Module Details

Module Code: CHEM S7013
Full Title: Pharmaceutical Processing
Valid From:: Semester 1 - 2019/20 ( June 2019 )
Language of Instruction: 
Duration: 1 Semester
Credits:: 7.5
Module Owner:: Noelle Cunning
Departments: Unknown
Module Description: • The aims of this module are to introduce the student to the current legislative and mandatory requirements for processing in the Pharmaceutical Industry and to explain to students the impact of the product's physical and chemical properties to Pharmaceutical processing. Students will also be introduced to topics which can be used to analyse and improve processing
 
Module Learning Outcome
On successful completion of this module the learner will be able to:
# Module Learning Outcome Description
MLO1 Discuss the current legislative requirements associated with the Pharmaceutical product and Pharmaceutical processing
MLO2 Explain how the Pharmaceutical process can be validated in line with mandatory requirements
MLO3 Recognise how the basic chemical and physical properties of the product affect Pharmaceutical drug Processing
MLO4 Describe how kinetics, thermodynamics and PAT are applied to Pharmaceutical processing
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 DkIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
No recommendations listed
 
Module Indicative Content
Pharmaceutical process legislation
Introduce legislation and mandatory requirements for processing - current EU, FDA,HPRA and ICH
Pharmaceutical Industry
Introduction to the pharmaceutical industry and the requirements for GMP and Quality systems related to processing. Quality systems will include Good documentation practice (GDP), laboratory out of specification (OOS) and change management.
Pharmaceutical Process
Effect of chemical and physical properties of the products (API or finished) on the process - To include: Salt formation, particle size, powder flow, kinetics and thermodynamics
Process validation
Process validation and validation master plan. Introduction to concept of Process Analytical technology (PAT)
Practicals
Practicals will be carried out to reflect and support the material covered in lectures. The practicals will include the determination of active ingredients in pharmaceutical preparations
Module Assessment
Assessment Breakdown%
Course Work10.00%
Practical40.00%
Final Examination50.00%
Module Special Regulation
 

Assessments

Full Time On Campus

Course Work
Assessment Type Other % of Total Mark 10
Marks Out Of 0 Pass Mark 0
Timing S1 Week 6 Learning Outcome 1,2
Duration in minutes 0
Assessment Description
Continuous assessment
No Project
Practical
Assessment Type Practical/Skills Evaluation % of Total Mark 40
Marks Out Of 0 Pass Mark 0
Timing n/a Learning Outcome 3,4
Duration in minutes 0
Assessment Description
The practical sessions will provide the student with the opportunity to use the theory covered in formal lectures. After each practical, students will be required to submit a scientific practical report and a mark will be attributed to it by the laboratory demonstrator.
Final Examination
Assessment Type Formal Exam % of Total Mark 50
Marks Out Of 0 Pass Mark 0
Timing End-of-Semester Learning Outcome 1,2,3,4
Duration in minutes 0
Assessment Description
End-of-Semester Final Examination

DKIT reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time On Campus
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact No Description Every Week 3.00 3
Practical Contact No Description Every Week 3.00 3
Directed Reading Non Contact No Description Every Week 3.00 3
Independent Study Non Contact No Description Every Week 3.00 3
Total Weekly Learner Workload 12.00
Total Weekly Contact Hours 6.00
This module has no Part Time On Campus workload.
 
Module Resources
This module does not have any book resources
This module does not have any article/paper resources
Other Resources