BIO09045 2019 BIOCONTAMINATION MONITORING AND CONTROL

General Details

Full Title
BIOCONTAMINATION MONITORING AND CONTROL
Transcript Title
BIOCONTAMINATION MONITORING AN
Code
BIO09045
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Mary Butler, Macdara Bodeker
Programme Membership
SG_SBIPR_E09 201900 Certificate in Science in BioPharmaceutical Processing SG_SBIOP_M09 201900 Master of Science in Biopharmaceutical Science SG_SBIOP_O09 201900 Postgraduate Diploma in Science in Science in Biopharmaceutical Science
Description

This module is taken by Masters students in Pharmaceutical or Biopharmaceutical Science or Engineering. It 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. It does this through consideration of basic microbiology, evaluation of relevant microbes, potential sources of microbial contamination, correction/prevention tools, monitoring and detection methods, consideration of all relevant regulations and case study evaluation.

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 identify and discuss appropriate prevention techniques for each contaminant.

2.

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

3.

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

4.

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

5.

Perform research on a relevant topic and analyse, evaluate, communicate and explain scientific data relating to biocontamination control.

Teaching and Learning Strategies

'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). 

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, practical work, essays, oral presentations, vivas etc.

Repeat Assessments

Repeat Continuous Assessment and/or project resubmission.

Indicative Syllabus

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.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Open Book Exam Continuous Assessment Multiple Choice 10 % Week 5 1,2
2 Open Book Exam Continuous Assessment Multiple Choice 10 % Week 10 1,2,3,4
3 Long Answer Question Continuous Assessment Closed Book Exam 30 % Week 14 1,2,3,4
4 Continuous Project Project Project 40 % End of Semester 1,2,3,4,5
5 Project Viva and Presentation Project Oral Exam 10 % End of Semester 1,2,3,4,5

Part Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Distance Learning Suite Live or Recorded lecture 2 Weekly 2.00
Independent Learning UNKNOWN Self Study 7 Weekly 7.00
Total Part Time Average Weekly Learner Contact Time 2.00 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).

Journal Resources

Biopharma International

Journal of Regenerative Medicine

URL Resources

www.fda.gov

www.usp.org

www.ich.org

Other Resources

None

Additional Information

None