Seminar:
Sterilization and cleaning
for sustainable medical devices

26 November 2024

Force Technology
Park Allé 345
2605 Brøndby

Registration before 1 November 2024

Topics

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.

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 herein

This seminar is organized by our surface steering group members Alexander Bruun Christiansen, Nicole Ciacotich and Rune Juul Christiansen.

Program

08:30 - 09:00	Registration and light breakfast
09:00 - 09:10	Welcome and introduction by Nicole Ciacotich, Director of Department, Materials Test & Analysis
09:10 - 09:45	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. Ambu works actively on product-level changes to improve the design of product and packaging. For example by introducing bioplastics into endoscopes and by working to create a safe path for the medical devices to be taken back for recycling. Join the session to get insights from Ambu on how it is still possible to act and design for circularity – even in a highly regulated sector. Nicklas works as a Senior Sustainability Specialist, leading Ambu’s effort to design for circularity and is also engaging the MedTech sector on the topic through his role as the chairman for Medtech Denmark’s network for sustainable design. As a trained engineer with a MSc. In Design & Innovation he is focusing on how to design products for circularity. Nicklas has throughout his career helped some of Denmark’s largest manufacturing companies in kick starting the transition towards a circular economy by design.
09:45 - 10:20	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.
10:20 - 10:40	Coffee and networking break
10:40 - 11:15	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. This presentation will provide an overview of the importance of validating your cleaning and sterilization processes, focusing on the critical parameters to consider in accordance with existing guidelines and standards. Helle Stendahl Andersen is an Experienced Business Manager specializing in the medical devices and pharmaceutical sectors. Expertise in conducting biocompatibility testing for medical devices to ensure compliance with regulatory requirements and extensive background in microbiology with a focus on testing disinfectants, antimicrobial materials, and conducting cleaning and disinfection validations.
11:15 - 11:50	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. This presentation focuses on EO sterilization and provides an update on changes to environmental legislation in US and EU. It discusses to which extent EO sterilization can be sustainable and what it takes. Alternative modalities and their relation to material selection will also be covered. Jan Douglas has spent the last 20 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.
11:50 - 12:50	Lunch and networking
12:50 - 13:00	Introduction to lab tour
13:00 - 15:00	Tour of the labs and coffee break Materials Characterization – introduction to analytical techniques with focus on medical devices Chemical Analysis – introduction to analytical techniques, e.g. extractables and leachables Center for Hygienic Design – introduction to services with focus on cleaning validation protocols and testing
15:00 - 15:35	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. The Danish Government defined the national Climate Partnerships to get recommendations from the industry on how to reach a national 70% CO2 reduction. The Climate Partnership for Biotech and Life Science delivered specific recommendations on how to reduce the use of steam and what kind of alternatives to consider. FORCE Technology, as a part of this Climate Partnership, will give a status on this topic. Kasper Brix Adsersen – FORCE Technology, Senior Business Development Manager - Life Science. He has worked with process automation and instrumentation since 1989. His career has been spanning from rom service and calibration to sales and contract management to business development.
15:30 - 15:40	Closing remarks

Registration fee