Water for Injection System (WFI Generation)
Water for injection (WFI) has an important in pharmaceutical production. It must meet strict quality standards set by international pharmacopoeias such as USP, EP, and CP to ensure it is free from endotoxins, microbes, and other impurities. WFI is typically used for injectable drugs, cleaning of process equipment, and preparation of parenteral solutions.
We design WFI generation systems based on multi-effect distillation, which is widely recognized for its stability and high purity output. Each WFI generation system is tailored to meet the user's production needs and validated according to GMP guidelines. Each water for injection system is engineered to ensure consistently low conductivity and tightly controlled endotoxin levels, meeting global pharmacopoeia standards for injectable-grade water.
- Multi-effect distillation ensures efficient thermal separation and reliable removal of endotoxins.
- Stainless steel construction (316L) with orbital welding and internal electropolishing for hygienic operation.
- Automatic control system (HMI PLC) with data logging, alarm management, and audit trail options.
- Integrated storage and distribution units available with hot water recirculation to prevent microbial growth.
- Compliance with USP, EP, and CP standards, with validation support including DQ, IQ, OQ, and PQ documents.
- The capacity range is customizable to match various production scales in injectable manufacturing and sterile processes.
- Sterile product manufacturing (e.g., injectables, infusions)
- CIP/SIP for cleanroom and process equipment
- Final rinse in washing systems for vials, ampoules, and syringes
- Dilution and formulation of parenteral solutions
- Biopharmaceutical production including vaccines and monoclonal antibodies
We offer a complete portfolio of pharmaceutical-grade water systems designed to meet various process requirements, including multi-effect distillers for Water for Injection (WFI), purified water generation units, pure steam generators, and desalination systems for specialized applications. Each pharmaceutical water solution is engineered to align with GMP standards and international pharmacopoeias such as USP, EP, and CP.
Our pharmaceutical water systems are designed with automated process control, real-time monitoring, and built-in alarms to ensure stability in water quality. Main parameters such as conductivity, temperature, and flow rate are continuously tracked to guarantee compliance. Equipment is validated with complete documentation (DQ, IQ, OQ, PQ) and supports routine calibration and maintenance procedures.
Yes. Every project begins with a technical evaluation of the feedwater quality and user requirements (URS). Based on this, we design tailor-made solutions that may include integrated CIP/SIP functions, modular layouts, and flexible control systems. We also offer standard models for facilities looking for fast deployment with minimal adjustments.
We provide multilingual technical assistance, remote diagnostics, and engineering consultation throughout the project lifecycle. Our team supports international validation, documentation in compliance with regulatory authorities, and long-term service contracts. Custom design requests and ODM/OBM options are also available to meet diverse market needs.
