May 25, 2023

Overview
Grantek was contacted by a radioisotope pharmaceutical industry client in an Ontario nuclear facility. The client needed to scale up an existing pilot plant’s production of a radioisotope to production level quantities. The exact specifics of the process were still unknown, and additional challenges were discovered with the larger vessels which required significant changes to the selected equipment to meet the desired process and maintenance goals. The client contacted Grantek due to our previous knowledge of process systems and device control, and we were able guide the process steps and provide solutions for the issues faced from a systems controls perspective.

Challenges
Grantek’s solution included equipment selection review, process implementation, and device control. The process performed a series of chemical reactions while controlling the vessel to target temperature setpoints and providing adequate agitation of the product. The starting material forms a wet or liquid slurry, which was then dried and processed into a drug substance. During the project, some unforeseen issues arose; however, Grantek was able to overcome them through close collaboration with the client and a thorough analysis of the process.

Another challenge faced by Grantek during this project was the need for strict adherence to safety and regulatory requirements. As the site was located in a nuclear facility, strict safety protocols and regulations had to be followed during the project’s execution. Grantek had to ensure that the panel design, equipment selection, and device control complied with these regulations to prevent potential safety hazards. Access inside the cell was heavily limited due to levels of radioactivity and thus most procedures were conducted via manipulators which was time consuming. Grantek’s expertise in regulatory compliance and safety ensured that the project was executed safely and successfully, meeting all the necessary requirements while achieving the desired production quantities of the radioisotope.

Solutions
The solution provided by Grantek alleviated the client’s pain point by scaling up the production of the radioisotope to production quantities, which had not been achieved before. The process developed could be recreated at other facilities, making it a potential solution for other production lines across their enterprise. The client mentioned cost and time savings since the project’s successful conclusion due to the improved production process’s efficiency. Additionally, Grantek was able to identify and suggest further possible cost and time savings for the client to realize since the project’s completion.