How Non-Destructive Headspace Analysis Advances Container Closure Integrity Testing

By Derek Duncan, Director, Product Lines, Lighthouse Instruments

With the continued growth of sterile injectable pharmaceutical products to treat unmet medical needs, chronic diseases, and global health crises, drug sponsors must activate rigorous quality control and risk management measures to ensure that these products are safe and efficacious upon reaching patients. This requires the activation of protocols that maintain product quality, efficacy, and sterility throughout manufacture, transport, and storage. Container closure integrity testing (CCIT) is a critical implement to guarantee that a product is securely sealed and protected from contamination and/or degradation throughout its shelf life.

As regulatory guidance on CCIT evolves to emphasize testing throughout the full product lifecycle, drug sponsors are looking for methods that offer rapid, reliable, and data-driven results for container closure systems. Non-destructive headspace analysis has become an appealing option, thanks to its sensitivity and flexibility across a range of containers. Download the full article to explore the benefits of leveraging non-destructive headspace analysis to secure your CCI data and ensure compliance with global regulators.