BIO08043 2022 BIOPHARMACEUTICAL FACILITIES AND UTILITIES
Full Title
BIOPHARMACEUTICAL FACILITIES AND UTILITIES
Transcript Title
BIOPHARMACEUTICAL FACILITIES A
Code
BIO08043
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
08 - NFQ Level 8
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2022 - Full Academic Year 2022-23
End Term
9999 - The End of Time
Author(s)
Yvonne Lang, Mary Butler
Programme Membership
SG_SAPPM_K08 202200 Bachelor of Science (Honours) in Applied Industrial Science (Add-On)
SG_SBIOT_E08 202200 Certificate in Bioprocessing Technologies SG_SBIOT_E08
SG_SBIOP_K08 202200 Bachelor of Science (Honours) in Biopharmaceutical Science (Add-on)
Description
This module aims to provide the student with a good understanding of the main support service areas involving both facilities and utilities that underpin the modern biopharmaceutical manufacturing industry.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Outline the main elements and features of facilities and utilities relating to the modern biopharmaceutical industry.
2.
List and describe the main facility design concepts including cleanroom technology for Biopharmaceutical Processing.
3.
Describe the key elements of a water treatment system for Biopharmaceutical Processing.
4.
Describe the key principles involved in cleaning and sterilisation systems for Biopharmaceutical Processing.
5.
Understand the application of minor equipment and design and testing principle of piping systems within a Bioprocessing Facility.
6.
Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly. Communicate and explain scientific data relating to facilities and utilities for biopharmaceutical processing.
Teaching and Learning Strategies
as above
Module Assessment Strategies
Continuous Assessment of Course Work - 30% of marks.
End of term online exam - 30% of marks.
Mini research project - 40% of marks.
The miniproject is a MANDATORY form of assessment for any modules on this programme with a miniproject component.
Repeat Assessments
as per moodle page
Module Dependencies
Prerequisites
None
Co-requisites
None
Incompatibles
None
Indicative Syllabus
1. General Overview of Facilities and Utilities.
2. Facility Design Concepts for Biopharmaceutical Processing.
3. Cleanroom Technology (design, operation and monitoring) for Biopharmaceutical Processing.
4. Water Treatment Systems for Biopharmaceutical Processing.
5. Cleaning Systems for Biopharmaceutical Processing.
6. Sterilisation Technologies for Biopharmaceutical Processing.
7. Other equipment, utilities and piping systems for Biopharmaceutical Processing.
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Open Book Exam Online | Coursework Assessment | Assessment | 15 % | Week 4 | 1,2,3 |
| 2 | Open Book Exam Online | Coursework Assessment | Assessment | 15 % | Week 9 | 4,5 |
| 3 | Other Exam Online | Coursework Assessment | Closed Book Exam | 30 % | Week 13 | 1,2,3,4 |
| 4 | Individual Project Mini Research | Coursework Assessment | Individual Project | 40 % | Week 15 | 6 |
Online Learning Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Online | Online | 2 | Weekly | 2.00 |
| Independent Learning | Online | Mini Research Activities | 4 | Weekly | 4.00 |
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours
Module Resources
Non ISBN Literary Resources
‘Pharmaceutical Biotechnology - Concepts and Applications' by Gary Walsh.
Wiley Publications. 2007. ISBN - 978-0-470-01244-4.
ISPE Baseline Guide Volume 6 - ‘Biopharmaceutical Manufacturing Facilities'.
ISPE Baseline Guide Volume 4 - ‘Water and Steam Systems'.
PDA Technical Report #1 - ‘Validation of Moist Heat Sterilisation Processes'.
2007. Supplement Volume 61. No. S-1.
Journal Resources
as per moodle page
URL Resources
as per moodle page
Other Resources
None
Additional Information
None