BIO06014 2011 Sterile Fill Finish for Biologics.
Full Title
Sterile Fill Finish for Biologics.
Transcript Title
Sterile Fill Finish.
Code
BIO06014
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 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;
1.
Demonstrate an understanding of techniques and skills relating to aseptic processing.
2.
Describe the fundamental aspects of sterile filling operations for modern biopharmaceuticals.
3.
Outline the main equipment involved in sterile fill finish operations and their modes of operation.
4.
Describe proper gowning principles and procedures for aseptic processing.
5.
Explain the use of media fill protocols for determining the sterility of a typical filling process.
6.
Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing.
Module Assessment Strategies
A combination of continuous assessment techniques and a final end-of-term exam.
Indicative Syllabus
The following is a summary indication of the main topics included in this module:
- Definition and scope of aseptic processing.
- The main equipment involved in sterile fill finish and their modes of operation.
- Aseptic process simulations - media fills.
- Gowning and personnel qualification and good aseptic technique.
- Filtration and liquid filter integrity testing
- Sterility testing and final product testing.
- Use of isolator and barrier technology.
- Environmental data trending and excursion analysis.
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 | 1,2,3,4,5,6 |
End of Semester / Year Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Final Exam | Final Exam | UNKNOWN | 50 % | End of Term | 1,2,3,4,5,6 |
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
Pharmaceutical Biotechnology: An Introduction for Pharmacists and Pharmaceutical Scientists, 2nd Edition. J. Daan and R. Sindelar. Publisher: Taylor and Francis. ISBN: 0415285003.
Other Resources
None
Additional Information
None