Procedure for Leak Testing of Sealed Containers

1) Purpose

The purpose of this SOP is to outline the procedure for conducting leak testing on sealed containers to ensure their integrity and prevent leakage of pharmaceutical products.

2) Scope

This SOP applies to all types of sealed containers (e.g., vials, ampoules, bottles) used for pharmaceutical products within the facility.

3) Responsibilities

Quality Control (QC) Department: Responsible for performing leak testing and ensuring compliance with this SOP.
Production Department: Responsible for providing sealed containers and supporting QC during testing.

4) Procedure

4.1 Equipment Preparation:
    4.1.1 Verify and calibrate the leak testing equipment (e.g., helium leak detector, bubble emission tester).
    4.1.2 Ensure all necessary accessories and consumables are available and in working condition.
    4.1.3 Perform equipment suitability checks according to validated procedures.

4.2 Sample Selection:
    4.2.1 Select representative samples of sealed containers from different batches.
    4.2.2 Ensure samples cover various container sizes, closure types, and production dates.
    4.2.3 Handle samples carefully to avoid compromising their integrity.

4.3 Leak Testing Procedure:
    4.3.1 Perform leak testing using the selected method (e.g., helium leak detection, bubble emission).
    4.3.2 Apply the testing method according to the manufacturer’s instructions and validated procedures.
    4.3.3 Record testing parameters, including test conditions, leakage thresholds, and results.

4.4 Interpretation of Results:
    4.4.1 Evaluate test results to identify any containers exhibiting leaks or breaches in integrity.
    4.4.2 Compare testing results against acceptance criteria specified in pharmacopeial standards or internal specifications.
    4.4.3 Document and investigate any deviations from expected results, including re-testing if necessary.

4.5 Acceptance Criteria:
    4.5.1 Sealed containers are considered acceptable if they pass the leak test without exceeding specified leakage limits.
    4.5.2 Ensure all testing parameters and acceptance criteria meet predefined standards.

4.6 Documentation:
    4.6.1 Record all leak testing procedures, results, and observations in the Leak Testing Record.
    4.6.2 Maintain detailed records of equipment calibration, sample selection, testing conditions, and any deviations encountered.
    4.6.3 Review and approve the documentation by QC Manager.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Leak Testing Record
Equipment Calibration Certificates
Sampling Plan Document

7) Reference, if any

USP General Chapter <1207> – Package Integrity Evaluation
Pharmacopeial standards for Leak Testing of Sealed Containers

8) SOP Version

Version 1.0