Objectives

The primary objective is to appoint a qualified supplier to deliver high-quality, sterile cell culture roller bottles to support biological product manufacturing. The procurement aims to secure competitively priced goods while complying with South Africa's preferential procurement framework, emphasizing value for money and socio-economic transformation.

Scope

The tender covers the supply of eighty boxes, containing forty units each, of cell culture roller bottles. Deliveries must adhere to the Government Procurement General Conditions of Contract (July 2010). Evaluation follows an 80/20 weighted scoring model, allocating 80% to price competitiveness and 20% to specific socio-economic preference goals.

Technical Requirements

• Quantity: 80 boxes (3,200 units total)
• Material & Compliance: USP Class VI certified resin; US Class I 510(k) exempt medical device; manufactured under cGMP in an ISO 9001 certified facility
• Capacity & Design: 850 cm² cell growth area, 2L working volume, tissue culture treated, non-vented wide-mouth neck, threaded top, easy-grip cap, dimensions 271mm height × 117mm diameter, black visible graduations
• Sterility & Safety: Sterile; pyrogen-tested per ANSI/AAMI ST 72 (bacterial endotoxin limit ≤ 0.1 EU/mL or 4 EU/device)
• Integrity Testing: Forward pressurization to 99.06 cm (39 inches) water column
• Packaging & Shelf Life: 2 units per pack, 40 packs per box; minimum 3-year shelf life from manufacture date
• Documentation: Certificate of Analysis (CoA) confirming DNase, RNase, pyrogen, and endotoxin-free status; original manufacturer technical datasheets/specification sheets; proof of prior supply within the past 36 months (minimum two stamped invoices, delivery notes, or reference letters)

Skills and Capability Requirements

Bidders must demonstrate proven experience in supplying regulated biomedical or pharmaceutical equipment, with established supply chain capabilities to ensure timely delivery and full documentation traceability. Suppliers must possess administrative competence to navigate public procurement portals, complete mandatory Standard Bidding Document (SBD) declarations, and accurately calculate and substantiate preference point claims under South African procurement regulations. Financial and operational stability to manage bulk orders without compromising quality assurance is implicitly required.

Explanation of Key Technical and Regulatory Terms

• USP Class VI Certified Resin: The highest pharmacopeial standard for plastics used in medical devices, ensuring strict biocompatibility, low chemical extractables, and patient safety.
• cGMP & ISO 9001: Current Good Manufacturing Practices and an international quality management standard that mandate rigorous process controls, batch consistency, and continuous improvement in production facilities.
• ANSI/AAMI ST 72: A recognized industry standard detailing validated methods for detecting and quantifying bacterial endotoxins in reusable medical devices to prevent pyrogenic reactions.
• Forward Pressurization Integrity Test: A non-destructive leak detection method that applies controlled air pressure to verify the physical seal and structural integrity of the bottle.
• 80/20 Preference Point System: A South African public procurement scoring mechanism where 80 points are awarded based on the lowest acceptable price, and 20 points are allocated for socio-economic goals such as verified black ownership (≥51%), women ownership (≥30%), and disability inclusion.
• SBD Forms: Standardized government declaration forms requiring bidders to disclose conflicts of interest, certify non-collusive bidding, declare company structure, and formally claim preference points.