Registry

Module Specifications

Archived Version 2013 - 2014

Module Title	Biopharmaceutical Facility Design & Operation
Module Code	BE587
School	School of Biotechnology
Online Module Resources
Module Co-ordinator	Dr Jenny Lawler	Office Number	X221
NFQ level	9	Credit Rating	5
Pre-requisite	None
Co-requisite	None
Compatibles	None
Incompatibles	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

Reassessment Requirement
Resit arrangements are explained by the following categories; 1 = A resit is available for all components of the module 2 = No resit is available for 100% continuous assessment module 3 = No resit is available for the continuous assessment component
Unavailable

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

Programme or List of Programmes

GCBE	Graduate Cert in Bioprocess Engineering
GDBE	Graduate Dip in Bioprocess Engineering
MSBE	Master of Science in Bioprocess Engineer
SAMPB	STAND ALONE MODULE (BIOTECHNOLOGY)

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