PDA Metro: The CCIT Toolbox

The Metro Chapter of PDA is proud to present The CCIT Toolbox- One Size Does NOT Fit All in-person event.

Abstract

Ensuring the container closure integrity of parenteral pharmaceutical products is vital to protecting and maintaining quality throughout the shelf life of a sterile drug product.  As a result of recent increases in the variety of container closure systems, including the use of prefilled syringes and autoinjection devices, testing techniques for container closure integrity have had to be modified and/or redeveloped.  In addition to this variety, there have been calls to perform 100% deterministic testing, which requires non-destructive techniques.

While dye ingress has been widely used for years because of familiarity, low capital cost, and ease of use, it is destructive and non-deterministic. 

This presentation provides an overview of CCIT techniques, the advantages and challenges of each, along with an in depth look on how dye ingress testing has evolved.  In addition, we will present studies to demonstrate the applicability of using different CCIT techniques for various applications.

Speakers

• Elizabeth Moroney
• Jessica Hankins, PhD
  Microbiology Center of Excellence, Bristol Myers Squibb, New Brunswick, NJ