Mueller PyroPure WFI System with P7310 Steam Generators and P4003 Condensing System

The Mueller PyroPure WFI System is a comprehensive water for injection (WFI) solution designed for pharmaceutical manufacturing and bioprocessing applications requiring ultra-high-purity water and steam. This fully operational system, installed in 2015, integrates key components aligned with USP WFI standards essential for molecular diagnostics, biomanufacturing, and synthetic biology workflows.

Key technical features:

• 2x Mueller P7310 Pure Steam Generators
• Capacity: 0 to 700 kg/hr pure steam production, suitable for large-scale bioprocessing and sterile fluid systems
• Alternate operation mode enhances system uptime and energy efficiency critical in continuous bioprocess workflows
• Stainless steel construction for hygienic steam generation, with external evaporator design allowing simplified maintenance and contamination control
• Allen Bradley Compact Logix PLC and Operator Interface Terminal (OIT) ensure precise control and monitoring, supporting GMP compliance
• Safety devices include pressure relief valves and temperature regulation to maintain sterile conditions

• 1x Mueller P4003 Pure Steam Condensing System
• WFI distillate output: 379 L/hr (100 gallons/hr) meeting USP WFI water purity requirements
• Pure steam inlet capacity of 366 kg/hr facilitates efficient condensation processes in pharmaceutical water systems
• Tangential nozzle design enhances impurity separation, while electro-polished 316/316L stainless steel surfaces prevent microbial contamination
• Removable condenser tube bundle with minimal instrument footprint allows convenient service access, promoting consistent product quality

• 1x Ormandy Newade 2000L WFI Storage Vessel
• Capacity optimally sized for mid-scale operations in biopharmaceutical manufacturing
• Constructed from high-grade austenitic and Duplex stainless steel, conforming to PD5500, ASME VIII, EN 13445 standards, and Pressure Equipment Directive (PED) CE marking
• Available in customizable horizontal and vertical configurations for tailored facility integration

• 1x Fristam FPE742/185A Centrifugal Pump
• 5.5 kW sanitary pump engineered for sterile fluid transfer with close internal clearances (0.5 mm) minimizing cross-contamination risks
• 316L stainless steel construction with advanced impeller design reduces cavitation, ensuring reliable aqueous media handling in sensitive bioprocesses

• 1x Freestead Technology WFI Storage Vessel Control Panel
• Custom-designed panel providing centralized, real-time control over WFI storage conditions and system operation

This Mueller PyroPure WFI System is critical in pharmaceutical and biotechnology environments for consistent delivery of Water for Injection and pure steam, supporting sterile manufacturing, molecular cloning workflows, and bioprocessing pipelines. Its robust design and compliance with stringent industry regulations make it widely adopted in synthetic biology research and biopharmaceutical production facilities focusing on molecular diagnostics and live-cell applications.