ATV-SEMAPP inviterer til ‘Sterilization of plastics and elastomers’

Medical devices made from polymers are radiation sterilized by gamma (Cobalt-60), e-beam or x-ray. The characteristics of these facilities are reviewed, as well as their pros and cons. The radiation sterilization process is validated and operated in accordance with the requirements in the international standard ISO 11137. It is discussed how these requirement are fulfilled, and how measurement of the radiation dose plays an important role in this context.

Arne Miller has worked at Risø since 1969. Arne has operated a radiation sterilization process at Risø, he has served as editor-in-chief for Radiation Physics and Chemistry, and he heads the accredited Risø High Dose Reference Laboratory. Arne is active in several Danish and international committees related to radiation sterilization and radiation processing.

Pen needles are made mainly from polypropylene – and then there is the metal cannula, some glue and the sealing paper. They all react differently during the autoclave process made to obtain sterility – but also made not to destruct the product.

This presentation will introduce the product, the sterilisation process, some of the regulatory expectations to qualification of the process (ISO 17665-1), and also highlight some of the main challenges we have had in relation to product quality.

Anne-Dorthe B. Loven is Senior Microbiologist at Novo Nordisk A/S, where she has been working with moist heat sterilisation since 2005. She holds an industrial PhD in Cryopreservation of porcine hepatocytes from The Royal veterinary- and Agricultural University / Novo Nordisk A/S.

Gaseous Ethylene Oxide has been utilized as a general sterilant since the 1950’s and specifically for Medical devices since the 1980’s. The effectiveness of this sterilization modality comes from high chemical reaction speed, the ability to penetrate and the overall material applicability. However, limitations such as density and residuals should be taken into consideration in dealing with polymers.
This presentation will provide a brief introduction to EO sterilization including advantages and limitations related to polymers.

Jan Douglas has spent the last 18 years working for Cook Medical in different Engineering management positions. He has from the beginning been responsible for designing, commissioning, implementing and operating EO sterilization systems in-house at Cook Medical’s Danish manufacturing site.
Jan is a member of EOSA, appointed national expert in EO sterilization by Danish Standards hereby participating in ISO/TC-198 WG1.
Jan’s current main function as Global Program Manager involves global business strategy and execution, Clinical and regulatory program strategy and business development. However, he continues to support local and global EO sterilization efforts and issues as Global EO sterilization SME.

While some polymeric materials resist degradation from relatively high sterilization doses, other polymeric material loose mechanical properties or become yellow as a result of only 25 kGy dose. In some cases, the type of radiation (gamma vs. e-beam) can determine whether a plastic survives sterilization or not. My presentation will introduce you to the effects of radiation on plastic materials so that informed material choices can be made and tested at an early stage.

For more than 20 years, Frederik R Steenstrup has worked with medical devices, both with early product development and late-stage verification testing. As head of DTI’s plastics laboratory, Frederik assists Danish industry with (among other) material change projects and ageing studies.

Sterilization by super critical CO₂ has been used for years, primarily on super sensitive biobased samples like implants. More recently it has been chosen by the FDA in 2019, as one of five technologies most promising to replace ethylene oxide. The FDA innovation challenge has sparked new life to the interest in super critical CO₂ as a sterilization technique for the broader market.
But why is it interesting and how does it work?

Mark Holm Olsen is a biomedical Engineer, working as a specialist at the Danish Technological Institute. His focus is on developing and processing polymer materials for healthcare applications and recycling. Mark is responsible for the super critical CO2 setup used for sterilization, extraction, impregnation, and cleaning of everything from medical devices to recycled plastics and spent coffee grounds.