BIO09045 2019 Biocontamination Monitoring and Control

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.

'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). 

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.