Abstract

DIAZ, Imeray; VILLEGAS, Maikel  and  HIDALGO, Luis Carlos. New methodology for the formulation of the vaccine Heberpenta-L. Rev. colomb. biotecnol [online]. 2014, vol.16, n.1, pp.99-103. ISSN 0123-3475.  https://doi.org/10.15446/rev.colomb.biote.v16n1.44250.

The vaccine Heberpenta-L, is suitable for the active immunization against the diphtheria, tetanuses, ferocious cough (pertussis), hepatitis B and Haemophilus influenzae type b. In the National Center of Bioproducts a new plant of production of products parenterals was designed, being the vaccine pentavalent one of the recently introduced products. With such a purpose a new methodology was designed for the formulation of the vaccine, adapting the procedures effective operation normalizative to this new installation. The validation with cultura medium broth triptone soy was one of the most important stages to guarantee, so much the sterilization operations and cooling of the solutions, as all the critical steps in the formulation and aseptic operations for future products. A new methodology settled down in the formulation process for the preparation of the solutions, which took place in an independent locate to the locate of the final formulation of the product. The satisfactory results obtained in the formulation of three batch of consistency of the vaccine Heberpenta-L, they guaranteed the execution of the established requirements of quality for this vaccine and constituted the preliminary base to long campaigns of other products.

Keywords : pentavalent vaccine; parenteral; production.

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