Saying Goodbye to Blue Dye: How to Navigate the Changing World of CCIT



A comparative study of different container closure integrity test methods on packaging for pharmaceutical products.

What is the whitepaper about?

The importance of leak testing in the world of pharmaceuticals is well-understood, and a range of different methodologies have been devised to test container closure integrity. The blue dye ingress test is a popular example but more sensitive and deterministic options include helium mass spectrometry, Mass Extraction, and optical emission spectroscopy.

This whitepaper explores the current CCI testing (CCIT) landscape and compares probabilistic and deterministic leak testing methods to determine which is fit for the future of pharmaceuticals. It includes a comprehensive scientific review comparing the detection limits of each method. In addition, we share the findings of our unique comparative study of more than 500 glass vials prepared with leak artifacts.

Who should read it?

The whitepaper is aimed at experts and decision-makers working in the field of pharma and biotech: Quality Engineers​, ​Quality Managers​, ​Process Engineers​, ​Project Engineer​s.