Articles by Mark Voaden - Pharmaceutical Technology

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Articles by Mark Voaden

Mark Voaden

Mark Voaden is head of service for validation and compliance for facilities with Merck, Sharp & Dohme in the United Kingdom.

A Single Adulteration Limit for Cleaning Validation in a Pharmaceutical Pilot-Plant Environment
January 2, 2007

An adulteration limit of 100 ?g/25cm? (4 ?g/cm?) was proposed for pilot-plant facilities. The dynamic changes in equipment, formulation, and residue determination made implementation of a constantly changing, calculated adulteration limit impractical. A single adulteration limit was simpler to communicate and document, making compliance achievable. The limit would be used only after it was determined to be lower than a health-based evaluation and a visual-cleanliness assessment.


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