Abstract

CASTILLA VALENTIN, Lisseux; HEVIA SANTAMARINA, Zulema; DIAZ DE ARMAS, Miriam  and  WALKER GOMEZ, Irene. Validación de la limpieza del reactor empleado en la preparación de medicamentos. Rev Cubana Farm [online]. 2001, vol.35, n.1, pp.34-39. ISSN 0034-7515.

At present, the validation of the processes is an imperative necessity of the Medicopharmaceutical Industry to guarantee the quality of its products and to commercialize them. To this end, the cleaning of the equipment began to be validated and the validation of the cleaning of the SEN reactor that is used for the preparation of injections was carried out. To attain this goal, a working methodology was designed, the most appropiate analytical methods were selected, the acceptance criteria were established and a validation protocol was written that was the fundamental working tool. Later on, the validation of the cleaning of the reactor was made and it was concluded that although the cleaning procedure does not guarantee the total elimination of the residuals of the product, it fulfills the established acceptance criteria.

Keywords : EQUIPMENT AND SUPPLIES; DRUG QUALITY; TECHNOLOGY, PHARMACEUTICAL; EQUIPMENT CONTAMINATION; DRUG CONTAMINATION; DRUG COMPOUNDING; AMIKACIN.

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