BIO06018 2011 Cleanroom Design and Operations.
Full Title
Cleanroom Design and Operations.
Transcript Title
Cleanroom Deign and Ops.
Code
BIO06018
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_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 general knowledge and understanding of the key aspects of cleanroom design, control and operations as they relate to the Biopharmaceutical Industry.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Describe the main design features of a typical cleanroom application and what design inputs are required for such a design.
2.
Explain the different cleanroom classifications and their typical applications.
3.
List the principal gowning and garbing practices for a typical cleanroom.
4.
Define the principal cleaning requirements for a cleanroom and the key elements of a cleaning validation.
5.
Describe the ongoing monitoring requirements for a cleanroom application.
Module Assessment Strategies
A combination of continuous assessment methods and a final end-of-term exam.
Indicative Syllabus
The following is an indicative summary of the main topics included in this module:
- Cleanroom classifications and standards.
- Materials and equipment for cleanrooms including HVAC systems, HEPA filters, isolator technology etc.
- Cleanroom practices.
- Cleanroom gowning and garbing.
- Cleanroom test equipment and monitoring - viable and non-viable entities.
- Cleaning, decontamination and segregation of working areas within cleanrooms.
- The nature of cleanroom contamination.
- Cleaning equipment and reagents.
- Validation of cleanrooms.
- Practical demonstrations relating to this module.
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 |
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 |
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
‘Cleanroom Technology' by William White.
Wiley-Blackwell; 2nd Edition edition (15 Jan 2010)
ISBN-10: 0470748060
ISBN-13: 978-0470748060
Other Resources
None
Additional Information
None