Standard Operating Procedure for Maintenance of Vacuum Pumps
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/098/2025 |
| Supersedes | SOP/CRM/098/2022 |
| 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 maintenance procedure for vacuum pumps used in the Creams Department. The objective is to ensure the vacuum pumps operate efficiently, extend their lifespan, and prevent downtime during the manufacturing process.
2. Scope
This SOP applies to all vacuum pumps used in the Creams Department for various manufacturing processes. It covers the maintenance activities such as cleaning, checking, and servicing to ensure optimal pump performance.
3. Responsibilities
- Maintenance Team: Responsible for performing regular maintenance checks, servicing, and troubleshooting of the vacuum pumps.
- Production Team: Responsible for reporting any issues related to vacuum pump performance to the maintenance team and ensuring that the pumps are used correctly during production.
- Quality Control (QC): Ensures that the vacuum pumps operate according to specified standards to maintain product quality and prevent contamination.
4. Accountability
The Head of Production is accountable for ensuring that vacuum pumps are maintained and operating properly. The Maintenance Manager is responsible for overseeing all maintenance activities and ensuring that the pumps are serviced according to the specified schedule.
5. Procedure
5.1 Pre-Maintenance Checks
- Ensure the vacuum pump is turned off and disconnected from the power source to prevent accidents during maintenance.
- Ensure that the area around the vacuum pump is clean and free from obstructions to facilitate maintenance work.
- Gather all necessary tools and replacement parts (e.g., seals, lubricants) for the maintenance tasks.
- Verify the maintenance schedule to ensure that the pump is being serviced at the appropriate time based on usage and hours of operation.
5.2 Inspection and Cleaning
- Visually inspect the vacuum pump for any signs of wear or damage. Check for oil leaks, unusual noises, and vibrations during operation.
- Check the filter and ensure it is clean. If the filter is clogged, clean or replace it according to the manufacturer’s instructions.
- Inspect the pump’s inlet and outlet ports for any blockages or obstructions. Clean the ports to ensure proper airflow.
- Clean the external surfaces of the pump with a soft cloth to remove dust and debris. Avoid using abrasive materials that could damage the surface of the pump.
5.3 Lubrication
- Check the pump’s lubrication system and ensure that the lubricant level is adequate. If the pump requires oil, top it up according to the manufacturer’s specifications.
- If necessary, replace the lubricant with the recommended type and quantity as specified in the manufacturer’s manual.
- Lubricate any moving parts that are exposed, such as bearings and seals, using the appropriate lubricant to reduce friction and wear.
5.4 Performance Testing
- After cleaning and lubrication, perform a performance test to ensure the vacuum pump is operating at the correct pressure and flow rate.
- Check the pump for any unusual sounds or vibrations during the test run. Any irregularities should be addressed before the pump is returned to service.
- If the performance is not within the specified range, further troubleshooting may be required, such as checking the motor, seals, or internal components.
5.5 Corrective Actions
- If the vacuum pump shows signs of malfunction during inspection or performance testing, the maintenance team should address the issue immediately.
- Common issues may include worn-out seals, blocked filters, or oil leaks. Replace any faulty parts and ensure that the pump is fully operational before returning it to service.
- Record all corrective actions taken during the maintenance process in the Maintenance Log (Annexure-1).
5.6 Reassembly and Start-Up
- Once the maintenance tasks are completed, reassemble any components that were disassembled during cleaning or servicing, ensuring everything is securely tightened and properly aligned.
- Reconnect the vacuum pump to the power supply and check that the pump starts up without issues.
- Monitor the pump during its initial operation after maintenance to ensure that it is functioning correctly and that there are no leaks, unusual noises, or performance issues.
5.7 Documentation
- Document all maintenance activities, including inspection results, cleaning, lubrication, parts replaced, and performance tests, in the Maintenance Log (Annexure-1).
- Record any corrective actions taken and ensure that all repairs are noted in the Equipment Maintenance Log.
- Ensure that the maintenance schedule is updated after the completion of each maintenance session.
5.8 Post-Maintenance Review
- After the pump has been returned to service, the QA team should perform a final check to verify that the vacuum pump is operating within the required specifications.
- If any issues are observed during production, notify the maintenance team immediately for further inspection and corrective actions.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: 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
- Vacuum Pump 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: Maintenance Log
| Equipment ID | Maintenance Date | Maintenance Type | Operator | Comments |
|---|---|---|---|---|
| VP-001 | 21/01/2026 | Cleaning, lubrication, calibration | John Doe | Successfully completed maintenance |
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 |