Standard Operating Procedure for Sealing Integrity Testing

1) Purpose

The purpose of this SOP is to define the procedure for conducting sealing integrity tests on packaging materials to ensure the integrity and safety of pharmaceutical products.

2) Scope

This SOP applies to the sealing integrity testing of packaging materials used in pharmaceutical packaging processes within the facility.

3) Responsibilities

3.1 Quality Control (QC) Personnel

• Perform sealing integrity tests according to approved procedures.
• Record and report test results accurately.

3.2 Production Operators

• Prepare samples for sealing integrity testing under controlled conditions.
• Assist in conducting tests and interpreting results.

4) Procedure

4.1 Sample Preparation

1. Select representative samples of packaging materials for testing.
2. Prepare samples according to specified dimensions and conditions.

4.2 Sealing Integrity Test Setup

1. Set up the testing equipment according to manufacturer’s instructions.
2. Calibrate equipment and sensors as per calibration schedule.

4.3 Testing Process

1. Place samples in the testing chamber or apparatus.
2. Apply pressure or vacuum conditions as required for the test.
3. Monitor and record any leaks or failures in seal integrity.

4.4 Evaluation of Results

1. Analyze test results to determine the integrity of seals.
2. Document findings and categorize results as pass or fail.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

• Sealing Integrity Test Protocol
• Test Results Log

7) Reference, if any

USP Chapter 1207: Package Integrity Evaluation — Sterile Products
FDA Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics

8) SOP Version

Version 1.0