TURNKEY STERILE PHARMACEUTICAL MANUFACTURING
Build an IV solution facility engineered for reliable supply.
Integrated water systems, formulation, sterile filling, terminal sterilization, quality control and technology transfer—from investment concept to operational production.
Request a feasibility study ↗Sterile processQuality designed into flow
Flexible formatsBottles or IV bags
Scalable outputMarket-sized capacity
Turnkey handoverPeople, process and plant
Essential medicines require dependable local capacity.
Infinity develops the investment around hospital demand, tender volumes, target formulations, selected container formats, utilities and regulatory expectations. The result is a resilient pharmaceutical operation—not disconnected equipment.
Core IV therapies.
A configurable portfolio.
01
0.9% Sodium Chloride solution
02
5% Dextrose solution
03
Ringer’s and Lactated Ringer’s
04
Dextrose-saline combinations
05
Irrigation solutions where applicable
06
100–1,000 mL bottle or bag formats
Final formulations and claims depend on the approved development, stability and regulatory program.
Controlled from pharmaceutical water to batch release.
Raw-material dispensing
Solution formulation and mixing
Bioburden-controlled transfer
Container preparation
Washing where applicable
Filling and closure
Terminal sterilization
Visual inspection and leak testing
Labeling, packing and batch release
FACILITY & CLEANROOM ENGINEERING
Flows that protect sterility and productivity.
Personnel, materials, components, product and waste are mapped separately. Airlocks, pressure cascades, clean utilities and environmental controls follow the selected process.
01Incoming material and sampling
02Dispensing and weighing
03Water and utility generation
04Formulation and holding
05Container preparation or forming
06Controlled filling and closure
07Sterilization and cooling
08Inspection and packaging
09QC chemistry laboratory
10Microbiology laboratory
11Quarantine and finished goods
12Technical and personnel support
The complete sterile manufacturing ecosystem.
Systems are selected against the approved URS, container format, capacity, sterilization strategy and service model.
Pretreatment, PW and WFI systems
Sanitary storage and distribution loops
Jacketed formulation vessels
CIP/SIP process skids
Bottle or flexible-bag production
Automated washing and filling
Stoppering, capping or port sealing
Autoclaves and loading systems
Inspection and integrity testing
Labeling and cartoning
Chemistry and microbiology laboratories
Clean utilities and monitoring
CAPACITY & FORMAT STRATEGY
Designed for demand today and expansion tomorrow.
The model connects batch size, filling speed, container mix, sterilizer cycles, shifts, changeover, yield and warehouse demand.
- Rigid bottle, flexible bag or phased hybrid
- Multiple fill-volume scenarios
- Single- or multi-shift production
- Modular water and utility expansion
- Future line and warehouse zones
One managed path to commercial production.
Feasibility
Demand, portfolio, site and investment model
Concept design
Capacity, process, zoning and utilities
Detailed engineering
Architecture, HVAC, water and MEP
Procurement
Process, laboratory and utility systems
Construction
Cleanrooms and technical areas
Commissioning
Start-up, balancing and calibration
Qualification
DQ/IQ/OQ and validation planning
Technology transfer
Documents, methods and training
Pilot batches
Optimization and stability start
Handover
Ramp-up and post-start support
QUALITY & REGULATORY READINESS
A sterile operation supported by evidence.
The plan can cover contamination control, water-system qualification, sterilization validation, analytical method transfer, cleaning validation and stability.
GMP-oriented designPW / WFI qualificationSterilization validationContainer integrityEnvironmental monitoringData integrity
A factory, a process and an operating system.
✓ Market and capacity feasibility
✓ Product and container strategy
✓ Facility and cleanroom design
✓ Water and clean-utility engineering
✓ Equipment URS and procurement
✓ QC and microbiology laboratories
✓ Qualification and validation support
✓ Technology and method transfer
✓ Pilot-batch and training support
✓ Ramp-up and after-sales service
Transform essential IV demand into regional manufacturing strength.
Share your country, annual demand, target formulations, container format and site status.
Start the IV facility discussion ↗