FREE WEBINAR

 

Join this webinar hosted by PTI and Amscorp Scientific.

 

PTI and Amscorp have joined forces to revolutionize container closure integrity testing in the Australia/New Zealand region with cutting-edge knowledge and products.  

 

Meet the Presenters:

 

Noba Ebaid, PTI

Global Manager,

Automation & Strategic Partners 

 

 

Anthony Georgiadis, Amscorp Scientific 

Sales Director 

This 1 hour 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.

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.