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

This pharmaceutical-grade water system, specifically tailored for pharmaceutical enterprises, formulation workshops, and active pharmaceutical ingredient (API) production lines in China, offers a robust solution for high-quality purified water production. Designed by leading suppliers, this system utilizes a proven process flow that includes pretreatment, precision filtration, reverse osmosis (RO), and electrodeionization (EDI). This ensures long-term and stable production of pharmaceutical purified water compliant with stringent industry standards, Our factory employs a modular design with high automation, facilitating online monitoring of essential parameters such as conductivity, temperature, and flow rate. This advanced feature guarantees consistent water quality and enables traceable data, fulfilling the core needs of the pharmaceutical industry for purified water systems—namely, being controllable, monitorable, and verifiable. With a commitment to operational safety and validation requirements, this system is ideal for continuous production environments in China

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

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.

Purified water treatment

Health-grade sterile design

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

Pharmeceutical Water System

Fully automated sterilization

Utilizes pasteurization and pure steam SIP sterilization, along with regular automatic disinfection to eliminate microbial growth.

GMP Validation Package

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 Skid Design

The modular skid design enables rapid installation and requires minimal floor space. With factory prefabrication and pre-commissioning, only pipeline connections are needed on-site, allowing production launch within 30 days and reducing civil construction work by 70%.

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

Industry Water Quality Standards and Industry Regulations

◈EU/FDA/GMP Standards compliant
◈Purified water conductivity ≤ 1.3 μS/cm (at 25°C)
◈TOC ≤ 500 ppb
◈Microbial limit ≤ 100 CFU/ml
◈Online monitoring, risk control, and verification
◈Technical Guidelines for Water System Design and Validation
◈GMP (Good Manufacturing Practice) compliance

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 production rate: 500 L/h to 50 m³/h
Resistivity: ≥1 MΩ·cm (PW/WFI)
TOC: ≤500ppb (PW); ≤100ppb (WFI)
Endotoxin: <0.25 EU/mL (WFI)
Material: 316L stainless steel (sanitary)
Control: PLC automatic + audit tracking

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 standards does the water quality comply with?
Our systems are fully compliant with China Pharmacopoeia, USP, EP, FDA, and EU GMP standards, ensuring global regulatory acceptance.
What materials are used in the construction?
We use 316L stainless steel sanitary-grade materials with electrolytic polishing and automatic welding to ensure a dead-angle <3D design.
How long does it take to install and launch?
Thanks to our modular skid design and factory prefabrication, the system can be production-ready within 30 days of on-site delivery.

Other Products

Modular Containerized

Modular Containerized Seawater Desalination...

Wastewater Reduction

High-Salinity Wastewater Volume Reduction...

OEM Manufacturing

OEM Precision Manufacturing

ODM Innovation

ODM Full Value Chain Innovation

Send Inquiry

Your Name*

E-mail*

Phone Number

Country

Company Name

Remarks*

Related Products