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: