Module Specifications..
Current Academic Year 2023 - 2024
Please note that this information is subject to change.
| |||||||||||||||||||||||||||||||||||||||||
None |
|||||||||||||||||||||||||||||||||||||||||
Description This module will provide an overview of the technical and managerial challenges associated with the design and construction of a modern biopharmaceutical manufacturing facility. It will address the major components of such an exercise including site planning through conceptual and detailed design and on to commissioning, start-up and validation. A typical case study illustrating the integrated approach to facility design will also be considered. Attention will be given to the day-to-day operation of a biopharmaceutical facility operating in a regulated environment. Following facility construction, issues such as materials flow, personnel flow and some general utilities necessary for successful production will also be discussed. | |||||||||||||||||||||||||||||||||||||||||
Learning Outcomes 1. Effectively plan the major elements of an investment in a biopharmaceutical manufacturing facility. 2. Demonstrate an understanding of the complex interconnecting elements of these major capital projects. 3. Address the operational requirements for the manufacturing facility within the design. | |||||||||||||||||||||||||||||||||||||||||
All module information is indicative and subject to change. For further information,students are advised to refer to the University's Marks and Standards and Programme Specific Regulations at: http://www.dcu.ie/registry/examinations/index.shtml |
|||||||||||||||||||||||||||||||||||||||||
Indicative Content and Learning Activities
Introduction to Biomanufacturing with respect to Facility DesignFacility Design Issues – A Regulatory PerspectiveSite Selection, Conceptual Design, Site Master PlanningFacility DesignFacility ConstructionFacility Equipping, Start-up and ValidationCleanroom Design and HVAC TechnologyUtilities; Water, Gas, Steam, AirGMP Facility: day to day operation (personnel, materials & waste flows)Environmental monitoring, theory and practiceNew Facility Build Case Study for a typical Biopharmaceutical manufacturer | |||||||||||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||||||||||
Indicative Reading List
| |||||||||||||||||||||||||||||||||||||||||
Other Resources None | |||||||||||||||||||||||||||||||||||||||||
Programme or List of Programmes
| |||||||||||||||||||||||||||||||||||||||||
Date of Last Revision | 10-MAR-11 | ||||||||||||||||||||||||||||||||||||||||
Archives: |
|