BIO09012 2020 FACILITY DESIGN AND OPERATION

General Details

Full Title
FACILITY DESIGN AND OPERATION
Transcript Title
FACILITY DESIGN AND OPERATION
Code
BIO09012
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Stage
Fee
Start Term
2020 - Full Academic Year 2020-21
End Term
9999 - The End of Time
Author(s)
Mary Butler
Programme Membership
SG_SBCQV_E09 201900 Level 9 Certificate in Science in CQV Commissioning, Qualification and Validation for Biologics Manufacturing
Description

This module will provide students with an overview of the technical and managerial challenges associated with the design and construction of a biopharmaceutical manufacturing facility.  It will address all the major elements of these projects from site master planning through conceptual and detailed design and onto commissioning and qualification.  It will also cover such associated project aspects as overall planning, budgeting and the organisational systems and structures required to successfully execute such major investments. 

An overview of how biopharmaceutical manufacturing facilities operate will also be addressed so as the design of the facility from the material and personnel flows through to the process controls and automation, meet the needs of the operations personnel after the facility is brought into production.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Effectively plan the major elements of an investment in a biopharmaceutical manufacturing facility.

2.

Evaluate and communicate the complex interconnecting elements of these major capital projects.

3.

Identify and address the operational requirements for the manufacturing facility within the design.

4.

Recognise and describe the main stages of facility design including cleanrooms and associated technology.

5.

Critically evaluate the principal steps involved in the overall commissioning and qualification of a new or modified biopharmaceutical facility.

6.

Appraise the typical organisational control systems and structures required for biopharmaceutical facility design and operation.

Teaching and Learning Strategies

100% CA

Module Assessment Strategies

This Module is 100% Continuous assessment

Repeat Assessments

Repeat assessments provided as per marks and standards and  Q manual

Indicative Syllabus

This module will provide students with an overview of the technical and managerial challenges associated with the design and construction of a biopharmaceutical manufacturing facility.  It will address all the major elements of these projects from site master planning through conceptual and detailed design and onto commissioning and qualification.  It will also cover such associated project aspects as overall planning, budgeting and the organisational systems and structures required to successfully execute such major investments. 

An overview of how biopharmaceutical manufacturing facilities operate will also be addressed so as the design of the facility from the material and personnel flows through to the process controls and automation, meet the needs of the operations personnel after the facility is brought into production.

The programme will include the following topics: Site Master Planning (Current, Future, Expandability),  Conceptual Design (Mass Balances & Manufacturing Logistics), Detailed Design (Layouts, Equipment, Process, Piping, HVAC, E&I, Finishes), Process Controls & Automation, Construction (Overview, Interfaces, Handover),  Commissioning & Qualification,  Budget & Schedule, Contracts,  Management of Vendor Packages (FAT, IQ & OQ requirements), Organisational Systems & Structures (Documentation & Change Control).               

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 MCQ Continuous Assessment Open Book Exam 10 % Week 4 1,5
2 mcq Continuous Assessment Open Book Exam 20 % Week 9 3,4
3 SAQ Continuous Assessment Closed Book Exam 30 % Week 13 1,2,3,4,5,6
4 report Project Assignment 40 % Week 14 1,2,3,4

Part Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Not Specified Lecture 2 Weekly 2.00
Independent Learning UNKNOWN Self Study 7 Weekly 7.00
Total Part Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Required Reading
2013-04-25 Pharmaceutical Biotechnology John Wiley & Sons
ISBN 9781118685754 ISBN-13 111868575X

Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific product category chapters focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed

Module Resources

Non ISBN Literary Resources

ISPE, Biopharmaceutical Manufacturing Facilities. Vol. 6. ISPE Baseline Guides, 2004

Whyte, W., Cleanroom Technology - Fundamentals of Design, Testing and Operations, John Wiley and Sons. Ltd., 2001

URL Resources
Other Resources

None