BIO07012 2019 Facilites and Utilities
This module aims to provide students 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;
To provide an explanation of the technical and managerial challenges associated with the design and construction of a biopharmaceutical manufacturing facility.
To appreciate the major elements of these projects from site master planning through conceptual and detailed design and onto commissioning and qualification.
To address the operational requirements for the manufacturing facility within an overall design.
To explain key concepts incorporated into cleanroom design and classification.
Describe the key principles involved in cleaning and sterilisation including CIP and SIP systems.
To understand the key elements of treatment and purification plant used to prepare water fit for bioprocessing operations.
Teaching and Learning Strategies
N/A
Module Assessment Strategies
A combination of continuous assessment strategies, some laboratory experiments and an end-of-term exam.
Repeat Assessments
N/A
Indicative Syllabus
· General Outline of Facilities and Utilities.
· Cleanroom Technology (design, operation and monitoring) and its application for Biopropcessing.
· Water Treatment Systems and their applications for Biopharmaceutical Processing.
· Cleaning Systems including CIP.
· Sterilisation Technologies including SIP.
· Other typical Utility Systems.
Coursework & Assessment Breakdown
Coursework Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Continuous Assessment Short-form exams and assessments. | Coursework Assessment | Assessment | 50 % | OnGoing | 1,2,3,4,5,6 |
End of Semester / Year Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Written Exam | Final Exam | Closed Book Exam | 50 % | End of Term | 1,2,3,4,5,6 |
Part Time Mode Workload
Type | Location | Description | Hours | Frequency | Avg Workload |
---|---|---|---|---|---|
Lecture | Distance Learning Suite | Online lecture. | 1 | Weekly | 1.00 |
Directed Learning | Not Specified | Directed self-study. | 4 | Weekly | 4.00 |
Module 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.
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