Cleanroom contractor in Argentina: rules for buyers

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

Which rules apply to your facility

ANMAT Disposición 4159/2023, dated 13 June 2023 and published on 16 June 2023, approved the Guía de Buenas Prácticas de Fabricación para Elaboradores, Importadores/Exportadores de Medicamentos de Uso Humano. It repealed Disposiciones 2819/04, 3602/18, 3827/18 and 1281/19 (ANMAT, Boletín Oficial, 16 June 2023). PIC/S lists INAME, the National Institute of Drugs, with accession in January 2008 (PIC/S, checked 31 October 2026).

For hospitals, Ministry of Health Resolución 810/2020, published on 24 April 2020, approved guidelines for the organisation and operation of a surgical centre in establishments with inpatient care. It also approved a categorising licensing grid, a patient flowchart and standards for the anaesthesia station (Boletín Oficial, 24 April 2020). Ask the owner which provincial authority will enable the building.

Who builds cleanrooms here

The ANMAT guide covers makers, importers and exporters of human-use medicines. Resolución 810/2020 covers surgical centres in hospitals with inpatient care. In Spanish, the rooms are called salas limpias or cuartos limpios, so use both terms when you brief suppliers or search for them.

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 which edition of the ANMAT guide INAME will inspect against, and whether the surgical centre falls under Resolución 810/2020. Say whether the rooms are sterile or non-sterile, and name the province.

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

• 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?
• Building a cleanroom inside an existing building
• Turnkey cleanroom contractor
• Room list builder

Sources

• PIC/S, list of participating authorities (checked 31 October 2026)
• Argentina.gob.ar, Disposición 4159/2023, official text (checked 31 October 2026)
• ANMAT, Disposición 4159/2023 of 13 June 2023, as published by CIRA from the Boletín Oficial of 16 June 2023 (checked 31 October 2026)
• Boletín Oficial, Ministry of Health Resolución 810/2020 (24 April 2020)