Setting up a stability test plan for vial products can be a daunting task with many variables to consider. Additionally, the array of options available for Container Closure Integrity (CCI) Testing can be confusing. This webinar on Stability and CCI testing aims to clarify these processes and help you make informed decisions for your vial products.
The presentation will start by outlining the basics of establishing a stability test plan for rigid containers. Key topics will include selecting appropriate aging conditions and determining the testing frequency. Understanding these fundamentals is essential for ensuring that your vial products remain stable and effective over their intended shelf life.
We will then delve into the different methods for Container Closure Integrity Testing. Probabilistic methods and deterministic methods are two primary approaches, each with its own advantages and applications. The webinar will explain how these methods differ and provide guidance on choosing the right one for your specific product needs.
In addition, we will cover the common CCI test options as outlined in USP 1207. This includes a detailed discussion of each method, its principles, and its applications. By understanding these options, you can better evaluate which method is most suitable for ensuring the integrity of your vial products.
The webinar will conclude with an overview of the basics of CCI method validation. Proper validation is critical to ensure that the chosen testing method reliably and accurately detects any breaches in container closure integrity. This final section will provide practical tips and best practices for validating your CCI testing methods.
By attending this webinar, you will gain a comprehensive understanding of how to set up a robust stability test plan and navigate the complexities of CCI testing. This knowledge will help ensure that your vial products meet regulatory standards and maintain their quality throughout their shelf life.