Closed loop granulation lines consist of a series of equipment connected with each other through flexible transfer pipes and there are no chances of product exposure with the environment during processing.The closed loop granulation line concept is increasing day by day in pharmaceutical industries and now it is one of the most important equipment used in pharmaceutical industries for wet granulation process.
Components of closed loop granulation line
Following are most important components of the closed loop granulation line
- Sifter
- RMG
- FBD
- Co Mill
- Blender
- Transfer pipes
- Pneumatic system
Working Principle
Closed loop granulation lines work on the principle of pneumatic transfering where all the materials are transferred from one equipment to other by using pneumatic pressure through closed flexible transfer pipes.
Working Layout
The materials are first of transferred to the sifter by using flexible transfer pipes with the help of pneumatic pressure.After sifting, the materials are collected in a sealed container and from this sealed container the sieved materials are transferred to the rapid mixing granulator.The transferring of sieved materials is also done by the pneumatic conveying.
The pre-mixing is performed in a rapid mixing granulator (RMG) and binder solution is transferred through pipes to sprinkle over the powders to start the kneading process.
After kneading, the wet granulated mass is passed through an inline wet mill and is delivered to the fluid bed dryer using flexible transfer pipes.
After drying the granules are transferred to the co mill through pneumatic transferring without opening the FBD product trolley.
The sieved materials are directly transferred to the blender through flexible silicone covering.
So all the steps starting from sifter to the bin blender are performed in a closed loop with minimum human interaction.
Benefits
Following are the benefits of closed loop granulation line
- Dust free
- Operator and product safety
- Reduction in line loss
- Reduced process time
- Cost saving
- Regulatory compliance
Dust free
As the transfer from one equipment to other is done through closed transfer pipes so there are no chances of dust generation in the cleanrooms.
Due to a dust free environment the chances of cross contamination are also reduced.
Product safety
Due to processing in a closed loop system there is no exposure of the product with the environment so it ensures enhanced products safety.
Operator safety
Due to closed transfering there is no contact between the product and operator so there are no harmful effects of potent products over operator.
Reduction in line loss
Continuous transfer of materials from equipment to other by pneumatic system results in reduction of product line loss.
Reduced process time
Auto shifting or transferring of materials without human involvement results in fast processing.The delays which are observed during manual transfering are overcomed in closed loop granulation line so processing time is short.
Cost Saving
Due to reduced line loss and less processing time the overall cost of the process is low as compared to the conventional granulation process.
Regulatory compliance
The closed loop granulation line complies with the regulatory guidelines like FDA, 21 CFR and CGMP.
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