Full Title BIOPHARMACEUTICAL FACILITIES AND UTILITIES

Short Title BIOPHARM FACILITIES AND UTILITIES

Code BIO08043
Level 08
Credit 05

Author Butler, Mary
Department Life Sciences

Subject Area Bio Tech/Eng/Chem
Attendence N/A%
Fee

Description
This module aims to provide the student with a good understanding of the main support service areas involving both facilities and utilities that underpin the modern biopharmaceutical manufacturing industry.

Indicative Syllabus
1. General Overview of Facilities and Utilities.

2. Facility Design Concepts for Biopharmaceutical Processing.

3. Cleanroom Technology (design, operation and monitoring) for Biopharmaceutical Processing.

4. Water Treatment Systems for Biopharmaceutical Processing.

5. Cleaning Systems for Biopharmaceutical Processing.

6. Sterilisation Technologies for Biopharmaceutical Processing.

7. Other utility systems for Biopharmaceutical Processing.

Learning Outcomes
On completion of this module the learner will/should be able to
  1. Outline the main elements and features of facilities and utilities relating to  the modern biopharmaceutical industry.  

  2. List and describe the main facility design concepts including cleanroom technology for Biopharmaceutical Processing. 

  3. Describe the key elements of a water treatment system for Biopharmaceutical Processing. 

  4. Describe the key principles involved in cleaning and sterilisation systems for Biopharmaceutical Processing. 

  5. Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly.

  6. Communicate and explain scientific data relating to facilities and utilities for biopharmaceutical processing.


Assessment Strategies
Continuous Assessment of Course Work - 30% of marks.

End of term online exam - 30% of marks.

Mini research project - 40% of marks.

The miniproject is a MANDATORY form of assessment for any modules on this programme with a miniproject component.

Module Dependencies
Pre Requisite Modules
None
Co Requisite Modules
None
Incompatible Modules
None

Coursework Assessment Breakdown %
Course Work / Continuous Assessment 70 %
End of Semester / Year Formal Examination 30 %

Coursework Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Open Book Exam Online 1,2 15 Week 4
Open Book Exam Online 3,4 15 Week 9
Individual Project Mini Research 5,6 40 Week 15


End Exam Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Other Exam Online 1,2,3,4 30 Week 13


Distance Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Part Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Lecture Not Specified Online 2 Weekly 2.00
Directed Learning Not Specified Course Notes 4 Weekly 4.00
Independent Learning UNKNOWN Mini Research Activities 4 Weekly 4.00

Total Average Weekly Learner Workload 6.00 Hours

Full Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Resources
Book Resources
'Pharmaceutical Biotechnology - Concepts and Applications' by Gary Walsh.

Wiley Publications. 2007. ISBN - 978-0-470-01244-4.



ISPE Baseline Guide Volume 6 - 'Biopharmaceutical Manufacturing Facilities'.

ISPE Baseline Guide Volume 4 - 'Water and Steam Systems'.

PDA Technical Report #1 - 'Validation of Moist Heat Sterilisation Processes'.

2007. Supplement Volume 61. No. S-1.
Other Resources
None
Url Resources
Additional Info