Multi product CDMO Facility – Best Practices on Setting Health-Based Cleaning Limits

Listen now and find out about Setting Health-Based Cleaning Limits in a Multi product CDMO Facility

Recorded May 13, 2021

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 discussing the best practice for setting and using cleaning limits within a multi-product CDMO facility.

Elements of the discussion covered translating the Allowable Daily Exposure (ADE)/ Permitted Daily Exposure (PDE) limits into usage analytical cleaning limits, 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.

Multi product CDMO Facility - Best Practice on Setting Health-Based Cleaning Limits


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