Supply of SIR-Spheres (Yttrium-90 Micro Resin Spheres)

The contract involves the procurement and delivery of sterile, radiolabeled microspheres specifically branded as SIR-Spheres, which are Yttrium-90 micro resin spheres designed for use in selective internal radiation therapy to treat liver cancer. These microspheres must meet stringent sterility and radiolabeling standards to ensure patient safety and therapeutic efficacy, with strict quality assurance protocols required throughout manufacturing, handling, and transport. The supplier is responsible for maintaining consistent product integrity, providing documentation for regulatory compliance, and ensuring batch-to-batch uniformity in activity concentration and particle size distribution. Emergency logistics capabilities are a critical component of the agreement, as the treatment timeline is time-sensitive and dependent on the radiological half-life of Yttrium-90. The contractor must guarantee rapid, reliable, and traceable delivery to designated medical facilities, with contingency plans in place for transportation disruptions, regulatory delays, or unexpected demand surges. All activities must comply with nuclear regulatory requirements and be coordinated with healthcare providers to align with treatment schedules. The contract is classified as a subcontract under the Department of Defense’s Defense Health Agency, reflecting its use in military and veteran healthcare settings, and is governed by stringent federal procurement standards for medical isotopes and radiopharmaceuticals.