Why and How to Replace Dye Ingress Test by Deterministic CCIT Methods?
What is the webinar about?
- How is the blue dye working (parameters, limits, etc.)
- Sensitivity of blue dye vs. defect geometry
- Comparative study with Optical Emission Spectroscopy, Mass Extraction and Helium
- Select the right method to replace your blue dye
Repeatable and prober Container Closure Integrity Testing of primary packaging 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 <1207> or EU GMP Annex 1 request statistical analysis and push for use of deterministic and non-destructive methods.
You will learn more about the results of a unique comparative study performed on more than 500 glass vials prepared with leak artifacts (microtubes and glass micropipettes), which refers to Kirsh 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 your needs (R&D, Production, Quality) the results will help you to find the right method to replace your blue dye test in order to follow the latest guidelines.
Who should attend?
The webinar is dedicated to people from the pharmaceutical industry and medical technology: quality assurance, quality management and engineering.