Pharmaceutical Pure Water System

The pharmaceutical pure water system is mainly used for infusion solutions, injection water treatment, oral solution water treatment, medicine bacteria free water and artificial kidney dialysis water treatment, etc.

Features
1. The conductivity value can be maintained at a steady state.
2. High efficiency of water utilization, which can reach 70%.
3. Each unit with a sample point ensures convenient inspection.
4. The water purifier can be set into self circulate situation within a low flux, which will have a shorter response time when restarting.
5. Save energy.
6. High manufacturing quality, all joints using automatic orbital welding and conforming to the 3D standards.
7. The low pressure switch can protect high pressure pump from being damaged by lack of water.
8. Concentrated water control valve can adjust outlet water capacity and system recovery rate at any time.
9. Rapid washing valve can regularly clean the membrane surface, reducing pollution on membrane and extending the service life of membrane.

Validation

Validation documents are provided with our pharmaceutical water system, like FAT, DQ, IQ, OQ, etc.

Specifications
0.5m³/h-50m³/h

Technical Parameters
• TOC<100ppb
• Conductivity<0.5μs/cm
• Microorganisms<100CFU/ml
• Endotoxin<0.25EU/ml
• Nitrate<0.06ppm
• Heavy Metal<0.1ppm

Certifications, Guidelines and Standards
1. Standards
The pharmaceutical purified water system is designed to prepare purified water in accordance with the existing Chinese Pharmacopoeia (2010 version), FDA and United States Pharmacopoeia (USP-36). Drinking water is taken as inlet raw water, after pretreatment, purification, and then becomes product purified water to meet requirements of URS.

2. Design Reference Standard
The system design, installation and documentation will comply with the GMP regulations and guidelines settled for a pharmaceutical preparation system.