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.
Conductivity ≤1.3 μS/cm, TOC ≤500 ppb, and endotoxin <0.25 EU/mL; Water for Injection fully complies with WFI standards.
316L EP piping, automatic welding + passivation, dual-sealed sterile storage tank, and fully circulating system with no dead zones.
Utilizes pasteurization and pure steam SIP sterilization, along with regular automatic disinfection to eliminate microbial growth via unmanned PLC + HMI control.
• GMP Validation: 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 Design: The 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%.
GMP (Good Manufacturing Practice): The water system must possess capabilities for online monitoring, risk control, and verification according to Technical Guidelines for the Design and Validation of Water Systems.
◈ Water for Injection (WFI): Injections, biologics, vaccines, and blood products.
◈ Purified Water (PW): Tablets, capsules, oral solutions, medical device cleaning.
◈ Pure Steam System: Sterilizer cabinet, pipeline sterilization, process gas.
◈ Biopharmaceuticals: Fermentation, Extraction, Concentration, and Chromatography.