Objectives

The primary objective of this tender is to supply and deliver Attest Super Rapid Biological Indicators to Victoria Mxenge Hospital, ensuring the testing of autoclaves for their ability to kill microorganisms. The indicators must meet specified standards and be compatible with existing equipment to ensure effective sterilization validation.

Scope

The scope includes the supply and delivery of 10 boxes of Attest Super Rapid Biological Indicators, each box containing 50 vials (totaling 200 vials). The indicators are intended for use in autoclave validation at Victoria Mxenge Hospital. The contract is a once-off delivery, with the product conforming to specified standards and detailed technical requirements.

Technical Requirements

• Single vial with indicator line and sticker at the base, sensitive to steam at 134°C.
• Vial containing live spores of a encapsulated microorganism, with the organism's name displayed on the outside.
• Food medium within the vial, separated by a thin glass film from Mycobacterium spores.
• Vial providing space for department, cycle number, autoclave number, and date; compatible with the Mini Auto Reader 490M by 3M.
• Labeling on the box and individual vials indicating content, supplier, batch and lot number, manufacture date, and expiry date.
• Product must comply with ISO 9000 quality standards.
• Packaging: Box of 4 mini boxes, each containing 50 vials (total 200).
• Sample submission is required for testing prior to acceptance.

Skills Requirements

• Understanding of sterilization validation processes and biological indicator specifications.
• Ability to interpret technical specifications and ensure product compliance with ISO standards.
• Knowledge of autoclave operation and validation procedures.
• Capability to provide technical documentation and support for product use and compatibility.
• Competence in quality assurance and adherence to regulatory standards.