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BIOE7004 - Biomedical Manufacture

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Title:Biomedical Manufacture
Long Title:Biomedical Manufacture
Module Code:BIOE7004
 
Duration:1 Semester
Credits: 5
NFQ Level:Intermediate
Field of Study: Biomedical Engineering
Valid From: Semester 1 - 2016/17 ( September 2016 )
Module Delivered in 1 programme(s)
Module Coordinator: GER KELLY
Module Author: HUGH O DONNELL
Module Description: This module has been designed to introduce the student to 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:
LO1 Describe the specifications and requirements for cleanrooms in the medical device industry
LO2 Describe the appropriate cleaning, packaging and sterilisation operations for medical devices
LO3 Explain the safety risks associated with a manufacturing operation and understand the requirements for guaranteeing a safe working environment.
LO4 Identify the requirements of a GMP system and explain the operation of regulatory bodies such as FDA/IMB.
LO5 Explain the validation requiments for medical device design and manufacture.
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 CIT 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
Co-requisites
No Co Requisites listed
 

Module Content & Assessment

Indicative Content
Cleanroom Technology
Cleanroom classification; particle size and counting; filter design and performance, cleanroom layout, materials & standards.
Cleaning and Sterilisation Technology
Requirements for cleaning, soil types, cleaning systems organic/aqueous /semiaqueous), cleaning equipment. Ethylene oxide. Gamma sterilisation, electron beam. Saturated steam - gravity displacement, porous load, ballasted cycles. Dry heat sterilisation/depyrogenation. Microbial inactivation/endotoxin inactivation.
Packaging
Functions of packaging, packaging requirements for sterilisation, physical properties of packaging, labelling and packaging control, distribution hazards, production of packages, forming materials and methods, lidding, sealing.
Machine Safety
Risk assessment, use of machines, identifying the hazards, machine situations giving rise to risk
GMP
Introduction to GMP, GMP documentation - SOPs/regulatory documentation/submissions, Role and requirements of the FDA/IMB/Notified Bodies, introduction to 21 CFR820/Medical Devices Directive, planning for audits.
Validation
Validation protocols - Installation, operational and performance qualification. Process validation, design Qualification, validation of sterilisation system, design verification, design validation.
Assessment Breakdown%
Course Work20.00%
End of Module Formal Examination80.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Short Answer Questions 1-hour examination 1,2 20.0 Week 7
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End-of-Semester Final Examination 1,2,3,4,5 80.0 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.

The institute 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 Class based instruction 4.0 Every Week 4.00
Independent & Directed Learning (Non-contact) Self directed learning to complement lecture material 3.0 Every Week 3.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 4.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Class based instruction 3.0 Every Week 3.00
Independent & Directed Learning (Non-contact) Self directed learning to complement lecture material 4.0 Every Week 4.00
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
 

Module Resources

Recommended Book Resources
  • Lerouge, Sophie and Simmons, Anne 2012, Sterilisation of Biomaterials and Medical Devices, 1 Ed., Woodhead Publishing [ISBN: 9781845699321]
  • W. Whyte 2010, Cleanroom Technology, John Wiley & Sons Chichester, West Sussex, U.K. [ISBN: 9780470748060]
  • edited by Max Sherman 1998, Medical device packaging handbook, Marcel Dekker New York [ISBN: 0824701992]
  • Itay Abuhav, 2011, ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry, 1st Ed., CRC Press [ISBN: 9781439866115]
  • edited by John Ridley and John Channing 2003, Safety at work, Butterworth Heinemann Oxford [England] [ISBN: 0750654937]
  • edited by Stephen P. Denyer, Rosamund M. Baird 2006, Guide to microbiological control in pharmaceuticals and medical devices, CRC Press Boca Raton, Fla. [ISBN: 9780748406159]
Supplementary Book Resources
  • Joseph F. Hanlon, Robert J. Kelsey, Hallie E. Forcinio 1998, Handbook of package engineering, Technomic Pub. Co. Lancaster, Pa. [ISBN: 9781566763066]
This module does not have any article/paper resources
Other Resources
 

Module Delivered in

Programme Code Programme Semester Delivery
CR_EBIME_7 Bachelor of Engineering in Biomedical Engineering 6 Mandatory

Cork Institute of Technology
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