Objectives

The primary objective of this tender is to secure a qualified and compliant supplier capable of providing high-quality glass vials for clinical laboratory operations at Inkosi Albert Luthuli Central Hospital. The procurement aims to ensure uninterrupted availability of specialized storage containers for radiopharmaceutical processing while adhering to public sector procurement regulations, quality standards, and socio-economic empowerment targets.

Scope

The scope covers a one-off supply and delivery of ten packs of 30ml clear glass vials to the specified hospital facility. The contract includes all associated logistics, such as secure packaging, transportation, and offloading at the designated site. Pricing must be firm, inclusive of value-added tax (where applicable), and cover all delivery-related costs. The contract validity period is ninety days, and the department reserves the right to evaluate quotations based on administrative compliance, technical specification adherence, pricing, and preferential procurement criteria.

Technical Requirements

• Specifications: Vials must be 30ml in capacity, transparent in colour, and manufactured entirely from glass.
• Functionality: Designed specifically for the storage of labelled Actinium-225 products during radiopharmaceutical labelling procedures, with three vials utilised per elution cycle.
• Quality Standards: Goods must be new, unused, free from design or workmanship defects, and compliant with applicable SANS/SABS specifications. Expired or second-hand products are strictly prohibited.
• Shelf-Life: All supplied items must retain a minimum validity period of six months from the date of delivery.
• Packaging: Must be robust enough to prevent damage, deterioration, or contamination during transit, accounting for environmental exposure and handling conditions.
• Sample Submission: Top-scoring bidders may be required to provide physical samples for objective technical evaluation before contract award.

Skills and Qualification Requirements

• Regulatory Licensing: Bidders must hold a valid licence issued by the South African Health Products Regulatory Authority (SAPHRA) authorising the manufacture, import, export, or wholesale distribution of medical devices.
• Supplier Registration: Active and verified registration on the Central Suppliers Database (CSD) with up-to-date tax compliance documentation is mandatory.
• Empowerment Documentation: Proof of Broad-Based Black Economic Empowerment (B-BBEE) status via a verification certificate or sworn affidavit, or updated CIPC registration documents, must be submitted to qualify for preference points.
• Operational Capacity: Bidders must demonstrate financial stability, logistical capability, and a clean record regarding previous contract performance, with no history of unexplained defaults.
• Compliance & Reporting: Ability to adhere to general and special conditions of contract, including warranty obligations, inspection rights, penalty clauses for delayed delivery, and anti-collusive bidding declarations.

Explanation of Unusual or Complicated Terms

Actinium-225 (225Ac): A radioactive isotope utilised in targeted alpha therapy for oncology treatments. The vials function as specialised containment vessels for this radiopharmaceutical, requiring materials that guarantee chemical inertness, radiation compatibility, and sterility during laboratory elution processes.

80/20 Preference Point System: A standard South African public procurement scoring model where eighty points are allocated to competitive pricing and twenty points to designated socio-economic goals. In this instance, the full twenty points are reserved for enterprises owned by youth.

SAPHRA Licence: Mandatory regulatory approval issued by South Africa’s national health products regulator. It certifies that the supplier meets stringent statutory requirements for the safe handling, distribution, and commercialisation of medical devices and related healthcare products.