BIO06017 2011 Sterile Operations Practical Laboratory.
This module aims to provide students with a practical, hands-on, knowledge and overall understanding of the key technologies and their applications in sterile operations for the pharmaceutical and biopharmaceutical industries.
Learning Outcomes
On completion of this module the learner will/should be able to;
Demonstrate an increased proficiency in the techniques and skills associated with aseptic processing.
Outline the main steps involved in setting up a sterile fill system for drug filling applications.
Incorporate proper gowning and cleanroom monitoring techniques for aseptic processing.
Demonstrate the concept of a media-fills run for a typical filling operation and its associated equipment.
Perform practical laboratory experiments for CIP and SIP operations.
Perform practical laboratory experiments for sterilisation/autoclaving.
Module Assessment Strategies
A combination of continuous assessment techniques and final end-of-term exam.
Indicative Syllabus
The following is an indicative summary of the main topics included in this module:
- Cleanroom preparation and monitoring for aseptic processing.
- Gowning technique for appropriate clearnoom classification.
- Setup of the filling operation for an aseptic cycle.
- Demonstrate the concept of a media-fills run on the filling operation.
- Perform practical experiments for Clean-in-Place (CIP) and Steam-in-Place (SIP) applications.
- Perform practical experiments for the sterilisation/autoclaving of components for aseptic processing.
Coursework & Assessment Breakdown
Coursework Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Continuous Assessment Short-form exams/quizzes and lab. practical write-ups. | Continuous Assessment | UNKNOWN | 70 % | OnGoing | 1,2,3,4,5,6 |
End of Semester / Year Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Final Exam | Final Exam | UNKNOWN | 30 % | End of Term | 1,2,3,4,5,6 |
Part Time Mode Workload
Type | Location | Description | Hours | Frequency | Avg Workload |
---|---|---|---|---|---|
Lecture | Distance Learning Suite | Online lecture. | 1 | Weekly | 1.00 |
Laboratory Practical | Science Laboratory | Laboratory practical experiments. | 24 | Once Per Semester | 1.60 |
Directed Learning | Not Specified | Directed self-learning. | 5 | Weekly | 5.00 |
Module Resources
‘Pharmaceutical Biotechnology - Concepts and Applications' by Gary Walsh.
Wiley Publications. 2007. ISBN - 978-0-470-01244-4.
‘Basic Biotechnology' by Colin Ratledge and Bjorn Kristiansen.
Cambridge Press. 2001. ISBN - 0-521-779170.
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