Wholesale China Pharmaceutical Purified Water & WFI System Suppliers - High-Quality Factory Solutions for APIs Factories, Manufacturers

Introducing our pharmaceutical-grade water system, specially engineered for pharmaceutical manufacturers, formulation labs, and active pharmaceutical ingredient (API) production lines in China. This state-of-the-art system utilizes a reliable process flow consisting of pretreatment, precision filtration, reverse osmosis (RO), and electrodeionization (EDI), ensuring the long-term, stable production of high-quality purified water for pharmaceutical applications. Our system architecture adheres to stringent pharmaceutical engineering standards, incorporating designs that prioritize online monitoring, validation needs, and operational safety, making it ideal for continuous production environments.
Designed with a modular approach, our system features high automation capabilities, allowing for real-time monitoring of essential parameters such as conductivity, temperature, and flow rate. This ensures consistent water quality and provides traceable data, fulfilling the pharmaceutical industry's essential requirements for water purification systems—being controllable, monitorable, and verifiable. As a leading factory and supplier in China, we are dedicated to delivering superior pharmaceutical water systems that meet your production needs.

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 with consistently compliant purified water characteristics

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 with zero dead-zone contamination

2.316L EP piping, automatic welding + passivation, dual-sealed sterile storage tank, and fully circulating system with no dead zones.

Pharmeceutical Water System

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.

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.

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

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Industry Water Quality Standards and Industry Regulations

EU / FDA / GMP Standards

  • Purified water conductivity: ≤ 1.3 μS/cm (at 25°C)
  • TOC: ≤ 500 ppb
  • Microbial limit: ≤ 100 CFU/ml

GMP (Good Manufacturing Practice)

  • Continuous online monitoring capabilities
  • Strict risk control and process verification
  • Technical Guidelines for the Design and Validation of Water Systems in Pharmaceutical Production

Application Scenarios

◈ Water for Injection (WFI): Used for preparing injections, biologics, vaccines, and blood products
◈ Purified Water (PW): Tablets, capsules, oral solutions, medical device cleaning, laboratory water
◈ Pure Steam System: Sterilizer cabinet, pipeline sterilization, process gas
◈ TCM & Biopharmaceuticals: Water for Fermentation, Extraction, Concentration, and Chromatography

Core Technical Parameters

  • ◈ Water type: Purified Water / Water for Injection (WFI)
  • ◈ Water production rate: 500 L/h to 50 m³/h (customizable)
  • ◈ Resistivity: ≥1 MΩ·cm (Purified Water); ≥1 MΩ·cm (WFI)
  • ◈ TOC: ≤500 ppb (PW); ≤100 ppb (WFI)
  • ◈ Endotoxin: <0.25 EU/mL (WFI)
  • ◈ Material: 316L stainless steel (sanitary grade, dead-angle <3D)
  • ◈ Control: PLC fully automatic + remote monitoring + audit tracking
  • ◈ Sanitization: Pasteurization / SIP Pure Steam / CIP Online Cleaning

Frequently Asked Questions (FAQ)

Q 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.

Q 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 to assist in passing certification audits on the first attempt.

Q 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 with regular automatic disinfection to eliminate microbial growth.

Q What regulatory standards and pharmacopoeias do the systems comply with?

Our water systems are fully compliant with China Pharmacopoeia, USP, EP, FDA, and EU GMP standards, ensuring purified water conductivity ≤1.3 μS/cm (at 25°C), TOC ≤500 ppb, and endotoxin <0.25 EU/mL.

Q How fast can the modular skid-mounted water system be installed?

Thanks to factory prefabrication and pre-commissioning, only pipeline connections are required on-site. This enables rapid production launch within 30 days and reduces civil construction work by 70%.

Q What are the available water capacities and sanitary specifications?

We offer customized water production capacities from 500 L/h to 50 m³/h. All contact piping uses sanitary-grade 316L stainless steel with electrolytic polishing, automatic orbital welding, and dead-angle <3D design.

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