Water for injections generation system

Ensure compliance with strict regulatory standards while providing pyrogen-free water essential for injectable drug production with this advanced generation system, integrating distillation and purification processes to maintain sterile conditions.

Purifies and Distributes Pyrogen-Free Water

The WFI Generation System from Fabtech is a crucial asset for pharmaceutical and biotech companies requiring consistent production of pyrogen-free water for injectable products. This system operates on the principles of multicolumn distillation, efficiently purifying water by removing ionic materials, particulates, and bacterial endotoxins, ensuring compliance with stringent USFDA, WHO, and cGMP standards.

Ideal for applications in sterile saline and ophthalmic solutions production, the system features an energy-saving design with falling film technology and an inbuilt sanitization mode to maintain sterility. With options for automatic and semi-automatic operational modes, it integrates seamlessly into existing processes, supported by SCADA for comprehensive control and monitoring.

Constructed from ASME BPE-grade materials, the system’s field piping is fully drainable and configured with zero dead leg valves, ensuring optimal flow and minimizing contamination risks. Furthermore, the equipment’s customization capabilities include options for integrating Pure Steam Generation, making it adaptable to a wide range of production needs.

Engineered with energy efficiency in mind, the system reduces operational costs without compromising performance. Supported by a detailed documentation package, including DQ, FAT, IQ, and OQ protocols, the WFI Generation System from Fabtech promotes high operational reliability and ease of maintenance through its compliant CIP systems.

Benefits

  • Ensures product safety with consistently pyrogen-free, injectable-grade water.
  • Lowers operational costs through energy-efficient falling film distillation technology.
  • Enhances process reliability with automated and seamless integration into production lines.
  • Complies with global pharmaceutical standards, supporting regulatory approval processes.
  • Minimizes contamination risk with fully drainable piping and inbuilt sanitization modes.

General


Applications
Sterile water production,Injectable products,Biopharmaceuticals,Healthcare,Pharmaceuticals
End products
Ophthalmic solutions,Vaccine formulations,Biopharmaceutical injections,Injectable drugs,Intravenous solutions,Sterile saline solutions
Steps before
Purification,Pre-treatment
Steps after
Sterilization,Distribution
Input ingredients
pre-treated feed water,purified water
Output ingredients
100% pyrogen-free water,residual ionic materials,particulates,colloids,non-volatile organic compounds,bacterial endotoxins
Market info

Technical Specifications


Pyrogen-free Water Production
100%
Operating Temperature
80-85°C
Operating Principle
Falling Film Technology
Automation
Automatic/Semi-automatic
Compliance
21 CFR Part 11
Sanitization Mode
Inbuilt for Sterile Conditions
Piping
ASME BPE Grade
Orbital Welding
High Quality with Boroscopy and Videoscopy
Skid Design
Standard/Reduced
Configuration Options
Customisable
Documentation
DQ,FAT Protocols,IQ,OQ

Operating Characteristics


Working Principle
Falling film technology
Temperature Maintenance
80-85 degrees C
Automation Level
Automatic/semi-automatic with SCADA
Inbuilt Sanitization Mode
Sterile conditions

Physical Characteristics


Compact footprint
Standard/reduced skids for optimum performance/minimum footprint
Control panel type
Automatic/semi-automatic variants with SCADA
Tank shape and size
Multicolumn Distillation Unit
Feed/discharge method
Inbuilt sanitization mode for maintaining the loop under sterile conditions
Customization
Customisable configuration and Combi-unit option
Construction
High quality orbital welding with boroscopy and videoscopy

Custom Options


Combi-unit option
Pure Steam generation from the 1st Still outlet
Automation variants
Automatic/semi-automatic with 21 CFR Part 11 compliance
Configuration type
Customisable
Control system
SCADA integration
Skid type
Standard/reduced for minimum footprint
Sanitization mode
Inbuilt for sterile conditions