Container Closure Integrity Testing

The safety and efficacy of any biopharmaceutical/pharmaceutical product is inextricably linked to its packaging integrity, where no material can enter or leak from the sealed container. Container closure integrity testing (CCIT) evaluates the adequacy of container closure systems to maintain a barrier against potential contaminants (microorganisms, gases etc.) throughout the product shelf-life.

As an industry leader in container testing (USP, EP and JP) we provide full pharmaceutical and medical device package testing for the drug industry, testing all aspects of your container closure systems:

• Primary packaging components: those components that come into direct contact with the product, such as a glass vial, septa, stopper, syringe plunger or barrel or flexible packaging like a bag
• Secondary packaging components: those that are vital to ensure correct package assembly, such as aluminum caps over stoppers or over packaging to protect the packaged product

Why choose container closure integrity testing from SGS?

Our container closure integrity testing services can help you to ensure the quality and protection of your packaged drug product and our testing includes:

• Conventional dye ingress
• Bubble emission test
• High voltage lead detection (HVLD) – detects leaks in containers made with non-conducting electrical insulating materials and where the sample is a conducting solution. This testing is also suitable for higher concentration biologic and vaccine type products
• Vacuum decay – for any containers with conductive, non-conductive solutions or lyophilized products in either; ampules, vials, syringes and flexible product packaging
• Laser headspace analysis for moisture, oxygen, carbon dioxide
• Microbial ingress tests – to evaluate the ability for any bacteria to enter the packaging to contaminate it
• Sterility testing to confirm primary and secondary package effectiveness

Comprehensive container testing services from a leading provider

As a world-leading provider of services to the pharmaceutical industry, we offer you unrivaled experience in container testing. With our global reach and extensive network of laboratories, we can help you to ensure the quality and protection of your drug products with fast results, a local service and global expertise.

To discuss your container testing requirements, contact us today.