Standard Operating Procedure for Operating Cooling Systems in Cream Processing Units
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/102/2025 |
| Supersedes | SOP/CRM/102/2022 |
| 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 procedure for operating cooling systems in cream processing units. The goal is to ensure that the cooling systems maintain the proper temperature to prevent spoilage, preserve product quality, and meet manufacturing standards.
2. Scope
This SOP applies to all cooling systems used in cream processing units within the Creams Department. It includes procedures for pre-operation checks, monitoring during operation, and post-operation shutdown to ensure safe and efficient cooling of cream products.
3. Responsibilities
- Production Team: Responsible for operating the cooling systems according to this SOP and ensuring that the cooling system is functioning correctly during production.
- Maintenance Team: Responsible for ensuring that the cooling systems are maintained regularly, repaired if needed, and properly calibrated for optimal performance.
- Quality Control (QC): Ensures that the cooling systems are monitored to maintain the required temperature and that product quality is not compromised due to cooling failures.
4. Accountability
The Production Supervisor is accountable for ensuring that the cooling systems are operated according to this SOP and that all required parameters are met during the manufacturing process. The Maintenance Manager is accountable for ensuring that the cooling systems are well-maintained and functioning properly.
5. Procedure
5.1 Pre-Operation Checks
- Before starting the cooling system, ensure that all necessary preparations are made, including verifying that the cream product is ready for cooling and that the equipment is clean and free of contaminants.
- Verify that the cooling system’s temperature control settings are set to the desired operating temperature based on the product specifications.
- Check the cooling system’s power supply, electrical connections, and emergency stop features to ensure they are in proper working order.
- Ensure that the cooling system’s sensors and controllers are calibrated and functioning correctly. Test the system by running it for a brief period and confirming that the system reaches the specified temperature.
5.2 Operating the Cooling System
- Start the cooling system as per the manufacturer’s instructions and ensure it begins cooling the cream product to the required temperature.
- Monitor the system to ensure that it maintains the desired temperature range throughout the cooling process. Use the cooling system’s temperature control panel or a separate temperature monitoring system for this purpose.
- Ensure that the cooling system operates without excessive noise, vibration, or other signs of malfunction. If any irregularities are observed, stop the system immediately and report the issue to the Maintenance Team.
- Verify that the cooling system is providing uniform cooling across the entire batch of cream, ensuring no hot spots or temperature variations that could affect product quality.
- Document the temperature at regular intervals during the cooling process in the Cooling Log (Annexure-1). This log should include the time, temperature, and any deviations from the required temperature range.
5.3 Monitoring During Operation
- Monitor the cooling system continuously during the operation to ensure it is maintaining the correct temperature.
- Regularly inspect the cooling equipment for signs of wear, leaks, or any malfunctioning parts such as compressors, cooling fans, or pumps.
- Ensure that the cooling system’s refrigerant levels are within the recommended range, and check for any signs of refrigerant leaks that could affect system efficiency.
- If the cooling system includes air filters or water filters, ensure that they are clean and functioning properly to ensure efficient operation.
- Immediately report any issues or temperature deviations outside of the specified range to the Maintenance Team for prompt corrective action.
5.4 Post-Operation Shutdown
- Once the cooling process is complete, shut down the cooling system following the manufacturer’s shutdown procedure.
- Ensure that the system is properly turned off and that all power supplies are disconnected. Allow the system to cool down if necessary before performing any maintenance tasks.
- Clean the cooling system’s components, such as filters and cooling coils, to ensure that the equipment is free of any product residues or contaminants.
- Check the cooling system for any damage or wear during post-operation. If any issues are detected, notify the Maintenance Team for further inspection and repair.
- Document the shutdown time and any post-operation issues in the Cooling System Log (Annexure-2).
5.5 Troubleshooting
- If the cooling system is not maintaining the correct temperature, troubleshoot by checking the following:
- Verify the refrigerant levels and check for leaks.
- Inspect the temperature sensors and controllers to ensure they are calibrated correctly.
- Check the power supply and fuses to ensure they are operational.
- Ensure that the system’s filters are not clogged and are allowing proper airflow or water flow.
- If the issue persists, contact the Maintenance Team for further assistance. Any corrective actions should be documented in the Maintenance Log (Annexure-3).
5.6 Documentation
- Record all details of the cooling system operation, including pre-operation checks, temperature monitoring, and troubleshooting actions, in the Cooling System Log (Annexure-1).
- Document any maintenance performed, including repairs, replacements, or adjustments, in the Equipment Maintenance Log (Annexure-3).
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Cooling System Log
- Annexure-2: Cooling System Shutdown Log
- Annexure-3: Equipment Maintenance 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
- Cooling System 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: Cooling System Log
| Date | Start Time | End Time | Temperature Monitored | Operator | Comments |
|---|---|---|---|---|---|
| 21/01/2026 | 08:00 AM | 04:00 PM | 5°C | John Doe | No issues, maintained temperature |
Annexure-2: Cooling System Shutdown Log
| Date | Shutdown Time | Operator | Comments |
|---|---|---|---|
| 21/01/2026 | 04:00 PM | Jane Smith | System shutdown after cooling cycle completed |
Annexure-3: Equipment Maintenance Log
| Equipment ID | Maintenance Date | Maintenance Type | Operator | Comments |
|---|---|---|---|---|
| CS-001 | 21/01/2026 | Inspection | John Doe | No issues, verified temperature calibration |
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 |