2,000 L/h dual-stage RO system for mid-scale pharmaceutical water production. cGMP-compliant, conductivity <1.1 uS/cm, ozone + UV sterilization, and full IQ/OQ documentation for regulatory audits.
The PW-2000 Production Purified Water System is engineered for mid-scale pharmaceutical manufacturing facilities requiring 2,000 L/h of pharmacopeia-grade purified water. Built on YohoAI's proven dual-stage reverse osmosis platform, the PW-2000 combines multi-barrier pre-treatment, Hyde Energy spiral-wound RO membranes, ozone sterilization, and 0.22 um PVDF final filtration to deliver water that meets USP, EP, and ChP pharmacopeia requirements with conductivity below 1.1 uS/cm. Sanitary 316L stainless steel construction and a PLC + HMI control system ensure full cGMP compliance throughout the production cycle.
Verified factory data - not marketing estimates
2,000 L/h output meets the water demand of medium-scale tablet, capsule, and topical product manufacturing lines. Multiple RO membrane housings in parallel ensure consistent throughput and easy maintenance without full system shutdown.
Dual-stage RO with second-stage concentrate recycling consistently delivers water at <1.1 uS/cm conductivity, meeting USP <645>, EP Chapter 16, and ChP purified water requirements for pharmaceutical manufacturing applications.
Ozone corona discharge (bacteriolytic-grade) + 0.22 um PVDF sterilizing filter + 254 nm UV provides comprehensive protection against bacteria, endotoxins, viruses, and biofilm accumulation in the distribution loop.
Advanced PLC + HMI system with VFD-controlled HP pumps, real-time conductivity/flow/pressure monitoring, alarm history logging, and optional SCADA integration for pharmaceutical facility management systems.
Second-stage RO concentrate returns to the raw water tank for recycling. The PW-2000 achieves >=75% overall water recovery, reducing feed water consumption and wastewater disposal costs significantly versus single-pass systems.
IQ/OQ/PQ protocols, FAT/SAT reports, P&ID drawings, material traceability certificates (3.1/3.2), risk assessments, and regulatory submission support included. YohoAI engineers assist with on-site validation execution.
Our team responds within 2 hours with CIF/CFR/FOB pricing and delivery timeline.
Yes, the PW-2000 is designed for integration with existing sanitary 316L SS distribution loops. The PLC control system communicates with loop circulation pumps, temperature sensors, and point-of-use valves. YohoAI provides P&ID drawings and engineering support for loop integration during commissioning. Custom distribution loop design is available as a separate service.
The PW-2000 base system (2,000 L/h, dual-stage RO, ozone + UV, PLC/HMI) ranges from USD 50,000-100,000 depending on configuration. The price includes free on-site installation, commissioning, and operator training. Optional EDI for ultra-pure water (<0.1 uS/cm), online TOC analyzer, and expanded IQ/OQ/PQ documentation packages are available at additional cost.
The multi-barrier pre-treatment train (multi-media filter, activated carbon, water softener, 5 um cartridge) protects the RO membranes from fouling caused by turbidity, free chlorine, hardness, and suspended solids. The Fleck automatic control heads adjust backwash/regeneration cycles based on operating hours rather than timers, compensating for feed water quality variations and maintaining consistent product water quality.
The PW-2000 is CE certified and manufactured under ISO 9001:2015 quality management. All wetted parts use 316L stainless steel or food-grade materials for cGMP compliance. The system is designed to meet FDA 21 CFR Part 211 requirements and ships with full IQ/OQ validation documentation. Pharmacopeia compliance includes USP, EP, and ChP purified water monographs.
YohoAI provides a complete validation dossier: URS (User Requirement Specification), FDS (Functional Design Specification), DQ (Design Qualification), IQ protocols, OQ test records, and PQ acceptance criteria. Our engineers support on-site PQ execution. All documents are available in English and can be adapted to your site-specific quality management system (QMS) for regulatory submissions in the US, EU, and international markets.
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 PW-2000 requires careful planning for integration into a pharmaceutical facility. Prepare a dedicated utility room with 380V three-phase power, floor drains capable of handling concentrate discharge, and sufficient ceiling height for the skid and membrane housings. The system connects to an existing or new sanitary 316L SS distribution loop with circulation pump and use-point valves. YohoAI provides P&ID drawings and engineering support for loop integration during the included on-site commissioning. Allow 1.5 meters clearance on all sides for membrane access, cartridge replacement, and VFD pump maintenance.
The VFD-controlled high-pressure pumps allow precise adjustment of operating pressure to match feed water conditions and membrane fouling trends. The PLC + HMI system automatically logs conductivity, flow rate, pressure, temperature, and ozone residual data with timestamps for batch traceability. Pre-treatment Fleck automatic control heads manage backwashing and regeneration cycles based on operating hours. The 5 um cartridge filter should be replaced every 3-6 months, and RO membrane chemical cleaning is required when operating pressure rises to 1.2 MPa versus the 0.8 MPa baseline.
Sanitization of the distribution loop is critical for maintaining GMP compliance. Perform weekly ozone sanitization cycles and monthly hot water sanitization at 80 degC for 30-60 minutes to prevent biofilm formation. The 0.22 um PVDF sterilizing filter requires integrity testing and replacement every 6-12 months. Keep comprehensive records of all sanitization cycles, filter replacements, and membrane cleanings for GMP audit readiness. YohoAI provides a sanitization SOP template and preventive maintenance schedule as part of the IQ/OQ/PQ documentation package included with every system.
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