We are happy to announce that Nelson Labs will be exhibiting with our sister company Sterigenics at the MD&M West 2023 tradeshow in Anaheim, California, February 7th – 9th.
We will have consultants available to answer even the most difficult testing and compliance questions. Stop by our booth, #3135, for a complimentary, personalized 30-minute consultation. Furthermore, attend one of our educational lectures. For details about the different lectures, refer to the information provided below.
Tech Theater Presentations on Tuesday, February 7th
The 3Rs of EO Sterilization: Sustaining the Continued Safe Use of Ethylene Oxide
Speaker: Nicole Palluck, Senior Manager, Expert Advisory Services, Sterigenics
Time: 11:30 a.m. – 12:15 p.m.
Location: MedTech Theater, Expo Education, MD&M West
Abstract: Ethylene Oxide (EO) sterilization technology plays a vital role in enabling critical medical products and devices to safely reach patients worldwide. For many medical devices, sterilization with EO is the only method available to effectively sterilize without damaging the device during the sterilization process. The same properties which make EO an effective sterilant require that it be carefully controlled to protect workers, communities, and patients. This webinar will present the 3Rs of EO Sterilization program implemented at Sotera Health businesses Sterigenics and Nelson Labs to support customers in reducing EO use. The benefits of reducing the amount of EO for employees, customers, and communities can include continued safe usage of EO, lower EO-residuals in products, reduction in required aeration time resulting in improved customer supply chain efficiencies, reduced cycle time resulting in additional capacity for manufacturers, and reduced fugitive emissions.
Removing Rabbits from Irritation Testing: Regulatory Acceptance of ISO 10993-23
Speaker: Thor Rollins, Director, Toxicology & E&L Consulting, Nelson Laboratories, LLC
Time: 1:30 – 2:15p.m.
Location: Tech Theater, Basement
Abstract: This will be a discussion of the most recent revisions to ISO 10993-1 and the current and future states of alternative testing. Attendees will walk away with a clearer picture of the alternatives to animal testing and what the alternatives might be next year and in the years to come.
For the past three to four decades, biocompatibility testing remained relativity unchanged, with basically a few simple steps to be followed: 1) look at your device 2) compare it to a chart 3) do the suggested testing. With the recent publication of ISO 10993-23, animal-free irritation testing is now being performed side by side with its animal counterpart. Current revisions to 10993-1 are emphasizing less animal testing and more alternative approaches. The following points in particular will be discussed:
- The proposed changes to 10993-1
- The general response of regulators regarding alternative testing approaches
- The outlook of 10993-1 for the future
The Impact of Radiation Sterilization Modalities on Flexible Sterile Barrier Packaging
Speakers: Chad Rhodes, Segment Leader, Accelerator Modalities, Sterigenics and Jeremy Elwell, Senior Principal Engineer,
Oliver Healthcare Packaging
Time: 4:15 – 5:00 p.m.
Location: 207CD Discover.Engineer.Build Conference, IME West
Abstract: When determining the sterilization technology that is best for your product and organization, many factors apply. In this webinar, you will learn about radiation sterilization technologies (Gamma, Electron beam and X-Ray), how they work and how medical device and pharma manufacturers are incorporating it into their processes. In addition, Sterigenics, Segment Leader, Accelerator Modalities, Chad Rhodes, an industry leader with over 25 years of radiation and sterilization expertise, and Oliver Healthcare Packaging’s Senior Principal Engineer, Jeremy Elwell, a medical packaging expert with over 16 years experience in the medical device industry will share technical data on common medical packaging materials to ensure appropriate considerations are made during material selection.
Attend this presentation and learn the following:
- Why/when irradiation is used
- How to select the modality of irradiation
- Common applications/products for each technology
- Pros and cons of each modality
Full-Day Seminar on Wednesday, February 8th: Medical Device Validation – Biocompatibility, Cleaning, Sterilization, and Packaging Testing
We encourage you to register now; however, we will allow on-site registration.
Big Changes to ISO 10993-1: What Is Happening to the Main Biocompatibility Standard Now?
Speaker: Thor Rollins, Director, Toxicology & E&L Consulting, Nelson Laboratories, LLC
Time: 8:30 – 9:30 a.m.
Abstract: In 2018, TC194, the ISO committee for biocompatibility, released a new version of 10993-1. This new version focused more on a risk-based approach and made significant changes. Then in 2021, a radial proposal to update the standard again was issued with a new draft of the standard. We are now more than a year into writing and compromising the draft of this crucial standard. In this talk we will go into the latest on the standard that is being changed, the reasoning behind those changes, and possible future acceptance of the standard around the globe.
Extractable and Leachable Fundamentals for Success
Speaker: Robert Mueller, Toxicologist, Nelson Labs, LLC
Time: 9:30 – 10:30 a.m.
Abstract: The past few years have seen broad changes in requirements and expectations from regulatory agencies regarding extractable and leachable (E&L) chemistry testing. If not done correctly, E&L can be a long and expensive endeavor. This presentation will highlight key considerations and steps that can optimize testing for a greater likelihood of a successful outcome.
Break from 10:30 to 10:45 a.m.
Product Adoption for Ethylene Oxide Sterilization
Speaker: Nicole Palluck, Senior Manager, Sterigenics
Time: 10:45 – 11:45 a.m.
Abstract: Adoption of a new product into a device family or changes to the design and configuration of an existing product requires a product change assessment to the currently validated sterilization process. This presentation will provide guidance for a product change assessment per ISO 11135:2014 to help limit the extent and costs of validation work, while at the same time, helping to ensure the safety of products and compliance to regulatory requirements.
If you are a medical device manufacturer developing new products or improving the design, packaging and/or load configurations of existing products consider attending this webinar to gain a greater understanding of the:
- Requirements of ISO 11135 for product adoption and change assessment
- Conduct of adoption studies for changes of new products
- Benefits of product adoption
Ask the Expert: Regulatory Hot Topics
Speaker: Jordan Elder, Director, Regulatory Affairs, Regulatory Compliance Associates
Time: 12:00 – 12:45 p.m.
Abstract: Our regulatory expert weighs in on industry hot topics, such as EO sterilization, biocompatibility, EU MDR, and clinical evaluations, as well as questions asked by conference attendees. The discussion will include current trends and common regulatory pitfalls and aims to provide answers to unanswered attendee questions. If you are interested in having a question included for review and discussion, please reach out to [email protected].
Lunch Break from 12:45 to 1:30 p.m. (Food will not be provided.)
Considerations in Validating Sterilization Dose Using Electron Beam Radiation
Speaker: Zabrina Tumaitis, Radiation Technical Director, Sterigenics and Todd Roberson, Validation Coordinator, Sterigenics
Time: 1:30 – 2:30 p.m.
Abstract: In this presentation a review of methods used to establish a minimum sterilization dose and guidance on considerations to be evaluated when using electron beam as the sterilization modality. Overview of material compatibility, verification dose map and considerations for PQ dose mapping.
Packaging Sterile Barrier System Validation Concepts and Test Plans
Speaker: Jennifer Gygi, Expert Technical Consultant, Nelson Labs, LLC
Time: 2:30 – 3:30 p.m.
Abstract: Have you ever wondered how to set up a sterile barrier packaging validation? Or better yet, why it is done the way it is. In this presentation we take a look behind the curtain to see some of the why behind how sterile barrier systems are validated.
Break from 3:30 to 3:45 p.m.
Is It Time to Re-Evaluate Your Design History File (DHF)?
Speaker: Alpa Patel, Director, Scientific Improvement, Nelson Laboratories, LLC
Time: 3:45 – 4:45 p.m.
Abstract: Standards for reprocessing have been a top priority for regulatory all over the world. Active work around reusable medical devices have challenged the medical device industry to think differently from what they were accustomed to. Updates in Medical Device Regulation (MDR), International Organization for Standardization (ISO) and Association for the Advancement of Medical Instrumentation (AAMI) alone have put forward a large leap in this area bringing attention to the predicate devices used for submissions for market approval of reusable products. With technological innovations, design and functional features of these devices have advanced bringing into question if design history files (DHF) are still valid. This talk will go over what a medical device manufacturer needs to evaluate for their design history file or device portfolio for reusable medical devices to comply with current standards and expectations. The presentation will also discuss the current trend of rethinking the path of single use devices to reusable and the challenges 3D printed devices brings to reprocessing.