Container Closure Integrity Testing (CCIT)

Maintaining the sterility and integrity of pharmaceutical, biological, and medical products is critical to ensuring patient safety and product efficacy. Container Closure Integrity Testing (CCIT) is an essential process used to verify that packaging systems provide an effective barrier against potential contaminants including microorganisms, reactive gases, and particulates.

At Goodfellow, we provide a comprehensive solution for CCIT validation: the creation of controlled, calibrated micro-defects and the testing of their integrity through our advanced network of facilities. This service enables companies to validate their leak detection systems and meet stringent quality assurance requirements.

Goodfellow’s CCIT services enable clients to replicate real-world defects in packaging materials with exceptional precision. Using advanced laser microfabrication technology, we can create micro-holes as small as 1 µm* in glass and polymer containers, accurately simulating cracks, pinholes, or other imperfections encountered during production.

Each defect is tailored to customer requirements and supplied with a Certificate of Conformance and Quality Data Sheet. Our capabilities extend to a variety of packaging formats, including:

• Glass and polymer vials

• Ampoules

• Foil and blister packs

• Pouches and bags (filled or unfilled)

• Metal and sealed containers

Our hole placement accuracy, NIST-traceable calibration standards, and ISO 13485-certified processes ensure consistency, reproducibility, and traceable quality across every project.

*Dependant on material and thickness. Standard achievable target around 2 µm (tolerance +2/−1 µm)

To complement our defect creation expertise, we offer complete testing and validation capabilities through our integrated Goodfellow group facilities.

• Precision laser drilling of the defects.

• Analytical testing and verification of container closure integrity using advanced, non-destructive methodologies.

These capabilities allow us to deliver end-to-end CCIT support, from the creation of calibrated standards to the validation of closure integrity performance.

Our CCIT solutions serve industries where package integrity and sterility are mission-critical:

• Pharmaceuticals – Validation of vial and syringe closure systems

• Medical Devices – Packaging verification for sterile products

• Biotechnology – Testing of containment systems and diagnostic cartridges

• Food & Packaging – Quality control for sealed packaging and barrier materials

By combining the expertise and capabilities of our different facilities, we provide a single, trusted source for CCIT services, ensuring consistent quality, validated performance, and fast turnaround times.

Benefits include:

• Controlled defects down to 2 µm (tolerance +2/−1 µm); 1 µm precision achievable for certain materials and thicknesses

• ISO 13485-certified processes

• NIST-traceable calibration

• Realistic defect simulation for accurate testing

• Rapid project turnaround

• Comprehensive documentation and traceability

Whether you require calibrated micro-defects for CCIT validation, or a fully integrated testing and analysis program, Goodfellow provides the expertise and global infrastructure to support your quality assurance needs.