Events

MONDAY NOVEMBER 4, 2024

Opening and Welcome

Presenters:
Riaz Bandali, President of Nordion
Mike Rutz, President of Sterigenics
When: 9:30-11:00am CST
Where: Guanacaste

Riaz Bandali, President of Nordion, and Mike Rutz, President of Sterigenics, will present a high-level overview of industry dynamics, technology and supply chain developments and global economic drivers.

High Level Updates on the Various Radiation Processing Technologies

Presenter: Richard Wiens, Director of Strategic Supply & Business Development
When: Monday, November 4th, 2:00-3:00pm CST
Where: Guanacaste

Richard Wiens, Director of Strategic Supply & Business Development, will provide an update on the gamma processing industry, including a discussion around the global supply chain for Cobalt-60.

TUESDAY NOVEMBER 5, 2024

Applications Of Mathematical Modelling at Gamma Irradiator Sites

Presenter: Chris Howard, Manager, Physics and Software Development, Nordion
When: Tuesday, November 5th, 9:00-10:00am CST
Where: Dosimetry Square Tech Theatre
Room: Exhibition Hall

This will present two case studies of applications at customer sites to help the sites improve efficiency and the processes, specifically here: OQ process optimization and rack size optimization and flexibility of the cobalt distribution in the rack.

Session: Radiation Sterilization Forum Part 1 & 2

When: Tuesday, November 5th, 10:00-11:20am CST
Where: Guanacaste 1-2

New Guidance on Bioburden Characterization For Radiation-Sterilized Products In 11137-1

Presenters:
Martell Winters, Director of Science, Nelson Labs
Chris Hardman, ISO Bioburden Radiation Department Scientist, Nelson Labs

As a result of industry discussions, new requirements and guidance on bioburden characterization will be added to the new version of ISO 11137-1, particularly in 7.2 and A.7.2. This presentation will provide a summary of the additions and include the science behind its importance, as well as options on demonstrating compliance.

The Standard Distribution of Resistances (SDR) – History and Future

Presenters:
Martell Winters, Director of Science, Nelson Labs

Population C, also called the Standard Distribution of Resistances, 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 bioburden data. Also, analysis of the SDR reveals a potential Achilles heel which is currently being discussed in the industry and is prompting additional guidance that is being included in the new revision of ISO 11137-1.

Considerations for Transferring Product from Gas to Radiation

Presenter: Thor Rollins, Vice President Global Market Segment Leader Medical Device, Nelson Labs

In this talk, we evaluate the biocompatibility assessments required, as it pertains to the transition from gas to radiation sterilization methods for medical products. As industries increasingly explore alternative sterilization techniques, understanding the nuanced implications on biocompatibility becomes imperative. The presentation will address key considerations, challenges, and strategies involved in ensuring the safety and efficacy of medical devices during this transformative shift. We will also address what materials are most impacted and why, and whether biocompatibility can get better or worse with the change. Join us as we navigate the intricate landscape of biocompatibility to facilitate a seamless and successful transition in sterilization processes.

Growing Cobalt-60 Supply for A Sustainable Future

Presenter: Michael Aube, Sr. Manager, Strategic Supply, Nordion
When: Tuesday, November 5th, 5:00-6:00pm CST
Where: Exhibition Hall
Session: Radiation Field Tech Theatre

This review of the global Cobalt-60 supply chain is critical in understanding the current state and future prospects of this essential isotope’s availability. Cobalt-60, a radioactive isotope used in medical, industrial, and food sterilization applications. Nordion is at the forefront, expanding Cobalt-60 production capacity to meet growing industry demands. A key initiative is the partnership with Darlington Nuclear Generating Station in Ontario, Canada, which is pivotal in increasing Cobalt-60 production. The station’s refurbishment is designed not only to extend its lifespan but also to create its Cobalt-60 production capabilities, ensuring a reliable isotope supply. Similarly, Westinghouse has been involved in an initiative to augment Cobalt-60 production. Leveraging its extensive experience in nuclear technology, the Westinghouse – Nordion partnership has developed an innovative method to optimize Cobalt-60 output from Pressurized Water Reactors (PWRs) operating in the U.S. This includes the development of specialized fuel assemblies and reactor core configurations that can maximize Cobalt-60 production without compromising the primary function of electricity generation. The Pickering Nuclear Generating Station in Ontario is currently in the planning phase of undergoing refurbishments to extend its operational life and potentially boost its Cobalt-60 production capacity. As a significant contributor to the global Cobalt-60 supply, Pickering’s enhancements will reinforce its supply chain role. These efforts, along with ongoing partnerships, signify a collective endeavour to ensure a steady Cobalt-60 supply for critical uses like sterilization and cancer treatment. Nordion’s investment in partnerships and technology aims to meet current and future Cobalt-60 demands.

WEDNESDAY NOVEMBER 6, 2024

Integrated Approach for Bulk Pharmaceutical Sterilization

Presenters:
Zabrina Tumaitis, Technical Director, Sterigenics
Bryce Telford, Senior Expert, Nelson Labs
When: Wednesday, November 6th, 9:00-10:00am CST
Where: Exhibition Hall
Session: Radiation Field Tech Theatre

Development of a holistic path to validation of bulk sterilized pharmaceuticals, from determination of the maximum dose through sterilization dose establishment and process qualification. This presentation provides guidance to optimize doses, testing strategies, and necessary considerations for a successful routine sterilization program.

An Examination of Improvements in Cobalt-60 Supply Chain Sustainability and Risk Mitigation

Presenter: Corby Nicholson, Director, Operations, Nordion
When: Wednesday, November 6th, 10:00-11:00am CST
Where: Guanacaste
Session: Plenary Session – Sustainability Key Note & Round Table

Manufacturing supply chains across every industry sector are increasingly focused on sustainability, emphasizing efforts to reduce environmental impact and promote efficiency. Manufacturers are implementing measures to understand the impact of their operations, minimize waste generation, and establish effective recycling programs. Embracing renewable energy sources and adopting energy-efficient technologies are becoming standard practices. This presentation will provide an overview of the Cobalt-60 supply chain, manufacturing facilities, and fundamental processes that have been developed to ensure the reliable supply of over a billion curies to the gamma sterilization industry. We will then examine improvements from across the supply chain that have steadily reduced the environmental impact of Cobalt-60 production while also reducing overall risk in areas such as facility design and operation, operational planning and execution, and innovations to optimize the recycling of Co-60 and minimize process wastes generated.

THURSDAY NOVEMBER 7, 2024

Radiation Security – Cobalt-60 Transport and Use in Industrial Irradiators in North America

Presenter: Greg Fulford, Manager, Radiation Protection and Nuclear Transportation, Nordion
When: Thursday, November 7th, 9:00-10:00am CST
Where: Exhibition Hall
Session: Radiation Field Tech Theatre

Security of sealed sources used in gamma processing has been a growing concern. Source security along with radiation safety requirements must be met to ensure effective management and operation of gamma irradiation facilities. GIPA, the Gamma Industry Processing Alliance, is an industry association of like-minded gamma processing industry leaders. GIPA companies are focused on safe and secure use of sealed sources in gamma processing. Security features are built into facility and transport package design as well as administrative and operational programs. Security controls are in place throughout the sealed source lifecycle; from the time of source manufacture, through transport, to use for gamma processing and with respect to source returns to manufacturers. This presentation will highlight the many ways that security concerns are addressed across GIPA member companies.