BIO09012 2019 FACILITY DESIGN AND OPERATION

General Details

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_SBIPR_E09 201900 Certificate in Science in BioPharmaceutical Processing 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 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

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