Validação de limpeza de equipamentos multipropósitos da linha de manipulação de comprimidos por granulação úmida: caso da furosemida.

As an integral part of the set of good practices in medicine fabrication, the purpose of cleaning validation is to guarantee the removal of remains of newly manufactured products and thus avoid cross-contamination. This article presents an approach to cleaning validation for the compounding of solid pharmaceutical forms by wet granulation. The method is demonstrated for furosemide, a diuretic drug, fabricated in the form of tablets by Lafepe® (Recife, PE, Brazil), in a multipurpose production line. To analyze drug residues left in the equipment after cleaning, samples were collected from surfaces by swab and traces of furosemide were quantitated by spectrophotometry and by a high performance liquid chromatography method developed and validated at the Lafepe® laboratories. To detect residues of detergent used in cleaning, the pH and conductivity of the inal rinsing water were measured and compared with those of known dilutions. The acceptance cleaning limit of the active principle was 8.26 µg mL-1 of furosemide in the subsequent product and for the detergent it was 10 ppm in the last rinse of the equipment. The results showed that the residues of contaminants found in the equipment after cleaning were below the acceptable limits, which certiies the effectiveness and security of the cleaning practices in this company. [ABSTRACT FROM AUTHOR]