Container Closure Integrity Testing (CCIT)
Expert Integrity Testing for Sterile Medical and Pharmaceutical Packaging
Container Closure Integrity Testing (CCIT) is used to verify that packaging systems maintain integrity and protect product sterility throughout their lifecycle. This testing plays a critical role in sterility assurance, product release, and investigation of packaging failures for medical devices and pharmaceutical products.
With decades of experience in packaging and integrity testing, Cormica supports manufacturers worldwide with robust, science-led CCIT services. Our expert scientists apply proven deterministic and probabilistic methods to generate reliable, defensible data that stands up to technical and regulatory scrutiny.
Container Closure Integrity Testing (CCIT) Services and Methods
A range of Container Closure Integrity Testing (CCIT) methods is available to assess container and package integrity across flexible and rigid packaging systems. Method selection is guided by packaging format, product risk, sensitivity requirements, and intended application.
Deterministic Container Closure Integrity Testing (CCIT) Methods
Deterministic methods deliver quantitative, repeatable measurements of package integrity and are widely recognised as best practice for integrity verification.
Pressure Decay Testing
Assesses integrity by measuring pressure loss over time and is commonly applied to rigid containers and sealed packaging systems.
Vacuum Decay Testing
Used to detect leaks in flexible and rigid packaging by monitoring pressure changes under controlled vacuum conditions. Suitable for a broad range of sterile packaging formats.
Hydrogen Leak Detection
A highly sensitive tracer gas technique used to identify very small leaks and quantify leak rates where defined sensitivity limits are required.
Probabilistic Container Closure Integrity Testing (CCIT) Methods
Probabilistic methods provide qualitative insight and are often used during development, troubleshooting, or as complementary techniques.
Bubble Emission Testing
A visual method for identifying gross leaks under vacuum conditions.
Microbial Ingress Testing
Used to assess resistance to microbial penetration under defined conditions, supporting integrity investigations where appropriate.
Blue Dye Ingress Testing
Container Closure Integrity Testing Compliance & Regulatory Standards
Our CCIT services comply with global regulatory requirements, ensuring your products meet the highest industry benchmarks:
- USP <1207> – General guidance on CCIT for parenteral products.
- ISO 11040-4 – Pre-filled syringes (PFS) integrity testing.
- ISO 8871-5 – Elastomeric parts for parenteral packaging.
- ISO 8362-2 – Injection containers and accessories.
Why Choose Cormica for Container Closure Integrity Testing
Decades of experience in packaging and integrity testing underpin every CCIT project. Our teams include highly experienced scientists who understand both the technical and regulatory expectations associated with sterile packaging.
- Proven expertise across medical device and pharmaceutical packaging
- Deterministic and probabilistic CCIT methods available
- Quantitative data suitable for regulatory and technical review
- Fast, reliable turnaround to support development and release timelines
- Global support across the Cormica laboratory network
This combination of experience, technical depth, and international reach ensures consistent, high-quality results wherever your product is manufactured or supplied.
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.
