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An investigation into the sterilisation capabilities of biopolymers and the introduction of an organisational knowledge management methodology for the medical device industry / CHARLEY HAYNES

Swansea University Author: CHARLEY HAYNES

  • E-Thesis – open access under embargo until: 8th July 2025

Abstract

The medical device industry is currently under pressure to improve the sustainability of the products that are manufactured and used. Two single use medical device products manufactured from Acrylonitrile Butadiene Styrene (ABS) and PolyCarbonate were chosen to explore whether they could be replaced...

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Published: Swansea 2022
Institution: Swansea University
Degree level: Master of Research
Degree name: MSc by Research
Supervisor: Ransing, Rajesh S. ; Harrison, Will
URI: https://cronfa.swan.ac.uk/Record/cronfa60547
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first_indexed 2022-07-20T10:05:04Z
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Seven alternative polymers are selected as candidate materials based on their mechanical properties being desirable for these devices. The first objective of this research is to assess the magnitude of deterioration in mechanical properties of alternative polymers with two sterilisation methods, Gamma and Ethylene Oxide sterilisation. The polymers are pull tested and three-point bend tested to determine their tensile and compressive properties respectively. These tests are completed before sterilisation, after gamma irradiation, and after ethylene oxide sterilisation. The results show that a biodegradable polymer manufactured from starch-based Poly(Lactic Acid) PLA is as a viable option to replace ABS. The tests also concluded polymers with a higher fibre content experience a larger deterioration in properties after sterilisation, however a non-linear variation was in this relationship. Such results provide valuable organisational knowledge. Much of which is difficult to access, reuse and is lost over a period of time. This leads to the second objective of this research i.e. to evaluate the use of Failure Modes and Effects Analysis (FMEA) tables to store and reuse organisational knowledge required for root cause analysis. A bottom up approach is followed wherein business questions were gathered from employees of a medical device manufacturing company to determine the type of information that staff require access for root cause analysis. The data/information stored is either stored in an enterprise resource planning (ERP) system or the FMEA tables. A methodology is proposed that stores information in a graphical database using entity relationship diagrams that are analogous to the terminology used within the FMEA guideline documents. The FMEA data for an industrial partner for the two selected medical devices is populated in a prototype graph date base software. 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Licensed under a Creative Commons Attribution-Share Alike (CC-BY-SA) License.Third party content is excluded for use under the license terms.</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language><licence>https://creativecommons.org/licenses/by-sa/4.0/</licence></document></documents><OutputDurs/></rfc1807>
spelling 2022-07-20T11:51:06.7466432 v2 60547 2022-07-20 An investigation into the sterilisation capabilities of biopolymers and the introduction of an organisational knowledge management methodology for the medical device industry 8bd62e8c9ba4aa64538479142c6b22f7 CHARLEY HAYNES CHARLEY HAYNES true false 2022-07-20 The medical device industry is currently under pressure to improve the sustainability of the products that are manufactured and used. Two single use medical device products manufactured from Acrylonitrile Butadiene Styrene (ABS) and PolyCarbonate were chosen to explore whether they could be replaced with biobased or biodegradable alternatives. Seven alternative polymers are selected as candidate materials based on their mechanical properties being desirable for these devices. The first objective of this research is to assess the magnitude of deterioration in mechanical properties of alternative polymers with two sterilisation methods, Gamma and Ethylene Oxide sterilisation. The polymers are pull tested and three-point bend tested to determine their tensile and compressive properties respectively. These tests are completed before sterilisation, after gamma irradiation, and after ethylene oxide sterilisation. The results show that a biodegradable polymer manufactured from starch-based Poly(Lactic Acid) PLA is as a viable option to replace ABS. The tests also concluded polymers with a higher fibre content experience a larger deterioration in properties after sterilisation, however a non-linear variation was in this relationship. Such results provide valuable organisational knowledge. Much of which is difficult to access, reuse and is lost over a period of time. This leads to the second objective of this research i.e. to evaluate the use of Failure Modes and Effects Analysis (FMEA) tables to store and reuse organisational knowledge required for root cause analysis. A bottom up approach is followed wherein business questions were gathered from employees of a medical device manufacturing company to determine the type of information that staff require access for root cause analysis. The data/information stored is either stored in an enterprise resource planning (ERP) system or the FMEA tables. A methodology is proposed that stores information in a graphical database using entity relationship diagrams that are analogous to the terminology used within the FMEA guideline documents. The FMEA data for an industrial partner for the two selected medical devices is populated in a prototype graph date base software. It is suggested that if the data is stored within a graphical database structure within the software, then this data pull can be automated allowing easy access and reuse. This also ensures that the knowledge is not lost over a period of time. E-Thesis Swansea Polymers, biopolymers, FMEA, organisational knowledge 8 7 2022 2022-07-08 COLLEGE NANME COLLEGE CODE Swansea University Ransing, Rajesh S. ; Harrison, Will Master of Research MSc by Research Kess 2 2022-07-20T11:51:06.7466432 2022-07-20T11:01:35.3518501 Faculty of Science and Engineering School of Engineering and Applied Sciences - Uncategorised CHARLEY HAYNES 1 Under embargo Under embargo 2022-07-20T11:36:42.2833689 Output 3422103 application/pdf E-Thesis – open access true 2025-07-08T00:00:00.0000000 Copyright: The author, Charley Haynes, 2022. Licensed under a Creative Commons Attribution-Share Alike (CC-BY-SA) License.Third party content is excluded for use under the license terms. true eng https://creativecommons.org/licenses/by-sa/4.0/
title An investigation into the sterilisation capabilities of biopolymers and the introduction of an organisational knowledge management methodology for the medical device industry
spellingShingle An investigation into the sterilisation capabilities of biopolymers and the introduction of an organisational knowledge management methodology for the medical device industry
CHARLEY HAYNES
title_short An investigation into the sterilisation capabilities of biopolymers and the introduction of an organisational knowledge management methodology for the medical device industry
title_full An investigation into the sterilisation capabilities of biopolymers and the introduction of an organisational knowledge management methodology for the medical device industry
title_fullStr An investigation into the sterilisation capabilities of biopolymers and the introduction of an organisational knowledge management methodology for the medical device industry
title_full_unstemmed An investigation into the sterilisation capabilities of biopolymers and the introduction of an organisational knowledge management methodology for the medical device industry
title_sort An investigation into the sterilisation capabilities of biopolymers and the introduction of an organisational knowledge management methodology for the medical device industry
author_id_str_mv 8bd62e8c9ba4aa64538479142c6b22f7
author_id_fullname_str_mv 8bd62e8c9ba4aa64538479142c6b22f7_***_CHARLEY HAYNES
author CHARLEY HAYNES
author2 CHARLEY HAYNES
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publishDate 2022
institution Swansea University
college_str Faculty of Science and Engineering
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hierarchy_top_id facultyofscienceandengineering
hierarchy_top_title Faculty of Science and Engineering
hierarchy_parent_id facultyofscienceandengineering
hierarchy_parent_title Faculty of Science and Engineering
department_str School of Engineering and Applied Sciences - Uncategorised{{{_:::_}}}Faculty of Science and Engineering{{{_:::_}}}School of Engineering and Applied Sciences - Uncategorised
document_store_str 0
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description The medical device industry is currently under pressure to improve the sustainability of the products that are manufactured and used. Two single use medical device products manufactured from Acrylonitrile Butadiene Styrene (ABS) and PolyCarbonate were chosen to explore whether they could be replaced with biobased or biodegradable alternatives. Seven alternative polymers are selected as candidate materials based on their mechanical properties being desirable for these devices. The first objective of this research is to assess the magnitude of deterioration in mechanical properties of alternative polymers with two sterilisation methods, Gamma and Ethylene Oxide sterilisation. The polymers are pull tested and three-point bend tested to determine their tensile and compressive properties respectively. These tests are completed before sterilisation, after gamma irradiation, and after ethylene oxide sterilisation. The results show that a biodegradable polymer manufactured from starch-based Poly(Lactic Acid) PLA is as a viable option to replace ABS. The tests also concluded polymers with a higher fibre content experience a larger deterioration in properties after sterilisation, however a non-linear variation was in this relationship. Such results provide valuable organisational knowledge. Much of which is difficult to access, reuse and is lost over a period of time. This leads to the second objective of this research i.e. to evaluate the use of Failure Modes and Effects Analysis (FMEA) tables to store and reuse organisational knowledge required for root cause analysis. A bottom up approach is followed wherein business questions were gathered from employees of a medical device manufacturing company to determine the type of information that staff require access for root cause analysis. The data/information stored is either stored in an enterprise resource planning (ERP) system or the FMEA tables. A methodology is proposed that stores information in a graphical database using entity relationship diagrams that are analogous to the terminology used within the FMEA guideline documents. The FMEA data for an industrial partner for the two selected medical devices is populated in a prototype graph date base software. It is suggested that if the data is stored within a graphical database structure within the software, then this data pull can be automated allowing easy access and reuse. This also ensures that the knowledge is not lost over a period of time.
published_date 2022-07-08T04:18:45Z
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score 11.037056

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