Container Closure Integrity Testing  

Specialized in Performance Testing of Pharmaceutical Packaging, Medical Device Packaging, Drug-Device Combination Product Packaging & Select Consumer Product Packaging  

Employ our container closure integrity (CCI) testing programs to provide accurate, sensitive, and reliable data regarding your product packaging performance. This information enables you to characterize packages and materials, optimize sealing parameters, evaluate package storage temperature impact, replace sterility tests for product stability batches, screen production lots for faulty packages, and support regulatory submission applications. Our testing is well suited for assisting your team in maintaining sterile packages that demand the highest degree of product protection to ensure safety and efficacy for the end patient.   

We offer numerous sophisticated programs for assessing package system integrity, including all crucial instrumentation for deterministic test methods as outlined in USP <1207>. Our services range from feasibility assessments to full method optimization and validation programs to stability program storage and routine testing.  

Our cGMP, FDA-registered Container Closure Integrity laboratory for USP <1207> technologies is powered by unparalleled experience, leading-edge test approaches, and advanced industry standards to ensure you have a quick and stress-free testing experience. 

 

CCI Test Methods 
  • Vacuum Decay Leak Detection – Method reference: ASTM F2338-09 

  • Helium Leak Detection – Method reference: ASTM F2391 

  • High Voltage Leak Detection 

  • Laser-Based Gas Headspace Analysis 

  • Dye Ingress Leak Detection 

  • Microbial Ingress Leak Detection 

 Testing the integrity of your container closure system is critical to ensure product compliance. Between high voltage leak detection, vacuum leak detection, and helium leak testing, we support a wide range of endpoints for optimal finished product protection. 

Ready to Get Started? Connect with our team to discuss your testing and development needs. 

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