A single adulteration limit for cleaning validation: in a pharmaceutical pilot-plant environment

Authors :: Forsyth, Richard J.
Leblanc, Alain
Voaden, Mark
Source :: Pharmaceutical Technology. January 2007, Vol. 31 Issue 1, p74, 6 p.
Publication Year :: 2007
Abstract: An adulteration limit of 100 µg/25[cm.sup.2] (4 µg/[cm.sup.2]) was proposed for pilot-plant facilities. The dynamic changes in equipment, formulation, and residue determination made implementation of a constantly changing, calculated adulteration [...]

Subjects :: Machinery -- Maintenance and repair -- Methods -- Research
Drug factories -- Maintenance and repair -- Research
Magneto-electric machines -- Maintenance and repair -- Methods -- Research
Cleaning -- Methods -- Research -- Maintenance and repair
Business
Pharmaceuticals and cosmetics industries
Maintenance and repair
Research
Methods

Tools