BIO06015 2011 Biocontamination Control Level 6.
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 the Biopharmaceutical industry.
Learning Outcomes
On completion of this module the learner will/should be able to;
Discuss and evaluate the most relevant biocontaminating organisms for the biopharmaceutical industry and the typical sources of each.
Identify and discuss appropriate prevention techniques for each biocontaminant organism.
Describe the theory behind the detection test methods available for biocontaminants including traditional and rapid identification testing.
Develop an appropriate biocontamination control monitoring regime for a biopharmaceutical facility.
Outline an appropriate system / process for biocontamination control and incorporate elements of a GMP quality control system.
Indicative Syllabus
The following is a summary of the main topics included in this module:
- Typical biocontaminant organisms related to the biopharmaceutical industry.
- General principles and methods of biocontamination control.
- Establishing and verifying the formal system for control and associated test methods and requirements for biocontamination control.
- Traditional and modern methods of biocontaminant detection and measurement.
- Expressing, interpreting and reporting biocontamination monitoring results.
- Training and GMP documentation requirements associated with biocontamination control.
- Some relevant demonstrations relating to biocontamination control.
Coursework & Assessment Breakdown
Coursework Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Continuous Assessment Short-form exams and assignments. | Continuous Assessment | UNKNOWN | 50 % | OnGoing | 1,2,3,4,5 |
End of Semester / Year Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Final Exam | Final Exam | UNKNOWN | 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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