BIO08001 2020 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;
Critically evaluate the most relevant microbes and their typical sources for the biopharmaceutical industry, explain the available detection tests, including traditional and rapid methods, and discuss appropriate prevention techniques for each contaminant.
Apply the design concept, justify an appropriate system/process, explain relevant regulatory expectations and identify correction and preventative action (CAPA) methodologies in relation to biocontamination control.
Develop and justify an appropriate monitoring regime for a pharmaceutical/biopharmaceutical facility, and evaluate biopharmaceutical contamination case scenarios.
Perform a series of laboratory experiments (or projects) relating to biocontamination control and generate a report and presentation.
Teaching and Learning Strategies
This module is taught by lectures supported by self-directed reading material, and project assignments involving laboratory practical work. A range of Computer-Aided Learning (CAL) packages are also used to support this module. Students are provided with electronic materials for self-assessment and preparation for examinations. Self-directed, student- centred, independent learning is also encouraged through completion of module coursework. The laboratory practical work will be carried out at National Institute for Bioprocessing Research and Training (NIBRT), Blackrock .
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.
This module will blend lecture material with applied content that includes the following: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; consideration of fundamental microbiology and specific microbes of relevance, potential sources of contamination, techniques and 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||Continuous assessment of coursework||Coursework Assessment||Multiple Choice/Short Answer Test||30 %||OnGoing||1,2,3|
|2||Written Assignment||Coursework Assessment||Written Report/Essay||20 %||Week 8||3|
|3||Project & Presentation||Project||Project||50 %||Week 12||1,2,3,4|
Online Learning Mode Workload
|Lecture||Not Specified||Online Lecture||2||Weekly||2.00|
Clontz, L. (2008) Microbial Limit and Bioburden Tests: Validation Approaches and Global
Requirements (2nd edition). Boca Raton, CRC Press.
Denyer, S.P., Hodges, N.A. and Gorman. S. P. (Editors) (2011) Hugo and Russell's: Pharmaceutical Microbiology (8th edition). Hoboken, Wiley-Blackwell.
Easter, M.C. (Editor) (2005) Rapid Microbiological Methods in the Pharmaceutical Industry. Boca Raton, Interpharm/CRC.
Students will also be directed to online resources as required, including relevant up-to-date scientific literature, and to other relevant reading material during teaching sessions and via the online module materials.