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