SOP Guide for Pharma

Elixir Department: SOP for Inline Homogenizer Operation – V 2.0

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Elixir Department: SOP for Inline Homogenizer Operation – V 2.0

Standard Operating Procedure for Inline Homogenizer Operation in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/126/2025
Supersedes SOP/ELX/126/2022
Page No. Page 1 of 10
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the procedure for the safe and effective operation of inline homogenizers used in elixir manufacturing to achieve consistent particle size reduction, uniform distribution of ingredients, and improved stability of the final product.

2. Scope

This SOP applies to all inline homogenizers used in the Elixir Department during mixing, emulsifying, or recirculating steps involving aqueous, alcoholic, or syrup-based formulations.

3. Responsibilities

  • Production Operator:
    • Setup, operate, and clean the homogenizer as per batch requirements.
    • Monitor flow rate and RPM during homogenization.
  • Production Supervisor:
    • Verify homogenizer settings, calibration, and log entries.
  • Engineering Department:
    • Maintain and calibrate pressure gauges, speed controllers, and seals.
  • QA Officer:
    • Ensure adherence to GMP and verify cleaning validation post-operation.

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4. Accountability

The Production Head is accountable for the proper execution of homogenization operations and the Engineering Head is responsible for maintaining the equipment.

5. Procedure

5.1 Pre-Operation Checks

  1. Verify that the homogenizer is labeled as “CLEANED” and approved for use by QA.
  2. Check the equipment for any visible damage, loose connections, or leaks.
  3. Ensure the inlet and outlet hoses are correctly fitted and the flow path is unobstructed.
  4. Confirm that the homogenizer motor, speed controller, and pressure indicators are functional and calibrated.

5.2 Setup and Product Charging

  1. Connect the inlet of the homogenizer to the source vessel (mixing tank or buffer tank).
  2. Connect the outlet to the recirculation line or collection tank as specified in the BMR.
  3. Prime the system by opening the product valve until the line is filled with liquid, removing any air pockets.

5.3 Operation Procedure

  1. Switch on the main power supply and homogenizer motor.
  2. Set the desired RPM and pressure (e.g., 3000–8000 RPM, 2–5 bar) as per batch-specific instructions.
  3. Start the flow gradually and monitor the consistency of the product.
  4. Observe:
    • Homogenization pressure and RPM on the control panel
    • Temperature rise in the product (do not exceed defined limit)
    • Visual appearance of the homogenized liquid
  5. Continue homogenization for the specified time (e.g., 20 minutes) or volume passed.
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5.4 Post-Operation and Cleaning

  1. Stop the product flow and switch off the motor and power supply.
  2. Disconnect inlet and outlet lines.
  3. Drain residual product using suitable collection trays.
  4. Clean the homogenizer head, stator, rotor, and internal surfaces using the validated CIP or manual cleaning procedure.
  5. Dry the equipment and affix “TO BE CLEANED” or “CLEANED” label post-cleaning.

5.5 Safety and Precautions

  1. Do not operate the homogenizer dry or without sufficient liquid in the system.
  2. Always use PPE (goggles, gloves, apron) during operation and cleaning.
  3. Check all seals and locking mechanisms before starting the machine.
  4. Never open housing while the rotor is in motion.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • BMR: Batch Manufacturing Record
  • RPM: Revolutions Per Minute
  • CIP: Clean-in-Place

7. Documents

  1. Homogenizer Operation Log (Annexure-1)
  2. Preventive Maintenance Record
  3. Cleaning Checklist

8. References

  • 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
  • WHO TRS 1010 – GMP Equipment Guidelines
  • ICH Q8 – Pharmaceutical Development

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Homogenizer Operation Log

Date Batch No. Homogenizer ID Set RPM Pressure (bar) Duration Operator Remarks
11/04/2025 ELX-1059 HMG-01 6000 4.5 25 min Sunita Reddy Operation Normal

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New SOP QA Head
11/04/2025 2.0 Added detailed safety steps and RPM range Process Improvement QA Head
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