| Title: | Manufacturing Technology |
|---|
| Long Title: | Manufacturing and Processing Technology |
|---|
| Field of Study: |
Manufacturing Engineering
|
| Valid From: |
Semester 1 - 2014/15 ( September 2014 ) |
| Module Coordinator: |
Michael J. OMahony |
| Module Author: |
ANN TOEBES |
| 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: |
| 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. |
| 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 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 |
Module Content & Assessment
| 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.
|
| Assessment Breakdown | % |
|---|
| Course Work | 40.00% |
| End of Module Formal Examination | 60.00% |
| Course Work |
|---|
| Assessment Type |
Assessment Description |
Outcome addressed |
% of total |
Assessment Date |
| Short Answer Questions |
Reactor Design and Operation, Unit Operations in API manufacturing, Sterilization,Manufacture of Medical Devices |
1,2,3 |
20.0 |
Week 9 |
| Other |
Site visits reports and laboratory practicals |
1,2,3 |
20.0 |
Week 12 |
| End of Module Formal Examination |
|---|
| Assessment Type |
Assessment Description |
Outcome addressed |
% of total |
Assessment Date |
| Formal Exam |
End-of-Semester Final Examination |
1,2,3,4 |
60.0 |
End-of-Semester |
| 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 institute reserves the right to alter the nature and timings of assessment
Module Workload
| Workload: Full Time |
| Workload Type |
Workload Description |
Hours |
Frequency |
Average Weekly Learner Workload |
| Lecture |
Classroom Instruction |
3.0 |
Every Week |
3.00 |
| Lecturer-Supervised Learning (Contact) |
Site Visits and Laboratory Practicals |
2.0 |
Every Second Week |
1.00 |
| Independent & Directed Learning (Non-contact) |
Student Study |
3.0 |
Every Week |
3.00 |
| Total Hours |
8.00 |
| Total Weekly Learner Workload |
7.00 |
| Total Weekly Contact Hours |
4.00 |
| Workload: Part Time |
| Workload Type |
Workload Description |
Hours |
Frequency |
Average Weekly Learner Workload |
| Lecture |
Classroom Instruction |
3.0 |
Every Week |
3.00 |
| Lecturer-Supervised Learning (Contact) |
Site Visits and Laboratory Practicals |
2.0 |
Every Second Week |
1.00 |
| Independent & Directed Learning (Non-contact) |
Student Study |
3.0 |
Every Week |
3.00 |
| 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 Ed., McGraw Hill New York [ISBN: 0071422943]
- Kirk-Othmer 2007, Encyclopedia of Chemical Technology, 5th Ed., Index to volumes 1- 26 [ISBN: 978-0-471-48496-7]
| | Supplementary Book Resources |
|---|
- Herbert Lieberman et al 1990, Pharmaceutical Dosage Forms :Tablets, 2nd Ed., 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 |
|---|
- Hard or Soft Copy: Course Notes
- Website: www.pharmaceuticalonline.com
- Website: www.imda.ie
- Website: FDADrug Recalls
- Website: MHRA 2012, Best Practice Guidance on the labelling
and packaging of medicines
|
Module Delivered in
|