A Collaborative Experience: Implementation of an Optimized Tc-99m Generator Assembly Process

Abstract

Technetium-99m (Tc-99m) has a 6-hr half-life making customer transportation times a challenge. Australian Nuclear Science and Technology Organization (ANSTO) health products group has overcome this by delivering the parent isotope molybdenum-99 (Mo-99), which has a half-life of 66 hr, in shielded GENTECH™ generators. As part of ANSTO's questioning attitude, an augmented risk assessment was undertaken to identify any potential exposure risks of the GENTECH™ assembly process. The evaluation identified potential areas of improvement in contamination control for the manual handling of the generator leads. Upon further analysis, contamination events from the generator leads had the potential for skin doses above the threshold for skin tissue reactions. Additional substitution and administrative controls were designed to mitigate the risks identified. The effectiveness of the new controls was assessed for efficiency in the manufacturing process through mock trials and fitness for use in a pharmaceutical cleanroom environment. The implemented controls were monitored, and data from each run were gathered. These data included changes in radiological conditions and dosimetry results. Upon implementation, there was an observable decrease in glove contamination. The decrease verified that there was a reduction in the risk of skin contamination events. The data analysis was used to model the dose averted, which revealed a reduction in potential extremity dose to production workers. This paper aims to show the optimization within an approved process through the implementation of engineering and administrative controls, resulting in a dose reduction to workers.