Croft announces renewed U.S. NRC approval for SAFKEG® LS 3979

Croft is pleased to announce that the U.S. Nuclear Regulatory Commission (NRC) has renewed the approval of the SAFKEG® LS 3979 packaging. The renewed approval (USA/9337/B(U)-96 Revision 8) extends the approval period to April 2031, significantly increases the allowable contents and adds 48 radionuclides to the approved contents, including several radionuclides of growing importance to the radiopharmaceutical and targeted radionuclide therapy sectors. The approval also includes an allowance for 0.25 A₂ of impurities. Updates to existing national validations based on the new NRC package approval will now be rolled out through the U.S. Department of Transportation and in a number of other countries, including Canada, the Netherlands (European ADR validation via AVNS) and Australia.

Existing registered users will be issued with the Revision 8 CoA. The CoA is also available for download from ADAMS, Package No. ML26211A388: https://www.nrc.gov/docs/ML2621/ML26211A390.pdf

The SAFKEG® LS is a Type B(U) package for the shipment of solid and gaseous radioactive materials. It has proven to be a popular package since first being licensed in 2010 and is extensively used in the radio-pharmacy industry for the transport of radionuclides worldwide. It appeals to users because of its robust and simple-to-operate design. Its relatively compact size and weight of less than 65 kg (144 lbs) also provide good handling characteristics, particularly for air transport. Additionally, through the range of shielding inserts available, a wide variety of radionuclides can be transported.

The permitted radionuclides are numerous and varied and include a range of important radionuclides used in radiopharmaceutical production and therapy, including Yttrium-90, Molybdenum-99, Lutetium-177, Actinium-225, Krypton-79 and Xenon-133. The updated approval adds 48 new radionuclides, including Scandium-47, Copper-67 and Lead-212, as well as significantly increasing the permitted quantities for some existing radionuclides, including Phosphorus-32, Yttrium-90, Iodine-131, Radium-223, Actinium-225 and Thorium-227. The expanded radionuclide range and increased permitted quantities are particularly relevant to the growing radiopharmaceutical and targeted radionuclide therapy sectors.

The SAFKEG® LS is available from stock to purchase or lease, with Croft providing lifetime support for spares and maintenance through its headquarters in the UK and its European Service Centre in the Netherlands (at NRG PALLAS, Petten).