A practical guide to water grade (Purified Water vs WFI), PW flow rates, conductivity and TOC, recovery and sterilization, GMP materials, and matching PW-500/2000/5000 and WFI to output.
Decide between Purified Water (PW, for general pharma use) and Water for Injection (WFI, for parenterals). PW meets USP/EP/ChP via dual-stage RO; WFI adds electrodeionization (EDI) for injection-grade purity.
Lab / pilot
Mid-scale
Industrial, 80k-200k USD
RO + EDI polish
PW achieves conductivity below 1.1 uS/cm at 25C with TOC below 500 ppb. WFI (after EDI) reaches conductivity below 0.1 uS/cm, TOC below 50 ppb, and endotoxin below 0.25 EU/mL - meeting the strictest pharmacopeia limits.
Overall water recovery is 75% or higher, with second-stage RO concentrate recycled to the raw tank. A triple sterilization barrier - ozone corona discharge, 0.22 um PVDF filter, and 254 nm UV - protects the loop from microbial growth.
Wetted parts are 316L stainless steel (sanitary orbital weld) and food-grade PVC-U, with a CIP/SIP-capable distribution loop. Pre-treatment uses Fleck (USA) automatic media, carbon, and softener control heads.
A PLC + HMI touch screen displays flow, pressure, temperature, and conductivity in real time, with batch logging and alarm history. The PW-5000 is SCADA-ready via Modbus/TCP for plant network integration.
Systems meet USP, EP Ch.16, ChP, FDA 21 CFR 211, and EU GMP Annex 1. Every unit ships with IQ/OQ/PQ, FAT/SAT, P&ID drawings, and material traceability certificates; on-site validation support and training are included.
Size by hourly demand and grade: PW-500 for labs, PW-2000 for mid-scale, PW-5000 for full-scale plants, and the RO+EDI WFI system when injection-grade water is required.
| Model | Flow rate | Grade | Recovery | Best for |
|---|---|---|---|---|
| PW-500 | 500 L/h | Purified Water | >=75% | Lab, pilot |
| PW-2000 | 2,000 L/h | Purified Water | >=75% | Mid-scale |
| PW-5000 | 5,000 L/h | Purified Water | >=75% | Industrial |
| WFI System | 250-5,000 L/h | Injection grade | >=75% | Parenterals |
Purified Water (PW) meets USP/EP/ChP via dual-stage RO with conductivity below 1.1 uS/cm. Water for Injection (WFI) adds electrodeionization (EDI) for conductivity below 0.1 uS/cm, TOC below 50 ppb, and endotoxin below 0.25 EU/mL, required for parenterals. Choose WFI only when product contacts the bloodstream.
PW systems run 500, 2,000, or 5,000 L/h; the RO+EDI WFI system covers 250-5,000 L/h depending on model. Size the flow rate to your peak hourly demand plus a margin for CIP and distribution losses. Mid-scale plants typically select PW-2000, while full-scale sites choose PW-5000 or parallel arrays.
PW reaches conductivity below 1.1 uS/cm at 25C and TOC below 500 ppb. WFI (post-EDI) reaches conductivity below 0.1 uS/cm, TOC below 50 ppb, and endotoxin below 0.25 EU/mL - the strictest pharmacopeia limits. Online conductivity monitoring at each stage proves water quality continuously for batch release.
Overall recovery is 75% or higher. The second-stage RO concentrate is returned to the raw water tank for recycling, and the PW-5000 uses multiple parallel membrane arrays for full-scale efficiency. Higher recovery directly lowers the cost per liter of pharma-grade water and reduces wastewater load.
Yes. Wetted parts are 316L stainless steel (sanitary orbital weld) and food-grade PVC-U, with CIP/SIP-compatible distribution. Triple sterilization - ozone, 0.22 um PVDF, 254 nm UV - and CE/cGMP/ISO 9001/FDA compliance protect the loop from microbial growth across the system lifecycle.
A PLC + HMI touch screen shows flow, pressure, temperature, and conductivity in real time with batch logging and alarm history. The PW-5000 is SCADA-ready via Modbus/TCP for plant integration. This gives operators full visibility and auditors a complete electronic record of critical water parameters.
Systems meet USP, EP Ch.16, ChP, FDA 21 CFR 211, and EU GMP Annex 1. Each ships with IQ/OQ/PQ, FAT/SAT, P&ID drawings, and material traceability certificates. YohoAI engineers provide on-site validation support during commissioning so your water system is compliant from startup.
Yes. YohoAI engineers provide on-site IQ/OQ/PQ execution support during commissioning, plus free on-site operator and maintenance training so your water system is compliant from startup. With exports to 30+ countries, service, spare parts, and membrane supply are coordinated globally across time zones.
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