Sánchez-González A, Hernández-González GR

Idioma: Ingles.
Referencias bibliográficas: 28
Paginas: 1221-1225
Archivo PDF: 477.20 Kb.

RESUMEN

El sistema para la detección de la fenilcetonuria (UMTEST^® PKU) en recién nacidos, se produce en el Centro de Inmunoensayo (CIE, La Habana, Cuba). La L-leucil-L-alanina, uno de los componentes del diagnosticador, requiere ser liofilizado debido a su limitada estabilidad en solución acuosa. La utilización de las técnicas de Análisis Térmico Diferencial/Impedancia (ATD/Zsinφ) y la liomicroscopía permitieron definir que en la liofilización de este reactivo, la congelación requiere ser realizada a temperaturas inferiores a –30 °C, mientras que en el secado primario la temperatura del frente de sublimación no puede sobrepasar el valor de temperatura de colapso (Tc) de –18.9 ºC. La liofilización de tres lotes a escala industrial, ejecutada con el procedimiento diseñado según los resultados de las determinaciones previamente descritas, garantizó la obtención de un producto acorde a las especificaciones de calidad, con una reducción del 32 % en el tiempo total del ciclo.

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