Container Closure Integrity Test

Container Closure Integrity Test detects the presence of communication between the contents of the container and its outside environment to determine if there is a leak (or fluid path) between the contents of a container and its surrounding. It assesses both the unwanted release of contents in a container and the possibility of contamination by solids, liquids or gases.

STEMart provides destructive and non-destructive container closure integrity tests to help manufacturer avoid contamination of product.

• Destructive and Probabilistic Tests
• Dye ingress testing

The dye ingress testing is designed to validate the leak of container by detecting the presence of dye inside the container which is placed in a chamber applied with a vacuum visually or by spectroscopy.

• Microbial ingress testing

The microbial ingress testing is designed to validate the leak of container by identifying the microbiological contamination of the content in the container after immersing it in the fluid containing microbes. It also can use powder coated in bacteria to dry the container.

• Bubble test



The bubble test is suitable to detect the leak of sterile medical device packaging. In this test the container is held underwater and a vacuum applied above the water.

• Non-Destructive and Deterministic Tests
• High voltage leak detection

The high voltage leak detection is designed to check the leak of packaging by detecting a voltage differential caused by the leaks when applying a high voltage and high frequency charge across the container.

• Vacuum decay test

The vacuum decay test is designed to detect the leak of container by measuring the flow required to maintain the vacuum of closed fitting tool in which containers are placed at a fixed level.

• Pressure decay

The pressure decay test is designed to detect the leak of container by measuring the flow required to maintain the pressure of closed fitting tool in which containers are placed at a fixed level.

• Headspace gas analysis

The headspace gas analysis is quite suitable for ampoules and vials that have a gas space above the solid or liquid contents. This test validates the leak of container in the submicron range by analyzing the gas inside the container through measurement of absorption of laser light and specific wavelengths.

• Tracer gas detection (vacuum mode)

The tracer gas detection (vacuum mode) is able to detect the leaks as small as 0.2 microns by quantitating the flow rate of helium or hydrogen from leaks in container after having been charged with helium or hydrogen as a tracer gas with mass spectrometer.

• Tracer gas detection (sniffer mode)

The tracer gas detection (sniffer mode) is used to locate the leaks of container by scanning across a test part which has been 'soaked' in hydrogen or helium in a saturation chamber with gas sensor.

• Mass extraction leak test

The mass extraction leak test provides a faster, easier, more efficient and more accurate way to check the leak of container. Just place the container under vacuum in a mass extraction test instrument, and then compare the mass flow values with the predetermined leak threshold.

STEMart provides comprehensive container closure integrity test to support manufacturers to meet the regulatory goals, and minimize the compliance risks. If you have any additional questions about Container Closure Integrity Test or would like to consult with the experts at STEMart, please feel free to contact us.

Reference

1. "Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility, Testing as a Component of the Stability Protocol for Sterile Products," U.S. Food and Drug Administration, 2008