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
- Production Team: Responsible for ensuring that the homogenization system is properly operated and that any maintenance issues are promptly reported.
- Maintenance Team: Responsible for performing preventive maintenance on the homogenization systems, including inspections, calibrations, and repairs as necessary.
- Quality Control (QC): Ensures that the homogenization systems maintain the required product quality standards by verifying that the systems are functioning correctly.
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
- 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.
- Verify that the homogenizer is clean and free from any residues. If necessary, clean the homogenizer following the cleaning SOP for processing equipment.
- Check that all tools and equipment required for maintenance are available and in good working condition.
5.2 Inspecting the Homogenization System
- Perform a thorough inspection of the homogenizer, focusing on key components such as the homogenizing valve, pump, motor, and pressure gauges.
- 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.
- Inspect the motor and electrical components for any loose connections or signs of overheating.
- Check the homogenizer’s pressure and temperature gauges to ensure they are accurate and within the specified range for optimal homogenization.
- Ensure that the homogenizer is properly aligned and that there are no blockages or restrictions in the flow path.
5.3 Lubricating Components
- 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.
- Ensure that lubricants are applied correctly and that excess lubricant is removed to avoid contamination of the cream product.
- Check the lubricant levels and top up as needed. Record the type and quantity of lubricant used in the Equipment Maintenance Log (Annexure-1).
5.4 Calibrating the Homogenizer
- 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.
- If the homogenizer is not operating within the required parameters, adjust the settings to achieve the correct pressure and flow rate.
- Test the system after calibration by running a small batch and checking that the homogenized cream meets the desired consistency and quality.
- 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
- Once maintenance tasks are complete, conduct a final inspection to ensure that the homogenizer is operating correctly.
- Run the homogenizer at the specified settings and monitor the system for any irregularities, such as unusual noises, vibrations, or pressure fluctuations.
- Verify that the homogenized cream meets the required specifications for consistency, particle size, and uniformity.
- Ensure that the homogenizer is functioning properly and that there are no leaks or malfunctions.
5.6 Documentation
- Record all preventive maintenance activities, including inspections, lubrications, calibrations, and repairs, in the Equipment Maintenance Log (Annexure-1).
- Ensure that all maintenance records are reviewed and approved by the Quality Assurance (QA) team for compliance with required standards.
- Maintain a log of calibration results in the Homogenizer Calibration Log (Annexure-2) for traceability and future reference.
5.7 Maintenance Frequency
- 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.
- Schedule additional maintenance if the homogenizer shows signs of malfunction or performance degradation during production.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Equipment Maintenance Log
- Annexure-2: Homogenizer Calibration Log
8. References
- Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
- International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- Homogenizer Manufacturer’s Manual
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 |