Abstract

CHUY-RAMON, Lianet; ZUMALACARREGUI-DE CARDENAS, Lourdes; LOBAINA-RODRIGUEZ, Tamara  and  PEREZ-DE LA CONCEPCION, Humberto. Improvement of the aseptic filling process for the production of recombinant hepatitis vaccine. Vaccimonitor [online]. 2021, vol.30, n.1, pp. 18-26.  Epub Feb 01, 2021. ISSN 1025-0298.

National Center for Biopreparations must increase the production of the recombinant hepatitis B vaccine because of its growing demand. In order to fulfill this challenge, the aseptic filling process required an investment. This work, presents the selection of the new filling machine and the economic indicators that support the investment. Inversion cost is recovered in the fourth year with a profit equivalent to $2,655,300. After the investment, the performance of the new machine was compared with the previous one. Volume dispensed per vial, filling speed, operational performance, major defects detected in filling batches, average filling time for a batch, production cost and payments to customers due to rejected products were compared. The control of the volume dispensed per vial is more accurate, reducing product losses. The filling speed increases 1.7 times compared to the previous machine. Operational performance increases by 13.63%. Product rejections are reduced by 40,897 vials, saving $24,538 for the 73 batches. Electricity consumption diminished, saving $14,718 monthly. The unit cost of the filling process decreases by $0.0648/vial.

Keywords : vaccines; hepatitis B; technology.

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