SOP Guide for Pharma

Creams: SOP for Preventive Maintenance of Homogenization Systems – V 2.0

Auditor

Creams: SOP for Preventive Maintenance of Homogenization Systems – V 2.0

Standard Operating Procedure for Preventive Maintenance of Homogenization Systems

Department Creams
SOP No. SOP/CRM/109/2025
Supersedes SOP/CRM/109/2022
Page No. Page 1 of 5
Issue Date 21/01/2026
Effective Date 26/01/2026
Review Date 21/01/2027

1. Purpose

The purpose of this SOP is to define the preventive maintenance procedures for homogenization systems used in the cream manufacturing process. This ensures that the homogenizers operate efficiently, minimizing downtime and ensuring consistent product quality.

2. Scope

This SOP applies to all homogenization systems used in the Creams Department. It covers the procedures for routine inspection, maintenance, and calibration of homogenizers to ensure optimal performance.

3. Responsibilities

4. Accountability

The Maintenance Manager is accountable for ensuring that preventive maintenance activities are completed on schedule and that the homogenization systems are maintained in optimal working condition. The Production Supervisor is accountable for reporting any issues related to homogenizer performance during production.

5. Procedure

5.1 Pre-Maintenance Setup

  1. Before starting the preventive maintenance procedure, ensure that the homogenizer is turned off and isolated from the production line. Follow all lockout/tagout (LOTO) procedures to ensure safety during maintenance.
  2. Verify that the homogenizer is clean and free from any residues. If necessary, clean the homogenizer following the cleaning SOP for processing equipment.
  3. Check that all tools and equipment required for maintenance are available and in good working condition.
See also  Creams: SOP for In-Line Filtration of Creams before Packing - V 2.0

5.2 Inspecting the Homogenization System

  1. Perform a thorough inspection of the homogenizer, focusing on key components such as the homogenizing valve, pump, motor, and pressure gauges.
  2. Check for any signs of wear, corrosion, or leakage in the system. Pay special attention to seals, gaskets, and valves to ensure they are intact and functioning correctly.
  3. Inspect the motor and electrical components for any loose connections or signs of overheating.
  4. Check the homogenizer’s pressure and temperature gauges to ensure they are accurate and within the specified range for optimal homogenization.
  5. Ensure that the homogenizer is properly aligned and that there are no blockages or restrictions in the flow path.

5.3 Lubricating Components

  1. Lubricate moving parts of the homogenizer, including the motor, pump, and any bearings or gears, using the appropriate lubricant as per the manufacturer’s recommendations.
  2. Ensure that lubricants are applied correctly and that excess lubricant is removed to avoid contamination of the cream product.
  3. Check the lubricant levels and top up as needed. Record the type and quantity of lubricant used in the Equipment Maintenance Log (Annexure-1).
See also  Creams: SOP for Lubricating Mechanical Parts of Cream-Filling Machines - V 2.0

5.4 Calibrating the Homogenizer

  1. Calibrate the homogenization system’s pressure and flow controls according to the manufacturer’s guidelines. Use calibrated instruments to verify that the pressure and flow rates meet the specified requirements.
  2. If the homogenizer is not operating within the required parameters, adjust the settings to achieve the correct pressure and flow rate.
  3. Test the system after calibration by running a small batch and checking that the homogenized cream meets the desired consistency and quality.
  4. Document all calibration details in the Homogenizer Calibration Log (Annexure-2), including the calibration method, results, and any adjustments made.

5.5 Post-Maintenance Inspection and Testing

  1. Once maintenance tasks are complete, conduct a final inspection to ensure that the homogenizer is operating correctly.
  2. Run the homogenizer at the specified settings and monitor the system for any irregularities, such as unusual noises, vibrations, or pressure fluctuations.
  3. Verify that the homogenized cream meets the required specifications for consistency, particle size, and uniformity.
  4. Ensure that the homogenizer is functioning properly and that there are no leaks or malfunctions.

5.6 Documentation

  1. Record all preventive maintenance activities, including inspections, lubrications, calibrations, and repairs, in the Equipment Maintenance Log (Annexure-1).
  2. Ensure that all maintenance records are reviewed and approved by the Quality Assurance (QA) team for compliance with required standards.
  3. Maintain a log of calibration results in the Homogenizer Calibration Log (Annexure-2) for traceability and future reference.
See also  Creams: SOP for Mixing Techniques for Cream Formulations - V 2.0

5.7 Maintenance Frequency

  1. Perform preventive maintenance on the homogenizer as per the manufacturer’s recommended schedule, typically on a monthly or quarterly basis, or after a set number of production hours.
  2. Schedule additional maintenance if the homogenizer shows signs of malfunction or performance degradation during production.

6. Abbreviations

7. Documents

  1. Annexure-1: Equipment Maintenance Log
  2. Annexure-2: Homogenizer Calibration Log

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: Equipment Maintenance Log

Equipment ID Maintenance Date Maintenance Type Operator Comments
HG-001 21/01/2026 Inspection and lubrication Jane Smith Lubricated moving parts, no issues found

Annexure-2: Homogenizer Calibration Log

Batch Number Calibration Date Calibration Method Operator Calibration Results Comments
12345 21/01/2026 Standard Volumetric Method John Doe Accurate within ±1% Calibration successful, no issues

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/03/2024 1.0 Initial Version New SOP Creation QA Head
01/03/2025 2.0 Format Revision and Updates Standardization of Document QA Head
Exit mobile version