Steris-Finn Aqua WFI Generation and Storage System

• Used in pharmaceutical manufacturing for producing Water for Injection (WFI) for sterile product formulation.
• Utilised in biotechnology for cell culture media preparation and purification processes.
• Essential for cleaning and sterilisation cycles of critical equipment in GMP environments.
• Supports active pharmaceutical ingredient (API) synthesis where high-purity water is required.

Typical capacity

WFI generation systems of this class typically range from 50 to 5,000 litres per hour, with storage tanks commonly sized from 500 to 20,000 litres.

Power supply

Units commonly require a three-phase electrical supply, typically 400V, 50Hz, with varying amperage depending on system size and heating elements.

Feed water requirements

Requires pre-treated feed water, typically purified water (PW) or deionised water, meeting specific conductivity and TOC levels.

Sterilisation method

WFI generation is typically achieved through multi-effect distillation or reverse osmosis combined with ultrafiltration, followed by heat sterilisation for distribution loops.

Materials of construction

Product-contact parts are typically constructed from 316L stainless steel with an electropolished finish to prevent microbial growth and facilitate cleaning.

Certifications

Systems of this type are designed to meet cGMP, FDA, and European Pharmacopoeia requirements for WFI quality.

• What is included in a typical WFI generation and storage system?

  A complete system typically includes the WFI generation unit (e.g., still), a WFI storage tank, a distribution pump, and a sanitised distribution loop with point-of-use panels.

• How is WFI quality maintained in the storage and distribution system?

• What maintenance is typically required for these systems?

• Can this system be integrated with existing plant utilities?

• What is the typical footprint for a system of this capacity?

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.

Vue d'ensemble pour ce type de machine