Container Closure Integrity Testing (CCIT) USP <1207>
Dye and microbial ingress testing have long been employed for assessing the integrity of container-closure systems. However, research and experience have shown such tests are limited in their ability to provide accurate, sensitive, and reliable data for definitive container-closure integrity verification, especially for packages that demand the highest degree of product protection. With the advent of new technologies, various sensitive and quantitative test methods have been developed to bring package integrity testing into the 21st century.
Whitehouse Laboratories’ Container Closure Integrity division is proud to offer numerous state- of-the-art options for assessing package system integrity, including all required instrumentation for deterministic test methods as outlined in proposed revisions to USP <1207>. Services range from routine testing to in-depth method development and validation. The CCIT Lab at Whitehouse provides expert-level services specifically tailored to the client and the package system.
Container Closure Integrity test programs established at Whitehouse Laboratories have been successfully used 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 for product commercialization around the world.
Whitehouse Laboratories operates a “Container Testing Center of Excellence”. The entire business unit brings multiple levels of experience to each container testing program. Staff members with specific areas of expertise are always available to consult on your testing needs.