BIO06014 2019 Sterile Fill / Finish for Biologics
Full Title
Sterile Fill / Finish for Biologics
Transcript Title
Sterile Fill/Finish for Biolog
Code
BIO06014
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
06 - NFQ Level 6
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Stephen Daly, Aodhmar Cadogan
Programme Membership
SG_SBIOP_E06 201900 Certificate in Biopharmaceutical Processing.
SG_SBIOP_E06 201900 Certificate in Biopharmaceutical Processing.
SG_SGOOD_C06 202300 Higher Certificate in Science in Good Manufacturing Practice and Technology
SG_SGOOD_C06 202300 Higher Certificate in Science in Good Manufacturing Practice & Technology
Description
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;
1.
Describe the fundamental aspects of sterile filling operations for biopharmaceutical drug products.
2.
Outline the main equipment involved in sterile fill finish operations and their modes of operation.
3.
Describe proper gowning principles and procedures for aseptic processing.
4.
Explain the use of media fill protocols for determining the sterility of a typical filling process.
5.
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.
Module Dependencies
Prerequisites
None
Co-requisites
None
Incompatibles
None
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 & Continuous Assessment
50 %
End of Semester / Year Formal Exam
50 %
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 |
Total Part Time Average Weekly Learner Contact Time 6.00 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.
Journal Resources
NOne
URL Resources
None
Other Resources
None