| Title: | Process Analytical Technology |
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| Long Title: | Process Analytical Technology |
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| Valid From: |
Semester 1 - 2019/20 ( September 2019 ) |
| Module Coordinator: |
Donagh OMahony |
| Module Author: |
David Goulding |
| Module Description: |
Process Analytical Technologies (PAT) involves the design, analysis and control of pharmaceutical manufacturing materials and processes through on/in-line measurement of the critical process parameters and quality attributes, to generate finished products of acceptable quality. The core idea of PAT is to generate product quality information in real time. PAT focuses on the use of in-line testing using near-infrared, Raman and other physiochemical and chemometric techniques for process monitoring, rather than traditional methodologies based on temperature, pressure, flow, pH and other physical measurements. |
| Learning Outcomes |
| On successful completion of this module the learner will be able to: |
| LO1 |
Explain and analyse the physical principles that underpin the application of physiochemical techniques to manufacturing process control technology. |
| LO2 |
Explain and demonstrate the principles and application of chemometric techniques in PAT. |
| LO3 |
Identify, interpret and analyse spectra qualitatively and quantitatively. |
| LO4 |
Evaluate current and emerging applications of PAT. |
| 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 CIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s). |
| None |
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. |
| None |
Co-requisite Modules
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| 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.
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| None |
Module Content & Assessment
| Indicative Content |
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Introduction to Process Analytical Technologies (PAT)
Historical perspective, regulatory framework, application to a simple manufacturing process, data collection and analysis, measurement technology: spectroscopy, chemometrics, on-line versus off-line applications, validation, process control, future trends.
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Introduction to Spectroscopy
Fundamentals of spectroscopy: hydrogen spectrum, quantum numbers, selection rules.
Basic elements of practical spectroscopy: sources, dispersing elements, detectors; S/N ratio, resolving power; line-widths; Fourier transforms.
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Infra-Red Spectroscopy
Vibrating diatomic molecule, pure vibrational spectra, anharmonicity;
Rotational-vibrational spectra e.g. carbon monoxide;
Techniques and instrumentation of IR spectroscopy: sources, dispersion, detector, sample preparation;
Applications: chemical analysis by IR spectroscopy.
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Nuclear Magnetic Resonance Spectroscopy
Nuclear magnetic resonance: the chemical shift, the coupling constant;
Techniques and instrumentation: pulsed NMR, other nuclei;
Applications: MRI, defects in solids.
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Mass Spectrometry
Types to include TOF, Quadrupole and Magnetic Sector. Operating principles, resolution and sensitivity specifications. Applications including solvent drying and residual gas analysis.
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Chemometrics
Physiochemical data processing and analysis. Techniques studied include principal component analysis (PCA) and partial least squares regression (PLS).
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PAT Applications
Use of simulation software.
Case Studies such as: 1) IR quality control in the food industry; 2) NIR for measurement of moisture and fat content of food; 3) NMR applications in the chemical industry; 4) Particle size distribution.
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| Assessment Breakdown | % |
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| Course Work | 30.00% |
| End of Module Formal Examination | 70.00% |
| Course Work |
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| Assessment Type |
Assessment Description |
Outcome addressed |
% of total |
Assessment Date |
| Open-book Examination |
Theory assessment |
1,4 |
15.0 |
Week 7 |
| Short Answer Questions |
Assessment |
2,3 |
15.0 |
Week 10 |
| 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 |
70.0 |
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 |
Delivery of module content |
4.0 |
Every Week |
4.00 |
| Independent & Directed Learning (Non-contact) |
Study and homework |
3.0 |
Every Week |
3.00 |
| Total Hours |
7.00 |
| 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 |
Delivery of module content |
4.0 |
Every Week |
4.00 |
| Independent & Directed Learning (Non-contact) |
Study and homework |
3.0 |
Every Week |
3.00 |
| Total Hours |
7.00 |
| Total Weekly Learner Workload |
7.00 |
| Total Weekly Contact Hours |
4.00 |
Module Resources
| Recommended Book Resources |
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- K. Bakeev 2010, Process analytical technology: spectroscopic tools and implementation strategies for the chemical and pharmaceutical industries, 2nd Ed., Blackwell USA [ISBN: 9781405121033]
| | Supplementary Book Resources |
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- H. Gunsler and H.U. Gremlich 2002, IR Spectroscopy: An Introduction, Wiley [ISBN: 3527288961]
- J. Kauppinen and J. Partanen 2001, Fourier Transforms in Spectroscopy, Wiley [ISBN: 3527402896]
- J.B. Lambert and E.P. Mazzola 2004, NMR Spectroscopy, Prentice-Hall [ISBN: 0130890669]
| | Recommended Article/Paper Resources |
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- Fonteyne, Margot; Vercruysse, Jurgen; De Leersnyder, Fien; et al. Process Analytical Technology for continuous manufacturing of solid-dosage forms, Analytical Chemistry, 2015, Volume 67
- Vargas, Jenny M; Nielsen, Sarah; Cárdenas, Vanessa; et al. 2018, Process analytical technology in continuous manufacturing of a commercial pharmaceutical product, International Journal of Pharmaceutics,, 538
| | Other Resources |
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- Website: Peter Scott 2008, Process Analytical Technology, AstraZeneca
- Website: Food and Drug Administration (FDA):
- Website: European Medicines Agency (EMA)
- Website: Bruker Optics
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Module Delivered in
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