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Authors
Advisor(s)
Abstract(s)
O controlo da qualidade microbiológica da água na indústria farmacêutica é fundamental para a garantia de qualidade do medicamento visto a água ser uma das principais matérias-primas para a produção de medicamentos. Pretende-se com o presente trabalho final de mestrado, na sequência de um estágio realizado na Hikma Farmacêutica S.A, com duração aproximada de quatro meses, descrever as funções desenvolvidas no laboratório de microbiologia da empresa e competências adquiridas no contexto do controlo de qualidade na indústria farmacêutica. As principais funções realizadas durante o período de estágio consistiram na amostragem de águas tendo sido estas posteriormente analisadas a partir do método de filtração. Foram enumerados os microrganismos totais nas cassetes de R2A Agar e feito o re-isolamento para Cetrimide Agar e XLD Agar sendo depois os microrganismos identificados mediante o sistema de identificação VITEK®. É ainda apresentado um estudo de caso referente à avaliação da eficácia do sistema de tratamento de águas no ano de 2020, onde foram recolhidos dados referentes ao número de colónias de microrganismos (bactérias, fungos e leveduras) bem como ao microrganismo identificado. Verifica-se que os microrganismos mais detetados foram Burkholderia Cepacea e Sphingomonas macrogoltabida/paucimobilis, microrganismos frequentemente encontrados em águas industriais e que apesar de algumas contaminações o método de purificação da água foi eficaz e a água encontra-se própria para a sua utilização. Em suma, foi possível adquirir aptidões práticas, que juntamente com o conhecimento teórico obtido no mestrado, permitiram um crescimento a nível pessoal e profissional, tendo sido todas as atividades concluídas e bem-sucedidas.
ABSTRACT - The microbiological quality control of water in the pharmaceutical industry plays a significant role in the quality control of the drug since water is the primary material deployed for the drug’s production. With this work it was pretended, in the sequence of an internship realized in Hikma Pharmaceutical S.A., with a duration of approximately four months, to describe the developed functions in the microbiology laboratory in the pharmaceutical industry. During the internship the main functions were water sampling being afterward analyzed employing the filtration method. It was numbered the total microorganisms in R2A Agar discs and the reisolating for Cetrimide Agar and XLD Agar being these microorganisms identified afterward through the identification system VITEK®. Furthermore, it presented a case study referring to the evaluation of the efficiency of the treatment water system in the 2020 year, where it collected data referent to the colonies number (bacteria, fungus, and yeasts) as well as the identified microorganism. It was verified that the microorganisms that were detected in higher numbers were the Burkholderia Cepacea and Sphingomonas macrogoltabida/paucimobilis, microorganisms which are frequently found in industrial water, and even though it contains some contaminations the method of water purification was efficient and it was fit for its use. In resume, it was possible to acquire practical skills that with the theoretical knowledge obtained in the degree, permitted growth at professional and personal levels, being all the activities concluded and well-done.
ABSTRACT - The microbiological quality control of water in the pharmaceutical industry plays a significant role in the quality control of the drug since water is the primary material deployed for the drug’s production. With this work it was pretended, in the sequence of an internship realized in Hikma Pharmaceutical S.A., with a duration of approximately four months, to describe the developed functions in the microbiology laboratory in the pharmaceutical industry. During the internship the main functions were water sampling being afterward analyzed employing the filtration method. It was numbered the total microorganisms in R2A Agar discs and the reisolating for Cetrimide Agar and XLD Agar being these microorganisms identified afterward through the identification system VITEK®. Furthermore, it presented a case study referring to the evaluation of the efficiency of the treatment water system in the 2020 year, where it collected data referent to the colonies number (bacteria, fungus, and yeasts) as well as the identified microorganism. It was verified that the microorganisms that were detected in higher numbers were the Burkholderia Cepacea and Sphingomonas macrogoltabida/paucimobilis, microorganisms which are frequently found in industrial water, and even though it contains some contaminations the method of water purification was efficient and it was fit for its use. In resume, it was possible to acquire practical skills that with the theoretical knowledge obtained in the degree, permitted growth at professional and personal levels, being all the activities concluded and well-done.
Description
Mestrado em Farmácia - Área de especialização: Farmacologia e Farmacoterapia Avançada
Keywords
Indústria farmacêutica Controlo de qualidade Microbiologia Águas para fins farmacêuticos Microrganismos Pharmaceutical industry Quality control Microbiology Water to industry employment Microorganisms
Citation
Oliveira AS. Estágio em indústria farmacêutica [dissertation]. Lisboa: Escola Superior de Tecnologia da Saúde de Lisboa/Instituto Politécnico de Lisboa; 2022.
Publisher
Instituto Politécnico de Lisboa, Escola Superior de Tecnologia da Saúde de Lisboa