Events

Improving Cobalt-60 Supply Chain Efficiency

Presenter: Corby Nicholson, Director, Operations, Nordion
When: Tuesday November 08, 2022 from 08:30 to 10:00 ITC
Where: Radiation Technology Forum, Lunar Room
Moderator: Richard Wiens, Director, Strategic Supply & Marketing, Nordion

Abstract:
Although the basic design of the industry-standard double-encapsulated C-188 sealed Cobalt-60 source has remained relatively unchanged since its introduction more than 55 years ago, the technology for producing these sources has advanced considerably. Given increasingly complex global supply chains and the current pressure on Cobalt supply, manufacturing planning approaches have also needed to adapt in order to maximize the number of Curies that are made available to the market. One of the more recent developments in production technology is the introduction of sophisticated recycling techniques at scale, not only virtually eliminating the need for disposal of radioactive material, but also incrementally increasing supply. The optimization of recycling involves a combination of planning, infrastructure, source design and manufacturing capability. This presentation will provide insight into challenges and solutions for sealed source production and recycling, and highlight changes in both the broader supply chain and Nordion’s manufacturing capabilities that will contribute to improved Cobalt-60 availability for gamma processing.

Improving Gamma Irradiator Efficiency Through Scheduling

Presenter: Chris Howard, Canada, Manager, Radiation Physics and Software Development Engineering, Nordion
When: Tuesday November 08, 2022 from 10:30 to 12:00 ITC
Where: Radiation Technology Forum, Lunar Room

Abstract:
At most Gamma Irradiation facilities, a common part of the process that can be improved is product scheduling. This process is largely manual and relies on institutional memory and intuition. Often, there is a large amount of historical data that goes unused or can only be coarsely used to inform new schedules. Nordion has been working to simply the data analysis process as well as automate, through Machine Learning, a predicted schedule based on available products.

This process can be improved further by adding information to the system through Mathematical Modeling to better inform the Machine Learning training data to further construct a more efficient product schedule.

This talk will discuss the current scheduling practices, future capabilities, and how Mathematical Modelling would improve scheduling efficiency. I will outline the current state of our capability and the process to create the Mathematical Model, show examples of CAD products within the product, and the current state of product scheduling within a Mathematical Model.

Bioburden and Sterility Testing of Product: Select a SIP or a Representative Product Portion?

Presenter: Martell Winters ² , John Logar¹ , Adam Staples²
When: Tuesday November 08, 2022 from 13:30 to 15:00 ITC
Where: Radiation Sterilization Forum, Moon Room
Moderator: Bart Croonenborghs, Belgium, Technical Director Irradiation, Sterigenics

¹Johnson and Johnson, Raritan, NJ, United States; ² Nelson Laboratories a division of Sotera Health, Salt Lake, UT, United States

Abstract:
Validation of a radiation sterilization process for product or component can sometimes be difficult when testing large or bulk products and components; especially those that are complex with multiple components or with large volumes. For these products this difficulty exists in bioburden and sterility testing as well as delivering the verification dose. Also, the typical approach of using the entire product bioburden of a large/complex/bulk product often results in an overestimation of bioburden and subsequently high sterilization doses. This is especially true in the case of large single-use systems and bulk drug substances for bioprocessing and pharmaceutical manufacturing. A review of the underlying principles of product bioburden and radiation processing (e.g., Table 1 and Clause 4 of ISO 11137-2) reveals an alternative approach to testing large, complex products that can greatly simplify bioburden/sterility testing and verification dose delivery.

This presentation/poster will review these underlying principles and provide alternatives to the SIP approach commonly used for large, complex products or bulk materials that will enable for the determination of a more representative product bioburden and validation using the appropriate verification dose. Examples will be shared to clarify the proposed approach and a case study to demonstrate how one might select the representative product portion to be used in future testing.