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A Solid Dose Granulation Line is a comprehensive manufacturing process used in the pharmaceutical industry to produce solid dosage forms such as tablets and capsules. The granulation line involves several key steps to transform raw powders into a final product that is uniform, stable, and easy to compress or fill into capsules. Below is an overview of the typical steps and equipment used in a solid dose granulation line.
1. Weighing and Dispensing:
- Equipment: Weighing scales, dispensing stations
- Process: The active pharmaceutical ingredients (APIs) and excipients (inactive ingredients) are carefully weighed and dispensed according to the formulation.
2. Dry Mixing:
- Equipment: Blender (e.g., V-blender, Double Cone Blender, or Octagonal Blender)
- Process: The weighed powders are blended to achieve a homogenous mixture. This ensures that the API is evenly distributed throughout the mixture.
3. Granulation:
- Wet Granulation:
- Equipment: Rapid Mixer Granulator (RMG) or High-Shear Mixer
- Process: A granulating liquid (e.g., water, binder solution) is added to the powder mixture. The high-shear action of the RMG forms wet granules.
- Dry Granulation:
- Equipment: Roller Compactor
- Process: Powders are compacted into ribbons or flakes, which are then milled to form granules. This process is used when the API is sensitive to moisture or heat.
4. Wet Milling :
- Equipment: Multi Mill or Comminuting Mill
- Process: Wet granules may be milled to achieve a uniform size before drying, ensuring that the granules are of a consistent size.
5. Drying:
- Equipment: Fluid Bed Dryer (FBD) or Tray Dryer
- Process: The wet granules are dried to remove moisture, ensuring stability and preventing degradation. The drying parameters are carefully controlled to avoid overheating.
7. Blending:
- Equipment: Octagonal Blender, V-Blender, or Double Cone Blender
- Process: The dried and milled granules are blended with additional excipients like lubricants (e.g., magnesium stearate) to ensure smooth compression or encapsulation.
Overview of Equipment in a Solid Dose Granulation Line:
1. Weighing and Dispensing Systems: Ensure accurate measurement of APIs and excipients.
2. Blenders (e.g., Octagonal Blender): For uniform mixing of powders and granules.
3. Rapid Mixer Granulator (RMG): For wet granulation, producing wet granules.
4. Fluid Bed Dryer (FBD): For drying wet granules.
5. Multi Mill: For size reduction and milling of wet or dry granules.
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