Navigating USP <382> & Annex 1 Compliance for Injectable Packaging

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As the pharmaceutical industry faces increasing regulatory scrutiny, understanding the intersection of packaging science, contamination control, and component performance has never been more critical. This webinar brings together timely insights on extractables, with a focus on how they relate to the revised EU GMP Annex 1, new and evolved expectations under USP <382>, and the growing use of VHP decontamination in aseptic manufacturing environments.

With the official implementation of USP <382> on December 1, 2025, drug manufacturers are now responsible for verifying the functional suitability of elastomeric components within their final packaging and delivery systems. This shift from supplier-led testing to manufacturer accountability demands a deeper understanding of how packaging components behave under real system, under real system conditions, conditions, including exposure to sterilization and decontamination processes. At the same time, Annex 1 has introduced a more holistic approach to contamination control, requiring manufacturers to develop a Contamination Control Strategy (CCS) that includes packaging components. The regulation emphasizes the importance of extractables and leachables data as part of risk-based decision-making, especially for components used in RABS and isolator-based filling lines, where Vaporized Hydrogen Peroxide (VHP) is commonly used for in-line decontamination.

Key takeaways:

  • USP <382> Implementation Requires System-Level Validation
  • Annex 1 Elevates the Role of Extractables in Contamination Control
  • VHP Decontamination Can Impact Elastomeric Component Integrity
  • Data-Driven Packaging Decisions Support Compliance and Risk Mitigation

Presenters - Will Parker

Will Parker

Manager, Extractables & Leachables Technology

Will Parker serves as the Extractables & Leachables (E&L) Technology Manager at West, where he provides strategic and technical support across multiple teams on E&L-related initiatives. With over 20 years of experience in the pharmaceutical and medical device sectors, Will has held a range of scientific and leadership roles, including positions in container closure integrity testing and quality assurance. His previous roles include Director at BA Sciences, Laboratory Supervisor at GSK, and Senior Chemist at Eurofins, reflecting a strong foundation in analytical chemistry and regulatory compliance. Will holds a Bachelor’s degree in Chemistry and a Master’s degree in Data Analytics, both from Penn State University, USA. He is a frequent speaker at industry conferences focused on E&L and medical devices, and actively contributes to the AAMI Biological Evaluation Committee, participating in Working Groups 1 and 14, which focus on the testing and evaluation of medical devices.
Presenters - Dr. Bjoern Henze

Dr. Bjöern Henze

Manager, Technical Customer Support

Dr. Bjöern Henze brings over 20 years of life sciences experience to his role as Manager of Technical Customer Support for Europe at West Pharmaceutical Services. He holds a Ph.D. in Biotechnology from the University of Braunschweig and has held key positions in sales and technical support at Operon Biotechnologies and Macherey-Nagel. Based in Germany, Dr. Henze is a recognized expert in packaging technologies for rubber components, offering deep technical insight and customer-focused solutions across the pharmaceutical sector.
Presenters - Peter Cao

Peter Cao

Senior Technical Account Specialist

Peter Cao is a Senior Technical Specialist on the Technical Customer Support team at West, supporting customers across North America with expert guidance on product selection and performance. Since joining West in August 2021, Peter has been instrumental in delivering technical insights related to component recommendations, as well as the company’s manufacturing processes that ensure the safety and quality of injectable pharmaceutical products. He brings over 10 years of experience in biomedical engineering and technical support, including a prior role at Siemens. Peter holds a bachelor’s degree from Penn State University, USA and a master’s degree from Drexel University, both in Biomedical Engineering.
Moderator - Dr. Marc Uerdingen

Dr. Marc Uerdingen

Director, Technical Customer Support, EU

Dr. Marc Uerdingen serves as Director of Technical Customer Support for Europe at West Pharmaceutical Services, bringing over 20 years of expertise in the life sciences and pharmaceutical sectors. He earned his Ph.D. in Organic Chemistry from the University of Dortmund and has authored more than 30 scientific publications and patents. Throughout his career, he has held leadership roles in R&D, business development, and customer engagement at companies such as Merck KGaA, Covestro, and Axplora. Based in Germany, Dr. Uerdingen is known for his strategic insight in healthcare market development and scientific project management.