Pharma Grade Water Systems
High Purity Water (HPW) & WFI Generation
USP/EP Compliant Systems with <1.3 µS/cm Conductivity and Thermal Sanitization.
Validatable Multi-Stage Process
Our 'Ionic' multistage approach ensures sterility and chemical purity through redundancy.
01
Pre-treatment & Softening
- Removal of hardness ions (Ca²⁺, Mg²⁺) to prevent scale.
- Activated Carbon / Ultrafiltration for chlorine and organics removal.
02
Double Pass Reverse Osmosis (DPRO)
- Pass 1: Removes >99% of dissolved salts, bacteria, and pyrogens.
- Pass 2: Polishing barrier reducing conductivity further.
- High recovery rates (75-85%) with low-energy membranes.
03
Continuous Electro-Deionization (CEDI)
- Electric regeneration of resin beds – Zero Acid/Caustic chemicals.
- Target Output: Resistivity 10–18 MΩ·cm.
04
Ultrafiltration (UF) Polishing
- Final endotoxin barrier for WFI limits (< 0.25 EU/ml).
- 6,000 Daltons MWCO ensuring complete pyrogen rejection.
Key Performance Specifications
Meeting USP/EP/JP standards for critical applications.
| Parameter | Purified Water (PW) | Water For Injection (WFI) | Ultrapure Water (UPW) |
|---|---|---|---|
| Conductivity (at 25°C) | < 1.3 µS/cm | < 1.3 µS/cm | < 0.055 µS/cm |
| Resistivity | > 0.7 MΩ·cm | > 0.7 MΩ·cm | 18.2 MΩ·cm |
| Total Organic Carbon (TOC) | < 500 ppb | < 500 ppb | < 5 ppb |
| Bacteria Count | < 100 CFU/ml | < 10 CFU/100ml | < 1 CFU/100ml |
| Endotoxins | < 0.25 EU/ml | < 0.25 EU/ml | < 0.03 EU/ml |
| Silica | – | – | < 0.5 ppb |
Advanced Engineering & Compliance
Designed for reliability, compliance, and ease of validation.
Hot Water Sanitization (HWS)
Thermal sanitization at 80°C - 85°C eliminates chemical use (Ozone/H₂O₂) and reduces validation risks.
Dead-Leg Free Design
Orbital welded SS316L piping following the '3D Rule' (<3x Pipe Diameter) to prevent biofilm stagnation.
21 CFR Part 11 Compliance
Secure PLC/SCADA control systems with uneditable audit trails for all critical process parameters.
Validation Ready
Full IQ/OQ documentation packages provided for fast-track FDA/MHRA audits.
Applications & Standards
Serving the most regulated industries.
Pharmaceutical
USP <643>, <645>
Bulk formulations, CIP, and final rinsing.
Biotechnology
EP / WFI
Buffer preparation, cell culture media, chromatography.
Medical Devices
ISO 23500
Hemodialysis and instrument sterilization.
Semiconductor
ASTM D5127
Wafer rinsing requiring ppt level purity.
FAQs: High Purity & WFI Systems
Expert answers regarding regulatory compliance and system design.
Get in touch with our experts
Have a custom requirement? Book a free consultation with our engineering team or drop us a message.
Contact Information
Call Us
020-27475272/73
+91 82754 86263
Mon-Sat, 9:30 AM to 6:30 PM
Visit HQ
S. No. 1, 5, 11-13, B Wing,
Mahalaxmi Heights, Mumbai-Pune Rd,
Pimpri, Pune-18, MH, INDIA.
