OEM China Pharmaceutical Purified Water & WFI System - High-Quality Suppliers and Factory Solutions Factories, Manufacturers
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
2.316L 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.
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%.
Industry Water Quality Standards and Industry Regulations
The purified water conductivity is ≤ 1.3 μS/cm (at 25°C).
TOC ≤ 500 ppb.
Microbial limit ≤ 100 CFU/ml.
The water system must possess capabilities for online monitoring, risk control, and verification.
Technical Guidelines for the Design and Validation of Water Systems in Pharmaceutical Production.
Application Scenarios
Used for preparing injections, biologics, vaccines, and blood products.
Tablets, capsules, oral solutions, medical device cleaning, laboratory water.
Sterilizer cabinet, pipeline sterilization, process gas.
Water for Fermentation, Extraction, Concentration, and Chromatography.
Core Technical Parameters
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