BIO08040 2019 BIOCONTAMINATION 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 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, communicate and explain scientific data relating to biocontamination control.
Teaching and Learning Strategies
'This module will be delivered part-time in the form of on line tutorials augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a means of assessment (e.g. quizzes, uploading assignments and journals).
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, practical work, essays, oral presentations, vivas etc.
Continuous Assessment of Course Work - 30% of marks.
End of term online exam - 30% of marks.
Mini research project - 40% of marks.
The miniproject is a MANDATORY form of assessment for any modules on this programme with a miniproject component.
Repeat Continuous Assessment or Project Resubmission.
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||Open Book Exam Online||Continuous Assessment||Multiple Choice||15 %||Week 5||1,2,3|
|2||Open Book Exam Online||Continuous Assessment||Multiple Choice||15 %||Week 10||2,3,4|
|3||LAQ Exam Online||Continuous Assessment||Closed Book Exam||30 %||Week 14||1,2,3,4|
|4||Individual Project Mini Research||Project||Project||35 %||End of Term||5|
|5||Oral||Continuous Assessment||Interview||5 %||End of Term||5|
Part Time Mode Workload
|Directed Learning||Not Specified||Course Notes / Slides||4||Weekly||4.00|
|Independent Learning||UNKNOWN||Mini Research Activities||4||Weekly||4.00|
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).
as per moodle page
as per moodle page