Standard Operating Procedure for Seal Integrity and Leak Testing

1) Purpose

The purpose of this SOP is to establish procedures for testing the seal integrity and leakage of packaging for pharmaceutical products to ensure product sterility and quality.

2) Scope

This SOP applies to all personnel involved in the packaging and quality control of pharmaceutical products within the manufacturing facility.

3) Responsibilities

3.1 Packaging Operators

• Perform seal integrity and leak tests according to approved procedures.
• Document test results accurately.

3.2 Quality Control (QC) Analysts

• Verify and validate seal integrity testing methods.
• Review and approve test results.

4) Procedure

4.1 Seal Integrity Testing

1. Select representative samples for testing.
2. Perform visual inspection of seals for defects or irregularities.

4.2 Leak Testing

1. Apply appropriate test methods (e.g., dye penetration, pressure decay).
2. Interpret test results to determine leakage.

4.3 Documentation and Reporting

1. Record seal integrity and leak test results in batch records.
2. Document any deviations or non-conformities.

5) Abbreviations, if any

SOP: Standard Operating Procedure; QC: Quality Control

6) Documents, if any

• Seal Integrity Testing Protocols
• Leak Test Reports
• Batch Record Documentation

7) Reference, if any

ISO 11607: Packaging for Terminally Sterilized Medical Devices
USP General Chapter <1207>: Sterile Product Packaging – Integrity Evaluation

8) SOP Version

Version 1.0