BIO06016 2011 Cleaning, Sanitisation and Utilities.
This module aims to provide students with a general knowledge and understanding of the main principles and methods of operation for cleaning systems, sanitisation systems and principal utilities involved for Biopharmaceutical processing.
Learning Outcomes
On completion of this module the learner will/should be able to;
Describe the key principles involved in cleaning systems for Biopharmaceutical Processing including CIP systems.
Describe the key principles involved in sanitisation systems for Biopharmaceutical Processing including detergents, disinfectants etc.
Explain the key elements of a purified water treatment system including the generation of PW and WFI.
List and describe other important utility systems for Biopharmaceutical Processing including Clean Steam, Process Air/Gases etc.
Outline the main analytical technologies and techniques that apply to cleaning, sanitisation and utilities.
Module Assessment Strategies
A combination of continuous strategies and final end-of-term exam.
Indicative Syllabus
The following is an indicative summary of the main topics included in this module:
- Cleaning agents, caustic and acid cleaning systems, types of residues.
- Operation of a CIP system for a typical Biopharmaceutical Process.
- Conductivity and TOC as measures for determining rinsewater cleanliness.
- Sanitisation using a variety of methodologies including detergents, disinfectants, steam (SIP) and hot-water systems etc.
- The generation and storage of Potable Water, Purified Water and Water for Injection.
- The generation of clean steam from purified water.
- Other process utilities including clean steam, process air, process gases etc.
- Relevant demonstrations associated with this module.
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
ISPE, Water and Steam Systems, Vol. 4., ISPE Baseline Guides., 2001
AWWA and ASCE, Water Treatment Plant Design., McGraw-Hill Professional., 2004
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