An in-depth discussion on the challenges to USP 1207 CCI Testing for IV Bags.

While being a generally high-volume package configuration used for decades, the application of deterministic container closure integrity test methods to these flexible, often large volume systems, has increased in recent years. A combination of increased adoption of current industry best practices, changing regulation, and a proliferation of small-batch cell and gene therapies stored, processed, or transported in these packages has in turn yielded increased inquiries regarding deterministic test method validation. However, flexible bags have numerous challenges they present for the application of CCI tests.