Module Details

Module Code: PHYS8017
Title: Process Analytical Technology
Long Title: Process Analytical Technology
NFQ Level: Advanced
Valid From: Semester 1 - 2019/20 ( September 2019 )
Duration: 1 Semester
Credits: 5
Field of Study: 4411 - Physics
Module Delivered in: 3 programme(s)
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:
# Learning Outcome Description
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.
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).
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
 
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.
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.
Mass Spectrometry
Types to include TOF, Quadrupole and Magnetic Sector. Operating principles, resolution and sensitivity specifications. Applications including solvent drying and residual gas analysis.
Chemometrics
Physiochemical data processing and analysis. Techniques studied include principal component analysis (PCA) and partial least squares regression (PLS).
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.
Module Content & Assessment
Assessment Breakdown%
Coursework30.00%
End of Module Formal Examination70.00%

Assessments

Coursework
Assessment Type Open-book Examination % of Total Mark 15
Timing Week 7 Learning Outcomes 1,4
Assessment Description
Theory assessment
Assessment Type Short Answer Questions % of Total Mark 15
Timing Week 10 Learning Outcomes 2,3
Assessment Description
Assessment
End of Module Formal Examination
Assessment Type Formal Exam % of Total Mark 70
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 Delivery of module content Every Week 4.00 4
Independent & Directed Learning (Non-contact) Non Contact Study and homework Every Week 3.00 3
Total Hours 7.00
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 Delivery of module content Every Week 4.00 4
Independent & Directed Learning (Non-contact) Non Contact Study and homework Every Week 3.00 3
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 4.00
 
Module Resources
Recommended Book Resources
  • K. Bakeev. (2010), Process analytical technology: spectroscopic tools and implementation strategies for the chemical and pharmaceutical industries, 2nd. Blackwell, USA, [ISBN: 9781405121033].
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].
Recommended Article/Paper Resources
  • 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
 
Module Delivered in
Programme Code Programme Semester Delivery
CR_SCHQA_8 Bachelor of Science (Honours) in Analytical Chemistry with Quality Assurance 7 Elective
CR_SPHYS_8 Bachelor of Science (Honours) in Applied Physics and Instrumentation 1 Mandatory
CR_SESST_8 Bachelor of Science (Honours) in Environmental Science and Sustainable Technology 7 Elective