Module Details

Module Code: PHAR S8009
Full Title: Recombinant Drug Manufacturing & Engineering
Valid From: Semester 1 - 2013/14 ( September 2013 )
Language of Instruction: 
Duration: 1 Semester
Credits: 5
Module Owner:: Richard Crowley
Departments: Unknown
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.
 
Module Learning Outcome
On successful completion of this module the learner will be able to:
# Module Learning Outcome Description
MLO1 Interpret P&ID's and select appropiate instrumentation to measure/control bio processes.
MLO2 Explain the characteristics of fluid distribution systems including pump/valve control technologies and safety systems.
MLO3 Examine and compare how purified water, clean steam, clean air etc. are processed, distributed and stored.
MLO4 Explain the principles and dynamics of heat transfer, fluid flow, mixing and aeration and solve associated technical problems.
MLO5 Discuss and analyse the major legislative and regulatory instruments in relation to waste and biohazard management.
Pre-requisite learning
Module Recommendations
This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named DkIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
No recommendations listed
 
Module 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.
Aeration:
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.
Module Assessment
Assessment Breakdown%
Course Work40.00%
Final Examination60.00%
Module Special Regulation
 

Assessments

Full Time

Course Work
Assessment Type Class Test % of Total Mark 20
Marks Out Of 0 Pass Mark 0
Timing Week 25 Learning Outcome 1,2,4
Duration in minutes 0
Assessment Description
Evaluate understanding and application of knowledge gained in lectures and tutorials
Assessment Type Practical/Skills Evaluation % of Total Mark 20
Marks Out Of 0 Pass Mark 0
Timing Every Second Week Learning Outcome 2,4
Duration in minutes 0
Assessment Description
To support theoretical knowledge
No Project
No Practical
Final Examination
Assessment Type Formal Exam % of Total Mark 60
Marks Out Of 0 Pass Mark 0
Timing End-of-Semester Learning Outcome 1,2,3,4,5
Duration in minutes 0
Assessment Description
End-of-Semester Final Examination
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

Workload: Full Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact No Description Every Week 3.00 3
Tutorial Contact No Description Every Week 1.00 1
Practical Contact 2hrs x 4 practicals Every Second Week 1.00 2
Independent Study Non Contact No Description Every Week 2.00 2
Directed Reading Non Contact No Description Every Week 2.00 2
Total Weekly Learner Workload 9.00
Total Weekly Contact Hours 5.00
This module has no Part Time workload.
 
Module Resources
Recommended Book Resources
  • Doran, P.M.. (2013), Bioprocess engineering principles, 2nd. Elsevier Ltd..
  • Collento V. William. (2010), Phrmaceutical Water: System Design, Operation and Validation, 2nd. 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. CRC Press, [ISBN: 978-089340697].
  • Charles E. Thomas. (2009), Introduction to Process Technology, 3rd. Delmar Cengage Learning, [ISBN: 978-1435454255].
  • Thomas E. Charles. (2010), Process Technology Equipment and Systems, 3rdge Learning. Delmar cenga, [ISBN: 978-1435499123].
  • Centre for the Advancement of Process Tech. (CAPT). (2009), Instrumentation, 1st. Prentice Hall, [ISBN: 978-0137004133].
  • Pandiyan Jaqadeesh. (2010), Introduction to SmartPLant P&ID: The Piping & Instrumentation Diagrams (P&ID) Handbook, 1st. 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. 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. 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. Irwin.
This module does not have any article/paper resources
Other Resources