Validación del método de limpieza aplicado a la ruta de fabricación de tabletas de matico en el Laboratorio NEOFÁRMACO del Ecuador Cía. Ltda.

Abstract

The Laboratory Neofármaco of Ecuador is a pharmaceutical company, which stands out for producing a wide variety of products, especially based on natural active ingredients, one of its natural products is the box of Matico tablets, made from Matico extract as API (Aristiguietia glutinosa), which, having flavonoids among its compounds, acts as an anti-inflammatory, antifungal and gastroprotective. However, Neofármaco, being a drug manufacturing company, must comply with good manufacturing practices (GMP) for its correct operation, standards established by the WHO, FDA and ARCSA. One of the many standards they must comply with is to validate their cleaning processes, mainly to avoid cross-contamination and microbiological contamination, especially if the same areas and equipment are used to manufacture different products. For the same reason, the cleaning validation of the Matico tablet manufacturing route has been carried out. It was demonstrated that the cleaning process does not leave soap residues, through the analysis of traces of detergent, and visual verification was also carried out. For sampling through the swabbing method, the characteristics of the swab were determined: absorption capacity (0.3401 mL), absence of swab interference, recovery test 96.54 percent, determination of the acceptance limit (75 ppm). On the other hand, in the analysis of samples, it was determined that the limit is not exceeded, in addition, no microbiological contamination was witnessed.