Sterilization of plastics and elastomers

– with a focus on different types of sterilization

19 May 2022

DTU Risø Campus
Auditorium Niels Bohr
Frederiksborgvej 399
4000 Roskilde

Topics
In the medical and food packaging industry some products made of polymers need to be sterilized. This is quite a challenge as polymers are much less robust, when it comes to sterilization, than steel. The seminar focuses on the different types of sterilization available for polymers: Radiation, ethylene oxide (EO or EtO) and steam. The presentations will not only cover the technical side of the methods but also give a regulatory insight. Radiation is especially tough for polymers so an in-depth presentation will cover the theoretical background for this. A glance into the future is provided by the talk on Super Critical CO2 – an upcoming sterilization method.
In the coffee breaks there will be plenty of possibilities to network and catch up with old and new acquaintances.

After the seminar the participant will:

  • Know the pros and cons of the different sterilization methods for polymers
  • Be capable of estimating the challenges in actual/future sterilization of own polymer products

Target audience
The seminar is interesting for engineers in R&D or production who works with sterilization of polymers, now or in the future. With speakers coming from both industry and academia the seminar aims to attract people from both worlds.

Program

09:30 - 10:00
Registration and breakfast
10:00 - 10:10
Welcome and introduction
10:10 - 10:45
Radiation facilities for radiation sterilization

Arne Miller, Specialist Consultant, DTU Health Technology

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.
10:45 - 11:20
Moist heat (steam) sterilization of pen needles

Anne-Dorthe Bonde Loven, Senior Microbiologist, Novo Nordisk 

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.
11:20 - 11:50
Coffee and networking break
11:50 - 12:25
EO sterilization; Process mechanisms, advantages and limitations in relation to sterilization of polymers

Jan Douglas, Global Program Manager – Aortic Therapies, Thoracic EO sterilization SME, Cook Medical 

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.
12:25 - 13:25
Lunch and networking
13:25 - 14:00
The effects of radiation on polymer materials

Frederik R. Steenstrup, Team Manager – Plastics and Packaging, Danish Technological Institute

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.
14:00 - 14:35
Sterilization by super critical CO2 – why and when?

Mark Holm Olsen, Specialist, ph.d., Danish Technological Institute

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.
14:35 - 14:45
Closing remark

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"Sterilization of plastics and elastomers"

  • Required on the invoice by some organisations
  • Needed for E-invoices to Danish State Organisations
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Registration fee

 DKK 1,995  Members of ATV-SEMAPP and promoting partners listed in the registration form
 DKK 2,495  Non-members
 DKK 975  PhD Students
 DKK 350  BSc and MSc students (Membership is free of charge – register here.)

All prices are excluded of Danish VAT 25 %.

The fee includes talks, breakfast, lunch and coffee break and access to speakers’ presentations.

Early bird discount of DKK 200 when registering before 22 April 2022.

Early-bird discount does not apply to BSc, MSc and PhD students.

Binding registration
Registration is binding, however substitutions are accepted at any time.

Covid
There are no Covid restrictions in Denmark as of now (april 2022) except use your common sense (wash or sanitize your hands regularly, keep distance and stay home if you feel sick). Should restrictions be reintroduced up to the seminar we will let you know. If the seminar is cancelled due to Covid the fee paid will be refunded.

Questions

Please do not hesitate to contact ATV-SEMAPP by e-mailing atv-semapp@mek.dtu.dk.

 

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