Standard Operating Procedure for Troubleshooting Filling Machine Malfunctions
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/111/2025 |
| Supersedes | SOP/CRM/111/2022 |
| 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 outline the procedure for troubleshooting filling machine malfunctions during cream packaging operations. This ensures minimal downtime, reduces product waste, and maintains packaging integrity during production.
2. Scope
This SOP applies to all filling machines used in the Creams Department. It includes procedures for identifying, diagnosing, and resolving issues that arise during the filling process.
3. Responsibilities
- Production Team: Responsible for identifying and reporting filling machine malfunctions during production, following troubleshooting procedures, and coordinating with the Maintenance Team for repair.
- Maintenance Team: Responsible for inspecting, diagnosing, and resolving mechanical or technical issues with the filling machine.
- Quality Control (QC): Ensures that the final filled product meets the required standards of volume and quality, and verifies that no defects occur during troubleshooting or repairs.
4. Accountability
The Production Supervisor is accountable for ensuring that all filling machine malfunctions are promptly reported and resolved in a timely manner. The Maintenance Manager is responsible for overseeing repairs and ensuring proper machine functionality after troubleshooting.
5. Procedure
5.1 Identifying Malfunctions
- Observe the filling machine during operation for any irregularities such as inconsistent filling volumes, slow filling speeds, or machine jams.
- Check for any visible leaks or product spills around the machine, which may indicate malfunctioning seals or hoses.
- Listen for any unusual noises such as grinding or clicking sounds that may suggest a mechanical issue with the machine.
- Look for error messages or warnings on the machine’s display panel or control system.
- If the filling machine fails to start or stops during operation, verify that all necessary settings are correctly configured.
5.2 Diagnosing the Issue
- Verify that the filling machine is receiving the correct power supply and that there are no electrical issues such as blown fuses or tripped circuit breakers.
- Check the air supply (if applicable) to ensure that the filling machine is receiving adequate pressure. Inspect the air compressor and filters for any blockages or issues.
- Inspect the machine’s mechanical components, such as the pumps, valves, and gears, for any signs of wear, damage, or blockages.
- Check the filling nozzles for clogs or obstructions. Clean the nozzles if necessary to restore proper flow.
- Verify that the filling volume settings are correct. If the machine is overfilling or underfilling, check the sensors and calibration settings for accuracy.
- If the machine continues to malfunction, refer to the machine’s manual for troubleshooting guidelines or consult the manufacturer’s support for further assistance.
5.3 Resolving the Issue
- For electrical issues, reset the circuit breaker or replace any blown fuses. Ensure that all electrical connections are secure and properly insulated.
- If the air supply is insufficient, check the air compressor and replace any worn or damaged components, such as air filters or hoses.
- For mechanical issues, replace any worn or damaged components, such as seals, pumps, or gears. Lubricate moving parts as necessary to ensure smooth operation.
- If the filling nozzle is clogged, clean it using appropriate cleaning solutions. Check for any damage to the nozzle that could affect its function.
- Recalibrate the filling machine if the filling volumes are inconsistent. Ensure that the sensors are properly calibrated and aligned to measure accurate volumes.
- If the issue persists, stop the machine and consult the Maintenance Team for further inspection and repairs.
5.4 Post-Troubleshooting Testing
- Once the malfunction is resolved, run a test batch to verify that the filling machine is operating correctly and filling the jars to the correct volume.
- Check the filled jars for consistency in volume, cap placement, and packaging integrity. Ensure that no leaks or defects are present.
- If the machine is functioning correctly, resume normal production. If further issues are detected, repeat the troubleshooting process or escalate the issue to the Maintenance Team.
- Document all troubleshooting actions, including the issue identified, the steps taken to resolve it, and any parts replaced, in the Filling Machine Troubleshooting Log (Annexure-1).
5.5 Preventive Measures
- Perform regular maintenance and inspections on the filling machine to prevent future malfunctions. Follow the manufacturer’s maintenance schedule for preventive care.
- Ensure that operators are trained on proper machine operation to reduce the likelihood of operator errors that may contribute to malfunctions.
- Keep the filling area clean and free from debris to prevent blockages or contamination of the filling process.
5.6 Documentation
- Record all troubleshooting activities, including the cause of the malfunction, the actions taken, and any parts replaced, in the Filling Machine Troubleshooting Log (Annexure-1).
- Ensure that the log is reviewed and approved by the Quality Assurance (QA) team to ensure that the troubleshooting process was completed according to GMP standards.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Filling Machine Troubleshooting 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
- Filling Machine 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: Filling Machine Troubleshooting Log
| Batch Number | Malfunction Date | Issue Identified | Actions Taken | Parts Replaced | Operator |
|---|---|---|---|---|---|
| 12345 | 21/01/2026 | Underfilling | Recalibrated filling machine, replaced nozzle | Nozzle | John Doe |
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 |