Webinar: Understanding E&L and Particulate Contamination Risks in Drug Delivery Devices
Medical device materials, components and packaging can play an important role in product safety, particularly where devices come into contact with pharmaceutical formulations.
For manufacturers of pre-filled syringes, injection systems and other drug delivery devices, understanding potential chemical interactions and particulate contamination risks is an important consideration during product development and validation.
Understanding the risks associated with materials and device components
As part of Cormica's Impurities Testing Webinar Series, our analytical chemistry specialists explore the assessment of extractables and leachables (E&L) and particulate contamination in pharmaceutical products and drug delivery systems.
Key topics include:
- How chemicals may migrate from product-contact materials into pharmaceutical formulations.
- The draft ICH Q3E guideline and its risk-based approach to E&L assessment.
- How component degradation and material interactions may contribute to particulate contamination.
- The 2026 updates to USP <788> and considerations for particulate testing.
- Practical testing approaches and case studies involving injectable and inhalation products.
Connecting device performance with chemical safety
At MET, physical and functional testing, packaging validation and chemical characterisation help manufacturers evaluate device safety and performance.
Across Cormica, additional analytical chemistry expertise supports the investigation of chemical impurities and particulate contamination, helping manufacturers build a more complete understanding of potential product risks.
For medical device engineers, R&D teams, quality professionals and manufacturers working with pharmaceutical combination products, this webinar offers useful insight into the analytical considerations that can influence product development and regulatory assessment.
Explore the webinar: From Regulation to Application: Best Practices in Extractables & Leachables and Particulate Contamination
