Medical-grade purified water preparation system
Model: Pharma-RO-250PW
Core Process: Pre-treatment + RO + EDI/Mixed Bed + Distribution and Circulation System
Standard: Complies with the Chinese Pharmacopoeia purified water standard, conductivity ≤5.1 μS/cm @25℃, microorganisms <100 CFU/ml
Applications: Pharmaceutical plant ingredient preparation, cleaning, oral drug production, medical device cleaning.
Key Points:
Compliance Design: Strictly adheres to GMP and GAMP5 principles, with complete DQ/IQ/OQ/PQ validation documentation support.
Materials and Surface: The entire system is made of 316L stainless steel, electropolished with an inner surface roughness of Ra≤0.5μm, and includes a 3D weld inspection report.
Sterilization and Disinfection: The purified water storage and distribution system must be equipped with pure steam sterilization or hot water disinfection capabilities.
Online Monitoring and Alarms: Comprehensive online monitoring of conductivity, TOC, ozone (if used), temperature, pressure, and flow rate, with integrated alarm recording.