Procedure for Container Closure Integrity Testing

1) Purpose

The purpose of this SOP is to outline the procedure for conducting container closure integrity (CCI) testing to ensure the integrity of sealed containers used for pharmaceutical products.

2) Scope

This SOP applies to all pharmaceutical products packaged in containers sealed with closures (e.g., vials, ampoules, bottles) within the facility.

3) Responsibilities

Quality Control (QC) Department: Responsible for performing container closure integrity 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 container closure integrity testing equipment (e.g., vacuum decay tester, high voltage leak detector).
    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 Container Closure Integrity Testing:
    4.3.1 Perform container closure integrity testing using validated methods such as vacuum decay or high voltage leak detection.
    4.3.2 Apply the testing method according to the manufacturer’s instructions and validated procedures.
    4.3.3 Record testing parameters, including pressure differentials, test duration, and results.

4.4 Interpretation of Results:
    4.4.1 Evaluate test results to determine if any containers exhibit 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 container closure integrity test without evidence of leaks.
    4.5.2 Ensure all testing parameters and acceptance criteria meet predefined standards.

4.6 Documentation:
    4.6.1 Record all container closure integrity testing procedures, results, and observations in the Container Closure Integrity 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
CCI: Container Closure Integrity

6) Documents, if any

Container Closure Integrity Testing Record
Equipment Calibration Certificates
Sampling Plan Document

7) Reference, if any

USP General Chapter <1207> – Package Integrity Evaluation
Pharmacopeial standards for Container Closure Integrity Testing

8) SOP Version

Version 1.0