Qualificação térmica do Leito Fluidizado Freund Vector FLN- 60 em uma industria farmacêutica brasileira localizada na região metropolitana de São Paulo
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Tipo
TCC
Data de publicação
2019-06
Periódico
Citações (Scopus)
Autores
Nakao, Julia Godoy
Orientador
Guimarães, Marcelo
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A dinâmica das Boas Práticas de Fabricação na Industria Farmacêutica engloba conceitos que visam a padronização, segurança, robustez e reprodutibilidade dos diversos processos de fabricação de medicamentos, e que são gerenciados prioritariamente pelo setor de Garantia de Qualidade. Os conceitos de Validação e Qualificação foram normatizados através da RDC n°17 de Abril de 2010 para a fiscalização e manutenção da qualidade dos processos envolvidos na cadeia da Industria Farmacêutica. Dessa forma, o conceito insere-se na área de Garantia de Qualidade de modo a aprimorar os padrões de qualidade de produção dos produtos que chegam ao consumidor final. A Validação consiste em um ‘’ato documentado atestando a robustez e qualidade de um procedimento, processo, equipamento, material, atividade ou sistema’’, enquanto a Qualificação consiste em um ‘’conjunto de ações realizadas para atestar e documentar que quaisquer instalações, sistemas e equipamentos estão propriamente instalados e/ou funcionam corretamente e levam aos resultados esperados’’ (ANVISA 4, 2010).
O presente trabalho abordou a Qualificação de Desempenho Térmico de um Leito Fluidizado Freund Vector FL-N-60 instalado em uma Industria Farmacêutica Brasileira localizada na região metropolitana de São Paulo. Para os testes, foram utilizados doze sensores tipo T, posicionados em pontos críticos de distribuição de temperatura na parte interna do equipamento, para monitoramento da temperatura durante 1 hora de secagem para os setpoints de 40,0°C e 85,0°C, com registros a cada 30 segundos. Os critérios de aceitação de ≥30,0°C e ≤50,0°C, para o setpoint de 40,0°C, e de ≥75,0°C e ≤95,0°C, para o setpoint de 85,0°C, foram atendidos para os estudos realizados, sem excursões de temperatura observadas nos períodos avaliados, demonstrando assim a capacidade do equipamento na manutenção do parâmetro estudado na monografia.
The dynamics of Good Manufacturing Practices in the Pharmaceutical Industry encompasses concepts that aim at the standardization, safety, robustness and reproducibility of the drug manufacturing processes, which are managed primarily by the Quality Assurance sector. The concepts of Validation and Qualification were standardized through RDC No. 17 of April 2010 for the inspection and maintenance of the process chain in the Pharmaceutical Industry. In this way, the concept is inserted in the area of Quality Assurance in order to export the quality standards of production of the products that reach the final consumer. Validation consists of a quality assessment document of a process, a process, a material, a system activity, a quality demonstration facility to display and document the same, systems and equipment are properly installed and / or work correctly and lead to expected results" (ANVISA 4, 2010). The present work deals with the Qualification of Thermal Performance of a Fluidized Bed Freund Vector FL-N-60 installed in a Brazilian Pharmaceutical Industry located in the metropolitan region of São Paulo. For the tests, twelve T-type sensors were used, located at critical points of temperature distribution inside the equipment, for monitoring the temperature during 1 hour of drying for the setpoints of 40.0 ° C and 85.0° C, with records every 30 seconds. The acceptance criteria of ≥30.0 ° C and ≤50.0°C, for the setpoint of 40.0° C, and of ≥75.0 ° C and ≤95.0 ° C, for the setpoint of 85,0°C, were attended for the studies performed, without temperature excursions observed in the evaluated periods, therefore demonstrating the equipment capacity in the maintenance of the parameter studied in the monograph.
The dynamics of Good Manufacturing Practices in the Pharmaceutical Industry encompasses concepts that aim at the standardization, safety, robustness and reproducibility of the drug manufacturing processes, which are managed primarily by the Quality Assurance sector. The concepts of Validation and Qualification were standardized through RDC No. 17 of April 2010 for the inspection and maintenance of the process chain in the Pharmaceutical Industry. In this way, the concept is inserted in the area of Quality Assurance in order to export the quality standards of production of the products that reach the final consumer. Validation consists of a quality assessment document of a process, a process, a material, a system activity, a quality demonstration facility to display and document the same, systems and equipment are properly installed and / or work correctly and lead to expected results" (ANVISA 4, 2010). The present work deals with the Qualification of Thermal Performance of a Fluidized Bed Freund Vector FL-N-60 installed in a Brazilian Pharmaceutical Industry located in the metropolitan region of São Paulo. For the tests, twelve T-type sensors were used, located at critical points of temperature distribution inside the equipment, for monitoring the temperature during 1 hour of drying for the setpoints of 40.0 ° C and 85.0° C, with records every 30 seconds. The acceptance criteria of ≥30.0 ° C and ≤50.0°C, for the setpoint of 40.0° C, and of ≥75.0 ° C and ≤95.0 ° C, for the setpoint of 85,0°C, were attended for the studies performed, without temperature excursions observed in the evaluated periods, therefore demonstrating the equipment capacity in the maintenance of the parameter studied in the monograph.
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Palavras-chave
garantia de qualidade , validação , qualificação , desempenho , sensores , temperatura , monitoramento , quality assurance , validation , qualification , performance , sensors , temperature and monitoring