Abstract

HERNANDEZ-MARTINEZ, Alexander; VIZCAINO-ZABALLA, Rebeca; RIOS-DUQUE, Joel  and  GASMURI-GONZALEZ, Caridad. Control of purified water supplied to the ABDALA vaccine. Rev Cub Quim [online]. 2022, vol.34, n.3, pp. 403-421.  Epub Oct 24, 2022. ISSN 2224-5421.

The control of parameters and quality attributes in water systems is a permanent objective to guarantee the quality of pharmaceutical products, such as vaccines. The objective of this work is to control the quality of purified water supplied to the production of the Active Pharmaceutical Ingredient of the Abdala vaccine against the SARS-CoV-2 virus causing Covid 19. The methodology was structured as follows: establishment of sampling points, execution of tests, data processing and evaluation of trends in compliance with quality specifications. The conductivity results were below 1,3 µS/cm, the Total Organic Carbon between 8,16 and 200 µg/L, and the mesophilic aerobic count remained between 0 and 20 cfu/mL, with the absence demonstrated of pathogenic microorganisms, which allowed to ensure that the Purified Water System the supply to Abdala's production, remain with a state of control during monitoring time .

Keywords : active pharmaceutical ingredient; vaccines; control; processes; purified water.

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