URS FOR PURIFIED WATER SYSTEMS

APRIL 27, 2013 MIKEWILLIAMSON LEAVE A COMMENT

WFI Still
Hello good people of the world! Todays post deals with the User Requirements Specification
(URS) for a Purified Water System. It may be RO/DI, Purified Water, or WFI, but it should
probably have a URS. As with any URS, make sure requirements are specific, measurable,
accurate, repeatable, and testable. Considerations specific to purified water systems include:
Process Requirements:

Capacity how much water is needed? What is peak load? Include number of users, use
points, and usage priorities, as applicable
Quality what water quality does the system need to produce? Site USP, EP and other
applicable standards
User Requirements:

Consider available support utilities (incoming water, compressed air, steam, power, drainage,
etc.) up front
Know what your incoming water looks like. This will ideally include more than one sample
on one day. Sample over time and look at variations in incoming water quality. Feed the
Purified Water System with RO water if possible.
Space layout where system will be installed be sure to consider operator access for both
normal operation and maintenance activities
Mechanical Requirements:

What piping standard(s) must be met (material of construction, surface finish)

User of sanitary components (valves, pumps, tri-clamp connections, etc.)
Welding requirements
Air break in floor drains to prevent contamination
 Piping slope requirements
Piping dead-leg requirements
System drainability
Inline monitoring requirements
Electrical Requirements:

NEMA, UL, etc. standards as applicable

Sanitization Requirements

How will system be sanitized? Ozone? Heat? UV?

Automation Requirements:

What automation hardware will be needed? PLC? HMI?

How will custom code be developed and documented? Software Design Specification (SDS)?
How will the controller/HMI interface with existing plant automation? What does the network
look like? What IP addresses should be used?
How will data be stored? Existing historian?
What other interfaces are required?
21 CFR Part 11 compliance, if applicable. How do you know if your system needs to comply
with 21CFR11? Click here for tips.
Documentation Requirements

As-built P&IDs
Panel layout and electrical diagrams
Isometric piping diagrams
O&M manuals
Documentation of piping leak testing
Documentation of sanitary welds (weld logs, coupons, welder qualification, weld inspection,
boroscope documentation)
Validation Requirements

Validation Plan
Equipment Qualification (IOQ, PQ)
Ongoing monitoring
Safety/Ergonomic Requirements

Pressure relief devices

Considerations for ease of operation and maintenance
Insulation of piping that may be hot
Guarding of moving parts (e.g. pumps, motors)
Required signage
Height/accessibility requirements for sample valves
What else do you put in your URS?