Objectives

The primary objective of this tender is to procure GOLD COMBISEALS (stoppers) to meet specified quality and safety standards. The procurement aims to select a qualified supplier capable of providing the required quantity of high-quality combiseals that conform to the detailed specifications, ensuring reliability and compliance with regulatory standards.

Scope

The scope of the tender includes:

• Supply of 70 boxes of GOLD COMBISEALS, each containing 6,000 units, totaling 420,000 units.
• Provision of combiseals with specific dimensions and construction as detailed in the specifications.
• Compliance with testing, safety, and quality standards outlined in the specifications document.
• Adherence to procurement procedures and submission of all compulsory documentation.

Technical Requirements

The technical specifications for the GOLD COMBISEALS include:

• Material: Construction aluminium that is 99% pure, non-toxic, and chemically stable in oil emulsion and water-based solutions.
• Dimensions:
  • Ring diameter: 20.2 mm (internal 20.57 mm)
  • Rubber insert: 20.20 mm diameter, 3.00 mm thickness
  • Ring thickness: 0.25 mm
• Design features:
  • Press-out section with a circular tear-off in the center
  • Rubber disc firmly fitted within the aluminum cap
  • Labeling with irradiation sticker and certificates attached
• Testing and quality standards:
  • Chemical stability and non-toxicity
  • Fragmentation: Total fragments visible not exceeding 5
  • Clarity & color: Solution not more opalescent than reference
  • Light absorption: Filtrate absorbance ≤ 2.0
  • Penetrability: As per British Pharmacopoeia (B.P.) standards
  • Self-sealing capability: No color in vials
  • Ammonium: NMT 2.0 ppm
  • Heavy metals: NMT 2.0 ppm
  • Soluble zinc: NMT 5.0 ppm
  • Volatile sulphides: Black stain not darker than standard
  • Reducing substances: Titration volume difference NMT 7.0 ml
  • Residue on evaporation: NMT 4.0 mg

Skills Requirements

The supplier must demonstrate:

• Proven experience in supplying similar pharmaceutical or sterile packaging components within the past 24 months, supported by signed invoices, delivery notes, or reference letters.
• Compliance with all regulatory and quality standards specified in the technical documentation.
• Ability to provide all required documentation, including BBBEE certificates, CSD reports (for South African companies), and proof of previous supply.
• Understanding of procurement procedures and ability to meet the specified testing and quality assurance standards.
• Capacity to deliver the specified quantity within the stipulated timeframe.