BIO06019 2011 Sterilisation Technologies.
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;
Describe the main forms and types of sterilisation technologies available to the Biopharmaceutical Industry.
Explain the sterilisation concepts of D-value, Z-value, Fo and SAL and their overall importance in the design and operation of sterilisation applications.
Describe the operation of a typical steam sterilisation application such as an autoclave or an SIP system.
Compare other forms of sterilisation such as ethylene-oxide, gamma irradiation, dry-heat depyrogenation.
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 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 |
Module Resources
‘Contamination Control in Practice: Filtration and Sterilisation'
by Matts Ramstorp.
Wiley. Mar. 2003.
ISBN-10: 3527307761
ISBN-13: 978-3527307760
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