A risk-management approach to cleaning-assay validation

The authors evaluate the effect of roughness average, material of construction, acceptance limit, molecule properties, and method variability on the observed recovery of a compound during cleaning validation. The authors also recommend a strategy for classifying similar nonstainless-steel surfaces into three groups based upon the analytical recovery that was observed in this study. The strategy includes a way of classifying new or uncommon surfaces into the groups. The authors believe that their approach improves efficiency and compliance during the swabmethod validation of product-contact surfaces. [PUBLICATION ABSTRACT]