Cleanroom contractor in Ireland: rules for buyers

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

Which rules apply to your plant

HPRA says separate manufacturer's or importer's authorisations (MIAs) are required depending on the scope of the products covered. It sends the MIA application form once a company is confirmed ready for inspection. A company that intends to apply within 6 months should request a pre-submission meeting with the Compliance department (HPRA, authorisation to manufacture).

HPRA also says an in-person meeting with its GMP inspectors can be arranged for early facility design review, and that companies considering a site in Ireland should contact the Inspection Group early (HPRA, same page).

Planned inspections are notified 4 to 6 weeks ahead, and unannounced inspections can be performed. A GMP certificate is issued within 90 days of the last day of the inspection, and its authenticity is checked on the EudraGMDP database (HPRA, GMP inspections page).

Who builds cleanrooms here

Companies applying for an MIA are the regulated buyers, because HPRA confirms a company is ready for inspection before it sends the application form. Owners adding sterile areas must also read Annex 1, which the EU Commission lists as fully applicable since 25 August 2024. This reading comes from the HPRA and Commission pages, 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 plant is new or existing, whether the rooms are sterile, and whether the owner has requested an HPRA pre-submission meeting. Name the quality head who will review the design.

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

• Writing a cleanroom URS: contents and testable wording
• Cleanroom cost per m²: published ranges by ISO class
• The Cleanroom Project Lifecycle
• What a cleanroom costs to run: energy, filters and testing
• Turnkey cleanroom contractor
• Room list builder

Sources

• HPRA, authorisation to manufacture medicines in Ireland (checked 1 November 2026)
• HPRA, GMP inspections (checked 1 November 2026)
• European Commission, EudraLex Volume 4, Annex 1 listed as fully applicable since 25 August 2024 (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)