Full Title:Recombinant Drug Manufacturing & Engineering
Module Code:PHAR S8009
Credits: 5
Valid From:Semester 1 - 2013/14 ( September 2013 )
Module Delivered in 1 programme(s)
Module Description:The aim of this module is to provide the students with an in-depth knowledge of the fundamental engineering principles and tools required to work effectively in a highly regulated and controlled biopharmaceutical process plant environment.
Learning Outcomes:
On successful completion of this module the learner should be able to
  1. Interpret P&ID's and select appropiate instrumentation to measure/control bio processes.
  2. Explain the characteristics of fluid distribution systems including pump/valve control technologies and safety systems.
  3. Examine and compare how purified water, clean steam, clean air etc. are processed, distributed and stored.
  4. Explain the principles and dynamics of heat transfer, fluid flow, mixing and aeration and solve associated technical problems.
  5. Discuss and analyse the major legislative and regulatory instruments in relation to waste and biohazard management.

Module Content & Assessment

Indicative Content
The Process Approach .
Process definitions and diagrams. How to document processes i.e. Flow charts, Block Diagrams (BD), Process Flow Diagrams (PFD) and Piping & Instrumentation Diagrams (P&ID).
Pipe & Instrument Drawings (P&ID)
P&ID definitions, symbols, TAG ID etc. as per ISA-5.1-1984 (R1992).
Instrumentation: Function, Types and Construction
Instrumentation function i.e. Indicators, Sensors, Transmitters and Controllers. Instrumentation types and construction i.e. measuring gauges, probes, thermocouples etc.
Process Control & Safety
Closed and Open loop control systems. Manual, semi-automatic and automatic control systems. Safety systems, i.e. pressure relief etc. Fail Open and Fail Closed systems
Fluid Flow
Force, Pressure, Friction and Flow Rates. How fluid distribution systems can negatively affect fluid flow and damage product and instrumentation
Pumping Technology
Pump Classification i.e. centrifugal and positive displacement pumps. The advantages and disadvantages of pumps as Constant Flow Machines. Linear and Rotary classifcation. Pump types i.e. Diaphragm, Lobe, Peristalic, Gear, Vane etc. Selecting pumps with Characteristics suitable to bio processing. The effect of cavitation and water hammer on hardware and instrumentation.
Valve Technology
Definition and function of valves. Valve types i.e. Diaphragm, Ball, Globe, Gate,Piston etc. Function and uses of Check valve technology. Types of Check valve i.e. Disc, Tilting Disc, Swing etc. The need for Safety Valves to protect equipment, product and instrumentation.
Plant & Utilities & HEVAC
Water i.e. grades (PW, HPW and WFI), uses, purification process and distribition. Water standards and specifications. Steam i.e. plant amd clean steam, uses for clean steam, purity and specifications. How to sample clean steam. Design of a typical Clean Steam System (CSS). Rouging and De-rouging. How to generate Clean Steam. Fundamentals of distributing Clean Steam. Validation of CSS. Heating, ventilation and air conditioning (HEVAC) systems.
Aseptic Operation
Aseptic operation and sterilistaion of process hardware. Cleaning in place (CIP) and steaming in place (SIP) principles.
Oxygen requirement of industrial fermentations, oxygen supply, sparger design, oxygen transfer from gas bubble to cell.
Waste management:
Biohazardous waste, effluent disposal and associated legislation. Environmental Standard ISO 14001.
Experimental Work
The following list is designed to serve as an illustration of possible practical exercises which would illustrate key concepts and techniques. Many of the practical situations are applicable to a range of biopharmaceutical products and so have a broad spectrum of merit. • How to generate a signal: The science behind a pH and/or dO2 probe. • Batch ultrafiltration of milk powder solutions. • Dynamics of heat transfer in a stirred tank reactor. • Dynamics of oxygen transfer in a stirred tank reactor. • Evaporation of sugar solutions. • Filtration in a bench top filter cell. • Sedimentation of calcium carbonate suspensions.
Assessment Breakdown%
Course Work40.00%
End of Module Formal Examination60.00%

Full Time

Course Work
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Class Test Evaluate understanding and application of knowledge gained in lectures and tutorials 1,2,4 20.00 0 0 Week 25 0
Practical/Skills Evaluation To support theoretical knowledge 2,4 20.00 0 0 Every Second Week 0
No Project
No Practical
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Formal Exam End-of-Semester Final Examination 1,2,3,4,5 60.00 0 0 End-of-Semester 0
Reassessment Requirement
A repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.

DKIT reserves the right to alter the nature and timings of assessment


Module Workload & Resources

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture No Description 3.00 Every Week 3.00
Tutorial No Description 1.00 Every Week 1.00
Practical 2hrs x 4 practicals 2.00 Every Second Week 1.00
Independent Study No Description 2.00 Every Week 2.00
Directed Reading No Description 2.00 Every Week 2.00
Total Weekly Learner Workload 9.00
Total Weekly Contact Hours 5.00
This course has no Part Time workload.
Recommended Book Resources
  • Doran, P.M. 2013, Bioprocess engineering principles, 2nd Ed., Elsevier Ltd.
  • Collento V. William 2010, Phrmaceutical Water: System Design, Operation and Validation, 2nd Ed., CRC Press [ISBN: 1420077821]
  • Morris, A.S. and Langari, R. 2012, Measurement and instrumentation: Theory and application, Elsevier
  • Seiberling A. Dale 2007, Clean -In-Place for Biopharmaceutical Processes., 1st Ed., CRC Press [ISBN: 978-089340697]
  • Charles E. Thomas 2009, Introduction to Process Technology, 3rd Ed., Delmar Cengage Learning [ISBN: 978-1435454255]
  • Thomas E. Charles 2010, Process Technology Equipment and Systems, 3rdge Learning Ed., Delmar cenga [ISBN: 978-1435499123]
  • Centre for the Advancement of Process Tech. (CAPT) 2009, Instrumentation, 1st Ed., Prentice Hall [ISBN: 978-0137004133]
  • Pandiyan Jaqadeesh 2010, Introduction to SmartPLant P&ID: The Piping & Instrumentation Diagrams (P&ID) Handbook, 1st Ed., APJ Books [ISBN: 978-0615339212]
  • Smith, J.M., Van Ness, H.C. and Abbott, M.M. 2005, Introduction to chemical engineering thermodynamics., McGraw-Hill
  • Bunn, G. 2006, Good manufacturing practice for pharmaceuticals, 6th Ed., Taylor & Francis
  • Walsh, G. 2003, Biopharmaceuticals: Biochemistry and biotechnology, J. Wiley and Sons
  • Shuler, M.L.L. and Kargi, F. 2002, Bioprocess engineering basic concepts, 2nd Ed., Prentice Hall
  • Harrison, R.G., Todd P.W., Rudge, S.R. and Petrides, D. 2003, Bioseparations science and engineering, Oxford University Press
  • Stanbury, P.F., Whitaker, A. and Hall, S.J. 1995, Principles of fermentation technology, 2nd Ed., Irwin
This module does not have any article/paper resources
Other Resources

Module Delivered in

Programme Code Programme Semester Delivery
DK_SBIOP_8 Bachelor of Science (Honours) in Biopharmaceutical Science 2 Mandatory