Pharmaceutical-grade WFI production system combining dual-stage RO with EDI polishing to achieve conductivity below 0.1 uS/cm. Built for USP/EP/ChP compliance with full cGMP 316L SS construction and complete IQ/OQ/PQ validation.
YohoAI's Water for Injection (WFI) System is the premium purification solution for pharmaceutical manufacturers requiring the highest water purity standards. By combining YohoAI's proven dual-stage reverse osmosis (RO) technology with Electrodeionization (EDI) polishing, the system achieves conductivity below 0.1 uS/cm-significantly exceeding the <1.1 uS/cm purified water threshold and meeting the most stringent pharmaceutical water quality requirements. Designed for injectable pre-treatment, sterile manufacturing, and biotech applications, the WFI system features 316L stainless steel wetted parts, ozone + UV sterilization, and a complete cGMP documentation package for regulatory compliance.
Verified factory data - not marketing estimates
Dual-stage RO pre-treatment reduces conductivity to <1.1 uS/cm, then EDI continuously polishes to <0.1 uS/cm without chemical regeneration. EDI removes ionized impurities (Na+, Cl-, Ca2+, Mg2+) and reduces endotoxin levels below 0.25 EU/mL for injection-grade purity.
Final water quality exceeds purified water pharmacopeia requirements and approaches WFI (Water for Injection) specifications. Ideal as the feed water for pharmaceutical WFI stills, or directly for rinse water in sterile manufacturing processes.
EDI stage removes ionic contaminants that contribute to endotoxin formation. Optional online TOC analyzer monitors organic carbon below 50 ppb in EDI output. Combined ozone + UV treatment provides three barriers against microbiological contamination and biofilm formation.
Unlike ion exchange resins that require chemical regeneration, EDI uses electrical current to continuously regenerate the ion exchange media in situ. This eliminates chemical handling, reduces operational costs, and produces consistent water quality without downtime for regeneration cycles.
Complete validation documentation includes IQ/OQ/PQ protocols, EDI performance qualification, endotoxin trend data, CIP/SIP (cleaning-in-place/sanitization-in-place) procedures, and regulatory submission files meeting FDA 21 CFR Part 211 and EU GMP Annex 1 requirements.
EDI modules are modular and can be added to increase polishing capacity. The RO stage can be sized from 250 L/h to 5,000 L/h to match production requirements. Custom WFI storage and distribution loop design is available for turnkey project delivery.
Our team responds within 2 hours with CIF/CFR/FOB pricing and delivery timeline.
The standard PW Series produces purified water at <1.1 uS/cm conductivity, meeting USP/EP/ChP purified water monographs for non-sterile applications. The WFI system adds EDI (Electrodeionization) polishing after dual-stage RO to achieve <0.1 uS/cm-approximately 10x purer-with endotoxin reduction below 0.25 EU/mL. This makes the WFI system suitable as pre-treatment for WFI stills or for injection-grade rinse water applications.
EDI combines electrodialysis with ion exchange media in a continuous process. An electrical current drives ionized contaminants through ion-selective membranes into a concentrate stream, while simultaneously regenerating the ion exchange beads. Unlike conventional ion exchange (which requires periodic chemical NaOH/HCl regeneration), EDI regenerates itself electrically, produces zero chemical waste, and delivers consistent water quality without operator intervention.
WFI system pricing starts at approximately USD 80,000-120,000 for a 500 L/h RO + EDI configuration and scales to USD 200,000-250,000+ for 5,000 L/h systems with full SCADA integration, multi-point distribution loops, and comprehensive IQ/OQ/PQ documentation. EDI module cost varies by capacity. A detailed water analysis and capacity assessment are required for an accurate project quote.
Yes. YohoAI's WFI system is designed for compliance with EU GMP Annex 1 (Manufacture of Sterile Medicinal Products) and FDA 21 CFR Part 211 requirements. Documentation package includes water system risk assessment (per ICH Q9), environmental monitoring protocols, trend analysis procedures, and deviation/CAPA templates. YohoAI engineers support on-site PQ execution and regulatory audit preparation.
EDI modules require periodic cleaning (every 6-12 months) with dilute acid (citric or oxalic acid) to remove scale and organic fouling from the concentrate channels-a 2-4 hour CIP procedure documented in the maintenance manual. EDI stack lifetime depends on feed water quality but typically ranges 3-5 years under normal operating conditions. Replacement stacks are available through YohoAI's spare parts service.
Pricing varies by configuration and accessories. Please send us your specific requirements including production capacity needs, tube/can/capsule format, and required certifications. We typically respond within 2 hours with CIF/CFR/FOB pricing.
Standard delivery ranges from 30-90 working days depending on the model and configuration. Pharmaceutical GMP configurations with validation documentation packages require additional 5-10 working days. Expedited manufacturing is available for urgent orders at a 15-25% premium.
All YohoAI machines carry CE certification and are designed to meet cGMP and ISO9001 standards. Additional certifications including FDA compliance and specific food-grade standards are available depending on the product line and configuration.
The WFI System requires a dedicated pharmaceutical utility room with precise environmental controls. Site preparation includes 380V three-phase power, a clean drain for concentrate and reject streams, and a municipal feed water supply with TDS below 500 ppm. The EDI modules require a stable feed water temperature between 10 and 35 degC for optimal performance. The system connects to a custom-designed WFI storage tank and distribution loop with sanitary orbital-welded 316L SS piping. YohoAI engineers provide full on-site commissioning, PQ execution support, and operator training as part of the turnkey delivery package.
The EDI polishing stage is the key differentiator of the WFI System, achieving conductivity below 0.1 uS/cm without chemical regeneration. Unlike conventional ion exchange systems that require periodic NaOH and HCl regeneration cycles, EDI uses electrical current to continuously regenerate the ion exchange media in situ. This eliminates chemical handling, reduces operational costs, and produces consistent water quality without downtime. The PLC + HMI system logs all critical parameters including EDI voltage, current, and concentrate flow for continuous performance monitoring and GMP batch traceability.
EDI modules require periodic cleaning every 6-12 months with dilute acid (citric or oxalic acid) to remove scale and organic fouling from the concentrate channels. This is a 2-4 hour CIP procedure documented in the maintenance manual. EDI stack lifetime typically ranges 3-5 years under normal operating conditions, with replacement stacks available through YohoAI spare parts service. The ozone + UV sterilization system and 0.22 um PVDF final filter provide three barriers against microbiological contamination. Weekly ozone sanitization and monthly hot water sanitization at 80 degC maintain the distribution loop free of biofilm.
Standard dual-stage RO for mid-scale pharmaceutical purified water production
Large-capacity multi-array RO system for commercial pharmaceutical manufacturing
Complete cGMP validation and documentation package for pharmaceutical water systems
