Module Details

Module Code: MNUF S7001
Full Title: Pharmaceutical Manufacturing
Valid From:: Semester 1 - 2018/19 ( September 2018 )
Language of Instruction:English
Duration: 1 Semester
Credits:: 5
Module Owner:: Arjan van Rossum
Departments: Unknown
Module Description: Provide the student with the necessary knowledge and understanding of the manufacturing processes, equipment, tools and control systems needed to function effectively in a highly regulated and controlled pharmaceutical manufacturing environment.
 
Module Learning Outcome
On successful completion of this module the learner will be able to:
# Module Learning Outcome Description
MLO1 Categorise the manufacturing activities, inputs, outputs etc. using a Generic Process Approach model.
MLO2 Explain how cGMP and the regulatory landscape impacts on the design, layout, construction and operation of manufacturing Facilities and Premises.
MLO3 Describe the basic concepts associated with the design, layout, operation and control of clean rooms, how they are applied and used to maintain regulatory conformance.
MLO4 Examine and discuss the principles of tablet /capsule production systems and the associated control/measurement systems i.e. Manual, CLAS and CMMS.
MLO5 Explain how the principles of Cleaning, Decontamination and Sanitation (CDS), Cleaning In Place (CIP), Fogging are applied and how to provide and distribute Purified Water, Water for Injection and Clean Steam.
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
Manufacturing Process Approach -
Definitions, transformation process diagrams i.e.inputs, outputs, activities, deliverables etc. Flow Charts and Process Flow Diagrams
Patents
Novelty, obviousness, disclosure and utility. Product, process and use
Regulatory Authorities
FDA, EMEA, PAB, organisational structure, purpose/objectives, processes and areas of responsibility. The need for and application of cGMP.
Site Selection and Premises Design
Criterion, decision and ranking matrix. Material, process and people flow. Weighing & Dispensing area design and environmental control
Premise and Regulatory GMP
Impact on and design of Ancillary, Storage, Production and Quality Assurance areas
Manufacturing GMP and regulatory requirements
How regulatory requirements impact personnel , premise and equipment,
Clean Rooms
Definitions and standards. Turbulent and Laminar flows. Layouts and design, including air locks, air showers and stepover benchs. Factors affecting effectiveness i.e. rest and occupancy. Air supply, distribution and filtration. Zone control and clean room clothing.
Water purification and distribution
Classification types and uses of water. Multistep purification process, Distillation and Reverse Osmosis, Distribution systems for WFI and PW.
Principles of steam generation – steam equipment, boilers.
Utility and Cleam steam. Generation and distribution of Clean Steam
CDS – Cleaning, Decontamination and sanitation
Cleaning, Decontamination and Sanitation (CDS). Clean In Place (CIP) and Fogging
Tablet Production Systems
Tablet forms and formulations, Physical propertie i.e. shape, size and strength. Granual an Dry compression mixes. Wet and Dry cranulation. Eccentric and Rotary presses. powder and granual delivery systems. Weight control systems i.e. Manual, CLAS and CMMS. Correlation betwen compaction force and weight.
Tablet Coating systems
Acid resistant v non resistant coatings. Types of coating processes
Capsule Filling Systems
Generic Filling steps. Filling methodologies, Plate, Auger, Tamping, Compression and Drug-pack
Module Assessment
Assessment Breakdown%
Course Work20.00%
Project30.00%
Final Examination50.00%
Module Special Regulation
 

Assessments

Full Time On Campus

Course Work
Assessment Type Class Test % of Total Mark 20
Marks Out Of 0 Pass Mark 0
Timing n/a Learning Outcome 1,2
Duration in minutes 0
Assessment Description
The test will evaluate knowledge, understanding and application of the subject matter covered in lectures and tutorials
Project
Assessment Type Group Project % of Total Mark 30
Marks Out Of 0 Pass Mark 0
Timing n/a Learning Outcome 5
Duration in minutes 0
Assessment Description
At a minimum the project will cover one of the following learning outcomes.
No Practical
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 2.00 2
Tutorial Contact No Description Every Week 1.00 1
Directed Reading Non Contact No Description Once per semester 2.00 30
Independent Study Non Contact No Description Once per semester 2.00 30
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
This module has no Part Time On Campus workload.
 
Module Resources
Recommended Book Resources
  • Augsburger L. Larry, Hoag W, Stephen. (2008), Pharmaceutical Dosage Forms- Tablets: Manufacturing and Process Control, 3. Informa healthcare, [ISBN: 978-0849390166].
  • Haider, Imtiaz Syed. (2006), Validation Standard Operating Procedures: Achieving Compliance in Pharmaceutical, Medical Devices and Biotech Industries, 2nd. Informa Healthcare, [ISBN: 978-0849395291].
  • Buckbee George, Alford Joseph. Automation Applications in Bio Pharmaceuticals, 2008. ISA, [ISBN: 978-1934394250].
  • LeBlanc L. Destin. (2000), Validated Cleaning Technologies for Pharmaceutical Manufacturing, Informa Healthcare, [ISBN: 978-1574911169].
  • Paikh, D.M.. (1997), Handbook of pharmaceutical granulation technology, Marcel Dekker Inc, [ISBN: 978-0824798826].
  • Allport-Settle J. Mindy. (2009), Current GMP Practices, Create Space Indep Publishing Platform., [ISBN: 978-144955236].
  • Whyte William. (2010), Cleanroom Technology: Fundsmentals nof Design, Testing and Operation, 2nd. Wiley, [ISBN: 978-0470748060].
  • Collentro V. William. (2010), Pharmaceutical Water: System: Design, Operation, and Validation, 2nd. CRC Press, [ISBN: 1420077821].
  • Lachman Leon. (2010), The theory an practice of industrial pharmacy, CBS Publishing and Distributors P Ltd, [ISBN: 978-8123916798].
  • Walsh, G. (2003), Biopharmaceuticals: Biochemistry and Biotechnology, Wiley.
  • Lachman Leon, Lieberman A. Herbert, Kanig L. Joseph. (1986), The Theory and Practice of Industrial Pharmacy, 3rd. Lea & Febiger, [ISBN: 978-0812109771].
This module does not have any article/paper resources
Other Resources