Module Details

Module Code: BIOE8001
Title: Biomedical Manufacture
Long Title: Biomedical Manufacture
NFQ Level: Advanced
Valid From: Semester 1 - 2016/17 ( September 2016 )
Duration: 1 Semester
Credits: 5
Field of Study: 5212 - Biomedical Engineering
Module Delivered in: 1 programme(s)
Module Description: This module has been designed to present the processes and work practices that are employed in the manufacture of medical devices.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Specify the engineering requirements and the standards that apply to cleanrooms employed in the manufacture of medical products and in clinical settings.
LO2 Discuss the appropriate cleaning, packaging and sterilisation operations for medical devices.
LO3 Assess the safety risks associated with manufacturing operations and discuss the requirements for guaranteeing a safe working environment.
LO4 Detail the requirements of a GMP system and discuss the operation of regulatory bodies.
LO5 Discuss the validation requiments for medical device design and manufacture.
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).
Not applicable
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.
Not applicable
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.
Not applicable
 
Indicative Content
Cleanroom Technology
Cleanroom classification; particle size and counting; filter design and performance, cleanroom layout, materials & standards, cleanroom air flow patterns, cleanrrom commissioning and qualification, clinical HVAC/Cleanroom requirements
Cleaning and Sterilisation Technology
Requirements for cleaning, soil types, cleaning systems (organic/aqueous /semiaqueous), cleaning equipment & chemistry. Ethylene oxide. Gamma sterilisation, electron beam. Saturated steam - gravity displacement, porous load, ballasted cycles. Clinical sterilisation/cleaning requirements guidelines - HTM2010/HTM2030. Dry heat sterilisation/depyrogenation. Establishing sterilisation dose/time for Gamma & Ehtylene Oxide sterilisation. Modes and kinetics of microbial/endotoxin inactivation. Effects of sterilisation on medical device components.
Packaging
Functions of packaging, packaging requirements for sterilisation, physical & chemical properties of packaging, labelling and packaging control, distribution hazards, production of packages, forming materials and methods, lidding, sealing. Testing of packaging and packaging materials. Regulatory aspects of packaging. Introduction to the ISO 15378-2011 packaging standard.
Machine Safety
Risk assessment, use of machines, identifying the hazards, machine situations giving rise to risk. Hazards associated with materials and chamicals - short term & long term. Safety legislation & ethics.
GMP
Introduction to GMP, GMP documentation - SOPs/regulatory documentation/submissions, Role and requirements of the FDA/IMB/Notified Bodies, introduction to 21 CFR820/EU Medical Devices Directive/ISO 13485 (Quality Management in the Medical Device Industry), planning for audits. Clasiification of devices. FDA/IMB submissions - 510k/PMA applications. Principles of GDP/GLP/GCP and GAMP. Introduction to clinical trials.
Validation
Validation protocols - Installation, operational and performance qualification. Process validation, design qualification, validation of sterilisation and cleanroom systems, design verification, design validation. URS/FDS/FAT/SAT master validation plans. Change control. Application of risk assessment to validation.
Module Content & Assessment
Assessment Breakdown%
Coursework20.00%
End of Module Formal Examination80.00%

Assessments

Coursework
Assessment Type Short Answer Questions % of Total Mark 20
Timing Week 7 Learning Outcomes 1,2
Assessment Description
1-hour examination
End of Module Formal Examination
Assessment Type Formal Exam % of Total Mark 80
Timing End-of-Semester Learning Outcomes 1,2,3,4,5
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 Class based instruction Every Week 4.00 4
Independent & Directed Learning (Non-contact) Non Contact Self directed learning to complement lecture material Every Week 3.00 3
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 4.00
This module has no Part Time workload.
 
Module Resources
Recommended Book Resources
  • Lerouge, Sophie and Simmons, Anne. (2012), Sterilisation of Biomaterials and Medical Devices, Woodhead Publishing, [ISBN: 9781845699321].
  • W. Whyte. (2010), Cleanroom technology, 2nd Edition. John Wiley & Sons, Chichester, West Sussex, U.K., [ISBN: 9780470748060].
  • Sherman, M. (Editor). (1998), Medical Device Packaging Handbook, 2nd Edition. Marcel Dekker, [ISBN: 0824701992].
  • Itay Abuhav,. (2011), ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry, 1st Edition. CRC Press, [ISBN: 9781439866115].
  • edited by John Ridley and John Channing. (2003), Safety at work, 6th Edition. Butterworth Heinemann, Oxford [England], [ISBN: 0750654937].
  • Denyer, S.P. & Baird, R.M.. (2007), Guide to Microbiological Control in Pharmaceuticals and Medical Devices, 2nd Edition. CRC Press, USA, [ISBN: 978-0748406159].
Supplementary Book Resources
  • Hanlon, J.F. & Kelsey, R.J.. (1998), Handbook of Packaging Engineering, 3rd Edition. CRC Press, USA, [ISBN: 9781566763066].
  • Fries, R.. (2006), Reliable Design of Medical Devices, 2nd Edition. CRC Press, USA, [ISBN: 9780824723750].
  • Joseph Kinsella.. (2008), Health, safety and welfare law in Ireland, Gill & Macmillan, [ISBN: 9780717144600].
  • Department of Health. Estates and Facilities Division,. (2007), Specialised ventilation for healthcare premises, TSO, London, [ISBN: 9780113228058].
This module does not have any article/paper resources
Other Resources
 
Module Delivered in
Programme Code Programme Semester Delivery
CR_EBIOM_8 Bachelor of Engineering (Honours) in Biomedical Engineering 5 Elective