USP<382>: Achieving Optimal Injectable Packaging Performance
USP<382> introduces a systems-thinking approach to injectable packaging, shifting from isolated component testing to holistic system evaluation. In this webinar, Aptar Pharma experts Laure-Hélène Guillemot and Pavan Hemmege Venkatappa will explain the new regulatory requirements, emphasize the critical role of collaboration with glass manufacturers to ensure container closure compatibility, and present case studies that highlight the importance of defining end-use conditions to develop effective functional testing strategies.
USP<382>: A Systems Thinking Approach to Achieve Optimal Primary Packaging Performance
The pharmaceutical industry is entering a new era of packaging qualification with the introduction of USP <382>, a regulation that redefines how injectable drug packaging is evaluated. Aptar Pharma’s webinar, “USP <382>: A Systems Thinking Approach to Achieve Optimal Primary Packaging Performance,” led by Technical Product Managers Laure-Hélène Guillemot and Pavan Hemmege Venkatappa, explores what this change means for pharmaceutical companies and how to adapt effectively.
Building on previous standards, USP <382> replaces parts of USP <381> and shifts the focus from testing individual components, such as stoppers, vials, plungers, and needle shields, to validating the injectable drug’s entire packaging system under real-world conditions. This holistic approach considers critical factors like storage temperature, multi-dose usage, and compatibility with glass containers. Packaging performance directly impacts drug safety and reliability, and under the new regulation, responsibility for compliance moves from suppliers to pharmaceutical companies, making collaboration across the supply chain more important than ever.
To help companies navigate these changes, the webinar introduces the main updates brought by USP <382> and provides actionable guidance for implementation. Rather than relying on isolated tests, companies must now adopt system-level evaluation and validation strategies. Our experts share practical insights on how to meet these requirements, supported by case studies that illustrate the impact of real-world conditions—such as deep cold storage—on container closure integrity and overall packaging performance. These examples highlight why robust, system-based testing is essential to ensure safety and reliability throughout the product’s lifecycle.
In alignment with USP<382>, Aptar Pharma is dedicated to providing comprehensive support that facilitates compliance, enhances packaging performance, and upholds drug safety. Through close collaboration with glass manufacturers, Aptar Pharma is committed to delivering data packages developed using validated methodologies consistent with USP<382> guidelines. These resources support pharmaceutical companies in the identification and validation of packaging solutions, while also facilitating efficient regulatory submission processes.
By attending the webinar, pharmaceutical professionals gain a clear understanding of the evolving regulatory landscape and practical strategies for compliance, empowering them to confidently navigate USP<382> and advance the safety and reliability of injectable products.
