Acceptable daily exposure (ADE) values and their application to cleaning validation

Acceptable daily exposure (ADE) values are an essential component of determining the amount of maximum safe carryover (MSC) in a multi-product pharmaceutical manufacturing facility. In this episode of Whiteboard Friday, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions discusses ADEs (PDEs) and their application in Cleaning Validation. For the purpose of this discussion, the term ADE, used in ISPE's Risk-MaPP Baseline Guide, is synonymous with Permissible Daily Exposure (PDE) used in the European Medicines Agency's "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities." If you need a qualified toxicologist to determine an ADE, please visit oelfastrac.com to checkout our entire catalog of OEL/ADE monographs that are available for purchase and instant download. If your specific compound is not listed please complete the contact form affygility.com/contact/ and we will get back to you within 24 hours.

• #science_technology
• #acceptable_daily_exposure
• #ade
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• #pde
• #pharmaceutical_manufacturing
• #emea
• #affygility
• #toxicologists
• #cleaning_validation