Wholesale China Pharmaceutical Purified Water & WFI System Factory | Reliable Suppliers for High-Quality Water Solutions Factory, Manufacturer

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Our pharmaceutical-grade water system is expertly engineered for pharmaceutical enterprises, formulation workshops, and active pharmaceutical ingredient (API) production lines in China. This state-of-the-art system utilizes a reliable process flow that includes pretreatment, precision filtration, reverse osmosis (RO), and electrodeionization (EDI). This ensures the long-term, stable production of high-quality pharmaceutical purified water. Designed to meet stringent pharmaceutical engineering standards, the architecture of our system incorporates necessary features for online monitoring, validation compliance, and operational safety, making it ideal for continuous production environments.
, The modular design of our system allows for high levels of automation, facilitating real-time monitoring of critical parameters such as conductivity, temperature, and flow rate. This guarantees consistent water quality and traceable data, aligning with the pharmaceutical industry's essential needs for purified water systems—being controllable, monitorable, and verifiable. As reputable suppliers in China, our factory is committed to providing solutions that enhance efficiency and reliability for pharmaceutical manufacturing.

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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.

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Complete GMP Validation: 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. 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

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📜 Industry Water Quality Standards

EU/FDA/GMP Standards
Conductivity ≤ 1.3 μS/cm (at 25°C).
TOC ≤ 500 ppb.
Microbial limit ≤ 100 CFU/ml.
GMP Compliance
Online monitoring, risk control, and verification capabilities are mandatory for modern pharmaceutical 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: Sterilizer cabinet, pipeline sterilization, process gas.
◈ TCM/Biopharmaceuticals: Fermentation, Extraction, Concentration, and Chromatography.

⚙️ Core Technical Parameters

◈ Water production rate: 500 L/h to 50 m³/h (customizable)

◈ Resistivity: ≥1 MΩ·cm (PW & WFI)

◈ TOC: ≤500ppb (PW); ≤100ppb (WFI)

◈ Endotoxin: <0.25 EU/mL (WFI)

◈ Material: 316L stainless steel (sanitary grade)

◈ Control: PLC fully automatic + remote monitoring + audit tracking

❓ FAQ

Q: Does the system support continuous year-round production?
A: Yes. It operates fully automatically 24/7 with redundant design, featuring automated sterilization/cleaning processes to ensure uninterrupted operation.
Q: Can you provide the complete GMP validation documentation?
A: Yes. We offer a comprehensive DQ/IQ/OQ/PQ validation package, including 3D models, material certificates, and welding records.
Q: Does the system support CIP/SIP?
A: The system features standard CIP online cleaning and SIP pure steam sterilization, meeting sterile production requirements.
Q: What materials are used for the piping and tanks?
A: All water contact parts are made of 316L sanitary-grade stainless steel with electrolytic polishing and automatic welding.
Q: What is the typical water production range?
A: Our systems range from 500 L/h to 50 m³/h and can be fully customized based on client requirements.
Q: Which international standards do your systems comply with?
A: Our systems are fully compliant with China Pharmacopoeia, USP (US), EP (Europe), FDA, and EU GMP standards.

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