BIO06017 2011 Sterile Operations Practical Laboratory.
Full Title
Sterile Operations Practical Laboratory.
Transcript Title
Sterile Ops. Lab. Practicals
Code
BIO06017
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
ASCI - Applied Sciences
Level
06 - NFQ Level 6
Credit
10 - 10 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_SASEP_E06 201100 Certificate in Science in Aseptic Processing.
SG_SGOOD_C06 201600 Higher Certificate in Science in Good Manuf Practive & Technol
Description
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;
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 for drug filling applications.
3.
Incorporate proper gowning and cleanroom monitoring techniques for aseptic processing.
4.
Demonstrate the concept of a media-fills run for a typical filling operation and its associated equipment.
5.
Perform practical laboratory experiments for CIP and SIP operations.
6.
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 & 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. | 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 |
Total Part Time Average Weekly Learner Contact Time 7.60 Hours
Module Resources
Non ISBN Literary 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.
Other Resources
None
Additional Information
None