Manufacturing Infrastructure
To meet the stringent, evolving demands of the global pharmaceutical industry, IV Tech Healthcare leverages cutting-edge Injection Stretch Blow Molding (ISBM) and Glass IV bottle manufacturing. Our ISO-certified and GMP-compliant facility features a versatile manufacturing and packaging envelope capable of producing Sterile LARGE VOLUME Parenterals ranging from 100 mL to 3000 mL.
With a built-up area of 170,000 sq.ft. , our state-of-the-art manufacturing complex integrates high-performance machinery, strict Quality Control (QC), and Quality Assurance to deliver a distinct competitive advantage.
Production Engineering & Capabilities
- Two Advanced ISBM machines with 8000 bottles/ hr capacity each.
- One Glass IV ttle manufacturing machine with 3000 bottles/ hr capacity.
- Irrigation solution manufacturing capacity of 3000 bottles/ day.
- Modular cleanrooms constructed using high-performance prefabricated panels.
- Filling is performed in a Grade A Laminar Air Flow backed by a Grade C cleanroom environment.
- Terminal Sterilization: Outfitted with high-efficiency Superheated Water Spray Sterilizers to guarantee absolute product sterility at 121 degree Celsius.
- Multi-Stage Generation: Employs a single-pass Reverse Osmosis (RO) system integrated with Demineralisation Plant, Ultraviolet (UV) disinfection, and Ultrafiltration (UF) to yield high-grade purified water, followed by a multi-effect distillation process to generate Sterile Water for Injection (SWFI).
- Real-Time Monitoring: Continuous, closed-loop data recording tracking WFI temperature and conductivity through online equipment.
- Dedicated HVAC Systems: Individualized Air Handling Units (AHUs) deployed across separate zones to mitigate any risk of cross-contamination.
- Biometric access controls installed at all classified room entry points.
- Interlocked airlocks for all man and material transit points, with material transfer points by dynamic Laminar Air Flow (LAF) pass-boxes.
