Standard Operating Procedure for Leak Testing of Blister Packs
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/248/2025 |
| Supersedes | SOP/TAB/248/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/07/2026 |
| Effective Date | 06/07/2026 |
| Review Date | 01/07/2027 |
1. Purpose
The purpose of this SOP is to define the procedure for conducting leak testing on blister packs to ensure that the packs are sealed correctly and no leakage occurs, which could lead to contamination or degradation of the product. The SOP ensures compliance with GMP standards and maintains the integrity and safety of the packaged tablets.
2. Scope
This SOP applies to all blister packs produced at the manufacturing facility. It outlines the procedure for conducting leak tests on blister packs that contain tablets, ensuring their integrity before the final packaging and distribution process.
3. Responsibilities
- Packaging Operators: Responsible for conducting the leak test on blister packs, ensuring all tests are completed as per the SOP and documenting the results.
- Quality Control (QC): Responsible for verifying the results of the leak tests, investigating any failures, and ensuring that the packaging process adheres to quality standards.
- Production Manager: Ensures that the leak testing procedure is followed by all relevant personnel and ensures that corrective actions are taken if any discrepancies are found during the process.
4. Accountability
The Production Manager is accountable for ensuring that the leak testing procedure is followed and that any leaks found are appropriately addressed. QC is accountable for verifying the results and ensuring compliance with quality standards.
5. Procedure
5.1 Preparation for Leak Testing
- Ensure that the blister packs are properly formed and filled with the tablets before testing.
- Gather the necessary testing equipment, including a vacuum chamber or air pressure testing apparatus (Annexure-1).
- Verify that the blister packs to be tested are free of visible damage (Annexure-2).
- Ensure that the environment is free from any contamination or interference that could affect the test (Annexure-3).
5.2 Performing the Leak Test
- Place the blister pack into the vacuum chamber or air pressure testing apparatus, depending on the method used (Annexure-4).
- Follow the equipment manufacturer’s guidelines for the correct setup of the testing apparatus.
- Activate the testing equipment and monitor for any signs of air leakage or vacuum failure (Annexure-5).
- If using a vacuum chamber, the blister pack should hold the vacuum for the specified duration without any drop in pressure (Annexure-6).
- If using an air pressure method, observe the blister pack for any inflation or bulging indicating a leak (Annexure-7).
5.3 Evaluation of Test Results
- Examine the blister packs after testing for any signs of leaks or integrity issues (Annexure-8).
- If no leak is detected, record the result in the Leak Test Log (Annexure-9) and proceed with the packaging process.
- If a leak is detected, reject the affected blister pack and investigate the cause of the failure (Annexure-10).
- Any failed tests should be documented with details of the failure, corrective actions taken, and the re-test results (Annexure-11).
5.4 Documentation and Record-Keeping
- Maintain a log of all leak tests conducted, including the date, batch number, operator, and test results (Annexure-12).
- Ensure that all records are retained for the required period, according to company policies (Annexure-13).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- FDA: Food and Drug Administration
- EMA: European Medicines Agency
7. Documents
- Leak Test Log (Annexure-1)
- Blister Pack Inspection Log (Annexure-2)
- Environment Inspection Log (Annexure-3)
- Vacuum Chamber Setup Log (Annexure-4)
- Pressure Test Log (Annexure-5)
- Leak Test Result Record (Annexure-6)
- Blister Pack Leak Detection Report (Annexure-7)
- Failed Test Investigation Report (Annexure-8)
- Leak Test Documentation Log (Annexure-9)
- Corrective Action Log (Annexure-10)
- Re-Test Report (Annexure-11)
- Leak Test Records Retention Log (Annexure-12)
- Packaging Records Retention Log (Annexure-13)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
- USP <1079> – Good Storage and Distribution Practices
- ISO 9001 – Quality Management Systems
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
| Batch Number | Test Date | Operator | Test Result |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | John Doe | Pass |
Annexure-2: Blister Pack Inspection Log
| Batch Number | Inspection Date | Inspector | Comments |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | Jane Smith | Compliant |
Annexure-3: Environment Inspection Log
| Inspection Date | Area Inspected | Inspector | Comments |
|---|---|---|---|
| 01/07/2026 | Packaging Area | Jane Smith | No issues found, environment suitable for testing |
Annexure-4: Vacuum Chamber Setup Log
| Equipment ID | Setup Date | Operator | Calibration Status |
|---|---|---|---|
| Vacuum Chamber 001 | 01/07/2026 | John Doe | Pass |
Annexure-5: Pressure Test Log
| Test Date | Batch Number | Operator | Test Status |
|---|---|---|---|
| 01/07/2026 | Batch 12345 | John Doe | Passed |
Annexure-6: Leak Test Result Record
| Batch Number | Test Date | Result | Operator |
|---|---|---|---|
| Batch 12345 | 01/07/2026 | Pass | John Doe |
Annexure-7: Blister Pack Leak Detection Report
| Batch Number | Test Date | Detection Method | Leak Detected | Action Taken |
|---|---|---|---|---|
| Batch 12345 | 01/07/2026 | Vacuum Test | No | Proceed with packaging |
Annexure-8: Failed Test Investigation Report
| Batch Number | Test Date | Test Result | Investigation Outcome | Corrective Action |
|---|---|---|---|---|
| Batch 12346 | 02/07/2026 | Fail | Leak detected in two packs | Repacked and retested |
Annexure-9: Leak Test Documentation Log
| Document Type | Document Number | Document Date |
|---|---|---|
| Leak Test Record | LTR-12345 | 01/07/2026 |
Annexure-10: Corrective Action Log
| Issue | Action Taken | Responsible Person | Action Date |
|---|---|---|---|
| Leak detected in test | Rechecked packaging process and replaced faulty packs | Jane Smith | 02/07/2026 |
Annexure-11: Re-Test Report
| Batch Number | Re-Test Date | Re-Test Result | Operator |
|---|---|---|---|
| Batch 12346 | 02/07/2026 | Pass | John Doe |
Annexure-12: Leak Test Records Retention Log
| Document Type | Retention Period | Stored By | Storage Location |
|---|---|---|---|
| Leak Test Records | 5 years | John Doe | Storage Area A, Shelf 4 |
Annexure-13: Packaging Records Retention Log
| Material Type | Retention Period | Stored By | Storage Location |
|---|---|---|---|
| Blister Packs | 5 years | John Doe | Storage Area B |
15. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP creation | New procedure | QA Head |
| 01/07/2026 | 2.0 | Updated leak testing procedure and added new logs for documentation | Process improvement and new testing equipment integration | QA Head |