Objectives

The primary objective of this tender is to procure and supply a range of radiopharmaceutical kits and related products, including Hida Kit, HMPAO Kit, Mag3 Vials, Nano-colloid Kit, DMSA Kit, Tc-99m PSMA Kit, and Trodat Kit, to Livingstone Tertiary Hospital for a period of twelve months. The aim is to ensure the hospital has a reliable supply of these diagnostic and imaging agents to support medical investigations and procedures.

Scope

The scope encompasses the supply and delivery of the specified kits and vials as per the detailed technical specifications provided for each product. The products are intended for diagnostic imaging and functional investigations related to liver, cerebral perfusion, renal function, lymphatic, inflammation, and prostate cancer detection. Delivery is to be made directly to Livingstone Tertiary Hospital, including the PE Provincial site, on an as-and-when-required basis over a 12-month period.

Technical Requirements

HIDA Kit

• Sterile, freeze-dried powder registered for use in South Africa.
• Reagents include Mebrofenin, Stannous chloride dehydrate, hydrochloric acid, sodium hydroxide, nitrogen gas.
• Chemical composition: HIDA 20 mg, Stannous chloride 0.24 mg, Sodium chloride 0.7 mg.
• Labeling features: HIDA 4 mg/mL, pH 5.5–7.5, radiochemical purity ≥95%.
• Shelf life: 12 months, 6 hours after reconstitution.

HMPAO Kit

• Sterile, freeze-dried powder registered for use in South Africa.
• Reagents include Exametazime, Stannous chloride dihydrate, sodium chloride, cobalt chloride.
• Labeling features: pH 6–8, radiochemical purity ≥95%.
• Shelf life: 12 months, use within 6 hours of reconstitution.

Mag3 Kit

• Sterile, freeze-dried powder registered for use in South Africa.
• Reagents include S-benzoylmercaptoacetyl-triglicine (MAG3), Stannous chloride dihydrate, disodium glucoheptonate, disodium tartrate, lactose, hydrochloric acid, sodium hydroxide, nitrogen gas.
• Labeling features: pH 5.0–5.5, radiochemical purity ≥95%.
• Shelf life: 18 months, 8 hours after reconstitution.

Nano-colloid Kit

• Sterile, freeze-dried powder registered for use in South Africa.
• Reagents include Human Serum Albumin nano-sized colloid, Stannous (II) chloride dihydrate, sodium phosphate, glucose.
• Labeling features: impurity >5%, radiochemical purity ≥95%, free pertechnetate ≤5%.
• Shelf life: 18 months, 6 hours after reconstitution.

DMSA Kit

• Sterile, freeze-dried powder registered for use in South Africa.
• Reagents include meso-2,3-dimercaptosuccinic acid (DMSA), Stannous chloride dihydrate, ascorbic acid, D-mannitol, calcium-gluconate.
• Labeling features: pH 2.3–3.5, radiochemical purity ≥95%, free perchlorate 0.9–1.0, technetium-succimer complex ≥95%.
• Shelf life: 24 months, 8 hours after reconstitution.

Tc-99m PSMA Kit

• Sterile, freeze-dried powder registered for use in South Africa.
• Reagents include 6-hydrazinopyridine, 3-carboxyl, tricine, ethylenediamine-N, N-diacetic acid, and others.
• Labeling features: pH 5–8, radiochemical purity ≥95%, use within 6 hours of reconstitution.
• Shelf life: 18 months.

Skills Requirements

• Proven experience in the supply and handling of radiopharmaceutical kits and related diagnostic agents.
• Knowledge of South African regulatory requirements, including registration and Section 21 import permits.
• Capability to ensure product sterility, stability, and radiochemical purity as per specifications.
• Ability to deliver products within specified shelf lives and handle sensitive radioactive materials appropriately.
• Competence in documentation, including proof of registration, quality certificates, and compliance with health and safety standards.
• Experience in managing logistics for timely delivery to healthcare facilities.