BIO08050 2016 Biocontamination Monitoring and Control
This module aims to provide students with a detailed 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.
On completion of this module the learner will/should be able to;
Discuss and critically evaluate the most relevant microbes for the biopharmaceutical industry and the typical sources of each.
Identify and discuss appropriate prevention techniques for each contaminant.
Source and interpret the theory behind the detection test methods available, including traditional and rapid identification testing.
Develop and justify an appropriate monitoring regime for a pharmaceutical/biopharmaceutical facility.
Describe the relevant regulatory expectations for Biocontamination Control including ICH Q8, Q9 and Q10.
Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly.
Formulate and communicate judgements with regard to practical Biopharmaceutical contamination case scenarios.
Communicate and explain scientific data relating to biocontamination control.
Teaching and Learning Strategies
Module Assessment Strategies
The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ's, project assignments, laboratroy practical work, essays, oral presentations, vivas etc.
Depends on the relevant failed elements.
General principles and methods of Biocontamination control. Establishing and verifying the formal system for control and associated test methods and requirements. Traditional and modern methods of microbial detection. Training and documentation requirements. Basic microbiology and specific microbes of relevance. Potential sources of contamination. Techniques & tools for prevention and correction/removal of biocontamination including, monitoring and detection methods.
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Continuous assessment of coursework||Continuous Assessment||Multiple Choice||20 %||OnGoing||2,5|
|2||End of term online exam||Continuous Assessment||Assessment||30 %||Week 12||1,2,4,5,7|
|3||Practical Assessment||Practical||Practical Evaluation||20 %||Week 8||2,4,6,7,8|
|4||Mini Research Project||Project||Project||30 %||Week 12||1,2,3,4,5,6,7,8|
Distance Learning Mode Workload
|Directed Learning||Not Specified||Course Notes/Slides||4||Weekly||4.00|
|Independent Learning||Not Specified||Mini-Research Project||4||Weekly||4.00|
|Laboratory Practical||Science Laboratory||Laboratory Practicals||8||Once Per Module||0.53|
Online Learning Mode Workload
|Lecture||Not Specified||Online Lecture||2||Weekly||2.00|
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).