Creams: SOP for Operating Tube-Sealing Machines – V 2.0

Standard Operating Procedure for Operating Tube-Sealing Machines

Department	Creams
SOP No.	SOP/CRM/107/2025
Supersedes	SOP/CRM/107/2022
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 establish a standard procedure for operating tube-sealing machines used in the packaging of cream products. Proper operation of these machines ensures the integrity of packaging, prevents contamination, and guarantees that the cream product is securely sealed for distribution.

2. Scope

This SOP applies to all tube-sealing machines used in the Creams Department for sealing cream-filled tubes. It covers the procedure for setting up, operating, and maintaining tube-sealing machines during the production process.

3. Responsibilities

Production Team: Responsible for operating the tube-sealing machines according to this SOP and ensuring that tubes are properly sealed without defects.
Maintenance Team: Responsible for inspecting, maintaining, and repairing the tube-sealing machines to ensure they operate efficiently and consistently.
Quality Control (QC): Ensures that the sealed tubes meet the required sealing standards and that no damage occurs to the product during the sealing process.

4. Accountability

The Production Supervisor is accountable for ensuring that the tube-sealing machines are operated according to this SOP. The Maintenance Manager is responsible for the maintenance and repair of the tube-sealing machines.

5. Procedure

5.1 Pre-Operation Setup

Before starting the sealing process, ensure that the tube-sealing machine is clean and free from product residues. Follow the cleaning SOP for packaging equipment to prepare the machine for use.
Check the machine settings, including the sealing temperature, pressure, and speed, to ensure they are set according to the specific requirements for the cream product being packaged.
Verify that the tubes are properly aligned in the machine’s feeding system and that there are no blockages or jams in the tube hopper.
Ensure that the sealing components, such as the heating bands and rollers, are in good condition and properly calibrated to prevent sealing defects.

5.2 Operating the Tube-Sealing Machine

Once the setup is complete, start the tube-sealing machine according to the manufacturer’s instructions.
Feed the filled tubes into the machine’s hopper, ensuring that the tubes are positioned correctly for sealing.
The machine will automatically position each tube, apply heat to the tube neck, and create a seal. Monitor the machine closely during operation to ensure the sealing process is running smoothly.
Check that the seal is applied uniformly and securely without any visible gaps or wrinkles in the tube’s neck. The sealing area should be smooth and consistent.
Ensure that the machine operates at the correct speed for the batch and that the tubes are sealed without over- or under-sealing.
Document the operation process, including any adjustments made to the machine settings, in the Tube Sealing Log (Annexure-1).

5.3 Monitoring and Troubleshooting

During the production run, monitor the machine regularly to check for issues such as tube misalignment, inconsistent sealing, or machine malfunctions.
If any irregularities are observed, stop the machine immediately and troubleshoot the issue. Common issues include tube jams, improper sealing temperature, or worn-out sealing components.
For tube jams, clear the blockage and resume the operation after ensuring that the machine is correctly aligned.
If the sealing is inconsistent, check the sealing temperature and pressure settings. Adjust them as necessary and re-test with a few tubes before continuing production.
Ensure that any adjustments or issues are documented in the Tube Sealing Log (Annexure-1) for traceability.

5.4 Post-Operation Shutdown

At the end of the production run, turn off the tube-sealing machine and disconnect the power supply according to the manufacturer’s instructions.
Perform a visual inspection of the sealing area to ensure that there is no remaining cream residue or product buildup that could cause contamination during the next production run.
Clean the machine’s sealing components and any other parts that came into contact with the product, following the equipment cleaning SOP.
Ensure that the machine is properly shut down and that no damage occurs to any components during the shutdown process.
Document the shutdown details, including any issues encountered during the sealing process, in the Tube Sealing Log (Annexure-1).

5.5 Documentation

Record all sealing operations, including pre-operation setup, monitoring activities, troubleshooting actions, and post-operation shutdown, in the Tube Sealing Log (Annexure-1).
Ensure that all documentation is reviewed and approved by the Quality Assurance (QA) team to ensure 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: Tube Sealing 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
Tube-Sealing 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: Tube Sealing Log

Batch Number	Start Time	End Time	Sealing Temperature (°C)	Sealing Pressure (Bar)	Operator	Comments
12345	08:00 AM	04:00 PM	150°C	4.5 Bar	John Doe	No issues, consistent sealing

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