Cleanroom contractor in France: rules for buyers

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

Which rules apply to your facility

ANSM's opening-authorisation file for a manufacturing or importing establishment is set by an ANSM director general decision under article R.5124-5 of the Public Health Code. ANSM says the file lets it assess, even without a prior on-site inquiry in the premises, whether the organisation matches the rules. The file asks for proof that the responsible pharmacist has the experience required by articles R.5124-16 to 18 (ANSM, application file).

For hospitals, AFNOR lists NF S90-351, Health care institutions, controlled environment areas, requirements for airborne contamination control, as current in its April 2013 edition. It replaced the June 2003 edition (AFNOR, checked 1 November 2026). Ask the owner whether its risk analysis follows this standard.

Who builds cleanrooms here

Manufacturers and importers of medicines are the regulated buyers of cleanrooms. Hospitals are the second group, because NF S90-351 sets airborne contamination control requirements for their controlled areas. 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 serve a manufacturer or a hospital, whether they are sterile, and which edition of NF S90-351 or EU Annex 1 the owner works to. Name the region.

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

• What a cleanroom costs to run: energy, filters and testing
• How to choose a cleanroom contractor: questions and evidence
• How to Import a Cleanroom from China
• The Cleanroom Project Lifecycle
• Turnkey cleanroom contractor
• Room list builder

Sources

• ANSM, application file for opening a manufacturing or importing pharmaceutical establishment (checked 1 November 2026)
• AFNOR, NF S90-351 (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)