BIO07005 2019 Biopharmaceutical Facilities and Utilities
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;
Outline the main elements and features of facilities and utilities relating to the modern biopharmaceutical industry.
Understand the main facility design concepts including cleanroom technology for Biopharmaceutical Processing.
Describe the key elements of a water treatment system for Biopharmaceutical Processing.
Describe the key principles involved in cleaning and sterilisation systems for Biopharmaceutical Processing.
List and describe other important utility systems for Biopharmaceutical Processing.
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.
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 Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | MCQ 1 | Coursework Assessment | Multiple Choice/Short Answer Test | 10 % | Week 5 | 1,2 |
2 | MCQ 2 | Coursework Assessment | Multiple Choice/Short Answer Test | 10 % | Week 11 | 3,4,5 |
3 | Project Assignment. | Coursework 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 |
Required & Recommended Book List
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
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
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.
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https://ec.europa.eu/health/documents/eudralex_en
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