Cleanroom contractor in Spain: rules for buyers

By ZY Cleanroom · Updated 2026-11-01 · Sources at the end of the page

Which rules apply to your facility

Royal Decree 824/2010 of 25 June regulates pharmaceutical laboratories. Article 5.1 says manufacturers must be authorised in advance by AEMPS. Article 6 requires the applicant to have adequate and sufficient premises, technical equipment and control equipment, and article 26.1 requires manufacturing and control operations to follow good manufacturing practice (Real Decreto 824/2010, text).

For hospitals, the Spanish standard UNE 171340:2020, on validation and qualification of controlled environments in hospitals, was released on 29 July 2020 and is listed as in stock (EN-Standard listing, checked 1 November 2026). In Spanish the rooms are called salas limpias or salas de ambiente controlado, so use both terms when you brief suppliers.

Who builds cleanrooms here

Pharmaceutical laboratories applying for AEMPS authorisation are the regulated buyers, because article 6 ties the authorisation to premises and equipment. Hospitals are the second group, because UNE 171340 addresses their controlled environments. This reading comes from the rules, not from market statistics.

What a foreign supplier must arrange

The EU Construction Products Regulation, Regulation (EU) 2024/3110, entered into force on 7 January 2025 and became generally applicable on 8 January 2026 (DIBt). For self-supporting double-skin metal insulating panels, CE marking is compulsory under EN 14509 (Tecnalia, 6 June 2023). A panel supplier from outside the EU should therefore expect to be asked for CE marking and a declaration of performance for each product. Agree with the owner who places the panels on the market.

What to send for a first scope

Send the room list with the ISO 14644-1 class and occupancy state for each room. Add floor plans and ceiling heights. State whether the rooms are for a pharmaceutical laboratory or a hospital, whether they are sterile, and which UNE edition the hospital works to. Name the autonomous community.

Send your room list to ZY Cleanroom, a cleanroom design-and-build contractor with its own panel factory in Tianjin, China, to have a first scope prepared. CE-marked and FM-approved panels can be supplied for projects that require them, and other certification can be arranged per project.

Who does the site work

Site work is delivered with a licensed local contractor: yours, or one named in the contract. ZY supplies the design, panels, doors and numbered drawings.

Related guides

• Cleanroom cost per m²: published ranges by ISO class
• What a cleanroom costs to run: energy, filters and testing
• How long does it take to build a cleanroom?
• How to audit a cleanroom panel factory, on site or by video
• Turnkey cleanroom contractor
• Room list builder

Sources

• Real Decreto 824/2010, de 25 de junio, text (checked 1 November 2026)
• EN-Standard, UNE 171340:2020, released 2020-07-29 (checked 1 November 2026)
• DIBt, revised Construction Products Regulation (EU) 2024/3110: in force 7 January 2025, generally applicable 8 January 2026
• Tecnalia, Insulating panels with CE marking according to EN 14509 (6 June 2023)
• PIC/S, list of participating authorities (checked 1 November 2026)