DCU Home | Our Courses | Loop | Registry | Library | Search DCU


Module Specifications

Archived Version 2012 - 2013

Module Title Biopharmaceutical Facility Design & Operation
Module Code BE587
School School of Biotechnology

Online Module Resources

Module Co-ordinatorDr Jenny LawlerOffice NumberX221
NFQ level 9 Credit Rating 5
Pre-requisite None
Co-requisite None
Compatibles None
Incompatibles None

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.

Workload Full-time hours per semester
Type Hours Description
Lecture16No Description
Independent Study109No 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 Assessment100% Examination Weight0%
Course Work Breakdown
TypeDescription% of totalAssessment Date
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
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

Programme or List of Programmes
GDBEGraduate Dip in Bioprocess Engineering
MSBEMaster of Science in Bioprocess Engineer