B. Braun Medical, WFI System Upgrade

B. Braun Medical, WFI System Upgrade | Irvine, California

B. Braun Medical, Inc.'s Irvine facility produced approximately 350,000 gallons per day of Water For Injection (WFI) using seven vapor compression distillation units that were manufactured and installed in the early 1970s. Although the system continued to produce acceptable water quality based on ongoing daily testing, the 35+-year-old stills could no longer repaired in a cost-effective manner, and needed to be replaced by newer, more reliable WFI generation equipment.

Specific

Scope Components

In addition, Irvine facility capacity increase plans necessitated a purified water system capable of supporting higher WFI demand. The stills had far outlasted their original life expectancy of 15-20 years and needed to be replaced by a robust, efficient generation system that complies with current GMP design standards and satisfies future production needs.

The ultimate goal of the Irvine WFI Storage & Generation System Upgrade Project was a robust, flexible, energy-efficient, GMP compliant, cost effective, automated purified water generation system that could quickly respond to changing production needs and future capacity expansion.

Specific scope components included:

  • Three (3) city feedwater booster pump replacement
  • Three (3) pretreatment trains consisting of carbon filtration, water softening, sanitization skid, and ancillary components
  • Three (3) 6000 gph vapor compression stills
  • Two (2) storage tanks (15k gallons each)
  • Interconnecting piping, pumps, heat exchangers
  • All necessary instrumentation and controls for a fully automated system
  • Arch/infrastructure/support utility modifications
  • Relocation of existing maintenance support areas and Men's restroom
  • All required installation, commissioning & qualification activities/costs/permits/fees
  • Upgrade of existing reverse osmosis system to ensure reliable sterilizer process supply
  • The new generation & storage system would be interfaced with the existing WFI distribution system – no modifications or enhancements to the current piping system are included in this scope
  • Existing brine pits were reused
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