Aplicação de ferramentas de análise de riscos para qualificação de equipamentos das principais operações unitárias de uma planta de produção de biomassa recombinante

• Ano de defesa: 2018
• Autor(a) principal: Herrera, Miguel Angel de La O
• Orientador(a): Costa, Antonio Carlos Augusto da
• Banca de defesa: Langone, Marta Antunes Pereira , Alberton, André Luis , Matos, Denise Cristina de Souza , Testoni, Irene Maria , Macedo, Elizabeth Valverde
• Tipo de documento: Tese
• Tipo de acesso: Acesso aberto
• Idioma: por
• Instituição de defesa: Universidade do Estado do Rio de Janeiro
• Programa de Pós-Graduação: Programa de Pós-Graduação em Engenharia Química
• Departamento: Centro de Tecnologia e Ciências::Instituto de Química
• País: BR
• Palavras-chave em Português: Risco; HAZOP; FMEA; biotecnologia; qualificação; biomassa recombinante
• Palavras-chave em Inglês: Risk; HAZOP; FMEA; biotech; qualification; recombinant Biomass
• Área do conhecimento CNPq: CNPQ::ENGENHARIAS::ENGENHARIA QUIMICA::OPERACOES INDUSTRIAIS E EQUIPAMENTOS PARA ENGENHARIA QUIMICA
• Link de acesso: http://www.bdtd.uerj.br/handle/1/11897

The transformation of raw materials into products in the process industry is the result of applying unit operations with a power source, where materials are manipulated to transform them into products of interest. In the particular case of the biopharmaceutical industry, unit operations used to generate recombinant biomass processes are responsible for promoting the metabolic functions of microorganisms. However, there is no a certain methodology that can be utilized for the identification, evaluation, and treatment of risks in unit operations used in these processesbiotech processes. This research proposes the integration of FMEA and HAZOP methodologies considering the most appropriate elements for risk assessment in the unit operations involved in the upstream stages in a recombinant biomass process, with the primary objective to identify and prioritize treatment to control the risks. The procedure developed for risk analysis in this study was defined as follows: a) The limit of the analyzed phase was defined; b) Each stage was divided into subunits, equipment or systems; c) It was selected a unit operation used in the equipment (parameter); d) Deviations, causes, effects and controls for each of the identified unit operations were established; e) Quantitative values of the degree of severity, probability of events based on Markov chain models, and detection level were estimated; f) The Risk Priority Number (RPN) from the values generated previously was determined and classify them as High, Medium and Low; g) Actions were proposed to reduce the level of impact of the deviations.After implementation of the integrated methodology, 05 critical stages were defined. In the cellular propagation stage, 15 deviations were observed in 04 nodes, 20% with medium RPN and 80% with low RPN. For bioreaction stage, 33 deviations were identified in 11 nodes, being 97% with low NPR and 03% medium. In the case of centrifugation of the bacterial culture were defined 06 nodes and 21 deviations, with 62% of low RPN and 38% medium. The cell disruption stage is comprised of 06 nodes with 17 deviations, 76% low RPN and 24% medium. In the inclusion bodies centrifugation and washing stage, 06 nodes and 22 deviations were identified, being 68% low RPN and 32% medium. Based on the analysis of the results it was concluded that the proposed methodology allowed identifying the main risk that is inherent to unit operations within processes. Also, the using of the NPR facilitated the decision to prioritize the treatment of the most critical risks in the system independently of the risk level