Desarrollo de un protocolo de validación de operación y desempeño para un sistema de ventilación mecánica en la planta inyectables de Ropsohn Laboratorios S.A.S, de acuerdo con la normatividad vigente

Abstract

This degree work focuses on the formulation and development of a validation protocol for a mechanical ventilation system in the field of the pharmaceutical industry. The project aims to establish the guidelines, tests and criteria necessary to validate a mechanical ventilation system in accordance with the standards and regulations in force in the pharmaceutical industry. The pharmaceutical laboratory Ropsohn Laboratorios S.A.S in its injectable plant helped as a real scenario to implement the validation protocol. The study will be enriched by an analysis of previous degree projects in similar situations, which will allow best practices to be adapted to this specific context. During the application of the validation protocol of the mechanical ventilation system in the pharmaceutical plant, favorable results were obtained in the viable and non-viable particle count tests, measurement of supply and air extraction grilles, as well as in the measurement test. of air pressure differentials, among other tests carried out. These results corroborate the effectiveness of the validation protocol in this critical process. Each of the tests carried out was rigorously adjusted to the criteria established in the protocol and complied with current regulations. Once the validation of the mechanical ventilation system is completed, these results validate the solidity and reliability of the validation protocol used in this project, ensuring comprehensive compliance with current regulations, providing a complete vision of the achievements and challenges faced in the process. Ultimately, this work seeks to improve quality and safety in the pharmaceutical industry by implementing a validated and efficient mechanical ventilation system, in line with current regulations and practices in the validation of critical systems.