Module: Biopharmaceutical Facility Design & Operation

Module Specifications.

Current Academic Year 2024 - 2025

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Date posted: September 2024

Module Title	Biopharmaceutical Facility Design & Operation
Module Code	BE587 (ITS) / BTE1038 (Banner)
Faculty	Science & Health	School	Biotechnology
Module Co-ordinator	Denis Collins
Module Teachers	Brian Freeland, David Collins, Denise Harold, Paul Cahill
NFQ level	9	Credit Rating	5
Pre-requisite	Not Available
Co-requisite	Not Available
Compatibles	Not Available
Incompatibles	Not Available

None

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

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

Assessment Breakdown
Continuous Assessment	100%	Examination Weight	0%

Type	Description	% of total	Assessment Date
Course Work Breakdown
Assignment	Written Assignment	100%

Reassessment Requirement Type
Resit arrangements are explained by the following categories: Resit category 1: A resit is available for both* components of the module. Resit category 2: No resit is available for a 100% continuous assessment module. Resit category 3: No resit is available for the continuous assessment component where there is a continuous assessment and examination element.
* ‘Both’ is used in the context of the module having a Continuous Assessment/Examination split; where the module is 100% continuous assessment, there will also be a resit of the assessment
This module is category 1

Indicative Reading List

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

Other Resources

None