Validación del Método de Limpieza de la Emvasadora de Polvos Dos Micro Después de la Producción de Bencilpenicilina Sódica en Betapharma S.A.

Abstract

The objective of this research work is to validate the cleaning method applied in the Dos Micro Powder Packing Machine of the Betapharma S.A. Pharmaceutical Company in the city of Quito, in order to guarantee quality medicines for the consumer. The reference active ingredient used was Benzylpenicillin Sodium, whose residues were analyzed by means of an organoleptic and visual inspection according to the protocol established by the FDA (Food and Drug Administration) and whose parameters for a determination of visual sensitivity range between 400 and 2000ug/100cm2, In addition, the presence of these Benzylpenicillin Sodium residues was determined using the High Pressure Liquid Chromatography technique after the samples were taken with direct surface sampling technique or Swabbing, to adjust the analytical data obtained, the recovery factor was determined with a result of 77. 28%, which is within the acceptance criteria of 70% or higher. The results of the samples analyzed were compared with the value of the acceptable residue level (ARL), which was 0.004mg/cm2, and it was observed that all the results were below this limit. In conclusion, after establishing each requirement for the validation, the cleaning method of the Dos Micro Powder Packer after the production of Benzylpenicillin Sodium is declared validated.