BIO08001 2020 Biocontamination Monitoring and Control

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.

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 .

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.