Pharmaceutical Water Purification Systems - 2025 GMP Compliance Guide

Why Purified Water is Critical for Medical Device Manufacturing

✔ Meets 2020 Chinese Pharmacopoeia standards - Ensures regulatory compliance

✔ Eliminates 99.9% contaminants - Removes particles, organics, microbes, and heavy metals

✔ Prevents product contamination - Maintains medical device safety and efficacy

✔ Reduces manufacturing risks - Ensures consistent water quality for production

Industry Fact: Over 75% of medical device manufacturing failures relate to water quality issues

3-Stage Purified Water Production Process

1. Pretreatment System

 • Multi-media filtration: Removes particles >10μm through quartz sand beds

 • Activated carbon adsorption: Eliminates organics, chlorine, and odors

 • Water softening: Ion exchange resins reduce hardness to prevent scaling

2. Dual-Stage RO Purification

 • Primary RO: Removes 97-99% dissolved salts and contaminants

 • Secondary RO: Polishes water to achieve higher purity levels

 • Membrane specifications: Dow Filmtec/LCLE-4040 elements

3. Post-Treatment System

 • pH adjustment: Automated dosing to maintain 6.5-8.5 range

 • UV sterilization: 254nm wavelength eliminates microorganisms

 • Microfiltration: 0.22μm final filtration for bacterial control

2020 Chinese Pharmacopoeia Quality Standards

4 System Advantages

✔ GMP-compliant design - 316L stainless steel construction with sanitary fittings

✔ Automated operation - PLC control with 21 CFR Part 11 compliance

✔ Energy recovery system - 30% lower operating costs than conventional systems

✔ Remote monitoring - Real-time water quality tracking and alerts

Case Study: Major medical device manufacturer reduced product rejection rate by 65% after installation

Technical Specifications

Medical Device Applications

1. Cleaning and Disinfection

 • Surgical instrument washing - Prevents staining and residue

 • Equipment sterilization - Ensures complete microbial elimination

 • Cleanroom surfaces - Maintains sterile manufacturing environments

2. Injection and Filling

 • Drug carrier water - No pyrogens or endotoxins

 • Solution preparation - Consistent ionic purity

 • Implantable devices - Meets ISO 13485 requirements

3. Laboratory Applications

 • Reagent preparation - No interference with reactions

 • Equipment calibration - Consistent water quality

 • Testing procedures - Meets USP <643> and <645> standards

4. Steam Generation

 • Autoclave feedwater - Prevents scaling and corrosion

 • Humidification systems - Pure steam production

 • Sterilization cycles - Maintains equipment longevity

Maintenance Protocol

✅ Daily: Conductivity and TOC verification

✅ Weekly: Sanitization and membrane performance check

✅ Monthly: Complete system calibration and validation

✅ Quarterly: Membrane cleaning and component replacement

✅ Annually: Full system revalidation and certification

Pro Tip: Maintain sanitization temperature >80°C for at least 4 hours to control microbial growth

System Validation Requirements

 • Installation Qualification (IQ) - Verify proper installation and documentation

 • Operational Qualification (OQ) - Verify system performance under operational conditions

 • Performance Qualification (PQ) - Verify consistent production of purified water

 • Ongoing Monitoring - Continuous quality verification and documentation

Why Choose Our Purified Water Systems?

✔ 15 years medical industry experience

✔ NMPA/FDA compliance guaranteed

✔ 24/7 technical support with validation specialists