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Updated: Nov 18, 2025

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
Published on: August 11, 2017
Improved clearance verification
Robert A Meck1, Jonatan Jiselmark2,3
1Science and Technology Systems, LLC, 9408 Corsica Drive, Bethesda, MD 20814-2814, United States of America.
Abstract:
This paper describes clearance as the sum of fractions (SOF) inequality with acceptable probability. We include scenario modelling uncertainties in SOF calculations. An illustrative contrast of results with and without the modelling uncertainties shows the differences in the probabilities that the standards were met. We present two methods for calculations, the analytical approach, GUM, and the Monte Carlo (MC) method. We prefer the MC. Inclusion of the scenario uncertainties can provide improved assurance that people are adequately protected. An example that used data from a Swedish reactor is included.
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