Standard Operating Procedure for Granulation Techniques

1) Purpose

The purpose of this SOP is to provide a standardized procedure for the different granulation techniques used in pharmaceutical manufacturing to ensure consistency, quality, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the granulation process within the pharmaceutical manufacturing facility, including operators, supervisors, and quality control personnel.

3) Responsibilities

Operators: Responsible for following the SOP and ensuring all steps are accurately performed.
Supervisors: Responsible for overseeing the process and ensuring compliance with the SOP.
Quality Control: Responsible for verifying that the granules meet the required specifications.

4) Procedure

1. Preparation of Equipment:
   1. Ensure all granulation equipment is clean, calibrated, and ready for use.
   2. Verify the availability and quality of raw materials to be granulated.
2. Weighing of Raw Materials:
   1. Weigh the required quantities of each raw material using a calibrated balance.
   2. Record the weights in the batch manufacturing record (BMR).
3. Wet Granulation:
   1. Add the weighed powders into the granulator.
   2. Gradually add the granulating liquid while mixing until the desired consistency is achieved.
   3. Continue mixing until uniform granules are formed.
   4. Transfer the wet granules to the drying equipment.
   5. Dry the granules to the specified moisture content.
   6. Pass the dried granules through the appropriate sieve to achieve the desired particle size distribution.
   7. Collect and label the sieved granules.
4. Dry Granulation:
   1. Add the weighed powders into the roller compactor or tablet press.
   2. Compact the powders to form sheets or slugs.
   3. Mill the sheets or slugs to form granules of the desired size.
   4. Pass the milled granules through the appropriate sieve to achieve the desired particle size distribution.
   5. Collect and label the sieved granules.
5. Fluid Bed Granulation:
   1. Add the weighed powders into the fluid bed granulator.
   2. Spray the granulating liquid onto the powders while fluidizing them with hot air.
   3. Continue the process until uniform granules are formed and dried.
   4. Collect and label the dried granules.
6. High-Shear Granulation:
   1. Add the weighed powders into the high-shear granulator.
   2. Mix the powders at high speed while adding the granulating liquid.
   3. Continue mixing until uniform granules are formed.
   4. Transfer the wet granules to the drying equipment.
   5. Dry the granules to the specified moisture content.
   6. Pass the dried granules through the appropriate sieve to achieve the desired particle size distribution.
   7. Collect and label the sieved granules.

5) Abbreviations, if any

BMR: Batch Manufacturing Record

6) Documents, if any

Batch Manufacturing Record (BMR)

7) Reference, if any

Regulatory guidelines as per FDA, EMA, and other relevant authorities.

8) SOP Version

Version 1.0