Procedure for Leak Testing of Ointment Tubes
| Department | Quality Assurance (QA)/Quality Control (QC)/Packaging |
|---|---|
| SOP No. | SOP/Ointment/094 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for leak testing of ointment tubes to ensure product integrity, prevent leakage, and comply with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Quality Control (QC), and Packaging departments responsible for conducting leak testing on ointment tubes during and after the packaging process.
3. Responsibilities
- Packaging Operator: Performs leak testing during packaging operations.
- Packaging Supervisor: Ensures leak testing is conducted according to the defined procedure.
- Quality Control (QC) Analyst: Conducts independent leak testing and records results.
- QA Officer: Reviews test reports and approves leak-tested batches.
- QA Manager: Oversees compliance and approves the final product batch for release.
4. Accountability
The QA and Packaging Managers are accountable for ensuring leak testing is performed according to GMP and regulatory standards.
5. Procedure
5.1 Pre-Test Preparations
- Ensure that leak testing equipment is calibrated and in proper working condition.
- Randomly select ointment tubes from the production batch for leak testing.
- Verify that each sample is properly sealed and does not have
visible defects.
5.2 Leak Testing Methods
5.2.1 Vacuum Leak Test (Preferred Method)
- Fill the leak testing chamber with water at room temperature.
- Place the selected ointment tubes into the vacuum chamber.
- Apply vacuum pressure as per standard testing parameters.
- Observe for any air bubbles escaping from the tubes, indicating leakage.
5.2.2 Compression Leak Test
- Manually squeeze the ointment tubes gently.
- Observe for any product leakage from the crimped end or cap.
- Document any tubes failing the test and report to QA.
5.2.3 Dye Penetration Test (For Defect Confirmation)
- Submerge the tubes in a dye solution for a specified duration.
- Remove and inspect tubes for dye penetration at sealed areas.
- Confirm leakage presence and document findings.
5.3 Acceptance Criteria
- No air bubbles should be observed in the vacuum test.
- No product leakage should occur during the compression test.
- No dye penetration should be visible in the dye test.
- Any failure must be documented and reported to QA for further action.
5.4 Handling of Defective Tubes
- Segregate failed tubes and record the defect type.
- Investigate root causes such as improper sealing or material defects.
- Report findings to QA and take corrective actions.
5.5 Documentation and Approval
- Record test results in the Leak Test Log.
- QC must review and verify leak test results before batch release.
- QA must approve the final batch for distribution.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- CAPA – Corrective and Preventive Action
7. Documents
- Leak Test Log (Annexure-1)
- Leak Test Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q10 – Pharmaceutical Quality System
- USP <1207> – Package Integrity Testing
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Leak Test Log
| Date | Batch Number | Test Method | Sample Size | Passed | Failed | Inspected By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Vacuum Test | 50 | 49 | 1 | QC Analyst |
| 01/02/2025 | OINT-102 | Compression Test | 50 | 50 | 0 | QC Analyst |
Annexure-2: Leak Test Report
| Date | Batch Number | Leak Test Type | Results | Action Taken | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Vacuum Leak Test | 1 tube failed | Rejected tube, rechecked batch | QA Officer |
| 02/02/2025 | OINT-102 | Compression Test | All tubes passed | Batch approved | QA Officer |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |