Standard Operating Procedure for Operating Tube Sealing Machines in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/047/2025 |
| Supersedes | SOP/GM/047/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 02/06/2025 |
| Effective Date | 04/06/2025 |
| Review Date | 02/06/2026 |
1. Purpose
To describe the procedure for operating tube sealing machines used for sealing gel-filled tubes to ensure consistent sealing quality and product integrity.
2. Scope
This SOP applies to all personnel involved in the operation of tube sealing machines in the gel packaging area.
3. Responsibilities
- Machine
Operator: Responsible for setting up, operating, and cleaning the sealing machine.
Production Supervisor: Ensures adherence to procedure and proper documentation.
Quality Assurance: Performs line clearance and periodic checks.
4. Accountability
Department Head – Gel Manufacturing is accountable for ensuring compliance with this SOP.
5. Procedure
5.1 Pre-Operational Checks
- Verify machine cleanliness and confirm cleaning status as per equipment label.
- Check electrical connections and machine settings.
- Ensure correct sealing jaws are installed based on tube type and size.
- Confirm sealing temperature and dwell time settings per batch requirement.
5.2 Line Clearance
- Inform QA to perform line clearance before starting operation.
- Ensure removal of previous product, if any, and cleaning completion.
- Document clearance in Line Clearance Record (Annexure-1).
5.3 Machine Setup
- Switch ON the main power and preheat the sealing jaws to the required temperature.
- Align filled tubes into holders or conveyor channels as applicable.
- Set sealing cycle time and sealing pressure as per validation parameters.
- Perform a dry run using empty tubes for alignment verification.
5.4 Operation
- Feed gel-filled tubes into the sealer as per machine design (manual or automated).
- Monitor seal quality—check for proper seal width, alignment, and no burn marks.
- Record sealing parameters for each shift.
- Randomly check samples every 30 minutes for seal strength.
5.5 Post-Operation
- Shut down machine as per manufacturer’s instructions.
- Allow jaws to cool before cleaning.
- Clean the machine as per SOP/GM/055/2025.
- Label equipment status accordingly.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
- GMP: Good Manufacturing Practice
7. Documents
- Batch Manufacturing Record (BMR)
- Line Clearance Record – Annexure-1
- Sealing Parameters Log – Annexure-2
- Sealing Defect Observation Log – Annexure-3
8. References
- Manufacturer’s Equipment Manual
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Line Clearance Record
| Date | Batch No. | Machine ID | Previous Product Removed | Area Cleaned | QA Signature |
|---|---|---|---|---|---|
| Yes / No | Yes / No |
Annexure-2: Sealing Parameters Log
| Date | Batch No. | Sealing Temp (°C) | Dwell Time (sec) | Pressure (bar) | Operator Signature |
|---|---|---|---|---|---|
Annexure-3: Sealing Defect Observation Log
| Date | Time | Defect Observed | Corrective Action Taken | QA Reviewed |
|---|---|---|---|---|
| None / Burn mark / Misalignment |
Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/05/2022 | 1.0 | Initial version | New SOP | QA Head |
| 02/06/2025 | 2.0 | Annexures added and updated sealing procedure | Review Update | QA Head |