Objectives

The primary objective of this tender is to procure raw materials and chemicals necessary for production activities at Onderstepoort Biological Products Ltd. The procurement aims to ensure the supply of specified chemicals and reagents that meet quality and safety standards, supporting the company's manufacturing processes.

Scope

The scope of the tender includes the supply of various chemicals and biological products, specifically:

• Gentamycin (Bottle, 20g, 50g, 100g)
• Sodium ThioGlycol (CP 100g)
• Meso-Inositol (50g, 100g, 1500g)
• Clindamycin (1500g)
• Dispase-2 (5g)
• Additional specified chemicals as detailed in the specifications

The procurement covers quantities ranging from small vials to kilogram quantities, with specific technical and quality requirements outlined for each item.

Technical Requirements

The technical requirements specify the quality, safety, and compliance standards for each product:

General Requirements

• All products must meet specified specifications and be accompanied by Certificates of Analysis (COA).
• Products must be sterile or non-sterile as specified, with expiry or retest dates of at least one year from the date of supply.
• Packaging must be airtight, clearly labeled with batch and expiry details, and compliant with safety standards.
• Material Safety Data Sheets (MSDS) must be provided for each product.

Specific Product Requirements

• Gentamycin: White or almost white powder, pH 3.5–5.5, potency ≥590 IU/mg, packaged in airtight containers, with endotoxin levels specified.
• Sodium ThioGlycol: Fine white hygroscopic powder, assay ≥96.5%, stored at -20°C, with batch-specific certificates.
• Meso-Inositol: Crystalline powder, chemical formula C6H12O6, molecular weight 180.2 g/mol, assay 97–102%, very soluble in water.
• Clindamycin: White powder, assay 95–102%, endotoxin levels <0.6 IU/mg, packaged in airtight containers.
• Dispase-2: Lyophilized in airtight vials, sterility confirmed, with specific activity ≥0.8 U/mg.

Compliance and Evaluation

• Suppliers must comply with the General Conditions of Contract (July 2010).
• All submissions must include specified documentation, including COA, MSDS, and certification for preference points evaluation.
• Preference points will be awarded based on BBBEE status, with 80% weight on price and 20% on preference criteria.
• Failure to submit required documentation will result in disqualification.

Additional Technical Conditions

All chemicals must be produced or sourced from approved manufacturers, meet pharmaceutical grade standards, and be stored under specified conditions to ensure integrity and safety.