ODM Pharmaceutical Purified Water & WFI System - Reliable China Suppliers and Factory Solutions for High-Quality Production Factories, Factory

This pharmaceutical-grade water system is expertly designed for pharmaceutical enterprises, formulation workshops, and active pharmaceutical ingredient (API) production facilities in China. As one of the leading suppliers in the industry, we deliver a reliable solution that incorporates a proven process flow of pretreatment, precision filtration, reverse osmosis (RO), and electrodeionization (EDI). This system guarantees the long-term and stable production of high-quality pharmaceutical purified water, Our factory adheres strictly to pharmaceutical engineering standards, with designs that prioritize online monitoring, validation requirements, and operational safety, making it ideal for continuous production environments. The modular design of the entire system promotes high automation, allowing for real-time monitoring of critical parameters such as conductivity, temperature, and flow rate. This ensures consistent water quality and traceable data, fulfilling the pharmaceutical industry's essential criteria for purified water systems: being controllable, monitorable, and verifiable. Choose our advanced water system to enhance your production capabilities and quality assurance in the pharmaceutical sector

Product Description

💧Our Solution

Shanghai Tongjie Environmental Protection provides a full range of pharmaceutical water systems, covering purified water (PW), water for injection (WFI), and pure steam, fully compliant with China Pharmacopoeia, USP, EP, FDA, and EU GMP standards. The systems employ a two-stage RO + EDI + multi-effect distillation process, featuring a 316L stainless steel sanitary-grade design, electrolytic polishing, automatic welding, and dead-angle <3D. They are equipped with pasteurization/SIP pure steam sterilization, CIP online cleaning, and online monitoring of TOC, conductivity, and microbiology. With over 10 years of experience in the pharmaceutical industry, the company delivers comprehensive validation documentation packages (DQ/IQ/OQ/PQ) to assist pharmaceutical enterprises in passing certification audits on the first attempt.

🚀Core Advantage (Digitalization)

pure water system
Purified water treatment
Pharmeceutical Water System

✔Pharmacopoeial-grade water quality

Conductivity ≤1.3 μS/cm, TOC ≤500 ppb, and endotoxin <0.25 EU/mL; Water for Injection fully complies with WFI standards.

✔Health-grade sterile design

316L EP piping, automatic welding + passivation, dual-sealed sterile storage tank, and fully circulating system with no dead zones.

✔Fully automated intelligent control

Utilizes pasteurization and pure steam SIP sterilization, along with regular automatic disinfection to eliminate microbial growth via unmanned PLC + HMI control.

• GMP Validation: A complete GMP validation package ensures hassle-free audits, providing 3D drawings, material certifications, welding records, and the full set of validation documents including DQ/IQ/OQ/PQ.

• Modular Design: The modular skid design enables rapid installation and requires minimal floor space. Factory pre-commissioning allows production launch within 30 days and reduces civil construction work by 70%.

An ideal solution for meeting short-term or long-term decentralized water supply demands

📋Industry Water Quality Standards

Conductivity ≤ 1.3 μS/cm (at 25°C)
TOC ≤ 500 ppb
Microbial Limit ≤ 100 CFU/ml
Compliance EU/FDA/GMP Standards

GMP (Good Manufacturing Practice): The water system must possess capabilities for online monitoring, risk control, and verification according to Technical Guidelines for the Design and Validation of Water Systems.

🏢Application Scenarios

◈ Water for Injection (WFI): Injections, biologics, vaccines, and blood products.

◈ Purified Water (PW): Tablets, capsules, oral solutions, medical device cleaning.

◈ Pure Steam System: Sterilizer cabinet, pipeline sterilization, process gas.

◈ Biopharmaceuticals: Fermentation, Extraction, Concentration, and Chromatography.

⚙️Core Technical Parameters

Water Type PW / WFI
Production Rate 500 L/h to 50 m³/h
Resistivity ≥1 MΩ·cm
Endotoxin <0.25 EU/mL (WFI)
Material 316L Stainless Steel
Control PLC + Remote Monitoring

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❓Frequently Asked Questions

Does the system support continuous year-round production?
Yes. It operates fully automatically 24/7 with redundant design, featuring automated sterilization/cleaning processes to ensure uninterrupted operation throughout the year.
Can you provide the complete GMP validation documentation?
Yes. We offer a comprehensive DQ/IQ/OQ/PQ validation package, including 3D models, material certificates, welding records, cleaning validation, and sterilization validation.
Does the system support CIP/SIP?
The system features standard CIP online cleaning and SIP pure steam sterilization, meeting the highest requirements for sterile pharmaceutical production.
What materials are used for the piping and tanks?
We use 316L sanitary-grade stainless steel with electrolytic polishing and automatic welding to ensure zero dead zones and compliance with pharmacopoeia standards.
How long does it take to launch production on-site?
Thanks to our modular skid design and factory pre-commissioning, on-site installation only requires pipeline connections, allowing for a production launch within 30 days.
What are the typical water quality parameters achieved?
Our systems consistently achieve conductivity ≤1.3 μS/cm, TOC ≤500 ppb, and endotoxin <0.25 EU/mL, fully meeting PW and WFI requirements.

✉️Send Inquiry

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