CCIT Comparative Study Between Dye Ingress Test And Deterministic Methods

By Dr. Philippe Bunod, Julien Palisson, Jean-Charles Mougin Côme Sciard, Yannick Poirier and Lukas Engel

Repeatable and proper container closure integrity testing (CCIT) of primary packaging is essential to ensure the quality and effectiveness of pharmaceutical products. The blue dye test and microbial ingress method have been used for decades. Recently, guidelines provided by regulatory organizations, such as USP <1207> or Annex 1, request statistical analysis and push for the use of deterministic and nondestructive methods.

A unique comparative study was conducted on more than 500 glass vials prepared with leak artifacts (microtubes and glass micropipettes), which refers to Kirsch and Burrel’s studies. Each sample has been tested with different technologies, including the Helium Leak test, Optical Emission Spectroscopy, Mass Extraction, and the Blue Dye test. Explore the results of the study to find a suitable deterministic test method to replace the blue dye test and follow the latest guidelines.