Module Details

Module Code: MANU6013
Title: Manufacturing Technology
Long Title: Manufacturing and Processing Technology
NFQ Level: Fundamental
Valid From: Semester 1 - 2014/15 ( September 2014 )
Duration: 1 Semester
Credits: 5
Field of Study: 5400 - Manufacturing Engineering
Module Delivered in: 3 programme(s)
Module Description: This module introduces the student to the unit operations and technology used in the manufacture of APIs, finished pharmaceuticals and medical devices. It covers topics such as, pumps, agitators, purification, filtration, drying, milling, tableting, forging, extrusion and packaging.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Describe the factors involved in the design and operation of manufacturing vessels in a GMP facility.
LO2 Identify and describe common heat and mass transfer technologies used in manufacturing processes.
LO3 Create typical process flow diagrams for the manufacture of pharmaceuticals and medical devices and explain the principles of the key unit operations employed.
LO4 Identify various healthcare packaging options, discuss the factors that dictate their selection and recognize the challenges faced by this sector of the industry.
Dependencies
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 MTU module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
841 CHEI6001 Fundamentals of Chemistry
6620 PHYS6039 Measurement and Calibration
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
No incompatible modules listed
Co-requisite Modules
No Co-requisite modules listed
Requirements

This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.
None
 
Indicative Content
Reactor Design and Operation
Design of reactors. Materials used in reactor construction. Agitation. Heating and cooling reactor units. Fluid flow, pumps, pumping and viscosity. The basics of mass and energy balances.
Unit Operations in API manufacturing
Product recovery and downstream processing. Review of unit operations including distillation, crystallisation, filtration, centrifugation, liquid-liquid extraction, drying, lyophilisation. Solvent recovery.
Tablet Manufacture & Encapsulation
Purpose and types of excipients. Unit operations in the common tabletting processes and encapsulation. Functional and non-functional coating operations.
Manufacture of Medical Devices
Introduction to materials used in medical device manufacture. Overview of moulding, extrusion, forging and casting, machining, bonding and polishing manufacturing processes. Manufacturing flow diagrams.
Sterilization
Sterilization methods in pharmaceutical, biopharmaceutical and medical device processes, sterility assurance.
Packaging of Healthcare Products
Purpose and types of packaging. Characteristics of pharmaceutical products and medical devices that influence packaging, risk based approach. Review of technology to ensure product and supply chain integrity.
Practical Programme
Site visits. Examples of laboratory practicals: Operation of a batch distillation column, comparison of agitators, operation of a centrifugal pump, operation and assembly of a diaphragm pump, operation of a heat-exchanger, operation of a tray-dryer, Liquid – liquid extraction, Conservation of mass. Demonstration of medical device machining and measuring. Examination of the medical devices manufactured locally.
Module Content & Assessment
Assessment Breakdown%
Coursework40.00%
End of Module Formal Examination60.00%

Assessments

Coursework
Assessment Type Short Answer Questions % of Total Mark 20
Timing Week 9 Learning Outcomes 1,2,3
Assessment Description
Reactor Design and Operation, Unit Operations in API manufacturing, Sterilization,Manufacture of Medical Devices
Assessment Type Other % of Total Mark 20
Timing Week 12 Learning Outcomes 1,2,3
Assessment Description
Site visits reports and laboratory practicals
End of Module Formal Examination
Assessment Type Formal Exam % of Total Mark 60
Timing End-of-Semester Learning Outcomes 1,2,3,4
Assessment Description
End-of-Semester Final Examination
Reassessment Requirement
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.

The University 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 Classroom Instruction Every Week 3.00 3
Lecturer-Supervised Learning (Contact) Contact Site Visits and Laboratory Practicals Every Second Week 1.00 2
Independent & Directed Learning (Non-contact) Non Contact Student Study Every Week 3.00 3
Total Hours 8.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 4.00
Workload: Part Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Classroom Instruction Every Week 3.00 3
Lecturer-Supervised Learning (Contact) Contact Site Visits and Laboratory Practicals Every Second Week 1.00 2
Independent & Directed Learning (Non-contact) Non Contact Student Study Every Week 3.00 3
Total Hours 8.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 4.00
 
Module Resources
Recommended Book Resources
  • Perry R.H.. (2008), Perry's chemical engineers' handbook, 8th. McGraw Hill, New York, [ISBN: 0071422943].
  • Kirk-Othmer. (2007), Encyclopedia of Chemical Technology, 5th. Index to volumes 1- 26, [ISBN: 978-0-471-48496-7].
Supplementary Book Resources
  • Herbert Lieberman et al. (1990), Pharmaceutical Dosage Forms :Tablets, 2nd. Marcel Dekker, [ISBN: -10: 0824782895].
  • Anthony J. Hickey and David Ganderton. (2001), Pharmaceutical Process Engineering, Marcell Dekker, [ISBN: 0824702980].
  • Wilmer A Jenkins, Kenton R.Osborn. (1993), Packaging Drugs and Pharmaceuticals, Technomic Publishing Company Inc, [ISBN: 1566760143].
  • Michael F. Ashby. (2011), Materials Selection in Mechanical Design, Fourth Edition, Butterworth-Heinemann, Burlington, MA, [ISBN: 9781856176637].
  • [edited by] Theodore R. Kucklick. (2006), The medical device R & D handbook, CRC/Taylor & Francis, Boca Raton, [ISBN: 0849327172].
  • Michael M. Domach. (2004), Introduction to biomedical engineering, Pearson/Prentice Hall, Upper Saddle River, N.J., [ISBN: 0130619779].
  • Al-achi, Antoine. (2013), Integrated Pharmaceutics [electronic resource] : Applied Preformulation, Product Design, and Regulatory Science, Wiley, Hoboken, [ISBN: 9781118356722].
This module does not have any article/paper resources
Other Resources
 
Module Delivered in
Programme Code Programme Semester Delivery
CR_ECPEN_8 Bachelor of Engineering (Honours) in Chemical and Biopharmaceutical Engineering 2 Elective
CR_SGMPP_6 Certificate in GMP and Process Operations 2 Elective
CR_SGMPR_6 Higher Certificate in Science in Good Manufacturing Practice and Technology 3 Elective