BIO08013 2011 BIOPHARMACEUTICAL FACILITIES AND UTILITIES

General Details

Full Title
BIOPHARMACEUTICAL FACILITIES AND UTILITIES
Transcript Title
BIOPHARM FACILITIES AND UTILITIES
Code
BIO08013
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
ASCI - Applied Sciences
Level
08 - NFQ Level 8
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2011 - Full Academic Year 2011-12
End Term
2014 - Full Academic Year 2014-15
Author(s)
Kieran Tobin
Programme Membership
SG_SBIOP_K08 201100 Bachelor of Science (Honours) in Biopharmaceutical Science. SG_SBIOP_E08 201100 Level 8 Certificate in Science in Biopharmaceutical Science SG_SBIOP_E08 201100 Level 8 Certificate in Science in Biopharmaceutical Science SG_SBIOP_E08 201100 Level 8 Certificate in Science in Biopharmaceutical Science SG_SBIOT_E08 201500 Certificate in Science in Bioprocessing Technologies SG_SBIOT_E08
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.

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.

Module Assessment Strategies

Continuous Assessment of Course Work - 30% of marks.

End of term online exam - 30% of marks.

Mini research project - 40% of marks.

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

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.    

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 Open Book Exam Online Continuous Assessment UNKNOWN 15 % Week 4 1,2
2 Open Book Exam Online Continuous Assessment UNKNOWN 15 % Week 9 3,4
3 Individual Project Mini Research Continuous Assessment UNKNOWN 40 % Week 15 5,6

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Other Exam Online Final Exam UNKNOWN 30 % Week 13 1,2,3,4
             
             

Part Time Mode Workload


Type Location Description Hours Frequency Avg 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 Part Time Average Weekly Learner Contact Time 6.00 Hours

Module Resources

Non ISBN Literary 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

Additional Information

None