Quality Risk Management and the Future of Container Closure Integrity


Free On-Demand Webinar


Join us for this webinar on Quality Risk Management and the Future of Container Closure Integrity Testing


Meet the Presenter

Oliver Stauffer



This 45-minute webinar (including Q & A) covers the following topics:


Dye ingress continues to be used to assess container closure integrity within the pharmaceutical industry. While newer more reliable solutions are available in the market space, validating alternative methods while dye ingress is in place seems daunting. Regulatory documents, including Annex 1 and USP 1207, provide explicit guidance on container closure integrity.


This presentation reviews:

  • How dye ingress and other technologies fit into the frameworks provided by regulatory bodies
  • Critical aspects to the dye ingress test method and how other test methods may compare in performance
  • Key approaches to validating a system, performing test method transfer and how regulatory bodies view test method adaption.


Dye ingress has maintained a legacy position within pharmaceutical quality.  Understanding all technology options and applying an effective Quality Risk Management (QRM) approach to container closure integrity will create the most effective path forward.

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Packaging Technologies & Inspection

PTI offers inspection systems for package leak testing, seal integrity and container closure integrity testing (CCIT). Our technologies exclude subjectivity from package testing, and use test methods that conform to ASTM standards. PTI's inspection technologies are deterministic test methods that produce quantitative test result data. We specialize in offering the entire solution including test method development and equipment validation.