BIO06019 2019 Sterilisation technologies
Full Title
Sterilisation technologies
Transcript Title
Sterilisation technologies
Code
BIO06019
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 principles and methods of sterilisation used in bio/pharmaceutical and healthcare industries. While the primary focus will be on steam sterilisation, consideration will also be given to other forms of sterilisation including filtration, dry heat sterilisation, chemical sterilisation, and the use of ionizing and non-ionizing radiation. A discussion of sterilisation validation will also be provided.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Describe the main forms and types of sterilisation technologies available to the Biopharmaceutical Industry.
2.
Explain the sterilisation concepts of D-value, Z-value, Fo and SAL and their overall importance in the design and operation of sterilisation applications.
3.
Describe the operation of a typical steam sterilisation application such as an autoclave or an SIP system.
4.
Compare other forms of sterilisation such as dry heat depyrogenation, ethylene-oxide, vaporised hydrogen peroxide, gamma irradiation and e-beam technology.
5.
Outline the main steps involved in the overall validation of a typical sterilisation cycle.
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 resources.
Module Assessment Strategies
This module is 50% continuous and 50% final exam.
Repeat Assessments
Repeat continuous assessment and/or final exam.
Module Dependencies
Prerequisites
None
Co-requisites
None
Incompatibles
None
Indicative Syllabus
The following is an indication of the main topics included in this module
- Principles of microbial sterilization.
- Different forms of sterilization - dry heat, irraditaion, ethylene-oxide and VHP.
- Design of sterile and sanitary processes.
- Clean steam quality.
- Bioburden load monitoring.
- Bowie Dick Testing.
- Fo calculations.
- D values and Z values - SAL (sterility assurance levels).
- BI's for wet and dry loads.
- Chemical indicators for monitoring sterilization
- Steam hold time requirements.
- Validation of sterilization cycles.
- Practical demonstrations relating to sterilisation.
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 | Continuous Assessment Short-form test | Coursework Assessment | Assessment | 25 % | Week 4 | 1,2,3 |
| 2 | Continuous Assessment Short form-test | Coursework Assessment | Assessment | 25 % | Week 7 | 3,4,5 |
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
‘Contamination Control in Practice: Filtration and Sterilisation', by Matts Ramstorp.
Wiley. Mar. 2003.
ISBN-10: 3527307761
ISBN-13: 978-3527307760
Journal Resources
N/A
URL Resources
N/A
Other Resources
None
Additional Information
None