BIO07026 2019 Biocontamination Control
This module aims to provide students with a fundamental knowledge and understanding of the general principles and methods of Biocontamination control; establishing and verifying the formal system for contamination control and associated test methods and requirements; traditional and modern methods of microbial detection; expressing, interpreting and reporting results; training and documentation requirements.
Learning Outcomes
On completion of this module the learner will/should be able to;
Discuss and evaluate the most relevant biocontamination organisms for the biopharmaceutical industry and the typical sources of each.
Identify and discuss appropriate prevention techniques for each contaminant.
Establish the theory behind the biocontamination detection test methods available, including traditional and rapid identification testing.
Develop and justify an appropriate monitoring regime for a pharmaceutical/biopharmaceutical facility.
Perform some research on a relevant topic and analyse, evaluate and draw conclusions accordingly.
Communicate and explain scientific data relating to biocontamination control.
Teaching and Learning Strategies
N/A
Module Assessment Strategies
Continuous Assessment of Course Work - 50% of marks.
End of term written exam - 50% of marks.
Repeat Assessments
N/A
Indicative Syllabus
General principles and methods of Biocontamination control.
Basic microbiology and specific biocontamination organisms of relevance.
The formal system for biocontamination control and associated test methods and requirements.
Traditional and modern methods of microbial detection.
Potential sources of biocontamination.
Techniques & tools for prevention and correction/removal of biocontamination including, monitoring and detection methods.
Coursework & Assessment Breakdown
Coursework Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Multiple Choice Questions | Coursework Assessment | Multiple Choice/Short Answer Test | 15 % | Week 6 | 1,2,3,4 |
2 | Multiple Choice Questions | Coursework Assessment | Multiple Choice/Short Answer Test | 15 % | Week 11 | 1,2,3,4,5,6 |
3 | LAQ | Coursework Assessment | Assessment | 20 % | Week 14 | 1,2,3,4,5,6 |
End of Semester / Year Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Final Exam | Final Exam | Closed Book Exam | 50 % | End of Term | 1,2,3,4 |
Full Time Mode Workload
Type | Location | Description | Hours | Frequency | Avg Workload |
---|---|---|---|---|---|
Lecture | Not Specified | Online | 1 | Weekly | 1.00 |
Practical / Laboratory | Not Specified | Course Notes / Slides | 3 | Weekly | 3.00 |
Independent Learning | UNKNOWN | Mini Research Assignment | 3 | Weekly | 3.00 |
Part Time Mode Workload
Type | Location | Description | Hours | Frequency | Avg Workload |
---|---|---|---|---|---|
Lecture | Not Specified | Online | 1 | Weekly | 1.00 |
Practical / Laboratory | Not Specified | Course Notes / Slides | 3 | Weekly | 3.00 |
Independent Learning | UNKNOWN | Mini Research Assignment | 3 | Weekly | 3.00 |
Module Resources
Hugo and Russell's: Pharmaceutical Microbiology (Seventh Edition) Editor(s): Stephen P Denyer, Norman A Hodges, Sean P Gorman Print ISBN: 9780632064670 Online ISBN: 9780470988329.
Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements,Second Edition, 2nd Edition By Lucia Clontz. ISBN: 978-1-4200534-8-7.
Rapid Microbiological Methods in the Pharmaceutical Industry Editors: Martin C. Easter ISBN: 978-1-57491-141-1 (hardback) 978-0-203-01087-7 (electronic).
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