How to Achieve 0.25EU/ml Endotoxin Water
Pharmaceutical-Grade Water Purification Systems - 2025 Guide
Medical Water Quality Standards
✔ Conductivity: ≤2μS/cm (≥0.5MΩ·cm)
✔ Microbial Limit: <10 CFU/100ml
✔ Endotoxin: <0.25 EU/ml
✔ Compliance: Meets USP, EP, and ChP requirements
Critical Fact: 78% of FDA 483 citations relate to water quality issues in pharma facilities
System Design Features
1. Dual RO Configuration
• 1st Stage: 304 stainless steel
• 2nd Stage: 316L stainless steel
• Recovery Rates:
1st RO: 60-65%
2nd RO: 70%
2. Advanced Monitoring
• Real-time conductivity tracking
• Automated pH adjustment
• Pressure protection switches
3. Sanitization Systems
• UV sterilization
• 0.2μm final filtration
• Clean-in-Place (CIP) capability
Technical Specifications
| Parameter | Specification |
|---|---|
| Capacity | 0.25-50 m³/h |
| Materials | 316L/304 SS |
| Controls | PLC + SCADA |
5 Key Advantages
✔ Dual safety - Low/high pressure protection
✔ Pharma-grade - All wetted surfaces 316L
✔ Paperless - Full data logging
✔ Low maintenance - Auto sanitization
✔ Compact - 30% smaller footprint
Case Study: Reduced water-related deviations by 92% at vaccine facility
System Components
1. Pretreatment
• Multimedia filtration
• Activated carbon
• Softening
2. Primary Treatment
• 1st RO with antiscalant
• Intermediate storage
3. Polishing
• 2nd RO with pH adjustment
• UV sterilization
• Final filtration
Maintenance Protocol
✅ Daily: Conductivity checks
✅ Weekly: Microbial testing
✅ Monthly: Membrane cleaning
✅ Quarterly: Full sanitization
✅ Annually: Revalidation
Pro Tip: Maintain >1.5m/s pipe velocity to prevent biofilm
Free Resources:
📥 Get: "FDA Water Compliance Guide"
📞 Get: "Free Validation Template"
