Standard Operating Procedure for Operating Automatic Cap Tightening Machines for Cream Jars
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/110/2025 |
| Supersedes | SOP/CRM/110/2022 |
| 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 automatic cap tightening machines used in the packaging of cream jars. Proper operation ensures that the cream jars are securely sealed, preventing leakage, contamination, and ensuring the integrity of the product during distribution.
2. Scope
This SOP applies to all automatic cap tightening machines used for sealing cream jars in the Creams Department. It covers the procedure for setting up, operating, monitoring, and shutting down the cap tightening machines during the production process.
3. Responsibilities
- Production Team: Responsible for operating the cap tightening machines according to this SOP, ensuring that all jars are securely sealed.
- Maintenance Team: Responsible for inspecting, maintaining, and repairing the automatic cap tightening machines to ensure optimal performance.
- Quality Control (QC): Ensures that the sealed jars meet the required sealing standards and that no defects are present in the final packaging.
4. Accountability
The Production Supervisor is accountable for ensuring that the cap tightening machines are operated according to this SOP. The Maintenance Manager is responsible for the maintenance and repair of the automatic cap tightening machines.
5. Procedure
5.1 Pre-Operation Setup
- Ensure that the automatic cap tightening machine is clean and free from any product residue or debris. If necessary, follow the cleaning SOP for packaging equipment to clean the machine before starting operation.
- Verify that the cap tightening machine is correctly positioned and aligned with the conveyor belt to receive cream jars.
- Check the machine’s settings, including the torque level for cap tightening, to ensure they match the specifications for the cream jars being sealed.
- Inspect the caps to ensure they are compatible with the jars and the tightening machine. Check that all jars and caps are free from defects before loading them onto the conveyor.
- Verify that the machine is connected to the power supply and that all safety mechanisms are engaged, including emergency stop buttons and safety guards.
5.2 Operating the Cap Tightening Machine
- Start the cap tightening machine according to the manufacturer’s instructions.
- Load the cream jars onto the conveyor belt, ensuring that they are aligned properly to prevent jams or misalignment during the sealing process.
- The machine will automatically position each jar and cap, tighten the cap, and securely seal it according to the preset torque values.
- Monitor the machine’s operation throughout the production run to ensure that the caps are being tightened evenly and securely without over-tightening or under-tightening.
- Check the tightened caps for any signs of leakage, defects, or uneven sealing. If any jars are not sealed properly, stop the machine and adjust the settings as necessary.
- Document the operation, including any adjustments made to the machine settings, in the Cap Tightening Log (Annexure-1).
5.3 Monitoring and Troubleshooting
- During the operation, monitor the cap tightening process for any signs of malfunction or inconsistency, such as inconsistent sealing pressure or the machine stalling.
- If a jar is found with a defective seal, stop the machine immediately and inspect the system for issues such as misaligned parts, faulty caps, or improper torque settings.
- Clear any jams or blockages in the system and restart the machine. Ensure that the jars are properly aligned and that the caps are correctly positioned.
- If the machine is malfunctioning or not operating correctly, notify the Maintenance Team for inspection and repairs. Document any troubleshooting actions taken in the Cap Tightening Log (Annexure-1).
5.4 Post-Operation Shutdown
- At the end of the production run, turn off the machine according to the manufacturer’s instructions. Ensure that the machine is properly shut down to prevent damage or wear during idle periods.
- Perform a visual inspection of the sealing area and the conveyor system to ensure that no jars are left behind or stuck in the system.
- Clean the machine and conveyor system according to the cleaning SOP for packaging equipment to ensure it is ready for the next production run.
- Document the shutdown details, including any issues encountered during operation, in the Cap Tightening Log (Annexure-1).
5.5 Documentation
- Record all cap tightening operations, including pre-operation setup, monitoring activities, troubleshooting actions, and post-operation shutdown, in the Cap Tightening Log (Annexure-1).
- Ensure that all records are reviewed and approved by the Quality Assurance (QA) team for compliance with required packaging standards.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Cap Tightening 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
- Cap Tightening Equipment 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: Cap Tightening Log
| Batch Number | Start Time | End Time | Torque Settings (Nm) | Operator | Comments |
|---|---|---|---|---|---|
| 12345 | 08:00 AM | 04:00 PM | 15 Nm | John Doe | No issues, consistent cap tightness |
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 |