How to Switch from a Probabilistic to a Deterministic Approach for Your Container Closure Integrity Testing

Overview

Over the past two decades, industries have seen a huge number of regulatory changes. These can be found in: 

• FDA Guidelines for Industry (2008), which replaced sterility testing with container closure integrity testing (CCIT) 
• USP Chapter (2019), which details the processes companies should follow when carrying out packaging integrity assessments for sterile products 
• EMA Annex 1 (2020), which outlines the appropriate manufacturing process for sterile medical products 

With these changes in mind, companies need to start using  a deterministic approach for any new pharmaceutical product or medical device they take to market. 

This new deterministic approach is more sensitive, more accurate and more non-restrictive, and helps ensure more reliable results during stability studies. 

Objective

Daniel Tatarsky will moderate a  discussion, with our panel of experts, on how clients can easily switch from a probabilistic to a deterministic approach. The panel will then review the different options for implementing a deterministic container closure integrity testing (CCIT) strategy based on regulatory guidelines – with a focus on vacuum, helium, and high voltage – and discuss how to choose the best methods. 

Agenda

• Introduction 
• Compare probabilistic and deterministic approaches 
• Review the different methods CCIT and its applications 
• Q&A