Introduction:

The Covid-19 pandemic has measured the response, adaptation and research capacity of chemical and pharmaceutical industry. Worldwide, pharmaceutical companies launched the race for a vaccine development. However, some micro, small, medium and large enterprises have adapted to meet the increase in disinfection products demand. A process requires quality assurance from the design phase, thereby reducing the number of defective products in the operation phase and adapting to market requirements.

Objective:

To design a production process for a hydroalcoholic gel, which meets quality specifications using artisanal alcohol as raw material.

Materials and Methods:

A procedure was used that considers product quality from conceptual design. It uses the guide to the expression of uncertainty in measurement (GUM) to determine the uncertainty of operational parameters.

Results and Discussion:

In the applied case study, carbopol concentration of 0.34 to 0.45 and pH of 5.07 to 6.16 were determined as the operational range, thus the quality attribute is within the specification limits and a sigma level higher than three is achieved, resulting in a productivity superior than 95 %.

Conclusions:

Reducing the uncertainty of operational variables standardizes the product viscosity and allows a better understanding of the process operational parameters. It is ensuring compliance with its quality attribute from the design phase.

        · resumen en Español     · texto en Español     · Español ( pdf )