Andreas Flueckiger

home / authors / andreas-flueckiger

Articles

Cleaning Limits—Why the 10-ppm and 0.001-Dose Criteria Should be Abandoned, Part II

Andreas Flueckiger;Michel Crevoisier;David G. Dolan;Ester Lovsin Barle;

August 2nd 2016

Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.

Cleaning Limits—Why the 10-ppm Criterion should be Abandoned

Allan Ader;Andreas Flueckiger;Michel Crevoisier;David G. Dolan;Ester Lovsin Barle;

January 2nd 2016

The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.