| Name: | Description: | Size: | Format: | |
|---|---|---|---|---|
| 7.07 MB | Adobe PDF |
Advisor(s)
Abstract(s)
A presente dissertação, no âmbito da conclusão do mestrado em Engenharia Química, foi realizada na empresa Vygon Portugal, empresa francesa, com a sua marca no mercado farmacêutico, essencialmente na produção e comércio de material médico-cirúrgico de uso único. O estudo efetuado nesta dissertação foi relevante tendo em conta a exigência que atualmente a indústria farmacêutica enfrenta a nível do controlo de qualidade, e da otimização e controlo dos processos. O primeiro objetivo deste trabalho foi conhecer e caracterizar a prevalência de defeitos e desvios face às especificações, que surgem no processo produtivo de sondas de nutrição entéricas. De forma a conseguir efetuar este estudo, foi feita uma análise FMEA, Failure Modes and Effects Analysis, para identificação dos potenciais modos de falha dos vários sistemas que compõem a sonda de alimentação, bem como as suas respetivas causas e efeitos. Com este estudo, foi possível conhecer os modos de falha do sistema que podem afetar a segurança, a operacionalidade, e a qualidade do produto. O segundo objetivo da dissertação foi o desenvolvimento da validação na máquina de termoformagem e selagem de blister – COLIMATIC THERA 650. Assim sendo, foi realizada a qualificação operacional, onde foram testadas três configurações para as variáveis consideradas críticas para o processo. Como principais conclusões, em relação ao primeiro objetivo a aplicação da ferramenta FMEA ao processo produtivo foi bem conseguida. Esta ferramenta permitiu identificar 28 potenciais modos de falha, das quais 17 apresentam nível de risco I, 7 apresentam nível de risco II e as restantes 4 nível de risco III. Assim, foi desenvolvida uma lista prioritária de ações corretivas, para que a empresa consiga identificar quais as prioridades e gerir o tempo disponível. Relativamente ao segundo objetivo, foi determinada a gama de operação ótima da máquina embaladora que permite produzir embalagens dentro das especificações, assegurando os critérios de qualidade. Nesta validação foi possível otimizar algumas variáveis consideradas críticas, tais como: os tempos de operação, com intenção de aumentar a produtividade da embaladora; a pressão de selagem, com o objetivo de reduzir o desgaste do molde a longo prazo e a determinação da temperatura ótima para a termoformagem.
This dissertation, within the scope of the conclusion of the Master's degree in Chemical Engineering, was carried out at Vygon Portugal, a French company, with its brand in the pharmaceutical market, mainly in the production and trade of single-use medical-surgical material. The study carried out in this dissertation was relevant given the current demand for quality control and process optimization and control. The first objective of this work was to know and characterize the prevalence of defects and deviations from the specifications, which arise in the production process of enteric nutrition tubes. To carry out this study, an Analysis was made FMEA, Failure Modes and Effects Analysis, to identify the potential failure modes of the various systems that make up the feeding tube, as well as their respective causes and effects. With this study, it was possible to acknowledge system failure modes that can affect the safety, operability, and quality of the product. The second objective of the dissertation was the development of validation in the thermoforming and sealing machine of the blister - COLIMATIC THERA 650. Therefore, the operational qualification was performed, where three configurations were tested for the variables considered critical to the process. As the main conclusions, concerning the first objective, the application of the FMEA tool to the production process was well achieved. This tool identified 28 potential failure modes, of which 17 have risk level I, 7 have risk level II, and the remaining 4 risk level III. Thus, a priority list of corrective actions has been developed, so that the company can identify the priorities and manage the time available. Regarding the second objective, the optimal operating range of the packaging machine was determined, which allows the production of the packaging within specifications, ensuring the quality criteria. In this validation it was possible to optimize some variables considered critical, such as operating times, to increase the productivity of the packer; the sealing pressure, to reduce mold wear in the long term and determine the optimum temperature for thermoforming.
This dissertation, within the scope of the conclusion of the Master's degree in Chemical Engineering, was carried out at Vygon Portugal, a French company, with its brand in the pharmaceutical market, mainly in the production and trade of single-use medical-surgical material. The study carried out in this dissertation was relevant given the current demand for quality control and process optimization and control. The first objective of this work was to know and characterize the prevalence of defects and deviations from the specifications, which arise in the production process of enteric nutrition tubes. To carry out this study, an Analysis was made FMEA, Failure Modes and Effects Analysis, to identify the potential failure modes of the various systems that make up the feeding tube, as well as their respective causes and effects. With this study, it was possible to acknowledge system failure modes that can affect the safety, operability, and quality of the product. The second objective of the dissertation was the development of validation in the thermoforming and sealing machine of the blister - COLIMATIC THERA 650. Therefore, the operational qualification was performed, where three configurations were tested for the variables considered critical to the process. As the main conclusions, concerning the first objective, the application of the FMEA tool to the production process was well achieved. This tool identified 28 potential failure modes, of which 17 have risk level I, 7 have risk level II, and the remaining 4 risk level III. Thus, a priority list of corrective actions has been developed, so that the company can identify the priorities and manage the time available. Regarding the second objective, the optimal operating range of the packaging machine was determined, which allows the production of the packaging within specifications, ensuring the quality criteria. In this validation it was possible to optimize some variables considered critical, such as operating times, to increase the productivity of the packer; the sealing pressure, to reduce mold wear in the long term and determine the optimum temperature for thermoforming.
Description
Keywords
Otimização Qualidade FMEA Validação Termoformagem Selagem Risco Optimization Quality Validation Thermoforming Sealing Risk