MP 2001 Speakers

 

Kirsten Bundgaard Nilesen

 

Materials Considerations for Radiation Sterilization of Medical Devices

LR Plast A/S, Formervangen 14-16, DK 2600 Glostrup, Denmark

Tel: +45 43480500   Fax: +45 43444313                                                       E-mail: lrpkbn@logstor.com

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.