Guide
Building a cleanroom – from idea to validated facility
Building a cleanroom is as much about process as about walls. Here we walk through the full chain: requirements, design, construction, validation and operation.
1. URS and feasibility – define requirements before you build
It all starts with a User Requirement Specification. We map your process, cleanliness class, personnel and material flows, equipment and future needs. A thorough URS is the cheapest way to avoid expensive changes later.
Which cleanliness class does the process require – ISO 5, 7, 8 or a controlled environment?
Which regulations apply: ISO 14644, GMP, MDR or customer-specific requirements?
Which flows must be separated, and are airlocks needed for staff and materials?
How much should the facility be able to grow over the next five years?
2. Design and budget price
With the requirements in place we design layout, pressure cascade, ventilation, electrics and surfaces. You receive drawings and an initial budget price before anything is ordered, so the investment can be approved internally.
Layout with zoning, airlocks and a cleanliness class per room.
Air flows, filter levels and pressure differentials sized against the class.
Choice of wall system, flooring, doors, penetrations and lighting.
A timeline and budget that hold throughout the project.
3. On-site construction
We build the cleanroom on site in your existing premises, with our own stock and production in Sweden for shorter lead times. Installation is planned to disturb your ongoing operation as little as possible.
Cleanrooms from 5 to 750 sqm, in operating or newly built premises.
Our own fitters with cleanroom experience – no unknown subcontractors.
Continuous check-ins and documentation throughout construction.
4. Validation and handover
Before the cleanroom is taken into use we measure particle counts, air flows, pressure differentials, recovery time and leakage to ISO 14644. You receive complete documentation that holds up in an audit.
5. Service and operation
A cleanroom only keeps its class if it is maintained. With a 1–3 year service agreement we handle filter changes, revalidation and adjustments – so the facility is always audit-ready.
Planning to build a cleanroom?
Tell us about your operation and we will get back to you with a suggested cleanroom class, layout and an initial budget price.