SOP Guide for Pharma

Tablets: SOP for Wet Granulation Equipment Setup and Operation – V 2.0

Auditor

Tablets: SOP for Wet Granulation Equipment Setup and Operation – V 2.0

Standard Operating Procedure for Wet Granulation Equipment Setup and Operation

Department Tablet
SOP No. SOP/TAB/002/2025
Supersedes SOP/TAB/002/2022
Page No. Page 1 of 10
Issue Date 20/02/2025
Effective Date 25/02/2025
Review Date 20/02/2026

1. Purpose

To establish a standardized, GMP-compliant method for setting up and operating the wet granulation equipment, ensuring optimal granule formation and product quality.

2. Scope

This SOP applies to the setup, calibration, and operation of the wet granulation equipment used in the tablet manufacturing process. It covers the preparation and granulation of active pharmaceutical ingredients (APIs) and excipients using wet methods.

3. Responsibilities

4. Accountability

The Production Manager is responsible for ensuring the proper setup and operation of the wet granulation equipment. The QA Manager ensures the equipment meets compliance standards and approves operational procedures.

5. Procedure

5.1 Equipment Inspection and Preparation

  1. Inspect all components of the wet granulation equipment, including the granulator, mixer, spray system, and drying system, to ensure they are clean and functioning correctly.
  2. Verify that the equipment is free of residues from previous batches. Clean and sanitize all parts that will come into contact with the materials to prevent cross-contamination.
  3. Check the calibration status of all instruments, including the spray system, temperature controls, and moisture analyzers, and document the calibration dates.
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5.2 Material Preparation

  1. Ensure that all materials for granulation, including active ingredients, excipients, and binder solution, are available and meet the specifications.
  2. Verify the identity, batch number, and certification of all incoming raw materials (e.g., Certificate of Analysis, Safety Data Sheets).
  3. Weigh and prepare the appropriate quantities of materials according to the batch formulation sheet.
  4. Prepare the binder solution, ensuring it is mixed to the correct concentration and is free from impurities.

5.3 Granulation Setup

  1. Load the dry powder blend (API and excipients) into the granulator, ensuring uniform distribution of all ingredients.
  2. Start the equipment and adjust the mixing parameters, including speed and duration, according to the formulation requirements.
  3. Slowly add the binder solution to the dry mixture while the equipment is running. Ensure the binder is evenly distributed to form a wet mass.
  4. Monitor the granulation process, adjusting the addition of binder and mixing speed as necessary to achieve the desired granule consistency and size.

5.4 In-Process Monitoring

  1. Monitor the temperature, humidity, and moisture content of the granulating mass throughout the process.
  2. Perform regular checks for uniformity of the wet granules, ensuring they meet the size and consistency specifications.
  3. If necessary, adjust the binder flow rate or granulation time to maintain uniform granule size and avoid over-wetting.
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5.5 Granule Drying

  1. Once granulation is complete, transfer the granules to the drying system.
  2. Set the drying parameters (e.g., temperature, airflow) to ensure that the granules dry to the desired moisture content.
  3. Regularly monitor the drying process by checking moisture levels at intervals using a moisture analyzer. Ensure that the moisture content meets the required specification.

5.6 Equipment Shutdown and Cleaning

  1. After the granulation and drying process is complete, turn off the equipment and document the completion of the batch in the equipment log.
  2. Clean and sanitize all parts of the wet granulation equipment that came into contact with the raw materials, following the approved cleaning procedure.
  3. Inspect the equipment again after cleaning to ensure no residues remain and that all parts are in good working condition for the next batch.

5.7 Documentation and Record-Keeping

  1. Document all setup, operational, and cleaning activities in the batch record, including material lot numbers, equipment settings, and any deviations.
  2. Record all in-process quality checks, including moisture content, granule size, and equipment calibration results in the QC log (Annexure-1).
  3. Ensure that all records are signed by the responsible personnel and stored as per regulatory requirements for future audits and reference.

6. Abbreviations

See also  Tablets: SOP for Optimizing Surface Coating Uniformity - V 2.0

7. Documents

  1. Wet Granulation Equipment Setup Log (Annexure-1)
  2. Granulation Batch Record (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: Wet Granulation Equipment Setup Log

Date Equipment ID Calibration Status Operator Comments
20/02/2025 Granulator 001 Calibrated John Doe No issues
21/02/2025 Granulator 002 Not Calibrated Jane Smith Calibration due next month

Annexure-2: Granulation Batch Record

Batch Number Material Name Binder Solution Granulation Parameters Test Results Remarks
Batch 001 Material A Starch Solution Mixing Time: 30 mins, Speed: 250 rpm Moisture: 4.5%, Size Distribution: 80% < 500 µm Within Specifications
Batch 002 Material B PVP Solution Mixing Time: 40 mins, Speed: 300 rpm Moisture: 5.2%, Size Distribution: 75% < 500 µm Minor Deviations

Revision History:

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 Setup Parameters Standardization of Wet Granulation Process QA Head
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