a) The National Nuclear Regulator cited safety concerns at the facility as its reason for issuing a directive to cease operations in NTP’s Radiochemical Production facility. This initially emanated from a situation in October 2017 when maintenance procedures related to calibration and certain safety protocols in the facility were not adequately followed. Hereafter, following a restricted restart of the facility in early 2018, operations ceased again in May 2018 following exceedance of certain technical specifications.
b) (i) NTP Radioisotopes SOC Ltd group of companies through its operation at Pelindaba produces Mo-99 and I-131 as active pharmaceutical ingredients (API’s) as input material to manufacture radiopharmaceutical products such as Tc-99M generators and I-131 capsules to supply almost 100% of the South African nuclear medicine market needs and selective African countries.
NTP mitigated the impact of the API plant closure on the South African nuclear medicine market by importing MO-99 and I-131 from its global supply partners. This strategy was largely successful with the exception of a few weeks during this outage when NTP’s supply partners also experienced short supply situations due to the unavailability of some nuclear reactors in the global network. Selective local nuclear medicine practices imported product directly from international suppliers during this period.
(ii) NECSA/NTP corrected the immediate safety concerns at the facility and put in place initiatives to improve safety culture and behaviour. NTP and NECSA continue to engage with the Regulator to return the facility to its safe, reliable, and full operational capacity.