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Generator production for Tc-99m in Australia suspended following mechanical fault

by John R. Fischer, Senior Reporter | July 12, 2018
Molecular Imaging
ANSTO has suspended production
of Tc-99m generators following a
mechanical fault in its transfer
The Australian Nuclear Science and Technology Organisation (ANSTO) has suspended production of generators due to a mechanical fault in its transfer conveyor.

The suspension, which took place in late June, is ongoing, with ANSTO working with international partners to curb disruptions in the transport of Molybdenum (Mo-99) to providers and imaging clinics throughout Australia and abroad.

“Nuclear medicine production is one of the most complex production processes in Australia today,” a spokesperson for ANSTO said in a statement. “Just like with any other production process, there are occasional mechanical faults and if those happen we work closely with our international partners to minimize impact. While there were no safety risks or issues associated with this mechanical fault, nonetheless, it is causing some inconvenience to our customers.”
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ANSTO produces around 10,000 doses of Mo-99 weekly for Australian patients and thousands more for international patients. Upon the completion of production, the parent isotope is placed inside a generator where it decays into the radioisotope, Tc-99m while delivered as a bulk Mo-99 export to hospitals nationwide as well as medical practices in New Zealand and Asia.

To offset delays, shipments of bulk Mo-99 have been sent to Lantheus Medical Imaging Inc. (LMI), a U.S. partner of ANSTO, which is storing the isotope inside its own generators and sending them back to providers in Australia.

Distribution took place on Monday, July 2, with generators delivered to 24 metropolitan hospitals, 12 regional and rural facilities and five Global Medical Solutions Australia (GMS) sites nationwide. Total deliveries equated to just more than 39 percent of normal weekly supply.

A second shipment scheduled to arrive Tuesday was held up in the U.S. due to mechanical issues and was expected to arrive the next morning, while a third batch was scheduled to be delivered to providers this week.

Restoration efforts are expected to continue over the next few weeks, a fact that ANSTO apologizes for and acknowledges may potentially disrupt practices at medical facilities.

“Engineers are continuing to work to rectify the mechanical fault that was identified with a piece of equipment called a transfer conveyer on Friday, June 22. This mechanical fault has not affected other nuclear medicine products from ANSTO, and has no impact on the operation of the OPAL nuclear reactor,” an ANSTO spokesperson said, adding that they are pleased that ANSTO “has been able to secure supply of Technetium-99m (Tc-99m) generators from one of our international partners.”

Unforeseen issues in radiopharmaceutical production and supply can have a serious impact on the ability of providers worldwide to diagnose and treat patients in a timely manner. NTP Radioisotopes recently resumed its own production of Mo-99 in March at its Pelindaba facility in South Africa, following a three-month shutdown initiated upon the discovery of a suspected hydrogen leak.

ANSTO did not respond to HCB News for comment.

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