Standard Operating Procedure for Verification of Tube Sealing Integrity in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/140/2025 |
| Supersedes | SOP/GM/140/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To define the procedure for checking and verifying the integrity of tube seals for gel-filled tubes to ensure they are leak-proof and tamper-resistant before release for packaging and distribution.
2. Scope
This SOP applies to the final product stage in the gel manufacturing
line where filled tubes are sealed, including both automated and manual sealing systems.
3. Responsibilities
- Production Chemist: Responsible for performing seal integrity tests.
- QA Executive: Responsible for reviewing and verifying seal integrity records.
- Machine Operator: Ensures sealing machine settings are as per specifications.
4. Accountability
Head – Manufacturing
5. Procedure
5.1 Pre-Verification Checks
- Ensure sealing machine is properly calibrated and cleaned as per SOP.
- Check availability of testing equipment: vacuum leak tester, squeeze test apparatus, and documentation sheets.
- Collect a representative sample of sealed tubes from each batch or sealing operation shift.
5.2 Tube Seal Integrity Test Methods
5.2.1 Vacuum Leak Test
- Place sealed tubes in a vacuum chamber containing water.
- Apply vacuum pressure of 27 inches Hg for 15 minutes.
- Observe any bubble formation indicating a leak in the tube seal.
5.2.2 Squeeze Test
- Apply manual pressure to the tube by squeezing gently.
- Observe for any gel extrusion through the seal or pinholes.
5.2.3 Visual Inspection
- Inspect seal area for crimping uniformity, burn marks, or folds.
- Check that batch number and manufacturing date are legible and properly positioned.
5.3 Acceptance Criteria
- No gel should leak or be forced out during squeeze test.
- No bubble formation should be observed during vacuum leak test.
- Seal must appear uniform, unbroken, and tamper-proof.
5.4 Handling of Rejected Tubes
- Rejected tubes must be segregated and recorded in the Rejection Logbook.
- QA to review and approve any reprocessing actions.
5.5 Documentation
- Fill the Seal Integrity Test Record (Annexure-1).
- Attach test results to the Batch Manufacturing Record (BMR).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
7. Documents
- Seal Integrity Test Record – Annexure-1
- Sealing Machine Calibration Log – Annexure-2
- Rejection Logbook
8. References
- Schedule M Guidelines for Packaging of Pharmaceuticals
- WHO Technical Report Series 986
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: Seal Integrity Test Record
| Date | Batch No. | No. of Tubes Tested | Vacuum Test Result | Squeeze Test Result | Visual Result | Checked By | Remarks |
|---|---|---|---|---|---|---|---|
Annexure-2: Sealing Machine Calibration Log
| Date | Machine ID | Calibration Parameters | Performed By | Remarks |
|---|---|---|---|---|
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 12/02/2022 | 1.0 | Initial version | New SOP | QA Head |
| 09/06/2025 | 2.0 | Revised with inclusion of vacuum leak test method | Annual review | QA Head |