Blood Collection Tube Manufacturing

What the facility produces and why it matters locally

Evacuated tube production with additive dosing, drying, assembly, evacuation, labelling and functional verification. The investment case is tested against import dependency, procurement demand, supply resilience, attainable local content and regional export access. Portfolio definition precedes equipment selection so capital is not locked into an incompatible process.

Indicative capital band

USD 4–11M. The range covers core equipment, controlled environments, process utilities, installation, qualification, technology transfer and initial training at the stated tier. Preliminary engineering range; excludes land, finance cost, taxes and import duty. Final scope and price are confirmed at the feasibility gate.

Footprint and clean environment

2,000–5,000 m² gross; 600–1,600 m² controlled component, dosing and assembly areas, commonly ISO 8.

ISO 8 controlled assembly is typical; additive formulation/dosing receives dedicated environmental and contamination control. Sterile products require a separately validated sterilisation strategy.

Programme from design basis to operation

14–22 months to validated production and packaging. Permit, authority review, civil-condition, customs and client approval delays sit outside the base programme unless expressly contracted.

Installed capacity tiers

Tier 1: 20–50M tubes/year; Tier 2: 80–180M tubes/year; two shifts, tube mix and line speed dependent.

Capacity assumes qualified materials, stated shifts, planned maintenance and validated yield; it is not the sum of nominal machine speeds.

Process flow and utilities

Core process

• Tube and closure preparation or moulding
• Anticoagulant/additive formulation and precision dosing
• Controlled drying where required
• Cap assembly, evacuation and closure
• Labelling, lot coding and packaging
• Vacuum retention, draw volume, additive and functional testing

Site and utilities

High-capacity power, chilled water for moulding, clean compressed air, vacuum, controlled HVAC, purified water for additives, backup power and sterilisation/logistics interface.

Regulatory and quality endpoint

ISO 13485 QMS readiness, product-specific performance, biocompatibility, shelf-life and local/CE registration pathway. Facility readiness typically 12–18 months.

Infinity IVD delivers the contracted facility, QMS, validation and dossier work. Certification or market authorisation is granted only by the competent independent authority.

Staffing and transfer of know-how

Indicative 45–110 FTE across moulding, formulation, assembly, QC, QA and maintenance; 8–14 weeks technical training.

Equipment classes and procurement boundary

• Injection moulding or tube-forming systems
• Precision additive dosing and drying equipment
• Automated capping and vacuum assembly
• Leak, vacuum and draw-volume inspection
• Labelling, packaging and dimensional QC

The feasibility equipment register identifies supplied equipment, client-supplied items, spares, initial consumables, FAT/SAT responsibility, calibration and qualification ownership.

Critical process risks and operating economics

• Additive dose non-uniformity
• Vacuum decay or closure leakage
• Incorrect blood-to-additive ratio
• Particle or moulding defects
• Shelf-life and label traceability failure

Operating economics are issued as a sensitivity model using local labour, utilities, materials, yield, utilisation and financing assumptions; they are not a guaranteed return.

Relevant delivery evidence

• Nigeria — medical-plastics production programme
• Azerbaijan — medical-consumables localisation scope
• Türkiye — blood-tube equipment and process portfolio

Client names and photography are disclosed only with permission; confidential programmes retain a technical envelope rather than an invented attribution.

Technical brief and feasibility gate

The investor brief records the published assumptions, process flow, capacity tiers, regulatory route and data required for a binding feasibility package.