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.
◈ 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
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