B. Braun Medical, Inc.'s Irvine facility produced approximately 350,000 gallons per day of WFI (Water For Injection) using seven vapor compression distillation units that were manufactured & installed in the early 1970's. Although the system continued to produce acceptable water quality based on ongoing daily testing, the +35 year old stills could no longer be cost-effectively repaired and needed to be replaced by newer, more reliable WFI generation equipment.
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:
- City feedwater booster pump replacement (3 total).
- 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 Mens bathroom.
- 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.
- Self Perform Work Detailing
- Self Perform Work Tracking
- MEP Coordination
- 4D Sequencing
- Constructability Analysis
- Laser Scanning
- Site Logistics Planning