BIO06015 2019 Biocontamination control
Full Title
Biocontamination control
Transcript Title
Biocontamination control
Code
BIO06015
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
06 - NFQ Level 6
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Stephen Daly, Aodhmar Cadogan
Programme Membership
SG_SASEP_E06 201900 Certificate in Aseptic Biopharmaceutical Operations
SG_SGOOD_C06 202300 Higher Certificate in Science in Good Manufacturing Practice and Technology
SG_SGOOD_C06 202300 Higher Certificate in Science in Good Manufacturing Practice & Technology
Description
This module aims to provide students with a general knowledge and understanding of the key principles and methods of biocontamination control as it relates to aseptic processing operations in the biopharmaceutical industry.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Describe the main stages involved in the production of a biopharmaceutical production process
2.
Identify the main sources of contamination and their entry routes into a biopharmaceutical production facility
3.
Describe the principles of environmental montoring in a biopharmaceutical production facility.
4.
Outline the key differences between cleaning, sanitisation and sterilisation
5.
Describe the different types of micro-organisms that may lead to contamination
Teaching and Learning Strategies
This module will be delivered part time. It will include lectures augmented by independent Learning and directed learning. Moodle will be used as a repository of educational material and for assessment.
Module Assessment Strategies
This module is 50% continuous assessment and 50% final exam.
Repeat Assessments
Repeat assessment and/or repeat final exam.
Module Dependencies
Prerequisites
None
Co-requisites
None
Incompatibles
None
Indicative Syllabus
The following is a summary of the main topics included in this module
- Bioprocessing operations
- Contamination entry routes
- Types of micro-organisms
- Environmental monitoring
- Cleaning, Sanitisation and Sterilisation methods
- Aseptic processing
- Media fills
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
50 %
End of Semester / Year Formal Exam
50 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Short form exams | Coursework Assessment | Assessment | 25 % | Week 9 | 4,5 |
| 2 | Short form exams | Coursework Assessment | Assessment | 25 % | Week 5 | 1,2,3,5 |
End of Semester / Year Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Final End of Semester Exam | Final Exam | Closed Book Exam | 50 % | End of Term | 1,2,3,4,5 |
Part Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Distance Learning Suite | Online lecture. | 1 | Weekly | 1.00 |
| Directed Learning | Not Specified | Directed self-study. | 4 | Weekly | 4.00 |
Total Part Time Average Weekly Learner Contact Time 5.00 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.
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
N/A
URL Resources
N/A
Other Resources
None
Additional Information
None