What information do you need to size a seawater RO or industrial water treatment system?

Send a recent raw water analysis (TDS, conductivity, hardness, silica, iron/manganese, SDI or turbidity, oil and suspended solids where relevant), feed water temperature range, required product water quality and daily capacity, target recovery, available power supply (voltage/frequency), site conditions and whether you prefer a skid or containerized layout. With this data our engineers prepare a process design, mass balance and equipment list.

How fast can a containerized seawater desalination plant start producing water?

Tongjie containerized seawater RO units are fully prefabricated, assembled and tested in our Shanghai factory before shipment. On arrival the unit only needs basic power, intake and product water connections, so commissioning is short and predictable, which suits emergency supply, remote islands, construction camps and decentralized permanent supply.

Can your oil and gas produced water system meet reinjection requirements?

Yes. The system combines oil removal, softening, disc tube reverse osmosis (DTRO) and concentration. Treated reinjection water reaches oil content of 5 mg/L or less and suspended solids of 1 mg/L or less, enabling zero-discharge reuse of fracturing flowback. The skid-mounted container design can be commissioned within about 15 days and supports unmanned operation with remote monitoring for sites such as the Middle East and Kazakhstan.

Do your pharmaceutical purified water systems support validation?

Our pharmaceutical water systems use pretreatment, precision filtration, RO and EDI, and are built to pharmaceutical engineering practice with online monitoring of conductivity, temperature and flow. Data is recorded and traceable, and documentation is prepared to support your validation and qualification activities.

Do you offer ODM/OEM water treatment equipment?

Yes. We supply ODM/OEM membrane systems for distributors, EPC contractors and equipment brands, including customized capacity, materials, control systems, container layouts, labeling and documentation.

Which certifications and qualifications does Tongjie hold?

Tongjie holds CE certification and ISO 9001, ISO 14001 and ISO 45001 management system certifications. The company is a National High-Tech Enterprise and Shanghai Specialized & Sophisticated Enterprise, holds Class II contracting qualifications in environmental protection engineering and in mechanical and electrical installation, and owns more than 38 invention and utility patents plus software copyrights.

CE Certification Pharmaceutical Purified Water & WFI System Suppliers, Supplier

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CE Certification Pharmaceutical Purified Water & WFI System Suppliers, Supplier

This pharmaceutical-grade water system is specifically designed for pharmaceutical enterprises, formulation workshops, and active pharmaceutical ingredient (API) production lines. It employs a proven process flow comprising pretreatment + precision filtration + reverse osmosis (RO) + EDI (electrodeionization), enabling long-term, stable production of high-quality pharmaceutical purified water. The system architecture complies with pharmaceutical engineering standards, with designs that fully account for online monitoring, validation requirements, and operational safety, making it suitable for continuous production conditions.
The entire system adopts a modular design with high automation, enabling online monitoring of critical parameters such as conductivity, temperature, and flow rate. This ensures stable water quality and traceable data, meeting the pharmaceutical industry's core requirements for purified water systems—namely, being "controllable, monitorable, and verifiable."

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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)

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%.

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

Pharmaceutical water systems must strictly comply with the following standards and regulatory requirements:

EU/FDA/GMP Standards
The purified water conductivity is ≤ 1.3 μS/cm (at 25°C)
TOC ≤ 500 ppb
Microbial limit ≤ 100 CFU/ml
GMP (Good Manufacturing Practice): 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

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

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.

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.

Q: What standards and regulations do your pharmaceutical water systems comply with?

Our systems strictly comply with China Pharmacopoeia, USP, EP, FDA, and EU GMP standards, ensuring full compliance for global regulatory audits.

Q: What are the installation requirements and timeline for the modular skid design?

With factory prefabrication and pre-commissioning, on-site installation requires only pipeline connections, enabling full production launch within 30 days and reducing civil work by 70%.

Q: How is zero dead-zone contamination ensured in the system piping?

We use 316L sanitary-grade stainless steel with electrolytic polishing, automatic orbital welding, passivation treatment, and guarantee a dead-angle design of less than 3D.