BIO07012 2019 Facilites and Utilities.

General Details

Full Title
Facilites and Utilities.
Transcript Title
Facilites and Utilities.
Code
BIO07012
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Paul Walsh
Programme Membership
SG_SBIOP_J07 201900 Bachelor of Science in Science in Biopharmaceutical Science SG_SBIOP_E07 201900 Certificate in Science in Biopharma Processing L7
Description

This  module aims to provide students 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.

To provide an explanation of the technical and managerial challenges associated with the design and construction of a biopharmaceutical manufacturing facility.

2.

To appreciate the major elements of these projects from site master planning through conceptual and detailed design and onto commissioning and qualification.

3.

To address the operational requirements for the manufacturing facility within an overall design.

4.

To explain key concepts incorporated into cleanroom design and classification.

5.

Describe the key principles involved in cleaning and sterilisation including CIP and SIP systems.

6.

To understand the key elements of treatment and purification plant used to prepare water fit for bioprocessing operations.

Teaching and Learning Strategies

N/A

Module Assessment Strategies

A combination of continuous assessment strategies, some laboratory experiments and an end-of-term exam.

Repeat Assessments

N/A

Indicative Syllabus

·         General Outline of Facilities and Utilities.                             

·         Cleanroom Technology (design, operation and monitoring) and its application for Biopropcessing.  

·         Water Treatment Systems and their applications for Biopharmaceutical Processing.

·         Cleaning Systems including CIP.                              

·         Sterilisation Technologies including SIP.      

·         Other typical Utility Systems.  

 

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 assessments. Continuous Assessment Assessment 50 % OnGoing 1,2,3,4,5,6
             
             

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Written 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

 ‘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.  

Journal Resources

N/A

URL Resources

N/A

Other Resources

None

Additional Information

None