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CE Certification High-Quality Pharmaceutical Purified Water & WFI System - Top China Suppliers & Factory Solutions Manufacturers, Manufacturer
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)
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.
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.
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.
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%.
Industry Water Quality Standards and Industry Regulations
- EU/FDA/GMP Standards: The purified water conductivity is ≤ 1.3 μS/cm (at 25°C), TOC ≤ 500 ppb, and microbial limit ≤ 100 CFU/ml.
- GMP (Good Manufacturing Practice): The water system must possess capabilities for online monitoring, risk control, and verification.
- Technical Guidelines: Complies with the 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.
- Traditional Chinese Medicine/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: ≤500ppb (PW); ≤100ppb (WFI)
Endotoxin: <0.25 EU/mL (WFI)
Material: 316L stainless steel (sanitary grade)
Control: PLC fully automatic + remote monitoring + audit tracking
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FAQ
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 A)?
The system features standard CIP online cleaning and SIP pure steam sterilization, meeting the highest requirements for sterile pharmaceutical production.
What water quality standards do your pharmaceutical water systems meet?
Our systems are fully compliant with China Pharmacopoeia (ChP), USP, EP, FDA, and EU GMP standards, achieving conductivity ≤1.3 μS/cm, TOC ≤500 ppb, and endotoxin <0.25 EU/mL.
What materials and design criteria are used to prevent contamination?
We utilize sanitary-grade 316L EP (electropolished) stainless steel piping with automatic welding and passivation. The entire system features a zero dead-zone design with dead-angles kept below <3D.
How long does it take to install and launch the system?
With our prefabricated modular skid design and factory pre-commissioning, on-site installation only requires basic pipeline connections. This allows for a production launch within 30 days and reduces civil construction work by 70%.
