Information Model for Pharmaceutical Smart Factory Equipment Design
Pharmaceutical production typically focuses on individual drug types for each production line, which limits flexibility. However, the emergence of Industry 4.0 technologies presents new opportunities for more adaptable and customized manufacturing processes. Despite this promise, the development of...
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| Format: | Article |
| Language: | English |
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MDPI AG
2025-05-01
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| Series: | Information |
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| Online Access: | https://www.mdpi.com/2078-2489/16/5/412 |
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| author | Roland Wölfle Irina Saur-Amaral Leonor Teixeira |
| author_facet | Roland Wölfle Irina Saur-Amaral Leonor Teixeira |
| author_sort | Roland Wölfle |
| collection | DOAJ |
| description | Pharmaceutical production typically focuses on individual drug types for each production line, which limits flexibility. However, the emergence of Industry 4.0 technologies presents new opportunities for more adaptable and customized manufacturing processes. Despite this promise, the development of innovative design techniques for pharmaceutical production equipment remains incomplete. Manufacturers encounter challenges due to rapid innovation cycles while adhering to stringent Good Manufacturing Practice (GMP) standards. Our research addresses this issue by introducing an information model that organizes the design, development, and testing of pharmaceutical manufacturing equipment. This model is based on an exploratory review of 176 articles concerning design principles in regulated industries and integrates concepts from Axiomatic Design, Quality by Design, Model-Based Systems Engineering, and the V-Model framework. Further refinement was achieved through insights from 10 industry experts. The resultant workflow-based information model can be implemented as software to enhance engineering and project management. This research offers a structured framework that enables pharmaceutical equipment manufacturers and users to collaboratively develop solutions in an iterative manner, effectively closing the gap between industry needs and systematic design methodologies. |
| format | Article |
| id | doaj-art-7fb2056d302c46db90756b87b641fd15 |
| institution | OA Journals |
| issn | 2078-2489 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Information |
| spelling | doaj-art-7fb2056d302c46db90756b87b641fd152025-08-20T01:56:28ZengMDPI AGInformation2078-24892025-05-0116541210.3390/info16050412Information Model for Pharmaceutical Smart Factory Equipment DesignRoland Wölfle0Irina Saur-Amaral1Leonor Teixeira2Doctoral School, University of Aveiro, 3810-193 Aveiro, PortugalSuperior Institute of Accounting and Business, University of Aveiro, 3810-193 Aveiro, PortugalDepartment of Economics, Management and Industrial Engineering and Tourism (DEGEIT)/Institute of Electronics and Informatics Engineering of Aveiro (IEETA), University of Aveiro, 3810-193 Aveiro, PortugalPharmaceutical production typically focuses on individual drug types for each production line, which limits flexibility. However, the emergence of Industry 4.0 technologies presents new opportunities for more adaptable and customized manufacturing processes. Despite this promise, the development of innovative design techniques for pharmaceutical production equipment remains incomplete. Manufacturers encounter challenges due to rapid innovation cycles while adhering to stringent Good Manufacturing Practice (GMP) standards. Our research addresses this issue by introducing an information model that organizes the design, development, and testing of pharmaceutical manufacturing equipment. This model is based on an exploratory review of 176 articles concerning design principles in regulated industries and integrates concepts from Axiomatic Design, Quality by Design, Model-Based Systems Engineering, and the V-Model framework. Further refinement was achieved through insights from 10 industry experts. The resultant workflow-based information model can be implemented as software to enhance engineering and project management. This research offers a structured framework that enables pharmaceutical equipment manufacturers and users to collaboratively develop solutions in an iterative manner, effectively closing the gap between industry needs and systematic design methodologies.https://www.mdpi.com/2078-2489/16/5/412axiomatic designpharmaequipment designV-Modelsmart factorymodel-based design and engineering |
| spellingShingle | Roland Wölfle Irina Saur-Amaral Leonor Teixeira Information Model for Pharmaceutical Smart Factory Equipment Design Information axiomatic design pharma equipment design V-Model smart factory model-based design and engineering |
| title | Information Model for Pharmaceutical Smart Factory Equipment Design |
| title_full | Information Model for Pharmaceutical Smart Factory Equipment Design |
| title_fullStr | Information Model for Pharmaceutical Smart Factory Equipment Design |
| title_full_unstemmed | Information Model for Pharmaceutical Smart Factory Equipment Design |
| title_short | Information Model for Pharmaceutical Smart Factory Equipment Design |
| title_sort | information model for pharmaceutical smart factory equipment design |
| topic | axiomatic design pharma equipment design V-Model smart factory model-based design and engineering |
| url | https://www.mdpi.com/2078-2489/16/5/412 |
| work_keys_str_mv | AT rolandwolfle informationmodelforpharmaceuticalsmartfactoryequipmentdesign AT irinasauramaral informationmodelforpharmaceuticalsmartfactoryequipmentdesign AT leonorteixeira informationmodelforpharmaceuticalsmartfactoryequipmentdesign |