Navigating Regulatory Expectations For Injectable Packaging

USP <382>, Annex 1 Extractables, and Packaging Readiness for RABS/Isolator Filling Lines

The pharmaceutical landscape is shifting. With heightened regulatory focus, a deep understanding of the relationship between packaging science, contamination control, and component performance is essential.

Find timely, practical insights into extractables and how they intersect with major regulatory updates: the revised EU GMP Annex 1, the newly mandatory USP <382>, and the increased use of Vaporized Hydrogen Peroxide (VHP) for decontamination in aseptic manufacturing.

Effective December 1, 2025, the official implementation of USP <382> for Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems marks a significant change. The burden has moved from the component supplier to the drug manufacturer, who is now accountable for verifying the functional suitability of elastomeric components (like stoppers and plungers) within their final packaging and delivery systems. This demands a closer look at how components behave under actual system conditions, including exposure to required sterilization and decontamination processes.

Simultaneously, the revised Annex 1 mandates a more integrated, holistic approach to quality via the Contamination Control Strategy (CCS). Packaging components must be included in the CCS. The regulation emphasizes using extractables and leachables (E&L) data for risk assessment, particularly for components used in modern aseptic lines (like RABS and isolators) where VHP is a common decontamination agent.

This session provides clarity on these complex topics, equipping you with the knowledge to ensure compliance and mitigate risk.

• USP <382>: Learn how the standard defines and tests for functional suitability across vials, cartridges, and prefilled syringes.
• Annex 1 Compliance: Understand the specific role of extractables data in meeting the requirements of the CCS.
• Component Selection: Gain practical considerations for choosing packaging components that can withstand VHP decontamination without performance degradation.
• Analytical Support: See how West's analytical capabilities can be leveraged to support your regulatory alignment and risk mitigation efforts.

Whether you work in regulatory affairs, quality assurance, or technical operations, explore the essential knowledge and tools to confidently navigate today's complex regulatory landscape and make informed decisions about packaging component selection.