Module Details
Module Code: |
ZPHA C3100 |
Module Title:
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Pharmaceutical Processing and Process Analytical Technologies
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Title:
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Pharmaceutical Processing and Process Analytical Technologies
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Module Level:: |
7 |
Module Coordinator: |
Paula Rankin
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Module Author:: |
John Cleary
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Module Description: |
The aim of this module is to give students an overview of the scientific principles underpinning pharmaceutical manufacturing processes, the principles of process control and monitoring, and the principles and implementation of Process Analytical Technology (PAT).
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Learning Outcomes |
On successful completion of this module the learner will be able to: |
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Learning Outcome Description |
LO1 |
Describe and apply the principles of process control and compare and select sensors and actuators for process control applications. |
LO2 |
Describe important processing steps in pharmaceutical manufacturing, compare the features of different reactor types, explain the properties and functions of excipients used in tablet formulations. |
LO3 |
Describe the theory and application of chemometrics, select chemometric data models, develop and validate models such as design spaces and data bases for use in PAT in-line or at-line process monitoring. |
Dependencies |
Module Recommendations
This is prior learning (or a practical skill) that is recommended before enrolment in this module.
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No recommendations listed |
Co-requisite Modules
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No Co-requisite modules listed |
Additional Requisite Information
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No Co Requisites listed
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Indicative Content |
PAT Process technology
Processing:
Process control: Basic principles, on/off control, feedback and feedforward control, PID control, case studies.
Sensors and actuators: Sensors for pressure, flow, and liquid level; Pumps and valves; Chemical sensors for process monitoring.
Chemical reactors: Reactor types – batch reactors, plug flow reactors, continuous stirred-tank reactors, semi-batch reactors; Non-ideal flow and residence time distribution; Scale-up issues.
Important processes in pharmaceutical manufacturing: Crystallisation, Filtration, Centrifugation, Drying, Milling, Blending.
Tablet production processes: Properties and functions of tableting excipients; Wet and dry granulation; Tableting machines.
PAT: Chemo-metrics, to introduce the learner to the theory and application of chemo-metrics, concepts and strategies. To illustrate how using multivariate statistics, applied mathematics and computer science in combination can lead to the ability to measure chemical and biological processes or issues in real time. (Sampling) To demonstrate how and when to sample a chemical or biological process. As well as define how sampling techniques such as bootstrap permutation and cross-validation can be used to verify the performance of PAT analytical methods. To provide the learner with the skills and ability to use spectroscopic data to produce mathematical models. As well as the rationale to select appropriate data models, calibrate instrumentation and identify outliers or spurious data points. Finally the process and procedures required to develop and validate PAT methods will be described and demonstrated in both theoretical and laboratory settings.
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Module Content & Assessment
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Assessment Breakdown | % |
Continuous Assessment | 10.00% |
Practical | 40.00% |
End of Module Formal Examination | 50.00% |
AssessmentsFull Time
End of Module Formal Examination |
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Reassessment Requirement |
Exam Board
It is at the discretion of the Examination Board as to what the qualifying criteria are.
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SETU Carlow Campus reserves the right to alter the nature and timings of assessment
Module Workload
Workload: Full Time |
Workload Type |
Workload Category |
Contact Type |
Workload Description |
Frequency |
Average Weekly Learner Workload |
Hours |
Lecture |
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Contact |
2 x 2 hour lectures per week for 12 weeks |
12 Weeks per Stage |
4.00 |
48 |
Laboratory |
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Contact |
10 x 3 hour laboratory practicals |
12 Weeks per Stage |
2.50 |
30 |
Estimated Learner Hours |
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Non Contact |
Independent learning |
15 Weeks per Stage |
3.13 |
47 |
Total Weekly Contact Hours |
6.50 |
Module Resources
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Recommended Book Resources |
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Colm P. O’Donnell • Colette Fagan • P.J. Cullen. (2014), Process analytical Technology for the Food Industry, 1. Springer.
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Katherine A. Bakeev. (2010), Process analytical technology, 2. all, 2010 John Wiley & Sons, Ltd. ISBN: 978-0-470-72207-7, [ISBN: 978-0-470-722].
| Supplementary Book Resources |
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Curtis D. Johnson. Process Control Instrumentation Technology, 8th edition. [ISBN: 1-292-02601-4].
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Octave Levenspiel. (1999), Chemical Reaction Engineering, 3rd edition. John Wiley & Sons Incorporated, p.668, [ISBN: 0-471-25424-X].
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Peter Kleinebudde,Johannes Khinast,Jukka Rantanen. (2017), Continuous Manufacturing of Pharmaceuticals, John Wiley & Sons, p.620, [ISBN: 9781119001324].
| Supplementary Article/Paper Resources |
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Wee Chew & Paul Sharratt. (2010), Trends in process analytical technology, RSC Analytical Methods, 2, p.27.
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Karen A. Esmonde-White, Maryann Cuellar,
Carsten Uerpmann, Bruno Lenain, &
Ian R. Lewis. (2017), Raman spectroscopy as a process
analytical technology for pharmaceutical
manufacturing and bioprocessing, Anal Bioanal Chem (2017) 409:637–649, 409, p.13.
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Niall O’ Mahony, Trevor Murphy, Krishna
Panduru, Daniel Riordan, Joseph Walsh. (2016), Smart Sensors for Process Analytical
Technology, 2016 IEEE International Conference on
Advanced Intelligent Mechatronics, July 12–15, 2016, p.6.
| This module does not have any other resources |
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