The Future of Sterilization: Deep Dive into Emerging Technologies. Validation, Scalability, Sustainability
This one-day course will explore the latest advancements in sterilization technology, regulatory updates and hurdles. Participants will gain insights and the latest developments and advancement of alternative sterilization methods including Supercritical Carbon Dioxide, Vaporized Hydrogen Peroxide, Chlorine Dioxide, Nitrogen Dioxide, Electron Beam technology, and X-Rays.
The course will also cover how companies can adopt newer technologies with new products and also a path to validating new sterilization with existing products that are currently in less sustainable processes. Big changes in regulatory acceptance and use cases from R&D to commercialization will be discussed.
Who Should Attend
Whether you’re an R&D engineer developing innovative technologies, a Quality Assurance specialist navigating evolving standards, or a Product Manager making strategic decisions, our conference offers valuable insights into technological advancements, regulatory shifts, and process improvements in sterilization that are critical for the medical device industry.
Discover how the latest advancements in sterilization can enhance your processes, ensure compliance, and ultimately improve patient outcomes.
R&D Engineers
Stay ahead of the curve with access to the latest research and innovations in sterilization technologies, helping you develop cutting-edge products.
Packaging Engineers
Critical for R&D and Commercialization to ensure packaging materials and design meet all product and performance requirements.
Quality Assurance and Regulatory Affairs Specialists
Moving away from conventional legacy sterilization to emerging and novel sterilization requires in depth knowledge and support of quality considerations and metrics as well as regulatory compliance and submissions.
Product Managers
Assessing the impact of new sterilization methods on product, packaging and perception by end users. Educating customers on the advantages and benefits of new technologies including sustainability.
Manufacturing and Operations Managers
Changes in modalities can bring changes in manufacturing materials and logistics. Some technologies can be brought in-house which bring advantages but also challenges. Considerations for scaling operations to meet demand.
Sterilization and Microbiology
Identifying testing and requirements to achieve approval. Process Challenge Devices for release and routine monitoring vs parametric release.
What Will Be Covered
The Future of Sterilization: Deep Dive into Emerging Technologies. Validation, Scalability, Sustainability
Testing and Implementation
Feasibility through commercialization – new products and transitioning existing products to new sterilization modalities.
Efficacy
Alternative methods have to effectively kill a broad spectrum of microorganisms, including bacteria, viruses, fungi, and spores, to ensure patient safety and prevent infection.
Material Compatibility
Assessing the impact of the sterilization process on packaging materials and devices.
Penetration
The sterilization method has to penetrate complex and hard-to-reach areas within medical devices, such as lumens, joints, and crevices, to ensure complete sterilization.
Temperature Sensitivity
Many medical devices are temperature sensitive and are damaged by high temperatures. Alternative methods are needed that offer low-temperature options for sterilization.
Processing Time
Faster sterilization methods are desirable to reduce turnaround time, enhance productivity, and minimize delays in healthcare delivery.
Sustainability
Ideally, alternative methods will have minimal environmental impact, including low emissions of greenhouse gases, reduced consumption of energy and water, and limited production of hazardous waste.
Cost-effectiveness
The sterilization method should be cost effective, considering factors such as equipment, consumables, maintenance, and energy costs as well as improvements in supply chain and logistics with potential to move to in-house sterilization.
Regulatory Approval
Alternative methods have to meet stringent regulatory requirements for safety and efficacy in various regions: the FDA in the United States and the European Medicines Agency in the European Union.
Scalability
The sterilization method will have to scale to accommodate varying volumes and sizes of medical devices.
Session Agenda
The session will cover six innovative sterilization technologies, each talk followed by a Q&A session. There will be 5-minute breaks between each talk and a lunch break from 12:45 PM to 1:45 PM. This agenda aims to facilitate knowledge sharing and discussion among professionals in the field.
The session will delve into how validation challenges, material compatibility concerns, and infrastructure limitations influence the adoption of new sterilization modalities for medical devices. The session will focus on future scenarios for adoption of these modalities, and explore how the modalities can enter the medical device market in an effective way.
9-9:30 a.m.: Introduction to Session
9:30-10:10 a.m.: Supercritical Carbon Dioxide
Speaker: Greg Mouchka, Novasterilis
- Overview of Technology
- Compatability & Residuals
- Regulatory Path Forward
10:10-10:25 a.m.: Q&A Session for scCO₂
10:30-11:10 a.m.: Vaporized Hydrogen Peroxide
Speaker: Juha Mattila, Steris
- Overview of Technology
- Compatability & Residuals
- Regulatory Path Forward
11:10-11:25 a.m.: Q&A Session for VHP
11:30-11:45 a.m.: Coffee Break
11:45 a.m.-12:25 p.m.: Chlorine Dioxide
Speaker: CL Tian, Phiex Technologies
- Overview of Technology
- Compatability & Residuals
- Regulatory Path Forward
12:25-12:40 p.m.: Q&A Session for ClO₂
12:45-1:45 p.m.: Lunch
1:45-2:15 p.m.: Nitric Oxide
Speaker: Kurt Yockey, SterileState
- Overview of Technology
- Compatability & Residuals
- Regulatory Path Forward
2:15-2:40 p.m. Q&A Session for Nitric Oxide
2:45-3:30 p.m.: X-Ray & Electron Beam
Speaker: Chad Rhodes, Sterigenics
- Overview of Technology
- Compatability & Residuals
- Regulatory Path Forward
3:30-4 p.m.: Q&A session for X-Ray and Electron Beam
4-4:15 p.m.: Coffee Break
4:15-4:45 p.m.: Panel Discussion — Attendees and Speakers
4:45-5 p.m.: Closing — Wrap-Up and Closing Remarks
Speakers
Peter Schmitt: [email protected]
Alison Tyler: [email protected]
Tony Eisenhut: [email protected] (Novasterilis)
Super Critical Carbon Dioxide – Terminal Sterilization & Decellularization processes for Medical Devices and Tissue Products.
Juha Mattila: [email protected] (Steris)
Vapor Hydrogen Peroxide (VHP): Hot off the press! VHP is recognized as an “Established Category A” by FDA in 2024 opening the door for rapid adoption and expansion. Conforming to ISO 22441 Requirements for Sterilization Process Validation
Megan Frost: [email protected] (SterileState)
Nitric Oxide NO (YES): A molecule inside a polymer. Highly efficient healthier customizable sterilization. Package. Ship. Done. Products sterilized by the packaging in the packaging safely and effectively.
Xiao “CL” Tian: [email protected] (Phie Technologies, Inc.)
Sterilization in-house without capital equipment. Devices sterilize themselves inside the package when exposed to ambient or LED light. Harnessing an FDA recognized sterilant: Chlorine Dioxide gas for safe effective sustainable terminal sterilization.
Chad Rhodes: [email protected] (Sterigenics)
Looking at processing capabilities of modern e-beam processing: efficient and effective for sterilizing complex devices. Sustainability with green electricity and options to use Xray as an alternative photon process that uses electricity instead of radioactive cobalt.
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