Packaging Validation - ISO 11607
Cormica is one of the leaders in comprehensive packaging validation testing to support compliance with ISO 11607 and demonstrate the performance of sterile barrier systems for medical devices and pharmaceutical products.
Packaging validation is a critical requirement for terminally sterilized products, ensuring that packaging maintains integrity, protects sterility, and performs as intended through processing, handling, and storage. Our services generate robust, defensible data to support regulatory submissions, product release, and ongoing change control.
We work with manufacturers at all stages, from early development through to commercial supply, delivering results you can trust and timelines that support your route to market.
Our Packaging Validation Services
ISO 11607 Packaging Validation Support
Standards: ISO 11607-1
Cormica provides packaging validation testing to support compliance with ISO 11607. Testing programmes are designed to generate robust evidence that packaging systems and sterile barrier systems perform as intended throughout processing, handling, and storage.
Burst and Creep Testing
Standards: ASTM F1140
Burst and creep testing evaluates package performance under internal pressurisation. These tests assess the ability of packaging systems to withstand pressure without failure, supporting validation of seals and package strength.
Sterile Barrier System Integrity Testing
Standards: ASTM F1886, ASTM F1929, ASTM F2096, ASTM D3078, ASTM F3039
Sterile barrier system integrity testing evaluates a package’s ability to maintain sterility and prevent microbial ingress. Testing supports detection of seal defects, channel leaks, and package failures that could compromise product safety. Methods are selected based on package type, risk profile, and regulatory expectations.
Seal Strength and Peel Testing
Standards: ASTM F88
Seal strength testing assesses the consistency and robustness of package seals under defined conditions. This testing helps demonstrate that seals are strong enough to maintain integrity, while remaining suitable for opening at the point of use.
Package Integrity Testing
Standards: ASTM F1886, ASTM F1929, ASTM F2096, ASTM D3078
Package integrity testing is used to evaluate overall packaging performance and identify potential defects introduced during manufacturing or sealing processes. Testing supports packaging validation, routine verification, and investigation of seal or package failures.
Pouch and Tray Seal Integrity Testing
Standards: ASTM F88, ASTM F1140, ASTM F1886
Testing of pouch and tray seals evaluates seal quality, uniformity, and integrity across flexible and rigid packaging formats. This supports validation of packaging systems used for terminally sterilised medical devices and pharmaceuticals.
Packaging and Distribution Testing Services
Laboratories near you, supporting global product success
With accredited laboratories in the UK, EU and US, we support pharmaceutical, medical device and combination product manufacturers worldwide. Local support combined with global quality, delivered by teams who understand your regulatory requirements.
