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Tuesday, August 9, 2011

Statistically Justifiable Visible Residue Limits
The standard of visual cleanliness is commonly applied to the evaluation of surface contamination. Numerous published studies have examined the visually clean standard as a means of verifying cleaning effectiveness in pharmaceutical manufacturing, and methods for the quantitation of visible residue limits (VRLs) have been provided. Current methods for establishing VRLs are not statistically justifiable, however. The author proposes a method for estimating VRLs based on logistic regression.
Visually clean (VC), a term that refers to inspection with the naked eye, is a common cleanliness standard employed for evaluating surface contamination and cleaning in high-technology manufacturing, including that of pharmaceuticals, where surface cleaning is of utmost importance. The importance of the VC standard for pharmaceutical manufacturing is evident in the following facts:
M. Ovais
Pharmaceutical Technology, Mar 2, 2010


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