Mr. Merrick continued, “In addition to the processing facility expansion, we are working toward final validation of two state-of-the-art fill lines at our Columbia, Missouri facility that, pending expected FDA approval this year, will further substantially increase the number of Mo-99 source vessels that we are able to ship to customers weekly. Activities for accelerator production of Mo-99 are underway, with the initial accelerators ordered and groundbreaking for a 20,000 square foot accelerator facility in Beloit scheduled for later this year.”
NorthStar’s 20,000 square foot processing facility in Beloit, Wis. will house state-of-the-art Mo-99 dissolution and source vessel filling equipment, as well as support a quality control laboratory, an automated packaging line and an advanced molybdenum recycling complex. The facility will begin processing upon completion of appropriate licensure and FDA approval.
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About the RadioGenix® System
The RadioGenix System is an innovative, high tech separation platform that is approved for processing non-uranium/non-highly enriched uranium based molybdenum-99 (Mo-99) for the production of the important medical radioisotope, technetium-99m (Tc-99m). Prior to availability of RadioGenix technology, the U.S. supply chain for Mo-99 has been subject to frequent and sometimes severe interruptions which negatively impact patient healthcare. Approved by the U.S. Food and Drug Administration in 2018, the RadioGenix System is the first and only on-site, automated isotope separation system of its kind for use with non-uranium/non-highly enriched uranium based Mo-99, designed to help alleviate shortage situations and expand domestic supply.
Indication and Important Risk Information about the RadioGenix® System and Sodium Pertechnetate Tc 99m Injection USP
The RadioGenix System is a technetium Tc-99m generator used to produce Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m Injection is a radioactive diagnostic agent and can be used in the preparation of FDA-approved diagnostic radiopharmaceuticals.
Sodium Pertechnetate Tc 99m Injection is also indicated in
Adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
Adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
IMPORTANT RISK INFORMATION
Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc 99m Injection. Monitor all patients for hypersensitivity reactions.
