Mueller - Full Mueller PyroPure WFI System

• Production of Water for Injection (WFI) for pharmaceutical manufacturing processes.
• Supply of high-purity water for biotechnology applications and laboratory use.
• Preparation of solutions and media requiring ultra-pure water in regulated environments.
• Cleaning-in-Place (CIP) and Sterilisation-in-Place (SIP) systems within biopharmaceutical facilities.

Typical WFI production capacity

Units of this class commonly produce WFI at rates suitable for high-volume operations, often ranging from hundreds to thousands of litres per hour, depending on configuration.

Pure steam generation capacity

For this class of equipment, pure steam generators typically offer capacities from 0 to 700 kg/hr per unit, with systems often featuring multiple generators for redundancy or increased output.

Power supply

These systems commonly require a three-phase electrical supply, with specific voltage and amperage requirements varying by model and capacity. Buyers should verify exact needs with the seller.

Control system

Advanced control systems, such as Allen Bradley Compact Logix PLCs with operator interface terminals (OITs), are typically integrated for real-time monitoring and control.

Regulatory compliance

WFI systems are designed to meet stringent pharmaceutical standards, such as USP WFI, EP, and JP, ensuring suitability for regulated applications.

Footprint

Full WFI systems, including generation, storage, and distribution components, require a dedicated plant room space. Specific dimensions vary significantly based on capacity and configuration.

• What is Water for Injection (WFI)?

  WFI is highly purified water used in the preparation of parenteral solutions and other pharmaceutical products where water quality is critical. It must meet specific chemical and microbiological purity standards.

• What is the typical maintenance schedule for a WFI system?

• Can this system be integrated into an existing facility?

• What utilities are required to operate a WFI system?

• What are the benefits of having two pure steam generators in an alternating system?

WFI generation and storage systems are considered essential infrastructure in pharmaceutical manufacturing. Buyers typically prioritise systems with verified maintenance records, as reliability and consistent water quality are critical. Key considerations include capacity requirements, sanitisation capability, and compliance with relevant pharmaceutical standards. Industry sentiment favours units demonstrating robust construction and proven track records in similar production environments. Used systems often provide good value when sourcing from established manufacturers with documented performance history and complete documentation of previous operating conditions and service schedules.

General overview for this equipment type