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

Published in: Pfeiffer Vacuum

Published on: February 3, 2023

Abstract Repeatable and proper Container Closure Integrity Testing of primary packaging’s is essential to ensure quality and effectiveness of pharmaceutical products. Blue dye test and microbial ingress are mainly used for decades. Recently, guidelines provided by regulatory organizations like USP or Annex 1 request statistical analysis and push for use of deterministic and non-destructive methods.

The following presents the results of a unique comparative study conducted on more than 500 glass vials that are prepared with leak artifacts (microtubes and glass micropipettes), which refers to Kirsch and Burrel’s studies. Each sample has been tested with different technologies: Helium Leak test, Optical Emission Spectroscopy, Mass Extraction and Blue Dye test. Depending on the needs (R&D, Production, Quality) the results can help the reader to find a suitable deterministic test method to replace the blue dye test and follow the latest guidelines.

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