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Estudo da Implementação de um Tanque de Armazenamento de Sorbitol 70%
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Na presente dissertação estudou-se a implementação de um tanque de armazenamento
de Sorbitol 70% com o propósito de maximizar recursos, reduzir possiveis riscos de
contaminação e proporcionar maior flexibilidade dentro do negócio.
Inicialmente, o estudo consistiu na determinação das especificações de armazenagem e
dos principais requisitos da instalação. Constatou-se que anualmente a empresa consome 171
toneladas e que o armazenamento não requer especial precaução, dado que a natureza e a
pureza microbiana foram garantidas nas condições de armazenamento estudadas.
Numa segunda fase, apurou-se a necessidade de otimização do processo atual e os
requisitos da automatização mediante avaliações de risco. Concluiu-se que, com a otimização,
disponibilizam-se 5 operadores e reduz-se o risco inicial em 68% e o tempo de operação em
58%. Relativamente aos requisitos, averiguou-se que, os riscos com maior impacto estão
relacionados com a segurança e o controlo das etapas operacionais e funcionais e com a
garantia da qualidade do excipiente. A adoção de medidas de mitigação permitiu diminuir o
impacto dos riscos.
Seguidamente, projetou-se, conforme os requisitos das GMP e as medidas apuradas,
dois casos de estudo: Instalação de um Tanque Vertical e Reaproveitamento de um Tanque
Horizontal. O segundo cenário revelou-se economicamente mais vantajoso. Porém, o primeiro
poderá trazer benefícios caso se considere aumentar a capacidade de produção e/ou negociar
o preço da matéria-prima.
Por fim, conferiu-se a viabilidade económica de cada cenário num período de 11 anos.
Concluiu-se que ambos os cenários propostos são viáveis nas condições estabelecidas,
apresentando um período de payback de aproximadamente 10 e 7 anos, respetivamente.
A otimização do armazenamento revelou-se uma estratégia benéfica para a empresa,
permitindo uma redução significativa no tempo de operação e do número de operadores por
etapa. Desta forma, promoveu-se o aumento da velocidade de execução e, consequentemente,
da produtividade total do processo.
This dissertation presents a study on the implementation of a Sorbitol 70% storage tank to maximise resources, reduce possible contamination risks, and increase flexibility in the workplace. Initially, the storage specifications and main installation requirements were determined in this study. The company consumes 171 tons annually, and the storage does not need any special precautions, given that the microbial nature and purity were guaranteed in the studied storage conditions. The second phase consisted of evaluating the necessity of optimising the current process and the automatization requirements according to risk assessment. It was found that by optimizing, five operators become available to perform another task, and the initial risk and operational times are reduced by 68% and 58%, respectively. As for the requirements, it was noted that the risks with huge impacts are related to safety and control of operational and functional tasks and excipient quality assurance. The mitigation measures lower the risk factor. Secondly, two case studies were designed according to the previous conclusions and the GMP: the installation of a vertical tank and the reusing of a horizontal tank. The second scenario seemed more economically viable. However, the first one could bring benefits if the production capacity increases and/or the cost of raw materials are negotiated. Lastly, the economic viability was determined for a future period of 11 years for both scenarios. It was concluded that both cases are viable projects for the conditions established in this study, with a payback period of approximately 10 and 7 years, respectively. The optimization of the storage process revealed a beneficial strategy for the company, significantly reducing the time of operation and the number of workers for each task. This process proportionately increased the speed at which the tasks are performed and, consequently, the productivity of the entire process.
This dissertation presents a study on the implementation of a Sorbitol 70% storage tank to maximise resources, reduce possible contamination risks, and increase flexibility in the workplace. Initially, the storage specifications and main installation requirements were determined in this study. The company consumes 171 tons annually, and the storage does not need any special precautions, given that the microbial nature and purity were guaranteed in the studied storage conditions. The second phase consisted of evaluating the necessity of optimising the current process and the automatization requirements according to risk assessment. It was found that by optimizing, five operators become available to perform another task, and the initial risk and operational times are reduced by 68% and 58%, respectively. As for the requirements, it was noted that the risks with huge impacts are related to safety and control of operational and functional tasks and excipient quality assurance. The mitigation measures lower the risk factor. Secondly, two case studies were designed according to the previous conclusions and the GMP: the installation of a vertical tank and the reusing of a horizontal tank. The second scenario seemed more economically viable. However, the first one could bring benefits if the production capacity increases and/or the cost of raw materials are negotiated. Lastly, the economic viability was determined for a future period of 11 years for both scenarios. It was concluded that both cases are viable projects for the conditions established in this study, with a payback period of approximately 10 and 7 years, respectively. The optimization of the storage process revealed a beneficial strategy for the company, significantly reducing the time of operation and the number of workers for each task. This process proportionately increased the speed at which the tasks are performed and, consequently, the productivity of the entire process.
Descrição
Palavras-chave
Sorbitol 70% GMP Tanques de Armazenamento Indústria Farmacêutica