China China Pharmaceutical Purified Water & WFI System Suppliers | High-Quality Factory Solutions for the Pharmaceutical Industry Factories, Factory

This pharmaceutical-grade water system, designed specifically for pharmaceutical enterprises, formulation workshops, and active pharmaceutical ingredient (API) production lines, is an ideal solution for China-based suppliers and factories. Utilizing a proven processing flow of pretreatment, precision filtration, reverse osmosis (RO), and electrodeionization (EDI), it ensures the consistent and stable production of high-quality pharmaceutical purified water, Our system architecture meets rigorous pharmaceutical engineering standards and incorporates designs that prioritize online monitoring, validation compliance, and operational safety—making it perfect for continuous production environments. Featuring a modular design and high automation, the system allows for real-time monitoring of critical parameters such as conductivity, temperature, and flow rate. This guarantees stable water quality and traceable data, aligning with the pharmaceutical industry's essential requirements for purified water systems to be controllable, monitorable, and verifiable. Support your production with our advanced water purification solutions, tailored for China's 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
Pharmacopoeial-grade water quality
Purified water treatment
Health-grade sterile design
Pharmeceutical Water System
Fully automated sterilization
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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.

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Health-grade sterile design with zero dead-zone contamination:

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

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Fully automated with sterilization capabilities:

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

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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.

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Modular skid design:

Enables rapid installation and requires minimal floor space. With factory prefabrication and pre-commissioning, 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 Regulations

◈ EU/FDA/GMP Standards compliant
◈ Conductivity ≤ 1.3 μS/cm (at 25°C)
◈ TOC ≤ 500 ppb | Microbial ≤ 100 CFU/ml
◈ Online monitoring, risk control, and verification

Application Scenarios

◈ Water for Injection (WFI): Injections, biologics, vaccines
◈ Purified Water (PW): Tablets, capsules, medical devices
◈ Pure steam system: Sterilizer cabinets, process gas
◈ Biopharmaceuticals: Fermentation, Extraction, Chromatography

Core Technical Parameters

▶ Water type: Purified Water / WFI
▶ Production: 500 L/h to 50 m³/h
▶ Resistivity: ≥1 MΩ·cm
▶ Endotoxin: <0.25 EU/mL (WFI)
▶ Material: 316L Stainless Steel
▶ Control: PLC automatic + Audit tracking

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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 and cleaning processes to ensure uninterrupted operation.
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 in the construction of the water system?
We use 316L sanitary-grade stainless steel for all contact parts, featuring electrolytic polishing and automatic welding with dead-angle <3D design.
How quickly can the system be installed and operational?
Thanks to our modular skid design and factory pre-commissioning, the system can typically be launched within 30 days of arriving on-site.
Which international standards do your systems comply with?
Our systems are fully compliant with China Pharmacopoeia, USP (US), EP (Europe), FDA, and EU GMP standards.

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