Biopharma Pure Water Systems | Endotoxin-Free Water Solutions

Medical Water Purification Overview

Critical Applications in Pharma Industry:

• Pharmaceutical formulations and preparations
• Medical solution compounding and dilution
• Equipment and container rinsing
• Injection and sterile water production
• Biopharmaceuticals production

Stringent Quality Requirements:

• Bacterial and endotoxin control
• Chemical purity compliance
• Consistent water quality
• Validation support documentation

Water Quality Standards Compliance

International Pharmacopoeia Standards:

• Chinese Pharmacopoeia 2005 Edition
• USP 23 Pharmaceutical Water Standards
• CAP Clinical Test Reagent Water Specifications
• AAMI Hemodialysis Water Quality Guidelines

Key Quality Parameters:

• Conductivity: ≤2 μS/cm
• Microbiological: <100 CFU/mL
• Endotoxin: <0.25 EU/mL
• TOC: Meets pharmacopoeia limits

Advanced System Configuration

Two-Stage RO Technology:

• Primary pretreatment filtration
• Double-pass reverse osmosis
• Continuous electrodeionization (optional)
• Ultraviolet sterilization

Core System Components:

• 304 stainless steel multistage pumps
• Automatic multimedia sand filters
• Activated carbon adsorption units
• Water softeners or scale inhibition
• Dual-stage RO high-pressure pumps
• American imported RO membranes

Technical Performance Specifications

Output Water Quality:

• Conductivity: 0.5-2.0 μS/cm range
• Bacterial Control: <100 CFU/mL
• Endotoxin Removal: >99% efficiency
• Particle Filtration: 0.22 micron final

System Operation Parameters:

• Automatic operation and monitoring
• Real-time quality verification
• Sanitization cycle capability
• Data recording and documentation

Key System Features & Advantages

Premium Component Selection:

• Pharmaceutical grade 316L stainless steel
• US-manufactured RO membrane elements
• Sanitary fittings and connections
• Electropolished surface finishes

Intelligent Control Systems:

• One-touch automated operation
• Real-time water quality monitoring
• Automatic flush and sanitize cycles
• Comprehensive alarm and protection

Reliability & Maintenance Features:

• Municipal water direct connection
• Automatic pretreatment backwash
• Membrane protection systems
• Low maintenance design

Pharmaceutical Application Areas

Drug Formulation Uses:

• Pharmaceutical solvent preparation
• Oral and topical medication bases
• External preparation diluents
• Herbal medicine extraction

Sterile Manufacturing Applications:

• Injection formulation solvents
• Sterile powder reconstitution
• Ophthalmic solution preparation
• Medical device cleaning

Production Support Functions:

• Equipment and container rinsing
• Laboratory testing and analysis
• Cleanroom surface cleaning
• Process water applications

Validation & Support Services

Quality Assurance:

• GMP compliance documentation
• Installation and operational qualification
• Performance validation support
• Regular quality testing protocols

Professional Services:

• System design and engineering
• Installation and commissioning
• Operator training programs
• Annual maintenance contracts

Warranty & Support:

• Comprehensive 1-year warranty
• 24/7 technical support availability
• Consumable and spare parts supply
• Emergency service response