Request feasibility ↗Lateral-flow manufacturing from conjugate and membrane preparation through automated assembly and packaged test release.
Request feasibility study ↗Lateral-flow manufacturing from conjugate and membrane preparation through automated assembly and packaged test release. 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 1.8–5.5M. 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.
1,000–2,500 m² gross; 300–850 m² controlled production, commonly ISO 8 with tightly controlled low-humidity membrane and assembly rooms.
ISO 8 controlled production is typical; humidity-critical coating, drying and assembly rooms are engineered separately, often at ≤30% RH depending on membrane and reagent system.
10–16 months from design basis to validated pilot lot. Permit, authority review, civil-condition, customs and client approval delays sit outside the base programme unless expressly contracted.
Tier 1: 5–15M tests/year; Tier 2: 25–60M tests/year; two shifts, strip format and automation dependent.
Capacity assumes qualified materials, stated shifts, planned maintenance and validated yield; it is not the sum of nominal machine speeds.
Stable HVAC with low-humidity capability, clean dry compressed air, redundant power, controlled reagent cold storage, purified water for buffers and calibrated environmental monitoring.
ISO 13485 QMS readiness; IVDR/local IVD registration and WHO PQ preparation where applicable. Typical facility/QMS readiness: 8–14 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 28–75 FTE depending on automation and shifts; 6–10 weeks production/QC training and three supervised validation lots.
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.