Resumen

FRAGA-GOMEZ, José Carlos  y  MAYO-ABAD, Orestes. Formulation of the Heberpenta-L Vaccine in an Automatic Aseptic Processing System. RTQ [online]. 2014, vol.34, n.1, pp. 71-81. ISSN 2224-6185.

The present work describes the operations carried out in order to dedicate the automatic aseptic processing system Steridose, installed in the Parenteral Products Plant 2 at the National Bioproducts center, to formulate the polyvalent Heberpenta-L vaccine. This project objective is to increase the production capacity as a result of the rising demand of such product. Steridose is a system initially designed and dedicated to the formulation of the Anti hepatitis B recombinant vaccine since its start up in 1999. The dedication change of this system required the operations and processes validation in the new functions. The formulation process was designed in such a way that all the solutions and active principles additions were to be performed aseptically and that the exposure time of the product in each step of the procedure was to be reduced to a minimum. El scope of this work applies up to the production of the first three batches, which were formulated complying with all the established quality assurance requirements, made evident by the results obtained on everyone of the formulated bulks. This also demonstrated the personnel's qualification and the potential of the plant to deal with this production.

Palabras clave : formulation; active principle; Heberpenta-L; validation; aseptic processing.

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