Understand challenges and limitations of the blue dye test. Compare the sensitivity of blue dye test to other methods based on a comprehensive study. - 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 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.
Our USP <1207> and ASTM (F-3287-17) recognized Mass Extraction Technology works on the principle of rarefied gas flow. Testing takes place in vacuum conditions to attain higher sensitivity. This patented technology type of testing is particularly suitable for pharmaceutical packaging such as IV-bags, pouches or glass vials. Larger defect and defects as small as
1 μm can be detected with this method. The technology is thereby suitable for laboratory applications as well as for the use in production environment allowing stability control as
well as automated 100 % testing (also in inline machines).
FDA laboratories in the US and major pharmaceutical companies have been using the Mass Extraction instruments for over 10 years.
1) American Standard for Testing and Materials
2) United States Pharmacopeia
3) American Society for Testing and Materials
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