Extractable and Leachables and Container Closure Integrity Testing

Ensuring the safety of your drug product throughout its entire lifecycle is becoming increasingly complex. As regulatory expectations continue to evolve, assessing substances that may leach from packaging materials into your product is more critical than ever. These substances can migrate from various materials and expose patients through different routes of administration, potentially impacting product safety, stability, and efficacy.

Our workshop is designed to support you in navigating these challenges. You will gain practical insights into pharmaceutical packaging testing and learn how to implement effective strategies that help you safeguard your products and meet regulatory requirements with confidence.

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• Extractables & Leachables and Container Closure Integrity Testing:
  Comprehensive overview of Container Closure Integrity Testing (CCIT) technologies and their selection based on product and packaging characteristics. The session also covers packaging–product compatibility, material assessment strategies, and recent updates from USP <382>, highlighting their impact on system-level functional testing and regulatory expectations.  
  
• Risk-based approach for E&L determination:
  This session explains how to build a robust E&L program using a risk-based approach to prioritize activities and resources. While offering a broad discussion on relevant pharmacopeia chapters such as USP 1663, 15664, 1665 and 665, we will also be discussing the emerging ICH Q3E chapter and the path toward adoption and implementation of this new chapter. 
  
• Extractables: Regulatory requirements and experimental design:
  Detailed guidance on designing extractables studies using worst-case and high-coverage conditions to maximize compound detection. The session addresses the use of orthogonal solvents, stress conditions, and tailored experimental workflows for different applications including pharmaceutical packaging, combination products, and single-use systems.  
  
• Toxicological risk assessment in E&L workflow:
  An in-depth look at the role of toxicological assessment within the E&L workflow, focusing on interpreting analytical results and supporting risk-based decisions. The session covers derivation of PDE, TTC, and AET values, and strategies to identify and manage critical impurities to ensure patient safety.  
  
• Leachables: Regulatory requirements and experimental design:
  This session focuses on the design of Leachables studies using both real-time and accelerated conditions to simulate product lifecycle scenarios. It includes considerations for lifecycle monitoring, analytical method development and validation, and ensuring long-term product safety, stability, and regulatory compliance. 
  
• Strategies to optimise testing and timelines:
  Practical strategies to streamline E&L programs by reducing testing burden and shortening timelines without compromising scientific quality. Topics include the use of equivalency matrices, expert-driven justifications, elimination of redundant studies, and effective project planning to accelerate decision-making and execution. 
  

Date and Location:

Date: 9th June 2026
Time & Location: 8.30 AM - 5 PM, Grefis Hotel, Lohenstraße 5, 82166 Gräfelfing (Munich), Germany
Registration Fee: Free
Workshop Language: ENGLISH

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