BIO06015 2019 Biocontamination Control
This module aims to provide students with a general knowledge and understanding of the key principles and methods of biocontamination control as it relates to aseptic processing operations in the biopharmaceutical industry.
Learning Outcomes
On completion of this module the learner will/should be able to;
Describe the main stages involved in the production of a biopharmaceutical production process
Identify the main sources of contamination and their entry routes into a biopharmaceutical production facility
Describe the principles of environmental montoring in a biopharmaceutical production facility.
Outline the key differences between cleaning, sanitisation and sterilisation
Describe the different types of micro-organisms that may lead to contamination
Teaching and Learning Strategies
This module will be delivered part time. It will include lectures augmented by independent Learning and directed learning. Moodle will be used as a repository of educational material and for assessment.
Module Assessment Strategies
This module is 50% continuous assessment and 50% final exam.
Repeat Assessments
Repeat assessment and/or repeat final exam.
Indicative Syllabus
The following is a summary of the main topics included in this module
- Bioprocessing operations
- Contamination entry routes
- Types of micro-organisms
- Environmental monitoring
- Cleaning, Sanitisation and Sterilisation methods
- Aseptic processing
- Media fills
Coursework & Assessment Breakdown
Coursework Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Short form exams | Coursework Assessment | Assessment | 25 % | Week 9 | 4,5 |
2 | Short form exams | Coursework Assessment | Assessment | 25 % | Week 5 | 1,2,3,5 |
End of Semester / Year Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Final End of Semester Exam | Final Exam | Closed Book Exam | 50 % | End of Term | 1,2,3,4,5 |
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
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.
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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