Cleanroom contractor in Germany: rules for buyers

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

Which rules apply to your facility

Section 13 AMG requires anyone who makes medicinal products or active substances on a commercial or professional basis to hold a licence from the competent authority (gesetze-im-internet.de, AMG section 13). The Medicinal Product and Active Substance Manufacturing Ordinance (AMWHV) requires the quality management system to be backed by suitable and sufficient premises and equipment, and applies Part I of the EU GMP Guide to medicinal products and Part II to active substances (AMWHV section 3).

PIC/S counts the Federal Ministry of Health and the Central Authority of the Laender (ZLG) as one participating authority, with accession to the PIC/S scheme in December 2000 (PIC/S, checked 1 November 2026).

For hospitals, DIN Media lists DIN 1946-4:2018-09, on ventilation systems in buildings and rooms of the health sector, as current. It shows the standard changed by DIN 1946-4/A1:2025-11 (DIN Media, checked 1 November 2026). Ask the owner which text the project will apply.

Who buys cleanrooms here

Licence holders making sterile medicines are the regulated buyers, because Annex 1 sets the sterile standard. Hospitals and clinics with operating rooms are the second group, because DIN 1946-4 covers ventilation in health-sector rooms. This reading comes from the rules above, 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. Say whether the owner needs an AMG licence or a change to one, and name the quality head who will review the design. For a hospital, state which DIN 1946-4 edition applies.

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

• Building a cleanroom inside an existing building
• How to audit a cleanroom panel factory, on site or by video
• The Cleanroom Project Lifecycle
• How to choose a cleanroom contractor: questions and evidence
• Turnkey cleanroom contractor
• Room list builder

Sources

• Gesetze im Internet, AMG section 13 (Herstellungserlaubnis), checked 1 November 2026
• Gesetze im Internet, AMWHV section 3 (checked 1 November 2026)
• DIN Media, DIN 1946-4:2018-09 (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)