by the Standard Group of Companies.
Dry Granulation Line
The Dry Granulation process is used to form granules without using a liquid solution. This process is typically employed if the mixture to be granulated is sensitive to moisture, physically or chemically unstable when exposed to moisture and heat. Forming granules without moisture involves compacting and size reduction of the mix to produce a granular, free flowing blend of uniform size.
Dry granulation can be done in two ways, either;
- a large tablet (slug) is produced in a heavy duty tableting press or
- the powder is squeezed between two rollers to produce a sheet of materials (roller compactor/chilsonator).
When a tablet press is used for dry granulation, the powders may not possess enough natural flow to feed the product uniformly into the die cavity, resulting in varying degrees of densification.
The roller compactor (granulator-compactor) uses an auger-feed system that will consistently deliver powder uniformly between two pressure rollers. When the product is compacted properly, it can then be passed through a mill and final blend before tablet compression.
By way of example, for such Dry Granulation applications the Standard Group has supplied Barrier Isolators with Dry milling, weighing and dispensing, Hoister, Hammer Mill and Sieving workstations.