Technology Transfer in Vaccine Production: Implementation of Physical-Chemical Quality Control and Sodium Hydroxide Purity Analysis

Abstract

The transfer of technology for vaccine production is crucial to ensuring the fight against infectious diseases on a global scale. Thus, among the various requirements for this production to be carried out safely, the implementation of quality control stands out, which involves everything from acquiring raw materials and qualifying suppliers to carrying out microbiological and physical-chemical tests. The objective of this work was to demonstrate the purity test used in the quality control of sodium hydroxide, one of the inputs acquired for the production of the RNA MCTI CIMATEC HDT vaccine. The limit of carbonates present in the sample under study was determined as described in the official compendium, obtaining results compatible with current specifications.