Objectives

The primary objective of this tender is to procure the supply and delivery of specific radiopharmaceuticals and kits, namely Iodine-131-74MBq Therapy Capsule, Red Blood Cell Kit, and Methylene Diphosphonate Kit, for a period of twelve months to Livingstone Tertiary Hospital. The aim is to ensure the hospital has a reliable supply of these medical products for diagnostic and therapeutic purposes related to thyroid cancer, bone scanning, and other medical conditions.

Scope

The scope of the tender includes:

• Supply and delivery of Iodine-131-74MBq Therapy Capsules, used for diagnostic imaging of malignant thyroid cancer.
• Supply and delivery of Red Blood Cell Kits for labeling and transfusion purposes.
• Supply and delivery of Methylene Diphosphonate Kits for bone scanning agents used in various bone-related medical conditions.
• Service provision directly to Livingstone Tertiary Hospital and associated provincial sites.
• All products must meet specified technical and registration requirements, including registration for use in South Africa (Section 21).

Technical Requirements

Iodine-131-74MBq Therapy Capsule

• Solution pH: 7-10
• Activity assay: 90-110%
• Radiochemical purity: 90-110%
• Radionuclidic purity: No contaminants
• Capsule appearance: Properly sealed, no visual damage, green color
• Content specifications: Disodium Hydrogen Phosphate 445-455 mg; total capsule mass 535-560 mg
• Registration: Must be registered for use in South Africa (proof required)

Red Blood Cell Kit

• Mass of freeze-dried product: 48-68 mg
• Moisture: ≤5%
• pH: 5.5 – 6.5
• Color: Clear and particle-free
• Sodium Pyrophosphate: 18-22 mg
• Total Tin Dichloride: 3.6 – 4.4 mg
• Registration: Must be registered for use in South Africa (proof required)

Methylene Diphosphonate Kit

• Reagents: Methylene diphosphonic acid, Ascorbic acid, Stannous chloride dihydrate, Hydrochloric acid, Sodium hydroxide, Nitrogen gas
• Chemical composition: MDP 10 mg, Ascorbic acid 2 mg, Stannous chloride 1 mg
• Labeling: MDP 2.5 mg/mL, pH 5-7, radiochemical purity ≥95%
• Shelf life: 2 years; 8 hours after reconstitution
• Registration: Must be registered for use in South Africa (proof required)
• Company registration with SAHPRA: Required (proof to be submitted)

Skills Requirements

• Capability to supply and deliver the specified radiopharmaceuticals and kits reliably over a 12-month period.
• Knowledge of handling, storage, and transportation of radioactive materials in compliance with safety standards.
• Registration and compliance with South African health and safety regulations, including registration of products (Section 21).
• Experience in supplying medical radiopharmaceuticals and related kits to healthcare facilities.
• Ability to provide technical support, documentation, and samples/demonstrations if requested during the evaluation process.
• Proficiency in managing logistics and ensuring timely delivery to meet hospital requirements.