BIO09012 2019 FACILITY DESIGN AND OPERATION
Full Title
FACILITY DESIGN AND OPERATION
Transcript Title
FACILITY DESIGN AND OPERATION
Code
BIO09012
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Stage
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Mary Butler
Programme Membership
SG_SBIOP_M09 201900 Master of Science in Biopharmaceutical Science
SG_SBIOP_O09 201900 Postgraduate Diploma in Science in Science in Biopharmaceutical Science
Description
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.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Effectively plan the major elements of an investment in a biopharmaceutical manufacturing facility.
2.
Evaluate and communicate the complex interconnecting elements of these major capital projects.
3.
Identify and address the operational requirements for the manufacturing facility within the design.
4.
Outline the main stages of facility design including cleanrooms and associated technology.
5.
Describe the principal steps involved in the overall commissioning and qualification of a new or modified biopharmaceutical facility.
6.
Detail the typical organisational control systems and structures required for biopharmaceutical facility design and operation.
Teaching and Learning Strategies
100% CA
Module Assessment Strategies
100% CA
Repeat Assessments
as per Q manual
Indicative Syllabus
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
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | MCQ | Coursework Assessment | Open Book Exam | 10 % | Week 4 | 1,5 |
| 2 | mcq | Coursework Assessment | Open Book Exam | 20 % | Week 9 | 3,4 |
| 3 | SAQ | Coursework Assessment | Closed Book Exam | 30 % | Week 13 | 1,2,3,4,5,6 |
| 4 | report | Project | Assignment | 40 % | Week 14 | 1,2,3,4 |
Part Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Not Specified | Lecture | 2 | Weekly | 2.00 |
| Independent Learning | UNKNOWN | Self Study | 7 | Weekly | 7.00 |
Total Part Time Average Weekly Learner Contact Time 2.00 Hours
Module Resources
Non ISBN Literary Resources
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
Journal Resources
as per moodle resources
URL Resources
as per moodle resources
Other Resources
None