Utilização de Métodos Estatísticos e de Análise Multivariada de Dados para melhor Compreensão de um processo da indústria farmacêutica

11/25/2022

Currently, several industries integrate Six Sigma approaches into their strategy, which in conjunction with statistical methods and multivariate data analysis (MVDA) allow the performance of processes to be understood and improved through variability reduction. In this dissertation, the Define, Measure, Analyse, Improve and Control (DMAIC) cycle approach was used to identify the problem currently having the greatest impact on the production process of an Active Pharmaceutical Ingredient (API) intermediate. The first stage of the work involved defining the problem, where it was determined that 13% of batches produced between 2019 and 2021 did not comply with the specification requirements due to two impurities: IMP682 and solvent H. Consequently, the study was limited to the analysis of these two impurities. Afterwards, the operational data was collected and analysed by univariate and multivariate statistical methods, namely by Multiple Linear Regression (MLR), Principal Component Analysis (PCA) and Partial Least Squares Regression (PLS), in order to find correlations between the two impurities and the operating variables of the unit operations under study. The obtained results allowed the conclusion that the content of IMP682 in the final product is correlated with the drying strategy used in the product final purification stage, while the amount of solvent H is related to an in-process control criterion (IPC) of the first product isolation operations. Finally, a set of improvement actions to be implemented were proposed, as well as monitoring and control strategies, in order to ensure that the requirements specified by the customer are met.

Authors in the community:

• 

  L

  Leonor Domingues Leal Baptista

  ist190478

Supervisors of this institution:

• 

  M

  Maria Joana Castelo-Branco de Assis Teixeira Neiva Correia

  ist12351

chemical-engineering - Chemical engineering

por - Portuguese

Instituto Superior Técnico