NTP Radioisotopes on Friday confirmed that the National Nuclear Regulator (NNR) had given it the go-ahead to resume production of essential medical radioisotopes at its Pelindaba facility.
NTP, which is a subsidiary of State-owned South African Nuclear Energy Corporation (Necsa), will start with preliminary production readiness runs before resuming full production runs, it said in a statement.
The NNR had to approve the facility’s restart, after it ordered NTP to shut down the facility in November last year, following a non-risk incident involving the activation of safety protocols that had halted the production of medical radioisotopes.
At the time, Necsa chairperson Dr Kelvin Kemm described the incident as a minor technical problem as a result of paperwork errors that could cause potential safety problems.
Kemm stated that work at the facility did continue, but NTP was not allowed to send the material out and, resultantly, there has been a 50% reduction in nuclear medicine material available in South Africa, with medical radioisotopes needing to be imported for several months.
Production restarted in February, but was shut down again in June, owing to the detection of a “slight hydrogen excess” in one of NTP’s production hot cells, NTP reported in May.
Energy Minister Jeff Radebe in September assumed oversight of the NTP board, through Deputy Energy Minister Thembisile Majola, to deal with the shortages of key radioisotopes.
“Our priority was to facilitate an uncompromised safe return to reliable supply of this active pharmaceutical ingredient (API) from South Africa to the global nuclear medicine fraternity with the emphasis being on safety and reliability,” the deputy Minister said on Friday.
She added that while the NNR’s processes were sometimes seen as time-consuming, they were essential to the outcome.
“The nuclear regulator’s primary mandate is to ensure that all safety standards are met, so that we can achieve safe operating conditions. The uncompromised integrity and independence of their work is what protects us all," she said.
NTP MD Tina Eboka commented that the extended shutdown had strengthened the company’s working relationship with, and appreciation of, the role of the regulator, as well as strengthened its corporate safety culture.
The company will now start rebuilding customer trust and lost business, she added.
“Before the shutdown we were a profitable R1.3-billion turnover company. Right now, we need to focus on returning to those levels of success as quickly as reasonably possible and position NTP for sustained growth over the medium term.
“Now, with the approval of the NNR and the support of the [Energy] Ministry, and Necsa as the licence holder, we can focus on a strategy of consolidation and then growth,” she stated.
Meanwhile, Kemm earlier this month said Necsa had agreed with Rusatom, a subsidiary of Russian company Rosatom, to consider the construction of two new dedicated and specialist nuclear reactors, as well as a cyclotron, at Pelindaba to increase radioisotope production.