Objectives

The primary objective of this tender is to procure paper steam sterilization bags, size 11, for use at Harry Gwala Regional Hospital, ensuring the supply of compliant, high-quality sterilization bags that meet specified standards and specifications.

Scope

The scope includes the supply of new, unused paper sterilization bags (size 11) manufactured from medical-grade paper with process indicators, packaged in bale or box quantities of 1,000 bags, and conforming to relevant standards such as ISO 11607, SANS 50868, DIN 58953-6, CKS 595, or equivalent. The procurement covers a once-off delivery to Harry Gwala Regional Hospital, with all associated documentation and compliance requirements.

Technical Requirements

• Manufactured from medical-grade paper with a process indicator that changes color when exposed to saturated steam.
• Includes a process indicator pattern/band that changes color to confirm proper steam autoclaving.
• Front printing: "Do not use if wrapper or seal is damaged," indicator pattern/band, and final color of indicator ink.
• Back printing: Manufacturer's name or trademark, size of bag, designation, batch number, with paper complying with ISO 11607, SANS 50868, DIN 58953-6, CKS 595, or equivalent, and ISO 9001.
• Packaging: Bale or box containing 1,000 bags, packed in a suitable rigid cardboard box/bale.
• Bag dimensions: Width 290mm, Length 445mm, Gusset 125mm.

Skills Requirements

• Understanding of medical sterilization standards and quality requirements.
• Ability to produce and supply sterilization bags that meet ISO 11607 and related standards.
• Experience in packaging and labeling in compliance with medical and regulatory standards.
• Capability to provide compliant documentation, including process indicators and batch information.
• Proficiency in adhering to procurement and delivery timelines, ensuring timely supply and documentation.