Industrial-Scale Production of 99mTc Generators for Clinical Use Based on Zirconium Molybdate Gel

Abstract

This paper is a narration of gel generator technology development and adoption in Iran including production of 99Mo by neutron activation of molybdenum [98Mo(n,γ)99Mo] in the research reactor of Tehran. The indigenous design and development of units for the manufacturing of gel generators included the setting up of shielded plant facilities with pneumatic-driven as well as manual controls and special gadgets, process adaptation to automation in the shielded facility, regulatory clearances and commencement of operations for periodic production of gel generators, demonstration of clinical utility, and adaptation of the generator design. Molybdenum-99 is being converted to zirconium molybdate gel under controlled conditions, and the resulting gel is dried at three steps, which include 2 h at 100°C, 2 h at 90°C, and 5 h at 70°C in order to reduce the time period between the end of reactor irradiation and completion of the processing of gel generators. The produced sodium pertechnetate solution from these gel-type 99Mo/99mTc generators fulfills all requirements of U.S. pharmacopeia. All the generators provide high-yield and pure elutions as well as sterile and pyrogen-free pertechnetate solution. In addition, it shows favorable-quality features to prepare various 99mTc complexes.