Request feasibility ↗Gel-card, antisera and screening-cell production for controlled immunohaematology testing.
Request feasibility study ↗Gel-card, antisera and screening-cell production for controlled immunohaematology testing. 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.
USD 3.2–8.5M. 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.
1,500–3,500 m² gross; 450–1,100 m² controlled reagent, cell and card production areas, typically ISO 8 with ISO 7 local filling protection.
ISO 8 is typical for controlled card production; ISO 7 local protection may be used over open filling. Cell/reagent preparation is segregated from plastics, packaging and microbiology testing.
14–22 months to validated pilot batches, excluding authority review. Permit, authority review, civil-condition, customs and client approval delays sit outside the base programme unless expressly contracted.
Tier 1: 3–8M cards/year; Tier 2: 12–25M cards/year; two shifts, card configuration and reagent portfolio dependent.
Capacity assumes qualified materials, stated shifts, planned maintenance and validated yield; it is not the sum of nominal machine speeds.
Purified water, controlled 2–8°C storage, backup power, clean compressed air, controlled HVAC, biological-waste management and temperature-mapped logistics.
ISO 13485 QMS readiness, IVDR classification-specific technical documentation, biological-material controls and local registration. Facility/QMS 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.
Indicative 35–85 FTE including immunohaematology specialists, biological QC, QA and engineering; 8–16 weeks training plus supervised comparability and stability work.
The feasibility equipment register identifies supplied equipment, client-supplied items, spares, initial consumables, FAT/SAT responsibility, calibration and qualification ownership.
Operating economics are issued as a sensitivity model using local labour, utilities, materials, yield, utilisation and financing assumptions; they are not a guaranteed return.
Client names and photography are disclosed only with permission; confidential programmes retain a technical envelope rather than an invented attribution.
Review programme evidence ↗The investor brief records the published assumptions, process flow, capacity tiers, regulatory route and data required for a binding feasibility package.