Full Title BIOCONTAMINATION CONTROL

Short Title BIOCONTAMINATION CONTROL

Code BIO08040
Level 08
Credit 05

Author Butler, Mary
Department Life Sciences

Subject Area Bio Tech/Eng/Chem
Attendence N/A%
Fee

Description
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.

Indicative Syllabus
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.

Learning Outcomes
On completion of this module the learner will/should be able to
  1. Discuss and critically evaluate the most relevant microbes for the biopharmaceutical industry and the typical sources of each.

  2. Identify and discuss appropriate prevention techniques for each contaminant.

  3. Source and interpret the theory behind the detection test methods available, including traditional and rapid identification testing.

  4. Develop and justify an appropriate monitoring regime for a pharmaceutical/biopharmaceutical facility.

  5. Describe the relevant regulatory expectations for Biocontamination Control including ICH Q8, Q9 and Q10.

  6. Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly.

  7. Communicate and explain scientific data relating to biocontamination control.


Assessment Strategies
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.

Module Dependencies
Pre Requisite Modules
None
Co Requisite Modules
None
Incompatible Modules
None

Coursework Assessment Breakdown %
Course Work / Continuous Assessment 70 %
End of Semester / Year Formal Examination 30 %

Coursework Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Open Book Exam Online 1,2 15 Week 4
Open Book Exam Online 3,4,5 15 Week 10
Individual Project Mini Research 6,7 40 Week 15


End Exam Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Other Exam Online 1,2,3,4,5 30 Week 13


Distance Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Part Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Lecture Not Specified Online 2 Weekly 2.00
Directed Learning Not Specified Course Notes / Slides 4 Weekly 4.00
Independent Learning UNKNOWN Mini Research Activities 4 Weekly 4.00

Total Average Weekly Learner Workload 6.00 Hours

Full Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Resources
Book Resources
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).
Other Resources
None
Url Resources
Additional Info