BIO06018 2019 Cleanroom Design and Operation
Full Title
Cleanroom Design and Operation
Transcript Title
Cleanroom Design and Operation
Code
BIO06018
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_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 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.
2.
Explain the different cleanroom classifications and their typical applications.
3.
Describe the principal gowning practices for cleanroom operations
4.
Describe how environmental monitoring is used to assess cleanroom cleanliness.
5.
Define the principal cleaning requirements for a cleanroom.
6.
Describe the benefits and applications of various pressure differentials and airflow patterns within cleanrooms.
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 50% continuous and 50% final exam.
Repeat Assessments
Repeat continuous assessment and/or repeat final exam.
Module Dependencies
Prerequisites
None
Co-requisites
None
Incompatibles
None
Indicative Syllabus
Cleanroom classifications and standards.
Materials and equipment for cleanrooms including HVAC systems and HEPA filters and clean room surfaces.
Cleanroom test equipment and monitoring - viable and non-viable particles.
Cleaning, decontamination and segregation of working areas within cleanrooms.
Cleanroom validation lifecycle.
Air filtration, pressure differentials and airflow patterns in cleanrooms.
Gowning practices and behaviour differences.
Integrity testing of cleanroom garb
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. | Coursework Assessment | Assessment | 50 % | OnGoing | 1,2,3,4,5,6 |
End of Semester / Year Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | End of Semester Final Exam | Final Exam | Closed Book Exam | 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
Cleanroom Technology, 2010, William White, Wiley-Blackwell; 2nd Edition, ISBN-10: 0470748060: ISBN-13: 978-0470748060
Journal Resources
N/A
URL Resources
N/A
Other Resources
None
Additional Information
None