News And Announcements

This first webinar is intended for participants of all experience levels. Historic regulatory language surrounding container closure integrity testing has led to the pervasive misconception that package integrity is specifically tied to prevention of microbial ingress, in turn creating challenges for the industry. Regulatory requirements and guidance set forth by USP <1207> and EU Annex 1, along with industry action, however, have expanded this definition.

This presentation seeks to impart upon participants an understanding of the changing CCI regulatory landscape (past, present, future) over the past decade or more, including the pitfalls of historical, probabilistic methods such as microbial ingress. Through this review, participants shall also gain a fresh perspective for reconsidering CCI requirements through the lens of the 1999 Container Closure Systems FDA Guidance.

In an attempt to adopt a modern, deterministic CCI method, companies are presented with the challenge of choosing a method for the given product-package system. Often, there is a strong desire to choose a single technology to be employed across a product’s lifecycle, or even across a product line.

This second webinar, best for those with a basic understanding of CCI, or those who have completed the first webinar, aims to provide a high level understanding of each of the deterministic technologies listed in USP <1207>, with honest, experience-based discussion around their relative uses, advantages, and disadvantages. Examples of how the product, package, or study goals can impact CCI method selection will be discussed, and a case example of an auto-injection system presented.

While regulatory authorities and professional organizations such as the PDA continue to develop best practices and new guidance, the act of applying these guidance documents in the real world can be a bit abstract. This third webinar seeks to build on the information presented earlier in the series by candidly discussing common questions and challenges when implementing CCIT, including overall testing strategy, appropriate use of positive controls, acceptable limit of detection, and test sample size.

This presentation does not seek to provide concrete answers, but instead equip participants with perspectives and information to make informed decisions. A portion of the webinar will be dedicated to participant review, directly addressing thematic questions arising from earlier webinars, or from pre-webinar participant questionnaires.