Project timeline
ANM was granted an operational licence by ARPANSA in August 2018, subject to the successful completion of “hot” commissioning and the fulfilment of a number of licence conditions.
Following completion of construction early in 2019, ANSTO's new Mo-99 Manufacturing Facility entered a 'transition phase', the final operational phase moving from sample production runs to commercial supply.
To commence normal operations, ANSTO required regulatory approval from both ARPANSA on safe operations and health regulator the Therapeutic Goods Administration for product quality.
The regulatory bodies undertook careful review processes before providing approval to ANM Pty Ltd for the supply of Mo-99 in 2019.
In 2019, following an operational incident in the new facility, ARPANSA restricted operations in an amended license to a limited number of production runs.
ANSTO addressed the operational and staffing issues identified by ARPANSA and in March 2020, ARPANSA amended the license to allow a measured increase in production