Abstract

GARCIA DIAZ, Nuria; PADRON YAQUIS, Alejandro; MATEU, Liliana  and  ALBERTUS JIMENEZ, Ivonne. Development and validation of a methodology for cleaning areas of production of penicillamine tablets Development and validation of a methodology for cleaning areas of production of penicillamine tablets. Rev Cubana Farm [online]. 2005, vol.39, n.1, pp.1-1. ISSN 0034-7515.

A cleaning methodology was developed to be used in production and development areas, where work with penicillamine is done. It is a highly contaminating and toxic compound. A method was validated by high performance liquid chromatography that was selected due to the versatility of this type of techniques for detecting traces. The method proved to be specific, lineal, accurate and precise in the range of working concentrations. The limits of detection and quantification were determined. The sampling method by brushing was used and satisfactory results were attained. It was concluded that the cleaning procedures were effective for the worst of the settings

Keywords : Penicillamine; validation; cleaning validation.

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