Standard Operating Procedure for Leak Testing of Sealed Containers

1) Purpose

This SOP outlines the procedures for conducting leak testing of sealed containers to ensure integrity and quality of packaging for pharmaceutical products.

2) Scope

This SOP applies to the leak testing of sealed containers used for pharmaceutical products, including vials, ampoules, and prefilled syringes.

3) Responsibilities

The Quality Control (QC) department is responsible for performing leak testing. Production personnel are responsible for preparing containers for testing. Quality Assurance (QA) oversees the process and ensures compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Equipment Setup

1. Review the leak testing protocol and ensure all necessary equipment is available (e.g., leak testing apparatus, vacuum chambers, pressure gauges).
2. Verify the calibration and functionality of testing equipment.

4.2 Preparation of Containers

1. Prepare the sealed containers according to the testing protocol.
2. Ensure containers are clean and free from external contamination.

4.3 Leak Testing Procedure

1. Place the sealed containers in the leak testing apparatus or chamber.
2. Apply a specified pressure differential (positive or negative) across the container.
3. Monitor for any pressure drop over a defined period to detect leaks.
4. Record the testing parameters, including pressure differentials and testing duration.

4.4 Acceptance Criteria

1. Compare the test results against the acceptance criteria defined in the testing protocol.
2. Ensure that containers meet specified leak rate limits.

4.5 Rejection and Rework

1. Identify and segregate containers that fail the leak test.
2. Initiate retesting or rework procedures as per approved protocols.

4.6 Documentation

1. Document all leak testing activities, including results and any deviations, in the appropriate logbooks and records.
2. Prepare a leak testing report summarizing the findings for each batch tested.

4.7 Reporting and Record Keeping

1. Review and approve the leak testing report to ensure accuracy and compliance with regulatory requirements.
2. Maintain records of all leak testing activities as per regulatory guidelines and internal procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6) Documents, if any

Leak Testing Protocol, Testing Records, Leak Testing Reports, Rejection and Rework Records

7) Reference, if any

Regulatory guidelines such as USP <1207> Sterile Product Packaging – Integrity Evaluation, USP <1601> Packaging Integrity Evaluation, European Pharmacopoeia (Ph. Eur.) 2.2.6 Closure Systems for Containers for Aqueous Parenteral Preparations, Ph. Eur. 2.2.38 Integrity of Sealed Containers

8) SOP Version

Version 1.0