Komal Industries

Water for Injection (WFI) System

water for injection

A Water for Injection (WFI) system is a critical component in pharmaceutical and biotechnology manufacturing, producing high-quality purified water that meets the stringent standards required for injectable drugs, sterile formulations, and other critical applications in the industry. The WFI system typically includes processes like reverse osmosis, distillation, and filtration to remove impurities and microorganisms, ensuring the water’s purity and quality. This purified water is a key ingredient in drug formulation and is used for cleaning, sterilization, and various other pharmaceutical processes.

Distillation is the primary process used for the production of USP Water for Injection for pharmaceutical applications. As the name suggests, MCDP consists of individual pressure vessels (single columns) assembled in series.

The Multi-Column Distillation Plants (MCDP) are designed to produce pyrogen/endotoxin-free water conforming to IP/BP/EP/USP standards. These individual columns are designed, constructed, and tested as per the American Society of Mechanical Engineers (ASME, Section VIII, Division 1- Unfired Pressure Vessels) since they operate as high as 6 to 10 bar pressures. Plants are available from 50 Liters/hour to 10,000 Liters/hour. Komal Industry’s WFI-Combo design optimizes the Control Panel by combining the panel for the WFI Generation and Distribution system.

Special Features
  • All Evaporator (columns) sheets and tubes as well as all surfaces in contact with Pure Steam or distillate are constructed of 316L stainless steel with inside electropolish and Teflon gaskets.
  • All tube joints are Orbital welded and qualified with videoscopy.
  • Fully-Automatic PLC-based Control Panel System with auto sanitization and printing facility.
  • The first column is equipped with a Double tube sheet as a provision to avoid boiler steam mixing with Purified water.
  • Pure steam generation port.
  • Complete documentation to meet and exceed international audit requirements.
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