GMP Skid Mounted Purified Water System Unit RO EDI

• Customization: Available
• Application: Biotechnology Industry, Food & Beverage Factory, Food Safety, Forensic Science, Pharmaceutical Industry
• Capacity: 5000 L/hr
• Model NO.: 2000L/H
• Certification: CE, FDA, GMP, ISO
• Control System: Fully Automatic
• Treatment Process: Electrodeionization, Filtration, Reverse Osmosis, Softening
• Warranty of core components: One Year
• Welding Method: Sanitary Welding / Orbital Welding (Optional)
• Sealing Material: FDA Approved EPDM / PTFE
• Distribution Loop: 316L Ss Piping
• Human-Machine Interface: Touch Screen HMI
• Toc: Complies with USP / Ep Requirements
• Water Temperature: 5 - 30 ℃
• Product Contact Material: Stainless Steel 316L
• Non-Contact Parts: Stainless Steel 304
• Purified Water Tank: 316L Stainless Steel
• Transport Package: Wooden
• Specification: other
• Trademark: WEMAC
• Origin: China
• HS Code: 8419409090
• Production Capacity: One Piece / Month
• Package Size: 400.00cm * 250.00cm * 150.00cm
• Package Gross Weight: 1500.000kg

Product Description

Product Description

Skid Mounted PW System with RO and EDI for  GMP Standard Water Treatment Equipment

GMP-compliant Pharmaceutical Purified Water Generation System, 5000 L/H, for pharmaceutical, biotech, and medical production.

1. Executive Overview
The Double-Pass RO + EDI Purified Water System is designed for ultra-pure water generation utilizing a state-of-the-art Pretreatment + Double-Pass Reverse Osmosis (RO) + Electro-deionization (EDI) process. Operating on municipal or municipal-grade water feed, the system continuously delivers high-purity water compliant with the latest ChP, USP, and EP purified water standards.

Engineered with a hygienic sanitary framework, the system actively suppresses microbial growth throughout the purification lifecycle. Featuring fully automated PLC control, continuous inline water quality monitoring, and periodic sanitization sequences, this platform is widely deployed across pharmaceutical manufacturing, medical devices, IVD reagents, biopharmaceuticals, and high-end cosmetics.

Turnkey Delivery: Factory skid-mounted design for rapid plug-and-play field installation.
GMP Validation Package: Complete DQ / IQ / OQ qualification documents supplied to guarantee audit compliance.

2. Compliance & Water Quality Standards

3. Process Flowchart

Pharmacopeia Alignment: Fully compliant with ChP (2025 Edition), USP, and EP standards for Purified Water (PW). 
Conductivity: ≤5.0 μS/cm @ 25°C (Stable operation routinely achieves ≤1.3 μS/cm). 
Microbial Limit: ≤10 CFU / 100 mL. 
Total Organic Carbon (TOC): ≤0.5 mg/L. 
Chemical Profile: Fully compliant with heavy metal, nitrate, pH, and physicochemical standards. 
Environmental Safety: Pyrogen-free process with zero acid/alkali chemical regeneration required.
Total Organic Carbon (TOC): $\le 0.5\text{ mg/L}$.
Chemical Profile: Fully compliant with heavy metal, nitrate, pH, and physicochemical standards.
Environmental Safety: Pyrogen-free process with zero acid/alkali chemical regeneration required.

Raw Water Tank → Feed Pump → Multi-Media Filter → Activated Carbon Filter → Auto Softener → 5μm Security Filter → 1st Stage HP Pump → 1st Stage RO → pH Adjustment → Intermediate Tank → 2nd Stage HP Pump → 2nd Stage RO → EDI Module → PW Storage Tank → PW Recirculation Pump → UV Sterilizer → 0.22μm Terminal Bacteria Filter → Points of Use (POU)
Optional Upgrades: Pasteurization Thermal Sanitization, Ozone Disinfection System, Online TOC Analyzer, Membrane Degasser.

4. Key Engineering Advantages

I. Sanitary-Grade Materials & Anti-Contamination Construction
316L Stainless Steel Construction: All fluid-wetted components constructed from 316L SS with internal electro-polishing down to Ra ≤ 0.8μm (Optional high-spec polish Ra ≤ 0.4μm).
Zero-Dead-Leg Architecture: Sanitary diaphragm valves, tri-clamp connections, and continuous loop flow velocity maintained at ≥ 1.0 m/s to prevent biofilm formation.
Tank Protection: PW storage tank integrated with a 0.22μm hydrophobic vent filter and 360° spray ball for full internal coverage.
II. Double-Pass RO + EDI Membrane Technology
Dual-Barrier Reliability: Double-pass RO combined with continuous electrodeionization guarantees ultra-stable output despite incoming feed water fluctuations.
Eco-Friendly Efficiency: Chemical-free continuous deionization eliminates hazardous waste handling. System recovery rates reach 65%–75%.
III. Smart PLC Control & Data Integrity (21 CFR Part 11 Compliant Design)
7-Inch Touchscreen Interface: Real-time visual dynamic flowcharts and operational metrics.
Fully Automated Operations: Auto-start/stop, auto-membrane flushing, high/low level interlocking control.
Automated Alarm & Divert: Continuous monitoring of conductivity, pressure, and flow rates with automatic off-spec water discharge and alarm notification.
Audit Trail Ready: Local data logging with PDF report export features supporting cGMP data integrity requirements. Remote telemetry and mobile alerts available.

Item	Specification
Conductivity	≤ 0.1 μS/cm @ 25℃
Resistivity (Optional)	≥ 10 MΩ·cm
TOC	Complies with USP / EP Requirements
Microbial Control	Meets Pharmaceutical Standards
Water Temperature	5 – 30 ℃
Product Contact Material	Stainless Steel 316L
Non-contact Parts	Stainless Steel 304
Surface Roughness	Ra ≤ 0.4 μm
Welding Method	Sanitary Welding / Orbital Welding (Optional)
Sealing Material	FDA Approved EPDM / PTFE
Purified Water Tank	316L Stainless Steel
Tank Volume	Customized (Standard 3000L Optional)
Circulation Pump	Sanitary Grade Pump
Distribution Loop	316L SS Piping
Dead Leg Control	Fully GMP Compliant Design
Control System	Siemens PLC
Human-Machine Interface	Touch Screen HMI
Operation Mode	Automatic / Manual
Data Logging	Available
Alarm & Protection	Automatic Alarm System
Compliance	GAMP 5 (Optional)
Power Supply	380V / 50Hz / 3 Phase (Customizable)
Installed Power	Approx. Customized
Compressed Air	Optional
Feed Water Source	Municipal / Well Water
Feed Water Pressure	≥ 0.2 MPa

IV. Multi-Mode Sanitization Protocols
Comprehensive Bio-burden Control: Integrated support for periodic Pasteurization Hot Water Sanitization, UV Irradiation, and CIP Chemical Disinfection.

Pre-Set SOPs: Factory-programmed sanitization cycles supplied with standard operating procedures (SOPs) and execution protocols.

V. Skid-Mounted Modular Engineering
Pre-assembled, pre-piped, pressure-tested, and factory-tested prior to shipment. Minimizes on-site welding and shortens qualification timelines.

After Sales Service

Scope of Supply & Services

Core Hardware Scope
• Fully integrated PW Generation Skid
• PW Storage & Loop Circulation Distribution System
• Sanitary Instrumentation, Valves, and Piping
• Complete O&M Manuals and Factory Test Reports (FAT)
Validation & Support Services
• Custom URS Engineering & CAD Layout Drawings
• Complete DQ / IQ / OQ Validation Protocol Package
• On-site Installation, Commissioning, and Operator Training
• Lifetime Technical Support & Consumables Supply
Pre-assembled, pre-piped, pressure-tested, and factory-tested prior to shipment. Minimizes on-site welding and shortens qualification timelines.

Company Profile

WEMAC, once Weifang Medical Instrument Factory (est. 1958), is in Weifang, the kite capital. We boast pharmaceutical water and pressure vessel design experts, top-tier processing, quality inspection equipment, and strong after-sales service.

WEMAC follows "Cherishing Life, Noble Responsibilities," aiming for "Professional solutions, high-quality manufacturing, timely and perfect after-sales service." Products reach over 2,000 enterprises including Guangzhou Green Cross, Shenzhen New Industry, and more. Exported to the U.S., Russia, India, and 40+ countries.

Packaging & Shipping

FAQ

1. How many years of experience do you have?

We have over 60 years of experience in pharmaceutical water production equipment

2. Where is your factory located?

Our factory is located in Weifang, Shandong Province, China

3.What can you buy from us?
Purified water system/ Purified Water Generation Plant/ Multi Effect Water Distiller/ Multi Column Distillation Plant/ Pure Steam Generator/ Looping System/ Liquid Solution Preparation System/ Purified water storage tank/ Shell and tube heat exchanger/ WFI storage tank/CIP system

4. How do we confirm the details of the product?

We provide design drawings prior to production. Post-confirmation, we proceed as per the drawings.

5.How will the company handle problems that occur after the product is delivered?

We offer long-term after-sales service and a one-year warranty on key components. We follow up on system usage via regular check-ins and on-site inspections, helping establish a systematic maintenance management system.

6.What water treatment solutions can your company provide?

We provide comprehensive water solutions from pretreatment to terminal use for industries like pharmaceuticals, healthcare, food, electronics, and cosmetics, including multi-effect distilled water machines and seawater desalination systems.

7.Does your company offer installation services?

Yes, we can provide you with installation services