BIO07005 2019 BIOPHARMACEUTICAL FACILITIES AND UTILITIES

General Details

Full Title
BIOPHARMACEUTICAL FACILITIES AND UTILITIES
Transcript Title
BIOPHARMACEUTICAL FACILITIES A
Code
BIO07005
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)
Stephen Daly
Programme Membership
SG_SBIOM_B07 201900 Bachelor of Science in Biomedical Science SG_SMEDI_H08 201900 Bachelor of Science (Honours) in Science in Medical Biotechnology
Description

This  module aims to provide the student with a broad 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.

Understand 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.

List and describe other important utility systems for Biopharmaceutical Processing.

6.

Communicate and explain scientific data relating to facilities and utilities.

Teaching and Learning Strategies

This module is taught face to face in the lecture room. It will combine a number of strategies including visualisation (e.g. audio clips), group work and some enquiry based learning. Lecture content will be the primary method towards achieving this. A visit to an industrial med-tech manufacturing site may also be incorporated into the module (whenever feasible) to help with the learning and understanding of the subject. 

Module Assessment Strategies

Assessment of this module will include a combination of both continuous assessment and a terminal exam. The continuous assessment will be broken into multiple choice question exams and a subject specific project.  A key focus of this module is to develop the student's team skills. To achieve this, students will be assigned a project and be expected to participate constructively within a team environment. The team project will require the student's to research the topic, plan it, and manage the organisation of tasks, people and resources. They may also give a team presentation on the project.  

Repeat Assessments

Students will have opportunities to re-submit work or repeat the terminal exam as agreed with their lecturer.

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 and purification 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
40 %
End of Semester / Year Formal Exam
60 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 MCQ 1 Continuous Assessment Multiple Choice 10 % Week 5 1,2
2 MCQ 2 Continuous Assessment Multiple Choice 10 % Week 11 3,4,5
3 Project Assignment. Continuous Assessment UNKNOWN 20 % Week 10 1,2,3,4,5,6

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 End of term exam. Final Exam UNKNOWN 60 % Week 14 1,2,3,4,5
             
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Tiered Classroom Lecture 2 Weekly 2.00
Independent Learning UNKNOWN Self Study 5 Weekly 5.00
Total Full Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Required Reading
2017-11 Biopharmaceutical Processing
ISBN 0081006233 ISBN-13 9780081006238

Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference

Required Reading
2007-08-13 Pharmaceutical Biotechnology John Wiley & Sons
ISBN 9780470012444 ISBN-13 0470012447

Offers a comprehensive introduction to the principles and concepts of pharmaceutical biotechnology.

Module Resources

Non ISBN Literary Resources

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.  

 

The Rules Governing Medicinal Products in the European Union, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. Part 1, Chapter 3: Premises and Equipment.

Journal Resources

None

URL Resources

https://ec.europa.eu/health/documents/eudralex_en

Other Resources

None

Additional Information

None