Turnkey Diagnostic Laboratories

What the facility produces and why it matters locally

Clinical laboratories configured around sample volume, test menu, biosafety, turnaround time and accreditation target. 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 0.8–4.5M. 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

350–1,800 m² gross; molecular, microbiology and sample-processing rooms segregated by risk and workflow.

Routine clinical laboratories generally require controlled, risk-based rooms rather than classified cleanrooms. PCR workflow uses separated reagent, extraction and amplification areas; microbiology uses appropriate biosafety controls.

Programme from design basis to operation

6–12 months from approved design basis to operational qualification. Permit, authority review, civil-condition, customs and client approval delays sit outside the base programme unless expressly contracted.

Installed capacity tiers

Tier 1: 500–1,500 samples/day; Tier 2: 2,000–6,000 samples/day; test mix, automation and operating hours 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

• Patient/sample reception and accessioning
• Pre-analytical centrifugation and aliquoting
• Chemistry, immunoassay, haematology and coagulation testing
• Microbiology and molecular workflows where included
• Result validation, LIS release and sample retention
• Internal QC, EQA and nonconformity management

Site and utilities

Redundant power/UPS, analyser-grade water, HVAC, drainage, medical/laboratory gases where needed, cold storage, network/LIS and infectious-waste pathway.

Regulatory and quality endpoint

Local laboratory licence, ISO 15189 accreditation readiness and applicable biosafety requirements. Typical readiness: 6–12 months; accreditation decision remains with the body.

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 18–80 FTE depending on departments and shifts; method, analyser, biosafety, quality and LIS training over 4–10 weeks.

Equipment classes and procurement boundary

• Pre-analytical and sample-tracking systems
• Chemistry, immunoassay, haematology and coagulation analysers
• PCR, extraction and microbiology platforms as scoped
• Cold storage, biosafety cabinets and autoclaves
• LIS, UPS and water systems

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

• Sample identification error
• Cross-contamination and carryover
• Calibration/QC failure
• Turnaround bottlenecks
• Cold-chain, LIS or power interruption

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

• Türkiye — laboratory and QC portfolio
• Nigeria — molecular and QC laboratory integration
• Azerbaijan — diagnostic laboratory integration

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.