Granulation is the process of enlarging the particle size of powder by various techniques in pharmaceutical industry. It transforms the powder into a form that can be easily used for further processes, and the equipment used to form this process is called Granulation Suite.
Granulation Suite is one of critical and important line of equipment in pharmaceutical industry. They are mainly used in the manufacturing of Oral Solid Dosage forms, and plays an important role in the quality, efficacy and safety of these products.
What is a Granulation Suite?
Granulation suite is a combination of different machines that are connected with each other in a serial manner. It means the output of one stage becomes the input of next level machine. Each machine is designed to perform a specific function according to the process and product requirement, and combines various components of formulation in a single product.
Like other equipment and process, the quality of product is required to be measured at machine level. Otherwise, it will affect the quality and product characteristics of the final finished form. For this purpose, the quality department keeps a check on the production at each machine level. The output is not allowed to advance to its next stage until checked and verified by the Quality department.
Like other pharmaceutical equipment, its product contact parts are made up of Stainless Steel 316L. Because, it resists corrosion, rusts and reaction with the product. If SS316L is not used, it will damage the product and product cannot be used for human consumption.
Components of a Granulation Suite?
As discussed above a granulation suite consist of series of machines that works serially with respect to each other and commonly consists of the following
High Shear Mixer granulator - HSMG
High Shear Mixer Granulator - HSMG is a machine, where powder is mixed with each other, or with different chemical powders. In this machine, liquid is also added during the process which acts as a binder. The purpose of binder is to make bond between different chemicals and is applied with a dedicated nozzle.
HSMG consists of different parts that aids in a successful operation and consist of the following
Bowl: it is a large metallic container that contains material, and mixing take place in this bowl.
Impeller: it is a rotating part inside the bowl which is equipped with blades. It can rotate at varying speeds, depending up on the process requirement
Chopper: It is a small rotating part, usually installed at one side of bowl, or near the impeller. Its main purpose is to cut lumps into smaller granules. Usually chopper rotates at fixed speed, or at two speed level - one is called high another is called low
Nozzle: It is used to add liquid in granules during the mixing process which is added as per the process requirement
The powder is added to the bowl and impeller is started. The mixing occurs due to the affect of rotating impeller, which rotates at variable speed. Chopper is also started and facilitates uniform granules by cutting large lumps into smaller. Liquid is also a added during the process, at varying speed that depends on the process requirement.
Fluid Bed Dryer
Fluid Bed Dryer is used to reduce the moisture content in the mixture of the powder, by the effect of hot air, that passes through the powder mixture. The moisture escapes the container through the exhaust
When hot air passes through the powder material, it starts to float in the product container and takes the form of fluid, which is why the machine is called Fluid Bed Dryer. The fluid shape facilitates the drying process, because every particle, from every dimension is exposed individually to heat and increases the heating efficiency, takes less time to complete the process.
During the process moisture content is continuousl...
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