Standard Operating Procedure for Ensuring Proper Sealing in Blister Packs
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/235/2025 |
| Supersedes | SOP/TAB/235/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 01/04/2026 |
| Effective Date | 06/04/2026 |
| Review Date | 01/04/2027 |
1. Purpose
This SOP outlines the process for ensuring proper sealing of blister packs containing tablets. The goal is to maintain product integrity, prevent contamination, and extend the shelf life of the tablets by ensuring that the seals are tight, secure, and free from defects.
2. Scope
This SOP applies to all blister packaging processes for tablet products. It covers the setup, monitoring, and inspection of the blister sealing process to ensure that the seals meet the required specifications for strength, integrity, and appearance.
3. Responsibilities
- Production Manager: Oversees the blister packing process and ensures that all sealing operations comply with the SOP.
- Packing Line Operator: Operates the blister packing machine, monitors the sealing process, and takes corrective action when necessary.
- QA Personnel: Verifies the seal integrity during and after the packing process through visual inspection and testing methods.
- Maintenance Personnel: Ensures that the blister packing machine and sealing equipment are properly calibrated and maintained to ensure consistent seal quality.
4. Accountability
The Production Manager is accountable for ensuring that the blister packs are properly sealed during the packing process. The QA department is responsible for verifying that the seals meet the specified quality standards and that any deviations are documented and addressed.
5. Procedure
5.1 Setup for Sealing Process
- Ensure that all necessary materials, including blister foils, backing materials, and seals, are available and meet the required specifications (Annexure-1).
- Inspect the blister packing machine to confirm it is clean, properly calibrated, and ready for use (Annexure-2).
- Set the sealing temperature, pressure, and dwell time according to the product’s requirements and manufacturer’s instructions (Annexure-3).
- Perform a dry run to ensure that the sealing system is functioning correctly (Annexure-4).
5.2 Sealing Process
- Load the tablets into the blister pockets and place the blister pack in the machine for sealing.
- Monitor the sealing temperature, pressure, and time throughout the process to ensure they remain within the specified range (Annexure-5).
- Ensure the blister pack is aligned properly with the machine, ensuring uniform sealing across all pockets (Annexure-6).
- Perform visual inspection of the sealed blister packs for any signs of inadequate sealing, such as wrinkles, incomplete seals, or weak spots (Annexure-7).
5.3 Quality Control and Inspection
- Conduct random sampling of the blister packs every 30 minutes to check seal strength and integrity (Annexure-8).
- Test the seals for strength by using a peel test or other appropriate method to ensure that the seals are firm and intact (Annexure-9).
- Inspect the seals for any visible defects, including misalignment, incomplete sealing, or tears (Annexure-10).
- Record all inspection results in the packaging log and immediately address any defects identified (Annexure-11).
5.4 Corrective Actions
- If any sealing defects are detected, stop the packing process immediately and investigate the root cause (Annexure-12).
- Take corrective actions such as adjusting the machine settings, replacing faulty materials, or performing maintenance on the equipment (Annexure-13).
- Re-inspect the seals after corrective actions have been implemented to ensure that the issue has been resolved (Annexure-14).
5.5 End-of-Line Procedures
- After the packing run, verify that all sealed blister packs are intact and meet the required specifications for seal integrity (Annexure-15).
- Ensure that the batch records are completed, signed, and filed for future reference and compliance audits (Annexure-16).
- Clean the packing machine and prepare it for the next batch of tablets (Annexure-17).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
- FDA: Food and Drug Administration
- QC: Quality Control
7. Documents
- Blister Packing Material Specifications (Annexure-1)
- Cleaning and Calibration Checklist (Annexure-2)
- Sealing Machine Settings Log (Annexure-3)
- Machine Dry Run Results (Annexure-4)
- Seal Strength Testing Log (Annexure-5)
- Sealing Inspection Log (Annexure-6)
- Quality Control and Inspection Logs (Annexure-7)
- Seal Integrity Test Log (Annexure-8)
- Seal Defect Report (Annexure-9)
- Packaging Logs (Annexure-10)
- Corrective Action Log (Annexure-12)
- Maintenance and Calibration Logs (Annexure-13)
- Post-Correction Inspection Log (Annexure-14)
- Final Quality Check Log (Annexure-15)
- Batch Record and QA Approval Log (Annexure-16)
- Machine Cleaning Log (Annexure-17)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- USP <1079> – Good Storage and Distribution Practices
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Blister Packing Material Specifications
| Material | Specification | Supplier |
|---|---|---|
| Blister Foil | Aluminum foil with PVC backing | PackTech Ltd. |
Annexure-2: Cleaning and Calibration Checklist
| Equipment | Calibration/Cleaning Date | Performed By | Action Taken |
|---|---|---|---|
| Sealing Machine | 01/04/2026 | John Doe | Filter replacement and system cleaning |
Annexure-3: Sealing Machine Settings Log
| Setting | Specification | Operator |
|---|---|---|
| Sealing Temperature | 180°C | John Doe |
| Pressure | 5 kg/cm² | Jane Smith |