Objectives

The primary objective of this tender is to secure a qualified supplier for the procurement of 500 units of single-use bioprocessing bags specifically engineered for sterile biopharmaceutical applications.

Scope

The contract covers the supply of 500 units of STD Flexboy 20L (or direct equivalent) bioprocessing bags. These containers are designated for the storage, mixing, sampling, and transport of sterile biopharmaceutical solutions and buffers within regulated manufacturing environments.

Technical Requirements

• Material Composition: Multi-layer film construction utilizing Thermoplastic Elastomer (TPE) for durability and chemical resistance.
• Interface Options: Fitted with quick-connect couplings, Luer locks, or Tri-Clamp sanitary flanges, selected according to the manufacturer’s specific catalog part number.
• Regulatory & Quality Standards: Must comply with current Good Manufacturing Practice (cGMP) and United States Pharmacopeia (USP) guidelines. Every unit must undergo 100% in-process leak and closure integrity testing prior to dispatch.
• Submission Documentation: Bidders must attach original manufacturer technical datasheets, Certificates of Analysis (COA), product brochures, or comprehensive specification sheets for each quoted item.
• Proof of Past Performance: Mandatory submission of evidence demonstrating supply of the exact or similar items within the preceding 48 months (via invoices, delivery notes, or reference letters).

Skills and Experience Requirements

The tender does not mandate specialized technical certifications beyond manufacturer compliance. Instead, it prioritizes demonstrated commercial experience in the biopharmaceutical supply chain. Suppliers must prove their capability through documented transaction records from the last four years. Additionally, bidders must possess robust administrative capacity to navigate public procurement protocols, including completing statutory bidder disclosure forms and submitting transformation-related compliance certificates.

Clarification of Key Terms

Flexboy 20L Bioprocessing Bag: A sterile, single-use plastic vessel replacing traditional rigid containers in biomanufacturing. It minimizes cross-contamination risks, eliminates cleaning validation steps, and supports scalable downstream processing.

cGMP & USP Standards: Current Good Manufacturing Practice ensures consistent, high-quality production processes, while USP provides official pharmacopeial benchmarks for material purity and performance. Both are non-negotiable for biopharmaceutical components.

In-Process Leak & Closure Integrity Testing: A mandatory quality control procedure where each bag is subjected to pressure or vacuum testing to verify seal integrity, guaranteeing sterility preservation during storage and transport.

80/20 Evaluation Weighting: Bids are assessed using an 80% price competitiveness score and a 20% preferential procurement score aligned with national economic transformation policies (e.g., black-owned, women-owned, or disability-certified enterprises). Missing preference documentation triggers automatic disqualification.