Bye, Bye Blue Dye: Moving on to Deterministic CCIT

1h 00m

Understand challenges and limitations of the blue dye test. Compare the sensitivity of blue dye test to other deterministic and non-destructive methods based on a study.

What is the webinar about?

As the first line of defense against the outside world, the importance of a pharmaceutical product’s primary packaging is not to be underestimated - A repeatable and proper Container Closure Integrity Test (CCIT) is essential. While relatively uncommon on a well set-up and maintained packaging line, occasional defects in the primary packaging are inevitable. It’s how a company tests, identifies, and measures them that can make the difference. 

Probabilistic methods like blue dye test have been mainly used for decades. Recently, guidelines provided by regulatory organizations like USP <1207> or EU GMP Annex 1 request statistical analysis and push for use of deterministic and non-destructive methods. 

In this webinar, we explore the current CCI testing landscape and compare blue dye test and deterministic leak testing methods (helium leak test, optical emission spectroscopy, Mass Extraction) with their unique set of advantages and limitations to determine which is fit for the future of pharmaceuticals. Furthermore, we will take a deep dive with our unique comparative study performed on more than 500 glass vials prepared with leak artifacts and taking a deeper look on: 

Evaluation of the sensitivity level of your blue dye test
Understanding of the requirements of your packaging system 
Definition of your desired test results and how you can reach it

Who should attend?

This webinar is dedicated to all working in the field of pharma and biotech: Quality Engineers, Quality Managers, Process Engineers, Project Engineers.