Request feasibility ↗Sterile parenteral solution production from pharmaceutical water and compounding through filling, sterilisation and microbiological release.
Request feasibility study ↗Sterile parenteral solution production from pharmaceutical water and compounding through filling, sterilisation and microbiological 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 18–55M. 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.
5,000–14,000 m² gross; 1,500–5,000 m² GMP production/support with Grade A–D areas according to container and process.
Terminally sterilised filling commonly uses Grade C/D backgrounds subject to risk assessment; aseptic filling requires Grade A with Grade B background. Utility and component preparation grades are separately defined.
24–40 months to qualified facility and process-validation batches. Permit, authority review, civil-condition, customs and client approval delays sit outside the base programme unless expressly contracted.
Tier 1: 8–20M units/year; Tier 2: 30–70M units/year; container size, cycle time and shifts dependent.
Capacity assumes qualified materials, stated shifts, planned maintenance and validated yield; it is not the sum of nominal machine speeds.
High-capacity PW/WFI, clean steam, plant steam, chilled water, compressed gases, redundant power, HVAC, wastewater treatment and microbiological monitoring.
National GMP and sterile-product registration; EU-GMP readiness where scoped. Facility/process readiness typically 24–36 months; authority approval separate.
Infinity IVD delivers the contracted facility, QMS, validation and dossier work. Certification or market authorisation is granted only by the competent independent authority.
Indicative 100–280 FTE; 16–28 weeks sterile GMP, utilities, aseptic/terminal process and microbiology training.
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.