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Radiation Effect On Polymer Materials Commonly
Used In Medical Devices
Project Type : Coordinated Research Project
Project Code : F23035
CRP : 2285
Approved Date : 24 June 2020
Start Date : 10 March 2021
Expected End Date : 30 June 2026
Participating Countries : Argentina, Brazil,
Egypt, France, India, Indonesia, Philippines, Poland, Portugal, Russian
Federation, Serbia, Tunisia, Türkiye, United States of America
Description
Industrial sterilization is primarily used for
medical and healthcare products including a wide range of single-use medical
products and devices. Historically, sterilization is mostly done using gamma
sources. However, recently we observe a transition to accelerator-based
sterilization, specifically uses of e-beam and X-ray. Lack of the knowledge of
radiation effects on polymers for e-beam and X-ray is one of the reasons to
impede the spreading use of these technologies. Therefore, the purpose of this
proposal is to expand our understanding of radiation effects on polymer
materials commonly used in medical devices by comparing gamma, e-beam, and X-ray
irradiation. The increased access to accelerator-based sterilization, in
addition to other sterilization methods, will have a collateral benefit aligned
to UN Sustainable Development Goals, specifically SDG 3 (good health and
well-being), SDG 9 (industry, innovation and infrastructure), and SDG 12
(responsible consumption and production).
Objectives
The overall objective of this CRP is to expand our
understanding of radiation effects on polymer materials common for medical
devices by comparing gamma, e-beam, and x-ray irradiation. The research outputs
covering material and mechanical studies, dosimetry, process control and
technology will include peerreviewed journal articles, book chapters, reports,
user cases, technical presentations, etc.
We propose the studies to focus on the polymers
commonly used in medical industry, including low density polyethylene (LDPE),
polypropylene (PP), poly (ether-block-amide) thermoplastic elastomers (PEBA),
polytetrafluoroethylene (PTFE), and others. However, biopolymers (e.g.,
biodegradable polyesters like polylactic acid, polyglycolic acid,
polysaccharides, and collagen) can also be of interest. Bioresorbable implants
sterilization or crosslinking applications such as for ultra-high molecular
weight polyethylene (UHMWPE) are of particular interest, where differences in
irradiation conditions are expected to introduce a significant difference in
critical attributes of products. Such effects are believed less likely to occur
for the majority of product currently sterilized using ionizing radiation. For
example, it has been reported by a patent of IMEDEX Biomateriaux [2] that
collagen presents significantly different biodegradation resistances, depending
on the radiation mode (e-beam versus gamma-ray). The effect of additives (e.g.,
anti-oxidants, stabilizers, friction lubricant, plasticizers), mainly present in
dominant polymers, should also be considered (investigation of radiation-induced
by-products and/or leachables).
Specific objectives
Physical and Chemical analysis of samples irradiated with:
- gamma sources (Co-60)
- e-beam of various energy and current (both pulsed and continuous)
- X-ray
The dose levels should be based on the purpose for the irradiation process (25 -
100 kGy). The effect of different dose rates should also be considered.
Biocompatibility studies of samples irradiated with:
- gamma sources (Co-60)
- e-beam of various energy and current (both pulsed and continuous)
- X-ray
The dose levels should be based on the purpose for the irradiation process (25 -
100 kGy).
Ageing studies of samples irradiated with:
- gamma sources (Co-60)
- e-beam of various energy and current (both pulsed and continuous)
- X-ray
The dose levels should be based on the purpose for the irradiation process (25 -
100 kGy).
Studies of functionalities of the whole product, often consisting of several
different polymers, irradiated with:
- gamma sources (Co-60)
- e-beam of various energy and current (both pulsed and continuous)
- X-ray
The dose levels should be based on the purpose for the irradiation process (25 -
100 kGy).
Models and simulations of irradiation effects in polymers assuming 25-100 kGy
dose.
https://www.iaea.org/projects/crp/f23035. |
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