BIO09012 2019 FACILITY DESIGN AND OPERATION
This module will provide students with an overview of the technical and managerial challenges associated with the design and construction of a biopharmaceutical manufacturing facility. It will address all the major elements of these projects from site master planning through conceptual and detailed design and onto commissioning and qualification. It will also cover such associated project aspects as overall planning, budgeting and the organisational systems and structures required to successfully execute such major investments.
An overview of how biopharmaceutical manufacturing facilities operate will also be addressed so as the design of the facility from the material and personnel flows through to the process controls and automation, meet the needs of the operations personnel after the facility is brought into production.
On completion of this module the learner will/should be able to;
Effectively plan the major elements of an investment in a biopharmaceutical manufacturing facility.
Evaluate and communicate the complex interconnecting elements of these major capital projects.
Identify and address the operational requirements for the manufacturing facility within the design.
Outline the main stages of facility design including cleanrooms and associated technology.
Describe the principal steps involved in the overall commissioning and qualification of a new or modified biopharmaceutical facility.
Detail the typical organisational control systems and structures required for biopharmaceutical facility design and operation.
Teaching and Learning Strategies
Module Assessment Strategies
as per Q manual
The programme will include the following topics: Site Master Planning (Current, Future, Expandability), Conceptual Design (Mass Balances & Manufacturing Logistics), Detailed Design (Layouts, Equipment, Process, Piping, HVAC, E&I, Finishes), Process Controls & Automation, Construction (Overview, Interfaces, Handover), Commissioning & Qualification, Budget & Schedule, Contracts, Management of Vendor Packages (FAT, IQ & OQ requirements), Organisational Systems & Structures (Documentation & Change Control).
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||MCQ||Continuous Assessment||Open Book Exam||10 %||Week 4||1,5|
|2||mcq||Continuous Assessment||Open Book Exam||20 %||Week 9||3,4|
|3||SAQ||Continuous Assessment||Closed Book Exam||30 %||Week 13||1,2,3,4,5,6|
|4||report||Project||Assignment||40 %||Week 14||1,2,3,4|
ISPE, Biopharmaceutical Manufacturing Facilities. Vol. 6. ISPE Baseline Guides, 2004
Whyte, W., Cleanroom Technology - Fundamentals of Design, Testing and Operations, John Wiley and Sons. Ltd., 2001
as per moodle resources
as per moodle resources