Abstract

RIVERON ALEMAN, Yamilka et al. Validation of critical features of Surfacen production. Rev Cubana Farm [online]. 2009, vol.43, n.2. ISSN 0034-7515.

Surfacen^® is a drug used in treatment of newborn respiratory distress syndrome, a significant cause of neonatal mortality and morbidity. This drug is manufactured by National Center of Farming and livestock Hygiene (La Habana, Cuba) under a Management System of Quality and Good Practices of Manufacture. Pig lung is the essential raw material, and it is from microbiologic quality and that of productive process, that a free of microbial contaminant and pyrogen end product is guaranteed. From design of specific protocols and of the available regulations, it was demonstrated that pig breeding, its sacrifice process, and materials used in achievement of lung lavages, allow us to obtain a defined microbiologic quality and under control. Production process was able to eliminate microbial charge present in lung lavages, which together with the remainder preparation tasks of sterile materials, its transfer, use, as well as cleaning and disinfection of clean areas, the aseptic filling, and staff guaranteed sterility of end product. All these results allow us to conclude that the critical processes of Surfacen^® production are validated and guarantee that this one be sterile, pyrogen-free, and without toxic residuals, demonstrating its safety, reproducibility and consistence.

Keywords : Surfacen; lung surfactant; newborn respiratory distress syndrome; processes validation; phospholipid; natural product; pig lung.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )