Seminar:
Sterilization and cleaning
for sustainable medical devices
18 March 2025
Force Technology
Park Allé 345
2605 Brøndby
Registration no later than 7 March 2025
About the seminar
This seminar will explore critical advancements and challenges in the medical device industry. The special focus will be on sustainability, safety and compliance. Participants will explore the growing emphasis on circular design, examining how medical devices can be developed to reduce environmental impact without compromising safety. Key topics will include innovative strategies for incorporating sustainable materials, such as bioplastics and establishing effective recycling processes within a highly regulated sector.
Another core theme of the seminar is the evolving landscape of biosafety and sterilization standards. Attendees will gain an understanding of the latest international regulations and best practices for ensuring the safety of medical devices, particularly in relation to cleaning, disinfection, and sterilization protocols. These discussions will emphasize the importance of maintaining compliance with stringent safety regulations, while also aligning with broader sustainability goals, such as reducing CO2 emissions in healthcare processes.
Lab tour
In addition to these in-depth presentations, the seminar will include a hands-on lab tour, offering participants the opportunity to explore advanced techniques in materials characterization, hygienic design, and chemical analysis. The event will also provide ample opportunities for networking, fostering connections between professionals committed to advancing sustainability and safety within the medical device industry.
After the seminar the participant will:
- Get insight on the latest updates from the international ISO technical committee – ISO TC194 in terms of sterilizing and cleaning medical devices
- Be inspired by examples from the industry about working with circularity for medical devices and stringent safety requirements
- Understand advantages and limitations of cleaning and disinfection validation methods, and sustainable alternatives to conventional processes
- Learn more about analytical techniques for material and chemical investigation for medical devices in the laboratories
Target audience
The seminar is aimed for specialists and engineers working on development, innovation and manufacture within the medical devices and medical technology industry. The seminar will cover specifically topics related to cleanability and sterilizability, regulatory aspects and considerations about sustainability and safety requirement.
Organizers
This seminar is organized by our surface steering group members Alexander Bruun Christiansen, Nicole Ciacotich and Rune Juul Christiansen.
Program
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Registration and light breakfast | |||
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Welcome and introduction by Nicole Ciacotich, Director of Department, Materials Test & Analysis | |||
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Circular design of medical devices – can safety and circularity co-exist? Nicklas Christian Funk, Senior Sustainability Specialist R&D, Ambu A/S ![]() Working with circularity for medical devices requires extra considerations. Sustainability efforts will need to be balanced with stringent safety requirements towards the patients. |
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Status of the International standardization of medical device biosafety Carsten Baun Senholt, Partner, Chief Technical Officer, Saxocon A/S ![]() Carsten will present the latest updates from the international ISO technical committee – ISO TC194, focusing on the upcoming rules for sterilizing and cleaning medical devices. He will also present the latest news about ISO 10993 – Part 7: Ethylene oxide sterilization residuals. As head of the Danish delegation, Carsten will, prior to this seminar, participate in the ISO TC194 plenary session 2024 this autumn in Paris. Carsten Baun Senholt is a Doctor of Veterinary Medicine with an MSc in Applied Toxicology and is a certified European Registered Toxicologist. He has worked as a toxicologist with specialized expertise in the toxicological assessment of drug product impurities and has been a sponsor monitor for GLP studies at CROs since 1999.Carsten is currently the principal toxicologist and chief technical officer at SAXOCON A/S, an ISO 13485-certified consultancy firm specializing in toxicological and biological safety. |
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Coffee and networking break | |||
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Cleaning disinfection & sterilization of medical devices Helle Stendahl Andersen, Business Manager, Chemical Characterization and Services, Danish Technological Institute ![]() In recent years, there has been a heightened emphasis on documentation of user safety, which is driven by the Medical Device Regulation (MDR) and the broader sustainability agenda. |
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Ethylene Oxide (EO) sterilization – a sustainability perspective Jan Douglas, Global Senior Program Manager – Aortic Therapies, Thoracic. Global EO Sterilization SME, Cook Medical ![]() As the sustainability discussion starts impacting how medical device companies choose sterilization modalities, it becomes crucial that we understand the challenges and implications of the use of different modalities. 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. |
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Lunch and networking | |||
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Introduction to lab tour | |||
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Tour of the labs and coffee break
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Sterilization and Cleaning for Sustainable Medical Devices Arne Miller, Technical Manager, Risø High Dose Reference Laboratory, DTU Health Tech. ![]() Sterilization by irradiation has historically been done using gamma (cobalt-60) and high energy electron beams, but safety and supply issues of cobalt-60 has led to increased interest in x-ray. Sustainability – interpreted as optimized product throughput – is a key parameter for choice of sterilization method, and factors that determine product throughput for the three modalities will be discussed. Specific measures for improved product throughput include, for example, the design of facilities and alternative methods for establishing the required sterilization dose. Arne Miller’s expertise is in industrial radiation dosimetry and process validation, mainly for radiation sterilization. He and his team at Risø have developed several of the dosimetry methods that are now used in the international standards for radiation sterilization.Arne is member of the national sterilization committees and of the committees in CEN and ISO, where the standards for radiation sterilization are written. |
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Sterilization and Cleaning for Sustainable Medical Devices Christina Ankjærgaard, Senior Scientist and Head of Risø High Dose Refence Laboratory, DTU Health Tech. Christina Ankjærgaard has a scientific background in dosimetry and has worked with both retrospective dosimetry (dating of sediment), medical and industrial dosimetry.Christina is member of the national sterilization committees and of the committees in CEN and ISO, where the standards for radiation sterilization are written. |
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Are there alternatives to Steam-in-place (SIP) sterilization? Kasper Brix Adsersen, Senior Business Development Manager, Force Technology ![]() Steam generation is one of the major CO2 emission sources within the Life Science sector. |
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Closing remarks |
Registration fee
DKK 2,750 | Members of Teknologisk Videndeling and promoting partners listed in the registration form |
DKK 3,280 | Non-members |
DKK 1,075 | PhD Students |
DKK 200 | 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 300 when registration before 14 February 2025.
Early-bird discount does not apply to BSc, MSc and PhD students.
Registration
Register at this LINK
Note registration before 8 March 2025
Binding registration
Registration is binding, however substitutions are accepted at any time. Just write us to tell us about the changes.
Questions
Please do not hesitate to contact Teknologisk Videndeling by e-mailing teknologiskvidendeling@construct.dtu.dk
Promoting partners