Cleaning validation procedure eased by using overpressured layer chromatography

In the manufacturing plants of many pharmaceutical companies the reaction a pparatus is suitable to produce different active pharmaceutical ingredients . After completing the production of a compound the equipment should be cle aned in order to avoid the cross contamination in the next lot of the other products. In the authors' laboratory several chromatographic methods were introduced to measure the amount of the residual substances remaining on th e surface of the apparatus after the cleaning procedure. A sensitive and fa irly rapid overpressured layer chromatographic (OPLC) procedure - suitable to separate and control five steroid hormone compounds (allylestrenol, estr adiol, ethynodiol diacetate, levonorgestel, norethisterone) produced in the same equipment at different times was developed and validated. (C) 2000 El sevier Science B.V. All rights reserved.