Medical Device Sterilization Workshop 2023: Past, Present, and Future

Contribution List

25. Welcome - Bonnie Fleming, Deputy Director for Science and Technology, FNAL

20/09/2023, 08:05

1. Keynote - Nick Butler, NNSA

20/09/2023, 08:15

Nick Butler, the Deputy Director of the National Nuclear Security Administration’s Office of Radiological Security (ORS), provides an overview of the office’s mission to enhance U.S. and global security by preventing high-activity radioactive materials from being used in acts of terrorism. As part of this mission, ORS promotes the use of non-radioisotopic alternative technologies through...

2. Medium-energy, Low-power Needs - Ilia Geltser, Terumo BCT

20/09/2023, 09:00

3. Packaging & Sterilization - Kiip, Srun & Blom

20/09/2023, 09:40

It is known that radiation sterilization can result in degradation of certain materials, and of particular concern is molecular changes to the polymers. Because of this, aging studies are typically required for most medical devices and their packaging. However, even though most packaging materials have been well characterized and studied, and there are no known cases where packaging has failed...

4. International Regulatory Panel - ANVISA, FDA, Health Canada, and TÜV-SÜD

20/09/2023, 10:40

including: ANVISA, FDA, Health Canada, and TÜV-SÜD

5. The evolution of a standard - AAMI TIR104 and beyond, Emily Craven, Boston Scientific

20/09/2023, 11:20

This presentation looks at the drivers behind the creation of industry guidance on the transfer of health care products between radiation sterilization sources. Some information existed within ISO 11137-1 but it was unclear and incomplete. In the process of writing TIR104, the AAMI radiation sterilization working group collaborated to clarify a process to follow when assessing the transfer...

6. Morning Wrap-up & Close of Virtual Session

20/09/2023, 12:15

7. Discussion - TIR 104 - Mark Pasmore, Mara Senescu, Baxter

20/09/2023, 13:30

8. Discussion - FDA Panel

20/09/2023, 14:30

9. Discussion - Risk Evaluations in Implementing X-ray for Single-Use Systems Sterilization, Samuel Dorey, Sartorius

20/09/2023, 16:00

The single-use disposable technologies for biopharmaceutical manufacturing combine single-use holistic processes and facility strategy to overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for many biologics. This industry is facing challenges with irradiation sterilization capacity resulting in assessing X-rays as a suitable and equivalent...

10. Close of Day 1

20/09/2023, 17:00

24. No-host Social - Two-Brothers Roundhouse

20/09/2023, 17:30

11. Welcome

21/09/2023, 08:00

12. Microbiological Resistance / Population C, Martell Winters, Nelson Labs

21/09/2023, 08:10

Population C, also called the Standard Distribution of Resistances (SDR), has been the microbiological benchmark for radiation sterilization since the early 1980s. The development of the SDR should be understood by industry and it provides insights into how the SDR, and associated dosing tables, can be used when investigating sterilization dose establishment or dose audit failures and aberrant...

13. Training - Beyond Read and Learn, Vu LeKate (Abbott), Kim Patton (PRI)

21/09/2023, 08:50

14. Training Resources - John Williams, Medtronic

21/09/2023, 09:30

23. Finding the optimal sterilization configuration using simulations - Funk & Badali, Triple Ring

21/09/2023, 09:50

The dose delivered during radiation sterilization is highly dependent on many factors, such as the orientation of the device relative to the beam, how the devices are arranged in the shipping box, and how devices are positioned within their packaging. Experimentally exploring this trade space to find the best sterilization configuration is a very expensive and time consuming process since it...

15. Engaging with the FDA - Radiation Master File Pilot

21/09/2023, 10:50

Engaging with FDA: Radiation Master File Pilot, Submission Review, Responses, & Misconceptions

This session will build on last year’s FDA mock Q-Submission session and cover several topics related to engaging with FDA.

1) The first topic will be an overview of FDA’s Radiation Sterilization Master File Pilot Program. This program was initiated in April 2023 to pilot a novel way for FDA...

22. Engaging wiht the FDA - Submission Review

21/09/2023, 11:20

Engaging with FDA: Radiation Master File Pilot, Submission Review, Responses, & Misconceptions

This session will build on last year’s FDA mock Q-Submission session and cover several topics related to engaging with FDA.

1) The first topic will be an overview of FDA’s Radiation Sterilization Master File Pilot Program. This program was initiated in April 2023 to pilot a novel way for FDA...

16. Engaging with the FDA - Responses & Misconceptions

21/09/2023, 11:50

Engaging with FDA: Radiation Master File Pilot, Submission Review, Responses, & Misconceptions

This session will build on last year’s FDA mock Q-Submission session and cover several topics related to engaging with FDA.

1) The first topic will be an overview of FDA’s Radiation Sterilization Master File Pilot Program. This program was initiated in April 2023 to pilot a novel way for FDA...

21. Morning Wrap-up & Close of Virtual Session

21/09/2023, 12:20

17. Discussion - Collaborating w/Kilmer/AAMI - FDA Collaborative Communities

21/09/2023, 13:30

18. Networking

21/09/2023, 14:30

19. Networking

21/09/2023, 16:00

20. Close of Workshop

21/09/2023, 16:30