From Regulation to Application: Best Practices in Extractables & Leachables and Particulate Contamination Webinar
This is the third instalment in our impurities webinar series. See part 1 on elemental impurities & residual solvent assessment, and part 2 on nitrosamines and polymorphic impurities.
Everyone is welcome for part 3, whether you attended the previous sessions or are joining us for the first time.
Join us for a webinar exploring how to assess and control extractables and leachables (E&L) and particulate contamination in pharmaceutical products and drug delivery systems. With a focus on the draft ICH Q3E guideline and the 2026 updates to USP <788>, our experts will connect regulatory expectations with practical testing strategies that support patient safety and product quality.
Drawing on Cormica’s decades of analytical testing experience supporting clients worldwide, our chemistry specialists will guide you through E&L study design and the investigation of foreign particulate matter. Practical examples and case studies will bring the science to life, showing how analytical testing can help assess chemicals migrating from product contact materials and identify particles associated with device component degradation.
Whether you’re developing a new product or investigating a contamination concern, this session will help you understand which analytical approaches to consider and how to turn results into informed decisions. The webinar will conclude with a live Q&A, giving you the opportunity to put your questions directly to our experts.
Why attend?:
By attending this webinar, you will:
- Understand the evolving E&L framework: Explore the draft ICH Q3E guideline and its implications for study design and risk assessment throughout the product lifecycle.
- Connect analytical results with patient safety: Learn how chemical identification, patient exposure and toxicological assessment work together to evaluate potential leachables.
- Navigate particulate testing: Understand the 2026 updates to USP <788> and how sample characteristics influence the choice of testing method.
- Investigate contamination sources: See how microscopy and Raman spectroscopy can help identify foreign particles and investigate their origins.
- Learn through practical examples: Explore analytical challenges involving injectable and inhalation products, with lessons to inform your own testing strategy.
Authors:
Luminita Moraru is Medical Device Chemistry Technical Lead at Cormica Bradford, with extensive experience in Extractables &; Leachables (E&L), chemical characterisation and biocompatibility. An expert committee member for ISO 10993 and ISO 18562, she specialises in designing studies to support medical device safety assessments and regulatory compliance.
Ayoob Patel is a Technical Leader with over 25 years’ experience in analytical chemistry, specialising in GC-MS, residual solvents and Extractables & Leachables (E&L) testing. His expertise includes GMP method development and validation, with particular experience in the chemical assessment of medical devices and wound dressings.
Katy Dickinson is a Senior Scientist and has worked in the Physical Characterisation team at Cormica Bradford for over 5 years following a Physics degree and PhD. With a passionate interest in nanoparticle characterisation, including DLS and NTA, she also leads on sub-visible particle / foreign particulate matter testing.
Caroline Aiken is Technical Director at Cormica, with over 15 years’ experience in pharmaceutical testing, specialising in complex generics and analytical characterisation. Having led the Physical Characterisation team for eight years, she now drives technical excellence and collaboration across Cormica’s global laboratories.
Who should attend?
This webinar will be particularly useful for professionals working with pharmaceutical products and drug delivery systems, including:
- Regulatory Affairs and CMC Professionals
- Quality Assurance and Quality Control Teams
- Analytical Development and E&L Scientists
- Formulation and Pharmaceutical Development Scientists
- Packaging and Drug Delivery Device Specialists
Register today to strengthen your approach to E&L and particulate contamination with practical insight from Cormica’s experts.
Cormica’s mission is to improve patients’ lives by providing comprehensive testing services, enabling clients to launch and release their products safely and rapidly across the world.
With Cormica as your partner, you can confidently outsource your impurity testing to a laboratory with deep regulatory knowledge and technical expertise. Whether you are developing a new drug product, conducting a risk assessment for existing formulations, or responding to updated ICH guidelines, our team is here to support your analytical needs. Contact us to discuss how we can assist with your impurity profiling strategy at sales@cormica.com