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PHYS8017 - Process Analytical Technology

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Title:Process Analytical Technology
Long Title:Process Analytical Technology
Module Code:PHYS8017
 
Credits: 5
NFQ Level:Advanced
Field of Study: Physics
Valid From: Semester 1 - 2009/10 ( September 2009 )
Module Delivered in 2 programme(s)
Module Coordinator: Donagh OMahony
Module Author:  
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 required 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
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
Co-requisites
No Co Requisites listed
 

Module Content & Assessment

Indicative Content
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.
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.
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.
Raman Spectroscopy
The Raman effect, rotational Raman spectroscopy, vibrational Raman spectroscopy; Techniques and instrumentation; Applications: molecular structure determination from Raman spectroscopy, solid state applications.
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.
Chemometrics
Physiochemical data processing and analysis. Techniques studied include principal component analysis (PCA) and partial least squares regression (PLS).
Regulatory Framework
Seeking regulatory approval. Regulatory risk versus data use. Parallel testing and working towards PAT data reliance. Timelines and schedule. Interactive exercise: SWOT analysis of approach used in selected manufacturing plants.
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.
Assessment Breakdown%
Course Work30.00%
End of Module Formal Examination70.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Open-book Examination Theory assessment 1 15.0 Week 7
Essay Application case study. 4 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
This module has no Part Time workload.
 

Module Resources

Recommended Book Resources
  • K. Bakeev 2005, Process Analytical Technology, 1st Ed., Blackwell USA [ISBN: 9781405121033]
  • J.M. Hollas 2004, Modern Spectroscopy, 4th Ed., Wiley [ISBN: 0470844167]
Supplementary Book Resources
  • 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]
This module does not have any article/paper resources
Other Resources
 

Module Delivered in

Programme Code Programme Semester Delivery
CR_SPHYS_8 Bachelor of Science (Honours) in Applied Physics and Instrumentation 7 Mandatory
CR_SINEN_8 Bachelor of Science (Honours) in Instrument Engineering 7 Mandatory

Cork Institute of Technology
Rossa Avenue, Bishopstown, Cork

Tel: 021-4326100     Fax: 021-4545343
Email: help@cit.edu.ie