We offer Container Closure Integrity (CCI) techniques and analysis for various packaging and delivery systems to meet the needs of pharmaceutical, biotech and medical device manufacturers.
Our CCI analytical group has the technology, expertise and insight to provide a thorough understanding of container closure systems. Our programs extend from package development to market launch through lifecycle management. In addition, we can support your sample testing needs for cold storage CCI testing.
ZebraSci has a complete and comprehensive understanding of packaging components and delivery systems that are commercially available for drug-device combination products.
EU GMP annex 1
Effective August 2023, the updated Annex 1 sets strict expectations for container–closure integrity:
- CCIT is mandatory for sterile products—no exceptions.
- Requires validated methods supported by a scientifically justified sampling plan.
- Visual inspection alone is no longer acceptable as an integrity test.
USP <382> and USP <1207> chapters
Effective December 2025, the new USP <382> chapter is reshaping integrity testing requirements for container–closure systems:
- System-level integrity testing of the final packaging system is now mandatory.
- For these tests, USP <382> points directly to USP <1207>, which strongly recommends deterministic methods—such as helium leak detection, high-voltage leak detection, vacuum decay or laser headspace —over traditional probabilistic (dye ingress).
FDA expectations are evolving: increasing requests for results from a deterministic method, in addition to legacy dye ingress tests.
Deterministic CCIT isn’t just best practice—it’s becoming the regulatory standard. These methods deliver quantifiable, reproducible results, reduce risk, and help you stay ahead of compliance requirements.
If you need more information, contact us
VIEW CAPABILITIES
High Voltage Leak Detection (HVLD)
Helium leak detection
Vaccum decay leak detection
Dye ingress
Headspace analysis
