A Model for MES in Pharmaceutical Production—An AstraZeneca Case Study
Abstract: The objective with the master thesis project is to develop an Electronic Batch Record (EBR) solution for the AstraZeneca TPS division and map it to the ISA 95 model for Manufacturing Execution System s (MES). The EBR solution in addition to current and new manufacturing systems will form an AstraZeneca TPS model for MES, which can be used for further evaluation and system development guidance. The first stage of the EBR development is to choose the most suitable production area, defined as a production line dedicated to a specific product group, for an EBR implementation. The selection is made according to product, technical, economical and risk criteria. Jointly they are estimated to give a valid indication of the suitability and potential benefits of introducing an EBR solution to a production area. When the most suitable production area is selected an extensive research of manufacturing procedures and systems is carried out. The identified systems together with project constraints and systems under development form a basis for the establishment of an AstraZeneca TPS EBR solution. Conceptual architecture for the EBR infrastructure is thereafter created and necessary EBR functionality is defined. The current systems and their functionality are mapped to the ISA 95 model for MES and presented together with the EBR solution to form an AstraZeneca TPS MES model. Subsequently, the benefits and detriments of the full EBR system are studied and discussed to additionally clarify the motives for introduc ing the system. Conclusively, certain metrics are introduced to measure the impact and the potential improvements gained from the EBR system implementation.
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