Standard Operating Procedure for Monitoring and Maintaining Vacuum Levels during Cream Processing
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/106/2025 |
| Supersedes | SOP/CRM/106/2022 |
| 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 monitoring and maintaining vacuum levels during cream processing. Maintaining the correct vacuum levels is essential for ensuring proper emulsification and texture, preventing contamination, and achieving the desired product quality.
2. Scope
This SOP applies to all vacuum systems used in cream processing. It includes the procedures for setting, monitoring, and maintaining vacuum levels to ensure they meet the required specifications throughout the production process.
3. Responsibilities
- Production Team: Responsible for ensuring that vacuum levels are properly set and maintained during cream processing and that any issues are immediately reported to the Maintenance Team.
- Maintenance Team: Responsible for inspecting, maintaining, and calibrating the vacuum systems to ensure they are operating correctly.
- Quality Control (QC): Ensures that the vacuum levels are within the specified range during the production process and that product quality is not compromised.
4. Accountability
The Production Supervisor is accountable for ensuring that the vacuum levels are properly set and maintained in accordance with this SOP. The Maintenance Manager is responsible for ensuring the proper maintenance and calibration of the vacuum system.
5. Procedure
5.1 Pre-Operation Setup
- Before starting the cream production process, check the vacuum system to ensure that it is operational and that all connections are secure.
- Verify that the vacuum pump is functioning correctly and that the system is free of leaks. Test the vacuum gauge to ensure it is calibrated and providing accurate readings.
- Ensure that the appropriate vacuum level is set according to the recipe or product specifications. This will vary depending on the type of cream being produced.
- Check the temperature and pressure levels in the processing area to ensure they are compatible with the required vacuum levels.
5.2 Monitoring Vacuum Levels During Processing
- During the processing, continuously monitor the vacuum levels using the vacuum gauge and ensure they remain within the acceptable range as specified in the product’s formulation.
- Ensure that the vacuum level is adjusted to suit the stage of production. For example, higher vacuum levels may be needed during emulsification to remove excess air, while lower vacuum levels might be required during other phases of processing.
- Monitor the vacuum pump’s performance. If there are any unusual fluctuations in the vacuum level, stop the process and troubleshoot the system to identify the cause of the fluctuation.
- Record the vacuum levels at regular intervals in the Vacuum Monitoring Log (Annexure-1) to ensure that they are consistently within the required range.
5.3 Adjusting Vacuum Levels
- If the vacuum level falls outside the acceptable range, take immediate corrective action:
- Check for leaks in the vacuum system and repair them promptly.
- Adjust the vacuum control valve to bring the vacuum level back to the desired range.
- If the vacuum pump is not functioning properly, report the issue to the Maintenance Team for further inspection and repair.
- Ensure that any adjustments to the vacuum level are documented in the Vacuum Monitoring Log (Annexure-1).
5.4 Post-Operation Shutdown
- Once the cream production process is complete, turn off the vacuum system according to the manufacturer’s instructions. Ensure that the system is properly shut down to prevent damage or contamination.
- Perform a visual inspection of the vacuum system to ensure it is free of debris or product residue.
- If necessary, clean the vacuum system components according to the equipment cleaning SOP to ensure the system is ready for future use.
- Document the final vacuum levels and any issues encountered during the operation in the Vacuum Monitoring Log (Annexure-1).
5.5 Troubleshooting
- If the vacuum system is not maintaining the desired vacuum level, check the following:
- Ensure that the vacuum pump is operating at full capacity and that it is not clogged or malfunctioning.
- Check for leaks in the vacuum hoses, seals, or other components.
- Inspect the vacuum gauge for accuracy and recalibrate it if necessary.
- If any issues persist, contact the Maintenance Team for further investigation and repair.
5.6 Documentation
- Record all monitoring activities, including the vacuum levels, any adjustments made, and any issues encountered, in the Vacuum Monitoring Log (Annexure-1).
- Document any maintenance or repairs performed on the vacuum system in the Equipment Maintenance Log (Annexure-2).
- Ensure that all records are reviewed and approved by the Quality Assurance (QA) team to ensure compliance with the required vacuum specifications.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Vacuum Monitoring Log
- Annexure-2: 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
- Manufacturer’s Manual for Vacuum Systems
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Vacuum Monitoring Log
| Batch Number | Start Time | End Time | Vacuum Level (in Hg) | Operator | Comments |
|---|---|---|---|---|---|
| 12345 | 08:00 AM | 04:00 PM | 25 in Hg | John Doe | Maintained throughout, no issues |
Annexure-2: Equipment Maintenance Log
| Equipment ID | Maintenance Date | Maintenance Type | Operator | Comments |
|---|---|---|---|---|
| VS-001 | 21/01/2026 | Inspection and calibration | Jane Smith | Successfully calibrated, 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 |