Podcast

Best Practice On Setting Health Based Cleaning Limits In A Multi-Product Facility

In this recording, PCI’s Director of Scientific Affairs David O’Connell, PCI’s Senior Development Scientist Gareth Phillips, and International Potent Compound Safety Expert Dean Calhoun, Founder and CEO of Affygility Solutions, discuss the best practices for setting and using cleaning limits within a multi-product Contract Development and Manufacturing Organization (CDMO) facility.

Elements of the discussion covered translating the Allowable Daily Exposure (ADE)/ Permitted Daily Exposure (PDE) limits into usage analytical cleaning limits and using the cleaning limits on a day to day basis for multiple equipment trains, ensuring that there is no toxicological significant carry over to the next product and the patient.

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