| MP 2001 Speakers |
Materials Considerations for
Radiation Sterilization of Medical Devices
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LR Plast A/S, Formervangen 14-16, DK 2600
Glostrup, Denmark
Tel: +45 43480500 Fax: +45 43444313 E-mail: lrpkbn@logstor.com |
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| Biography
Kirsten Bundgaard-Nielsen has a Masters Degree in Chemical Engineering from the DTU, specialising in food microbiology. In 1995 and 1996 she was employed as a Teaching Assistant at the DTU and as a consultant for Tulip International, respectively. In 1996, Kirsten was employed at LR Plast A/S as a Laboratory Manager where she was responsible for LR Plast's micro-biological service laboratory, which advises customers from the irradiation plant on appropriate sterilisation doses for their contaminated products. Since January 1999 she has been the Chairman for the Danish Medical Device Association (DMDA) sterilisation group. In connection with LR Plast's production of heat shrinkable fittings, she is also resonsible for the development of plastic compounds for blow moulding and the cross linking of polymers by irradiation. |
Abstract
When
a medical device is designed considerations must be made for which
sterilization process is going to be used. It has been long known,
that gamma and electron-beam radiation can lead to significant
alterations in the materials being treated, and these damages must
be considered when polymers for a medical device is chosen. It is
known that some materials is damaged at very low doses, while some
can take higher doses before material changes occur. Materials
that are damaged at low doses shall not be considered, but in some
cases it can be necessary to use a polymer where changes can be
detected at sterilization doses (25 kGy for e-beam sterilization).
In such cases microbiological methods can be used to reduce
sterilization doses, making it possible to use a radiation
sensitive material. This
lecture will be about the background for radiation chemistry of
some polymers, the microbiological methods available and a case.
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