BIO06019 2011 Sterilisation Technologies.
Full Title
Sterilisation Technologies.
Transcript Title
Sterilisation Technologies.
Code
BIO06019
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
ASCI - Applied Sciences
Level
06 - NFQ Level 6
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2011 - Full Academic Year 2011-12
End Term
2019 - Full Academic Year 2019-20
Author(s)
Kieran Tobin
Programme Membership
SG_SGOOD_C06 201600 Higher Certificate in Science in Good Manuf Practive & Technol
Description
This module aims to provide students with a general knowledge and understanding of the general principles and methods of sterilisation focusing primarily on steam sterilisation.
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 ethylene-oxide, gamma irradiation, dry-heat depyrogenation.
5.
Outline the main steps involved in the overall validation of a typical sterilisation cycle.
Module Assessment Strategies
A combination of continuous assessment methods and final end-of-term exam.
Indicative Syllabus
The following is an indicative summary of the main topics included in this module:
- Principles of microbial sterilization.
- Different forms of sterilization - steam, gamma-ray irradiation, ethylene-oxide.
- 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.
- 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 exams and assignments. | Continuous Assessment | UNKNOWN | 50 % | OnGoing | 1,2,3,4,5 |
End of Semester / Year Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Final Exam | Final Exam | UNKNOWN | 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
Other Resources
None
Additional Information
None