Drug Preparation & Packaging

What the facility produces and why it matters locally

GMP-oriented material dispensing, formulation, filling, packaging, inspection and quality-control capability for a defined dosage form. 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 8–30M. 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

3,000–9,000 m² gross; 1,000–3,500 m² GMP production and support areas, grades determined by dosage form.

Grades are dosage-form and process specific. Non-sterile production commonly uses controlled Grade D/C-equivalent zones; sterile filling requires Grade A critical protection with appropriate background.

Programme from design basis to operation

20–36 months to facility qualification and engineering batches. Permit, authority review, civil-condition, customs and client approval delays sit outside the base programme unless expressly contracted.

Installed capacity tiers

Cannot be stated responsibly until dosage form, pack, batch size and campaign strategy are fixed; feasibility publishes batch and annual tiers.

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

• Material receipt, quarantine, sampling and dispensing
• Product-specific formulation or compounding
• Filtration/filling or solid-dose processing as selected
• Primary packaging and in-process controls
• Secondary packaging, coding and serialisation readiness
• Chemical, microbiological and stability release

Site and utilities

Purified water and possibly WFI/clean steam, process gases, high-reliability HVAC, compressed air, dust/containment systems, backup power and waste treatment.

Regulatory and quality endpoint

National GMP licence and product-registration pathway; EU-GMP readiness where contracted. Typical facility qualification: 18–30 months; product approval is separate.

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 70–220 FTE depending on dosage form and shifts; 12–24 weeks GMP, process, QC and qualification training.

Equipment classes and procurement boundary

• Dispensing booths and contained transfer
• Product-specific mixers, granulators or solution vessels
• Filling, capping and inspection systems
• Blister, bottle, cartoning and coding lines
• QC, microbiology and stability chambers

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

• Cross-contamination and mix-up
• Blend/formulation non-uniformity
• Fill-weight or seal failure
• Cleaning-validation failure
• Data-integrity and stability deviation

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

• Pharmaceutical references supplied after dosage-form matching and client permission

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.