Publicação
Internship Reports and Monograph Entitled"Continuous manufacturing: implementation, applications and future perspectives in the pharmaceutical industry"
| Resumo: | Since the emergence of human intelligence, mankind has sought to overcome new challenges. Nowadays, scientific progress is the main catalyst for evolution. Along with the emergence of innovative technologies, we are witnessing exponential growth in several fields of knowledge. Pharmaceutical industry is no exception.Over the past decade, continuous manufacturing (CM) has evolved from a mere aspiration to a groundbreaking manufacturing approach within the pharmaceutical industry. CM involves integrating a series of unit operations to maintain an uninterrupted flow of materials, ultimately resulting in the production of the final pharmaceutical product. This approach offers numerous benefits. It holds the potential to enhance efficiency and the quality of pharmaceutical products while simultaneously reducing costs and saving time. Additionally, CM enables real-time monitoring and control of processes, aligning with the principles of the Quality by Design concept. Regulatory bodies play a pivotal role in reshaping the manufacturing landscape of the pharmaceutical industry. Their support is exemplified by the issuance of comprehensive CM guidelines, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q13. Nevertheless, despite the array of advantages linked with CM, there are challenges that need to be overcome in order to unlock its full potential.The aim of this dissertation is to explore the implementation context of CM in the pharmaceutical industry, undertake an extensive examination of advanced control strategies and the most recent cutting-edge technologies, and offer a critical assessment of the challenges encountered upon implementation, all while delving into its potential future perspectives. |
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| Autores principais: | Silvestre, Miguel Maria Correia Dias |
| Assunto: | Modern Manufacturing Continuous Manufacturing Batch Manufacturing Quality by Design (QbD) Process Analytical Technology (PAT) Modern Manufacturing Continuous Manufacturing Batch Manufacturing Quality by Design (QbD) Process Analytical Technology (PAT) |
| Ano: | 2023 |
| País: | Portugal |
| Tipo de documento: | dissertação de mestrado |
| Tipo de acesso: | acesso aberto |
| Instituição associada: | Universidade de Coimbra |
| Idioma: | inglês |
| Origem: | Estudo Geral - Universidade de Coimbra |
| Resumo: | Since the emergence of human intelligence, mankind has sought to overcome new challenges. Nowadays, scientific progress is the main catalyst for evolution. Along with the emergence of innovative technologies, we are witnessing exponential growth in several fields of knowledge. Pharmaceutical industry is no exception.Over the past decade, continuous manufacturing (CM) has evolved from a mere aspiration to a groundbreaking manufacturing approach within the pharmaceutical industry. CM involves integrating a series of unit operations to maintain an uninterrupted flow of materials, ultimately resulting in the production of the final pharmaceutical product. This approach offers numerous benefits. It holds the potential to enhance efficiency and the quality of pharmaceutical products while simultaneously reducing costs and saving time. Additionally, CM enables real-time monitoring and control of processes, aligning with the principles of the Quality by Design concept. Regulatory bodies play a pivotal role in reshaping the manufacturing landscape of the pharmaceutical industry. Their support is exemplified by the issuance of comprehensive CM guidelines, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q13. Nevertheless, despite the array of advantages linked with CM, there are challenges that need to be overcome in order to unlock its full potential.The aim of this dissertation is to explore the implementation context of CM in the pharmaceutical industry, undertake an extensive examination of advanced control strategies and the most recent cutting-edge technologies, and offer a critical assessment of the challenges encountered upon implementation, all while delving into its potential future perspectives. |
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