Objectives

The primary objective of this tender is to procure Bowie Dick Test Packs for sterilization validation at Dr Pixley Ka Isaka Seme Memorial Hospital, ensuring effective sterilization processes in accordance with ISO standards and national regulations.

Scope

The scope includes the supply of 20 units per box of Bowie Dick Test Packs suitable for pre-vacuum steam sterilizers operating at 134°-137° for up to 3.5 minutes. The packs must conform to ISO11140-4:2007, bear the Kite mark KM57632, and include process indicators. The procurement covers the delivery of 30 cases of these test packs to the hospital, with samples provided upon request.

Technical Requirements

• Single-use test packs for pre-vacuum steam sterilizers at 134°-137° for up to 3.5 minutes.
• Conformance to ISO11140-4:2007 standard.
• Certification with Kite mark KM57632 from independent testing authorities.
• Inclusion of a process indicator on packaging (Class 1).
• Chemical indicator sheet at the center of the pack showing a uniform color change during the test cycle when no air or non-condensable gases are present.
• Packaging of 20 test packs per box.
• Samples must be provided for evaluation.

Skills Requirements

• Knowledge of sterilization standards and validation processes.
• Ability to supply compliant medical sterilization testing materials.
• Understanding of ISO standards and certification requirements.
• Experience in providing quality assurance documentation and certification.
• Capability to deliver samples and meet technical specifications as per the detailed requirements.