In the evolving landscape of pharmaceutical packaging, ensuring the integrity and functionality of Container Closure Systems (CCS) requires a shift from isolated component testing to a holistic, system-based approach, highlighted by the USP<382> implementation. This presentation explores how systems thinking enhances the qualification of primary packaging for injectable drugs, bridging the regulatory & qualification requirements to real-world performance expectations.
The presentation will also highlight the importance of cross-functional collaboration, particularly with glass manufacturers, to align rubber and glass components in a system context, enabling better risk assessment and performance prediction.
Finally, we have dedicated a section of the webinar to presenting insights that traditional methods may overlook—specifically, the impact of ambient and ultra-low temperatures on container closure integrity (CCIT) evaluations and the resulting implications for testing reliability.
This system-based approach supports compliance with regulatory expectations and derisks product functionality in real-world conditions.
Key Learning Objectives
- Introduction of the System Thinking Approach Introduced by USP<382>.
- Demonstrate, through a case study on pre-filled syringe (PFS) and vial systems, the critical importance of identifying end-use conditions to develop appropriate functional testing strategies.
- Highlight the role of collaboration between glass manufacturers and rubber component providers in ensuring container closure compatibility.
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