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Why a Cleanroom Project Must Start with a URS?
Created on Today
Before you contact a supplier for a quote, complete this step first.
In cleanroom projects, we often encounter situations like this:
"I want to build a cleanroom. How much does it cost?""Give me a price for a modular cleanroom. As soon as possible."
These questions seem reasonable, but without a clear URS (User Requirement Specification), any quotation is just a guess — and guesses often lead to cost overruns, delivery delays, and even project failure during validation.
What is a URS?
URS stands for User Requirement Specification.
It is a document drafted by you (the user) to explain:
What kind of cleanroom you need
What standards it must meet
What it will be used for
Simply put: The URS is the starting point of technical consensus between you and your supplier.
What happens without a URS?
1. Inaccurate quotes, final costs far exceeding budget
Without a URS, suppliers can only quote based on "standard configurations." But your actual needs may include:
Higher cleanliness class (e.g., ISO 5 instead of ISO 7)
Special temperature and humidity control requirements
Specific materials (e.g., 304 stainless steel vs. ordinary cold-rolled steel plate)
These differences significantly impact cost. Without a URS, the quote you get is just a "starting price."
2. Repeated design changes, delaying project progress
After the supplier starts designing based on their own understanding, you realize: "This is not what I wanted." — Rework wastes time and may incur additional costs.
A URS aligns both parties on Day 1.
3. Disputes during acceptance
Without a URS as the basis, acceptance standards become a matter of opinion. What is acceptable? What is a defect? Without it written down, it's hard to reach an agreement.
The URS serves as the legal and technical basis for acceptance.
What does a URS include?
A standard cleanroom URS should include at least the following:
Item | Description |
Cleanliness Class | ISO 5 / 6 / 7 / 8 or GMP A/B/C/D |
Temperature & Humidity | e.g., 22±2°C / RH 40-60% |
Air Change Rate (ACH) | Depends on cleanliness class |
Room Dimensions & Layout | Length, width, height, and functional zones |
Wall Material | Painted steel panel, cold-rolled steel plate, stainless steel, etc. |
Flooring Material | PVC, epoxy self-leveling, stainless steel, etc. |
Doors & Pass-Throughs | Interlocking doors, sliding doors, quantity and location of pass-throughs |
Lighting & Outlets | Illuminance requirements, number and type of outlets |
Pressure Differential | Pressure gradient between different clean zones |
Validation Requirements | IQ/OQ/PQ needed? Third-party testing? |
How we can help
If you:
Are purchasing a cleanroom for the first time
Are unsure how to write a URS
Want to ensure your URS is complete with no omissions
We can provide:
✅ URS Templates (customized for pharmaceutical / medical device / electronics industries)✅ URS Review Service — help you fill in missing technical items✅ Reference Cases — URS examples from similar projects in Southeast Asia
Not sure how to write a URS? We can guide you through cleanliness class, materials, air change rate, and validation requirements.
Conclusion
A URS is not an optional document — it is the starting point of a successful cleanroom project.
Spending a few days to write a clear URS can avoid months of rework, cost increases, and acceptance disputes.
Before you contact a supplier for a quote, ask yourself one question:
"Is my URS ready?"
Contact us to get a URS template
Email: Jim@gzkunling.com
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