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Tuesday, August 9, 2011

Correlation of Visible-Residue Limits with Swab Results for Cleaning Validation

The use of visual inspection as a criterion for equipment cleanliness has always been a component of cleaning validation programs. Mendenhall proposed the use of only visual examination to determine equipment cleanliness as long ago as 1989 (1). He concluded that visible cleanliness criteria were more rigid than quantitative calculations and clearly adequate. The US Food and Drug Administration limited the use of visually clean criterion between lots of the same product (2). LeBlanc raised the question of whether a visible limit as the sole acceptance criterion could be justified (3).
A visible-residue limit (VRL) currently is used in a clinical pilot plant for the introduction of new compounds (4, 5) in cases for which the VRL is lower than the acceptable-residue limit (ARL). The ARL is the amount of a formulation component that can be carried over to the next formulation with no pharmacological or adulteration concerns. The initial use of an active pharmaceutical ingredient (API) in the facility is followed by cleaning and a visual inspection against the previously determined VRL. Visually clean equipment means the current cleaning procedure is effective and the new API is not a new worst case that would require cleaning validation.
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Richard J. Forsyth , Julia Roberts , Tara Lukievics , Vincent Van Nostrand
Pharmaceutical Technology, Nov 2, 2006


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