Module Details

Module Code: ZPHA C3100
Module Title: Pharmaceutical Processing and Process Analytical Technologies
Title: Pharmaceutical Processing and Process Analytical Technologies
Module Level:: 7
Credits:: 5
Module Coordinator: Paula Rankin
Module Author:: John Cleary
Domains:  
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).
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# 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.

No recommendations listed
Co-requisite Modules
No Co-requisite modules listed
Additional Requisite Information
No Co Requisites listed
 
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.
Module Content & Assessment
Assessment Breakdown%
Continuous Assessment10.00%
Practical40.00%
End of Module Formal Examination50.00%

Assessments

Full Time

Continuous Assessment
Assessment Type Examination % of Total Mark 10
Timing Week 8 Learning Outcomes 1,2,3
Non-marked No
Assessment Description
n/a
No Project
Practical
Assessment Type Practical/Skills Evaluation % of Total Mark 40
Timing Every Week Learning Outcomes 1,3
Non-marked No
Assessment Description
Laboratory experimental procedures and concepts will be documented by the learner and their ability to practically perform the experiment and theoretically evaluate the results of the experiment and demonstrate the understanding of the scientific concepts involved will be assessed.
End of Module Formal Examination
Assessment Type Formal Exam % of Total Mark 50
Timing End-of-Semester Learning Outcomes 1,2,3
Non-marked No
Assessment Description
Formal exam
Reassessment Requirement
Exam Board
It is at the discretion of the Examination Board as to what the qualifying criteria are.

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 Contact 2 x 2 hour lectures per week for 12 weeks 12 Weeks per Stage 4.00 48
Laboratory Contact 10 x 3 hour laboratory practicals 12 Weeks per Stage 2.50 30
Estimated Learner Hours Non Contact Independent learning 15 Weeks per Stage 3.13 47
Total Weekly Contact Hours 6.50
 
Module Resources
Recommended Book Resources
  • Colm P. O’Donnell • Colette Fagan • P.J. Cullen. (2014), Process analytical Technology for the Food Industry, 1. Springer.
  • 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
  • Curtis D. Johnson. Process Control Instrumentation Technology, 8th edition. [ISBN: 1-292-02601-4].
  • Octave Levenspiel. (1999), Chemical Reaction Engineering, 3rd edition. John Wiley & Sons Incorporated, p.668, [ISBN: 0-471-25424-X].
  • Peter Kleinebudde,Johannes Khinast,Jukka Rantanen. (2017), Continuous Manufacturing of Pharmaceuticals, John Wiley & Sons, p.620, [ISBN: 9781119001324].
Supplementary Article/Paper Resources
  • Wee Chew & Paul Sharratt. (2010), Trends in process analytical technology, RSC Analytical Methods, 2, p.27.
  • 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.
  • 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
Discussion Note: