Objectives

The primary objective of this tender is to procure 100 ML sterile diluent bottles to meet the operational needs of Onderstepoort Biological Products Ltd. The supplier must provide high-quality, sterile, and compliant bottles that adhere to specified technical standards and safety requirements.

Scope

The scope of the tender includes the supply of:

• 199 boxes of 100 ML sterile plastic bottles (each box containing 972 units)
• Specifications as detailed in the attached documentation, including material, dimensions, and quality standards
• Compliance with gamma irradiation and packaging requirements
• Provision of certificates of conformance and quality assurance documentation upon delivery

The supplier is responsible for ensuring all bottles meet the specified technical and quality standards, including packaging, labeling, and documentation.

Technical Requirements

• Material: 100% virgin high-density polyethylene (HDPE), odourless and transparent
• Dimensions:
  • Total height: 82.4mm ± 0.50mm
  • Bottom width: 50.3mm ± 0.50mm
  • Internal neck-rim diameter: 13.0mm ± 0.20mm
  • Outside neck rim diameter: 20.0mm ± 0.20mm
  • Brim thickness: 3.70mm ± 0.20mm
  • Outer neck diameter: 15.8mm ± 0.25mm
• Shape: Flat circumference with no projections, bottom concave, surface smooth
• Mass per bottle: 14.15 – 14.40g
• Gamma irradiation: Minimum dose of 8 kGy; certificate of irradiation must be provided
• Packaging:
  • 81 bottles per cardboard tray (460mm x 460mm x 60mm)
  • 12 trays sealed in dust-proof plastic bags (minimum 35g each)
  • Sealed in a sturdy cardboard box (940mm x 470mm x 546mm) capable of stacking four boxes
  • Each box sealed with a plastic shroud to prevent dust entry
• Documentation:
  • Certificate of conformance/analysis signed by the supplier on company letterhead
  • Quality control samples labeled with product name, date, time, batch number, and operator signature

Skills and Requirements

• Proven experience in supplying sterile plastic bottles, preferably for pharmaceutical or biological applications
• Compliance with South African and international quality standards, including gamma irradiation certification
• Ability to provide detailed technical documentation and certificates of conformance
• Capacity to meet packaging and delivery timelines as specified
• Knowledge of Good Manufacturing Practices (GMP) and relevant safety standards
• Demonstrated ability to produce consistent quality samples from different production batches
• Effective communication and documentation skills to ensure traceability and compliance