Module: Biopharmaceutical Facility Design & Operation

Latest Module Specifications

Current Academic Year 2025 - 2026

Module Title	Biopharmaceutical Facility Design & Operation
Module Code	BTE1038 (ITS: BE587)
Faculty	Biotechnology	School	Science & Health
NFQ level	9	Credit Rating	5

Description

This module will provide an overview of the technical and managerial challenges associated with the design and construction of a modern biopharmaceutical manufacturing facility. It will address the major components of such an exercise including site planning through conceptual and detailed design and on to commissioning, start-up and validation. A typical case study illustrating the integrated approach to facility design will also be considered. Attention will be given to the day-to-day operation of a biopharmaceutical facility operating in a regulated environment. Following facility construction, issues such as materials flow, personnel flow and some general utilities necessary for successful production will also be discussed.

Learning Outcomes

1. Effectively plan the major elements of an investment in a biopharmaceutical manufacturing facility.
2. Demonstrate an understanding of the complex interconnecting elements of these major capital projects.
3. Address the operational requirements for the manufacturing facility within the design.

*Type*	*Hours*	*Description*
Workload	Full time hours per semester
Lecture	16	No Description
Independent Study	109	No Description
Total Workload: 125

Section Breakdown
CRN	20119	Part of Term	Semester 2
Coursework	0%	Examination Weight	0%
Grade Scale	40PASS	Pass Both Elements	Y
Resit Category	RC1	Best Mark	N
Module Co-ordinator	David Collins	Module Teacher	Brian Freeland, Denis Collins, Denise Harold, Paul Cahill

Type	Description	% of total	Assessment Date
Assessment Breakdown
Assignment	Written Assignment	100%	Week 1

Reassessment Requirement Type
Resit arrangements are explained by the following categories; RC1: A resit is available for both^* components of the module. RC2: No resit is available for a 100% coursework module. RC3: No resit is available for the coursework component where there is a coursework and summative examination element. ^* ‘Both’ is used in the context of the module having a coursework/summative examination split; where the module is 100% coursework, there will also be a resit of the assessment

Pre-requisite	None
Co-requisite	None
Compatibles	None
Incompatibles	None

All module information is indicative and subject to change. For further information,students are advised to refer to the University's Marks and Standards and Programme Specific Regulations at: http://www.dcu.ie/registry/examinations/index.shtml

Indicative Content and Learning Activities

Introduction to Biomanufacturing with respect to Facility Design

Facility Design Issues – A Regulatory Perspective

Site Selection, Conceptual Design, Site Master Planning

Facility Design

Facility Construction

Facility Equipping, Start-up and Validation

Cleanroom Design and HVAC Technology

Utilities; Water, Gas, Steam, Air

GMP Facility: day to day operation (personnel, materials & waste flows)

Environmental monitoring, theory and practice

New Facility Build Case Study for a typical Biopharmaceutical manufacturer

Indicative Reading List

Books:

B. Lydersen, N. Dâ€™Elia and K. Nelson;: 1994, Bioprocess Engineering: Systems, Equipment & Facilities,, John Wiles & Sons, Inc.,
Richaardson & Peacock: 2005, Chemical Engineering; Coulson & Richardsonâ€™s Chemical Engineering Series, vol 3, 3rd Edition,

Articles:
None

Other Resources

None