sealing equipment is operating correctly. The QA Manager is responsible for reviewing product quality and ensuring compliance with sealing standards.

5. Procedure

5.1 Pre-Operation Setup

1. Ensure that the tube sealing machine is clean and free of any residues or contaminants. Follow the cleaning SOP for sealing equipment.
2. Check that the sealing machine is assembled correctly, with all components, including the tube holders, heating elements, and sealing jaws, properly fitted and functioning.
3. Verify that the correct type of tubes (e.g., plastic or aluminum) are available and ready for sealing. Ensure that all tubes are defect-free and properly aligned on the packing line.
4. Set up the sealing machine to the correct temperature and pressure settings based on the type of material and batch specifications.
5. Ensure that the tubes are properly filled and aligned in the sealing machine, with no overfilling or underfilling issues.

5.2 Operating the Sealing Machine

1. Start the sealing machine and ensure that the tubes are moving smoothly through the conveyor system.
2. Monitor the sealing process to ensure that the tubes are properly sealed at the correct temperature and pressure. Check that the seal is secure and there are no leaks in the tubes.
3. Inspect the sealed tubes for consistent seal quality, including correct sealing position and uniform appearance. Reject any tubes with visible defects such as misalignment or incomplete seals.
4. Adjust the sealing temperature and pressure as needed to maintain proper sealing for different tube materials or batch requirements.

5.3 Monitoring During Operation

1. Continuously monitor the tube sealing process for any malfunctions such as inconsistent sealing, incomplete seals, or tube misalignment.
2. Ensure that the sealing process is operating smoothly without excessive noise or vibration, indicating potential issues with the equipment.
3. Periodically check for leaks or defects in the tubes by gently squeezing the sealed areas and inspecting for any cream leakage.
4. If any tubes are found with issues, stop the machine, identify the cause, and take corrective action. Document any defects and corrective actions in the Production Log (Annexure-1).

5.4 Post-Sealing Checks

1. After the sealing process is complete, inspect the sealed tubes for any visible defects such as wrinkles, tears, or incomplete seals.
2. Perform a leak test on a sample of sealed tubes to ensure the seal is intact and no cream is leaking from the tube.
3. Verify that all tubes are properly labeled with batch numbers, expiration dates, and product details as per the labeling SOP.
4. Record the number of tubes sealed, any discrepancies in sealing, and any maintenance performed in the Batch Production Record (Annexure-2).

5.5 Maintenance and Cleaning

1. After completing the sealing process, clean the sealing machine thoroughly to remove any cream residues, dust, or contaminants that may affect the next production run.
2. Perform routine maintenance on the sealing machine, including inspecting heating elements, pressure settings, and sealing jaws for wear and tear. Ensure that all components are properly calibrated.
3. Document all maintenance activities in the Equipment Maintenance Log (Annexure-3).

5.6 Documentation

1. Record all relevant details in the Batch Production Record (Annexure-2), including the number of tubes sealed, any discrepancies in sealing, and the performance of the sealing machine.
2. Document any maintenance or issues encountered during sealing in the Equipment Maintenance Log (Annexure-3) and the Production Log (Annexure-1).

5.7 Final Approval

1. The QA team must review the final product, including the sealed tubes and batch production records, to ensure compliance with quality standards before approving the product for further processing or shipment.
2. If any deviations from the set parameters or product quality are identified, the batch should be reviewed, and corrective actions should be taken before proceeding to the next phase.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment

7. Documents

1. Annexure-1: Production Log
2. Annexure-2: Batch Production Record
3. 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
• FDA Guidelines for Cosmetics Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Production Log

Batch Number	Production Date	Number of Tubes Sealed	Operator	Comments
12345	21/01/2026	5000	Jane Smith	No issues encountered

Annexure-2: Batch Production Record

Batch Number	Filling Volume	Sealing Details	Operator	Comments
12345	5000 L	Sealed with no defects	John Doe	Successfully completed sealing

Annexure-3: Equipment Maintenance Log

Equipment ID	Maintenance Date	Maintenance Type	Operator	Comments
FM-001	21/01/2026	Inspection, calibration	Jane Smith	Successfully calibrated

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