BIO08016 2011 BIOCONTAMINATION CONTROL

General Details

Full Title
BIOCONTAMINATION CONTROL
Transcript Title
BIOCONTAMINATION CONTROL
Code
BIO08016
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
ASCI - Applied Sciences
Level
08 - NFQ Level 8
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2011 - Full Academic Year 2011-12
End Term
2014 - Full Academic Year 2014-15
Author(s)
Anne Hayden, Kieran Tobin
Programme Membership
SG_SBIOP_K08 201100 Bachelor of Science (Honours) in Biopharmaceutical Science. SG_SBIOP_E08 201100 Level 8 Certificate in Science in Biopharmaceutical Science SG_SBIOP_E08 201100 Level 8 Certificate in Science in Biopharmaceutical Science SG_SBIOP_E08 201100 Level 8 Certificate in Science in Biopharmaceutical Science SG_SBIOT_E08 201500 Certificate in Science in Bioprocessing Technologies SG_SBIOT_E08
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.

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.

Module Assessment Strategies

Continuous Assessment of Course Work - 30% of marks.

End of term online exam - 30% of marks.

Mini research project - 40% of marks.

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.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
70 %
End of Semester / Year Formal Exam
30 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Open Book Exam Online Continuous Assessment UNKNOWN 15 % Week 4 1,2
2 Open Book Exam Online Continuous Assessment UNKNOWN 15 % Week 10 3,4,5
3 Individual Project Mini Research Continuous Assessment UNKNOWN 40 % Week 15 6,7

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Other Exam Online Final Exam UNKNOWN 30 % Week 13 1,2,3,4,5
             
             

Part Time Mode Workload


Type Location Description Hours Frequency Avg 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 Part Time Average Weekly Learner Contact Time 6.00 Hours

Module Resources

Non ISBN Literary 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

Additional Information

None