Reliable High-Purity Water for the Pharmaceutical Industry
In pharmaceutical and personal care manufacturing, water quality isn’t optional—it’s essential. Whether used as Purified Water (PW) or Water for Injection (WFI), high-purity water is a key input in processes that impact patient safety, regulatory compliance, and product integrity.
Applications range from drug manufacturing and medical device production to cosmetics, personal care products, and vision care. Each use case requires water that meets exacting standards—consistently and reliably.
Producing pharmaceutical-grade water that meets global standards set by the United States Pharmacopeia (USP) and similar bodies worldwide requires a highly controlled process. Parameters like conductivity, total organic carbon (TOC), microbial content, and endotoxin levels must be closely managed.
Achieving this level of performance often involves a multi-step treatment process, including reverse osmosis, UV disinfection, and deionization. Ensuring consistent ion-level purity—while minimizing bacterial growth—remains an important consideration in system design and operation.
CEDI: Delivering High-Purity Water Safely and Sustainably
Continuous Electrodeionization (CEDI) is an electrochemical process and a proven solution for producing ultrapure water without chemicals. With hot water sanitization, Xylem’s Ionpure® technology creates a bacteriostatic environment using ion exchange resins, ion exchange membranes, and direct current to continuously remove dissolved ions from water. The result is high-purity water with microbial control achieved through the electric field without the addition of chemicals for regeneration, waste treatment, or process interruptions.
Xylem’s Ionpure LX-HI CEDI modules are engineered specifically for pharmaceutical applications that require hot water sanitization. It consistently provides high-purity water with conductivity levels below 0.1 μS/cm, well within the USP requirements of between 1.0 to 2.0 µS/cm*, and supports continuous operation with minimal maintenance.
Minimizing Microbial Risk in Water Systems
Microbial control is a top priority in pharmaceutical water systems. While chemical sanitization is common, hot water sanitization has been proven to be more effective at controlling microbial growth.
Xylem’s Ionpure LX-HI CEDI modules are uniquely engineered to handle instant sanitization at 85°C, without requiring a temperature ramp-up. They return quickly to standard operation, minimizing downtime.
The modules can tolerate up to 60°C (140°F) and 2 bar (30 psi) feed pressure during hot water sanitization and has been field-proven to withstand over 150 sanitization cycles, making it one of the most durable options available.
Built for Compliance and Integration
Modern pharmaceutical operations demand both high performance and system-wide integration. Xylem’s G4 power controllers, designed for Ionpure modules, easily integrate with most existing plant control systems through common digital communications protocols, enabling real-time monitoring of the modules and system optimization.
Ionpure modules are manufactured in ISO 9001 and ISO 14000 certified facilities and comply with all applicable regulatory requirements for the ISO certification. They are also Halal certified.
Proven in the Field
Many of the top 10 global pharmaceutical manufacturers rely on Ionpure hot water sanitizable modules as part of their water treatment systems for consistent water quality and operational efficiency.
Trusted Water Treatment Solutions
Regulatory pressures, evolving standards, and operational demands make water treatment a critical part of pharmaceutical manufacturing. Xylem’s Ionpure CEDI technology offers a forward-looking solution: high-purity water, continuous performance—all backed by Xylem’s global experience and support.
Connect with our experts to explore how our water treatment solutions can help you meet your production and sustainability goals while improving operational efficiency.
*Measurement is done with a conductivity meter.