Short Title:Process Control
Full Title:Process Control and PAT
Language of Instruction:English
Module Code:PROC H1002
 
Credits: 5
NFQ Level:8
Field of Study:Food processing
Module Delivered in 1 programme(s)
Reviewed By:JOHN BEHAN
Module Author:ED CAREY
Module Description:This module will provide the students with the knowledge and skills to understand the principles of process control and how Process analytical Technology (PAT)can be applied to gain process understanding and implement greater process control.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Interpret the principles of Quality by Design (QBD)and PAT control appropriate to manufacturing processes.
LO2 Evaluate powder physical measurement values as part of material specifications.
LO3 Identify Critical Process Parameters (CPPs) and critical to Quality Attributes (CQAs) that can be measured by sensors.
LO4 Apply chemometric measurement systems for material identification using NIR
Pre-requisite learning
Co-requisite Modules
No Co-requisite modules listed
 

Module Content & Assessment

Content (The percentage workload breakdown is inidcative and subject to change) %
Guidelines
ICH Q8,9 and 10. FDA PAT Guidance for Industry
15.00%
Powder Rheology
Shear cells, Compressibility, flowability energy, hopper design
20.00%
Particle Size
Sieve, Malvern, Icon and Microscopy
20.00%
Sensors
NIR, Raman, Eyecon, Focused beam Reflectance
20.00%
Chemometrics
Spectra pretreatment, multivariate analysis.
25.00%
Assessment Breakdown%
Course Work50.00%
End of Module Formal Examination50.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Continuous Assessment In class exam based on interpreting the ICH and PAT regulatory guidelines 1 30.00 Week 5
Laboratory Physical powder measurements and NIR analysis 2,4 20.00 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 50.00 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.
Reassessment Description
Repeat examination and or CA

IT Tallaght 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 In class delivery 2.00 Every Week 2.00
Laboratories Experiments in the PAT laboratory 1.00 Every Week 1.00
Independent Learning Time Researching, revision and preparing for the exam 2.00 Every Week 2.00
Tutorial Case studies from the literature 1.00 Every Week 1.00
Total Weekly Learner Workload 6.00
Total Weekly Contact Hours 4.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture In class delivery 2.00 Every Week 2.00
Laboratories Experiments in the PAT laboratory 1.00 Every Week 1.00
Independent Learning Researching, revision and preparing for the exam 2.00 Every Week 2.00
Tutorial Case studies from the literature 1.00 Every Week 1.00
Total Weekly Learner Workload 6.00
Total Weekly Contact Hours 4.00
 

Module Resources

Required Book Resources
  • ICH 2011, ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation
  • ICH 2009, ICH Q8 Pharmaceutrical Development
  • ICH 2005, ICH Q9 Quality Risk Management
  • ICH 2008, ICH Q10 Pharmaceutical Management Systems
  • FDA, Guidance for Industry- PAT
  • Dietmar Schulze 2007, Powders and Bulk Solids, Springer [ISBN: 978-3-540-73767]
  • Reiner Salzer and Heinz W. Siesler 2009, Infrared and Raman Spectroscopic Imaging, Wiley VCH [ISBN: 978-0-471-67201]
This module does not have any article/paper resources
Other Resources
 

Module Delivered in

Programme Code Programme Semester Delivery
TA_SFSCT_HD Higher Diploma in Food Science and Technology 2 Mandatory