On-Demand Webinar

Risk Based Assessment of Extractable and Leachable Substances from Single-Use Systems

Duration: 1 Hour
Speaker: Ross Acucena Regulatory Consultant, Merck

Abstract: Adoption of Single-use systems and components within pharmaceutical manufacturing processes is increasing. The motivations for implementing single-use technologies are numerous including reduced capital cost, reduced risk of contamination, smaller environmental footprint, and faster changeovers. Despite the many advantages of single-use technologies many drug manufacturers continue to view the assessment of extractable and leachable substances as a primary factor restricting their adoption of single-use technologies. This presentation will discuss the application of a systematic, risk-based rationale combining standard worst-case test methods with appropriately chosen analytics and known toxicological thresholds to investigate the impact of extractables and leachables in a pharmaceutical process. A practical and scientific treatment of the assessment of extractable and leachable substances will be demonstrated through case studies for a variety of single-use components and systems employed in various unit operations.

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