WFI CAPACITY INCREASE
Estimated Project Cost: $1,300,000
Project Description
The project involved the planning, design, installation, startup and commissioning of a facility to produce WFI (Water for Injection) to support a drug manufacturing facility. Building renovations were required to support the process and the required equipment including locker rooms, mechanical space, maintenance/testing area, and controlled ventilation including HEPA filtration. The facility featured automation of the processes required to meet validation requirements.
Scope of Work
- Water pretreatment skid to produce RO quality water
- RO water storage tank and distribution loop
- WFI vapor compession still installation
- WFI storage tank and distribution loop
- Locker room for support staff
- Laundry area
- Controls and instrumentation to meet validated system
- HVAC
Engineering
Services
- Conceptual design and cost estimate
- Preliminary design and cost estimate
- Detailed design and cost estimate
- Equipment and instrument specifications
- Bid and bid evaluations
- Control system design
- Factory Acceptance Testing (FAT) support
- Checkout, startup and commissioning
- Standard operating procedures
- Operator training
- Code review
- Validation support
