Objectives

The primary objective of this tender is to supply and deliver Ga-68-peptide (dotatate) in vial form for use with the Gallium generator at Inkosi Albert Luthuli Central Hospital. The aim is to facilitate early diagnosis, staging, treatment planning, and monitoring of disease recurrence in cancer patients through advanced molecular imaging techniques.

Scope

The scope encompasses the supply and delivery of three boxes of Ga-68-peptide (dotatate) vials to Inkosi Albert Luthuli Central Hospital. The procurement is a once-off requirement, with the goods to be supplied in accordance with specified technical and quality standards, and delivered to the hospital's premises within the stipulated timeframe.

Technical Requirements

• Item Description: Ga-68-peptide (Dotatate) for gallium generator, vial
• Size: Vial
• Material: Lyophilized (freeze-dried) powder
• Color: Clear or white
• Packaging: Box
• Functionality: Capable of localizing disease at a molecular level, suitable for early detection of disease recurrence, staging, and treatment response monitoring.
• Compliance: Must conform to specifications outlined in the bid documentation and meet quality standards as approved by the specifications committee.
• Validity: Products must be valid for a minimum of six months from the date of delivery.

Skills and Qualification Requirements

• The bidder must possess valid licensing from the South African Health Products Regulatory Authority (SAPHRA) to manufacture, import, export, or distribute medical devices related to the product.
• The bidder should demonstrate capacity to supply the specified quantity (03 boxes) reliably and within the required timeframe.
• Technical competence in handling, packaging, and delivering radiopharmaceuticals, ensuring compliance with safety and quality standards.
• Provision of relevant documentation, including a B-BBEE status level verification or sworn affidavit, CIPC registration, and CSD compliance, to substantiate capacity and compliance.
• Ability to provide technical support and documentation as required for the proper use and handling of the product.