Gel Manufacturing: SOP for Using Homogenizers in Gel Production – V 2.0

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Gel Manufacturing: SOP for Using Homogenizers in Gel Production – V 2.0

Standard Operating Procedure for Using Homogenizers in Gel Production


Department Gel Manufacturing
SOP No. SOP/GM/042/2025
Supersedes SOP/GM/042/2022
Page No. Page 1 of 10
Issue Date 02/06/2025
Effective Date 04/06/2025
Review Date 02/06/2026

1. Purpose

To establish a standard procedure for operating homogenizers used in the manufacturing of pharmaceutical gels, ensuring consistent particle size reduction, uniform dispersion of active and inactive ingredients, and adherence to GMP standards.

2. Scope

This SOP applies to all types of homogenizers used in the Gel Manufacturing Department for processing topical and transdermal

gel formulations.

3. Responsibilities

  • Production Operator: Responsible for executing the homogenization process as per instructions.
  • Production Supervisor: To verify settings and approve process start.
  • QA Executive: To ensure line clearance and compliance during operation.
  • Engineering: To provide preventive maintenance and resolve equipment issues.
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4. Accountability

The Head – Manufacturing is accountable for proper and compliant use of homogenizers as per this SOP.

5. Procedure

5.1 Pre-Use Checks

  1. Ensure that the homogenizer has been cleaned and released by QA (Refer to Equipment Status Label).
  2. Verify electrical connections, RPM settings, and emergency stop functionality.
  3. Check for the presence of guards and ensure that shaft seals and inlet/outlet connections are intact.

5.2 Equipment Setup

  1. Connect the homogenizer inline or in recirculation mode depending on process requirements.
  2. Secure all clamps and valves; avoid loose fittings.
  3. Fill the vessel with a minimum volume of gel base to prevent cavitation.
  4. Ensure the correct direction of flow as per manufacturer’s manual.

5.3 Homogenization Operation

  1. Switch on the power supply and start the motor at a low RPM.
  2. Gradually increase the speed to the desired RPM (as specified in the BMR).
  3. Monitor temperature during operation. Do not exceed validated heat limits (typically 30–35°C for thermolabile ingredients).
  4. Continue homogenization for the specified time (generally 15–30 minutes).
  5. Record actual homogenization time, RPM, temperature, and batch number in Annexure-1: Homogenization Logbook.
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5.4 Completion and Cleaning

  1. After completion, turn off the motor and allow the impeller to stop fully before disassembling or disconnecting.
  2. Disconnect the inlet and outlet tubing. Drain any remaining product.
  3. Follow the cleaning SOP (refer SOP/GM/052/2025) for post-use sanitization and cleaning of homogenizer.

5.5 Safety Precautions

  • Do not operate without safety guards in place.
  • Ensure operator hands and PPE do not come in contact with moving parts.
  • Use thermal gloves if homogenizer surfaces heat up during operation.
  • Any abnormalities (leakage, abnormal sound, heat) must be reported immediately.

6. Abbreviations

  • BMR: Batch Manufacturing Record
  • RPM: Revolutions Per Minute
  • QA: Quality Assurance
  • GMP: Good Manufacturing Practice
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7. Documents

  1. Homogenization Logbook – Annexure-1
  2. Equipment Pre-Use Checklist – Annexure-2
  3. Batch Manufacturing Record (BMR)

8. References

  • WHO GMP Guidelines
  • Schedule M – Equipment Operation & Maintenance
  • OEM User Manual of Inline Homogenizer

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation Jr. Production Chemist QA Executive Head – Manufacturing
Department Gel Manufacturing Quality Assurance Manufacturing

11. Annexures

Annexure-1: Homogenization Logbook

To record Batch No., Product Name, Date, Time Started, Time Completed, RPM, Observations.

Annexure-2: Equipment Pre-Use Checklist

Checklist to verify equipment condition, power connectivity, calibration tags, and safety compliance before use.

Revision History:

Revision Date Revision No. Details Reason Approved By
01/05/2022 1.0 Initial release New SOP QA Head
02/06/2025 2.0 Added safety precautions and annexure formats Periodic Review QA Head
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