BIO06017 2019 Sterile operations practical
Full Title
Sterile operations practical
Transcript Title
Sterile operations practical
Code
BIO06017
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
06 - NFQ Level 6
Credit
10 - 10 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_SASEP_E06 201900 Certificate in Aseptic Biopharmaceutical Operations
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 aims to provide students with practical skills and an overall understanding of the key technologies used in sterile filling operations in the biopharmaceutical industry.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Demonstrate an increased proficiency in the techniques and skills associated with aseptic processing.
2.
Outline the main steps involved in setting up a sterile fill system.
3.
Outline the gowning and environmental monitoring techniques required for aseptic processing.
4.
Demonstrate the concept of a media-fill for a typical filling operation.
5.
Perform practical laboratory experiments for clean out of place and steam out of place operations.
6.
Perform practical laboratory experiments for sterilisation and autoclaving.
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 a repository of educational resources.
Module Assessment Strategies
This module is 70% continuous and 30% final exam.
Repeat Assessments
Repeat continuous assessment and/or repeat final exam.
Module Dependencies
Prerequisites
None
Co-requisites
None
Incompatibles
None
Indicative Syllabus
The following is an indicative summary of the main topics included in this module:
-
Environmental monitoring for aseptic processing.
-
Gowning requirements for aseptic processing
-
Media fill/process simulation
-
Cleaning and steaming operations
-
Sterilisation and autoclaving
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
70 %
End of Semester / Year Formal Exam
30 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Continuous Assessment Short-form exams/quizzes and lab. practical write-ups. | Coursework Assessment | Assessment | 70 % | OnGoing | 5,6 |
End of Semester / Year Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | End of semester Final Exam | Final Exam | Closed Book Exam | 30 % | End of Term | 1,2,3,4 |
Part Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Distance Learning Suite | Online lecture. | 1 | Weekly | 1.00 |
| Practical / Laboratory | Science Laboratory | Laboratory practical experiments. | 24 | Once Per Semester | 1.60 |
| Directed Learning | Not Specified | Directed self-learning. | 5 | Weekly | 5.00 |
Total Part Time Average Weekly Learner Contact Time 7.60 Hours
Module Resources
Non ISBN Literary Resources
Pharmaceutical Biotechnology: Concepts and Applications, Gary Walsh, Wiley 2013. ISBN: 978-1-118-77301-7
Basic Biotechnology, 3rd edition, Edited by Colin Ratledge, Bjorn Kristiansen, Cambridge University Press 2006, on line 2012, 9780511802409.
Journal Resources
N/A
URL Resources
N/A
Other Resources
None
Additional Information
None