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Tablets: SOP for High Shear Granulation Process Optimization – V 2.0

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Tablets: SOP for High Shear Granulation Process Optimization – V 2.0

Standard Operating Procedure for High Shear Granulation Process Optimization

Department Tablet
SOP No. SOP/TAB/051/2025
Supersedes SOP/TAB/051/2022
Page No. Page 1 of 8
Issue Date 26/10/2025
Effective Date 31/10/2025
Review Date 26/10/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the procedure for optimizing the high shear granulation process in tablet manufacturing. The objective is to ensure uniformity in granule size, improve batch-to-batch consistency, and enhance the quality of the final tablets.

2. Scope

This SOP applies to the high shear granulation process used in tablet manufacturing. It covers the optimization of granulation parameters such as binder addition, granule formation, drying conditions, and mixing times to achieve the desired product quality.

3. Responsibilities

4. Accountability

The Production Manager is accountable for ensuring the granulation process is optimized and adheres to this SOP. The QA Manager is responsible for reviewing the optimization process and ensuring that all necessary documentation is complete and compliant with GMP standards.

5. Procedure

5.1 Pre-Granulation Setup

  1. Verify that all necessary raw materials are available and meet the required specifications (e.g., excipient quality, moisture content, particle size).
  2. Ensure that the granulation equipment is clean and properly calibrated before use. Verify that all components such as the granulator, mixing paddles, and sieve are in good condition.
  3. Prepare the binder solution (if required) according to the formulation, ensuring the correct concentration and viscosity for optimal granule formation.
  4. Review the granulation parameters (e.g., mixing speed, binder addition rate, wet massing time) as outlined in the batch record, ensuring that they align with optimized values for the specific formulation.
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5.2 Granulation Process

  1. Load the dry powder mixture into the granulator, ensuring even distribution of ingredients.
  2. Start the granulation process by adding the binder solution at the prescribed rate while continuously mixing the powders to ensure uniform wetting.
  3. Monitor the mixing process to ensure that the granules are forming evenly. If necessary, adjust the mixing speed to ensure that the granules are adequately mixed but not over-processed.
  4. Periodically stop the granulation process to inspect the granules. Assess the granule size, texture, and moisture content to ensure uniformity.
  5. If granules are not forming properly (e.g., too dry or too wet), adjust the binder addition rate or mixer speed. Ensure that granules are neither too dry (which may result in poor compaction) nor too wet (which may lead to clumping).

5.3 Granule Testing and Optimization

  1. Perform a sample test of the granules for the following parameters:
    • Particle size distribution
    • Moisture content
    • Bulk density
    • Flow properties
  2. Ensure that the particle size distribution meets the required specifications for the final tablet formulation. If the distribution is outside of the acceptable range, adjust the granulation parameters (e.g., increase mixing time or reduce binder solution viscosity).
  3. Ensure that the moisture content is within the acceptable range for tablet compression. If the granules are too wet, consider drying them further in a fluidized bed dryer before proceeding to compression.
  4. If the granules fail to meet any of the quality criteria, adjust the granulation process parameters (e.g., binder addition rate, mixing speed) and conduct another test batch until the desired specifications are achieved.
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5.4 Post-Granulation Drying

  1. After granulation, transfer the wet granules to the drying equipment. Ensure that the drying temperature and airflow are set according to the product specifications to prevent over-drying or under-drying.
  2. Monitor the drying process, periodically checking the granules for moisture content. Ensure that the granules are dried uniformly and that the moisture content meets the target for tablet compression.
  3. If the granules are not drying adequately, adjust the temperature or airflow. Avoid excessive drying that could lead to granule degradation or excessive dust formation.

5.5 Granule Screening and Sieving

  1. Once the granules have dried, screen the granules through the appropriate sieve mesh size to ensure uniform particle size and to remove any oversized or undersized particles.
  2. Perform an additional test to assess the flow properties and compressibility of the granules. If the granules have poor flowability, consider adding a flow agent (e.g., magnesium stearate) to improve flow during compression.
  3. Document the test results and any adjustments made to the granulation or drying process in the batch record (Annexure-1).

5.6 Optimization of Binder and Granulation Parameters

  1. If the granulation process does not yield the desired tablet quality or if granule properties are inconsistent, consider optimizing the binder formulation, the binder addition rate, or the mixing time.
  2. Consult with the formulation team to ensure that the binder and excipient ratios are optimized for the specific formulation.
  3. Record any modifications to the granulation parameters in the batch record (Annexure-1) and update the standard operating procedure if necessary for future production runs.

5.7 Documentation and Record-Keeping

  1. Document all granulation parameters, test results, adjustments made, and final product specifications in the batch record (Annexure-1) for traceability and future reference.
  2. Any deviations from the standard procedure must be documented in the deviation report (Annexure-2) along with corrective actions taken to address the issue.
  3. Maintain all records for the required retention period and ensure that they are readily accessible for audits or regulatory inspections.
See also  Tablets: SOP for Achieving Consistent Tablet Thickness in Manufacturing - V 2.0

5.8 Final Approval

  1. Once the granules meet all required specifications, approve the batch for the next production stage (e.g., tablet compression) and notify the relevant departments.
  2. Ensure that all relevant documentation is reviewed and approved by Quality Assurance (QA) before starting the next manufacturing stage.

6. Abbreviations

7. Documents

  1. Batch Record (Annexure-1)
  2. Deviation Report (Annexure-2)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number Granulation Type Binder Type Granule Testing Results Comments
Batch 001 High Shear PVP Pass: Particle size, moisture content No deviations
Batch 002 High Shear PVA Pass: Bulk density, flow properties Minor adjustments made to binder concentration

Annexure-2: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
15/09/2025 Batch 003 Granules too wet Reduced binder solution rate John Doe

Revision History:

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Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated Granulation Parameters Improved Product Consistency QA Head
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