Cleanroom contractor in Chile: new GMP annexes for 2026

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

Which rules apply to your facility

Decree 26 was published on 2 April 2026 and takes effect 12 months later. The new Annex 2 is based on current European Union rules. Laboratories with authorisations under the old text keep them but must meet the new text within five years of publication (Diario Oficial, 2 April 2026).

Decree 40 was published on 3 July 2026. Annex 8 applies 12 months after publication and draws on WHO TRS 999 Annex 2 and TRS 996 Annex 3 (Diario Oficial, 3 July 2026).

Who builds cleanrooms here

Makers of sterile and biological medicines are the groups most affected. The decree records the ISP view that sterile products have the highest criticality and complexity in manufacture (Diario Oficial, 2 April 2026). Buyers search for salas limpias and cuartos limpios.

Seismic design standard

Decree 28 exempt of the Ministry of Housing and Urban Planning, dated 31 July 2026, makes NCh433:2026 Diseño sísmico de edificios an official standard. It replaces NCh433:2010 once six months have passed from publication on 10 August 2026 (Diario Oficial, 10 August 2026).

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 lines are sterile, biological or other, and the date by which the owner must comply.

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. Certification and testing 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
• The Cleanroom Project Lifecycle
• How to Import a Cleanroom from China
• Cleanroom cost per m²: published ranges by ISO class
• Turnkey cleanroom contractor
• Room list builder

Sources

• Diario Oficial, Decree 26 exempt of 6 March 2026, Ministry of Health, new Annex 2 of Technical Norm 127 (2 April 2026)
• Diario Oficial, Decree 40 exempt of 29 May 2026, Ministry of Health, new Annex 8 of Technical Norm 127 (3 July 2026)
• Diario Oficial, Decree 28 exempt of 31 July 2026, Ministry of Housing and Urban Planning, NCh433:2026 (10 August 2026)