BIO09045 2019 BIOCONTAMINATION MONITORING AND CONTROL
This module is taken by Masters students in Pharmaceutical or Biopharmaceutical Science or Engineering. It 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. It does this through consideration of basic microbiology, evaluation of relevant microbes, potential sources of microbial contamination, correction/prevention tools, monitoring and detection methods, consideration of all relevant regulations and case study evaluation.
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.
Repeat Continuous Assessment and/or project resubmission.
The following is a summary of the main topics included in this module: 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; expressing, interpreting and reporting results; training and documentation requirements. The module does this through consideration of 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, and case study evaluations.
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Open Book Exam||Coursework Assessment||Multiple Choice/Short Answer Test||10 %||Week 5||1,2|
|2||Open Book Exam||Coursework Assessment||Multiple Choice/Short Answer Test||10 %||Week 10||1,2,3,4|
|3||Long Answer Question||Coursework Assessment||Closed Book Exam||30 %||Week 14||1,2,3,4|
|4||Continuous Project||Project||Project||40 %||End of Semester||1,2,3,4,5|
|5||Project Viva and Presentation||Project||Oral Exam/Presentation||10 %||End of Semester||1,2,3,4,5|
Part Time Mode Workload
|Lecture||Distance Learning Suite||Live or Recorded lecture||2||Weekly||2.00|
|Independent Learning||UNKNOWN||Self Study||7||Weekly||7.00|
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.
Rapid Microbiological Methods in the Pharmaceutical Industry
Editors: Martin C. Easter
ISBN: 978-1-57491-141-1 (hardback) 978-0-203-01087-7 (electronic).
Journal of Regenerative Medicine