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Webinar On-Demand

Annex 1 in Practice: How Component Design and Manufacturing Support Your Contamination Control Strategy

In this webinar, experts will demonstrate how primary packaging component design, manufacturing controls, and supplier documentation directly support your contamination control strategy under EU GMP Annex 1 — with practical tools for mapping CCS requirements to component-level controls, sharpening supplier qualification, and closing audit readiness gaps before inspectors find them.

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White Paper 2026 Report

Double Sterilization in Pharmaceuticals: The Impact of Annex 1 on Component Strategy

Since the 2022 revision of EU GMP Annex 1, double sterilization has emerged as a new compliance standard for injectable packaging — but combining RTU components with terminal sterilization creates real complexity in method selection, component performance, and validation strategy. This report examines how Annex 1 is reshaping sterilization decisions for elastomeric components, from steam vs gamma trade-offs and cumulative irradiation effects on plunger functionality, to the validation data requirements manufacturers must plan for from day one.

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White Paper 2026 Report

Vial Packaging for the Biologics Market: Trends, Requirements, and Solutions

Biologics are projected to reach $881 billion in sales by 2030, yet their structural complexity makes packaging one of the most critical variables in drug safety and efficacy. This report examines the unique challenges of vial packaging for biologics — from extractables and leachables to lyophilization and regulatory compliance — and how advanced stopper technologies are engineered to meet them.

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