Selecting the correct deterministic ccit method for your container closure system

Pharmaceutical products and medical devices are expected to be free from microbial contamination and safe to use from production through the end of their shelf-life. A container closure system needs to be able to contain the product without leaks while also providing a barrier to keep harmful materials from reaching the drug product. Due to the variety of product/packaging configurations and regulations, there is no one method of container closure integrity testing (CCIT) that can test all products. Per USP <1207> there are multiple techniques that can be used for CCIT; and determining the best method for a product requires understanding of the product being tested and the technique being employed.

The purpose of this webinar is to: