SOP Guide for Pharma

Creams: SOP for Sealing Cream Tubes in Packing Lines – V 2.0

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Creams: SOP for Sealing Cream Tubes in Packing Lines – V 2.0

Standard Operating Procedure for Sealing Cream Tubes in Packing Lines

Department Creams
SOP No. SOP/CRM/088/2025
Supersedes SOP/CRM/088/2022
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 sealing cream tubes in the packing line. The objective is to ensure that cream tubes are sealed properly to maintain product integrity, prevent contamination, and ensure accurate labeling.

2. Scope

This SOP applies to the sealing of all cream tubes on the packing line in the Creams Department. It includes the setup, operation, and maintenance of sealing equipment to ensure the correct sealing of tubes prior to labeling and packaging.

3. Responsibilities

4. Accountability

The Head of Production is accountable for ensuring that the sealing process follows this SOP and that the 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.
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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).
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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.
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6. Abbreviations

7. Documents

  1. Annexure-1: Production Log
  2. Annexure-2: Batch Production Record
  3. Annexure-3: Equipment Maintenance Log

8. References

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
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