BIO06014 2019 Sterile Fill / Finish for Biologics
This module provides students with a general knowledge and understanding of the critical aspects of aseptic/sterile technique as it relates to filling operations for the biologics Industry.
Learning Outcomes
On completion of this module the learner will/should be able to;
Describe the fundamental aspects of sterile filling operations for biopharmaceutical drug products.
Outline the main equipment involved in sterile fill finish operations and their modes of operation.
Describe proper gowning principles and procedures for aseptic processing.
Explain the use of media fill protocols for determining the sterility of a typical filling process.
Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing.
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 repository of educational resources.
Module Assessment Strategies
This module is 50% continuous assessment and 50% final exam.
Repeat Assessments
Repeat continuous assessment and/or final exam.
Indicative Syllabus
The following is a summary indication of the main topics included in this module:
- Definition and scope of aseptic processing
- Equipment involved in sterile fill finish operations and their modes of operation
- Aseptic process simulations - media fills
- Aseptic gowning procedures and personnel qualification
- Filtration and filter integrity testing
- QC Bioanalytic and QC Microbiology final product testing.
- Use of isolator and barrier technology
- Environmental Monitoring principles and data trending.
Coursework & Assessment Breakdown
Coursework Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | MCQ 1 | Coursework Assessment | Multiple Choice/Short Answer Test | 25 % | Week 6 | 1,2 |
2 | MCQ 2 | Coursework Assessment | Multiple Choice/Short Answer Test | 25 % | Week 12 | 3,4,5 |
End of Semester / Year Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Final Exam | Final Exam | Assessment | 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. | 2 | Weekly | 2.00 |
Directed Learning | Not Specified | Directed self-study. | 4 | Weekly | 4.00 |
Module Resources
Pharmaceutical Biotechnology: An Introduction for Pharmacists and Pharmaceutical Scientists, 2nd Edition. J. Daan and R. Sindelar. Publisher: Taylor and Francis. ISBN: 0415285003.
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