Cleanroom contractor in Guatemala: rules for buyers

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

Which rules apply to your plant

Under the Health Code, Decree 90-97, MSPAS supervises the production, import, export and sale of pharmaceutical products. The medicines regulation is Government Agreement 712-99 of 17 September 1999. MSPAS posts a draft replacement marked as under review, so ask the owner which text applies (MSPAS, draft reform of 2025).

An MSPAS presentation of 2 October 2012 gives the older audit rules. Article 73.4 of Agreement 712-99 required a manufacturing laboratory to pass the inspection guide with at least 70 points. Ministerial Agreement 858-2010, published on 29 November 2010, let laboratories optionally obtain a GMP certificate under the Central American regulation RTCA 11.03.42:07. That route required 100 percent of critical criteria, 80 percent of major criteria and 80 percent of minor criteria, and a typical inspection lasted five working days (MSPAS presentation, 2012).

The same presentation lists the plans the laboratory files before inspection: a site plan, personnel circulation, material circulation, the air supply system for all areas, and the pharmaceutical water treatment and distribution system. Treat these dates as a starting point and confirm the current rule with the owner.

Who builds cleanrooms here

Authorised manufacturing laboratories are the regulated buyers, because MSPAS reviews the plant layout and its air and water system plans before inspection. The 2012 presentation reported that 5 of 72 authorised laboratories had been evaluated against the regional guide, so the share certified today may differ. This reading comes from MSPAS documents, not from market statistics.

What a foreign supplier must arrange

MSPAS inspects the owner's laboratory, and the owner files the plans. A foreign supplier should therefore expect requests for air-system and layout drawings in a form the owner can submit. This page found no official Guatemalan source on construction-product approvals or contractor registration, so ask the owner's engineer which approvals apply.

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 is seeking the optional RTCA certificate. Name the technical director who will receive the inspection.

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

• Cleanroom cost per m²: published ranges by ISO class
• The Cleanroom Project Lifecycle
• How long does it take to build a cleanroom?
• Writing a cleanroom URS: contents and testable wording
• Turnkey cleanroom contractor
• Room list builder

Sources

• MSPAS, Requisitos para optar a auditorías de BPM según RTCA 11.03.42:07, presentation of 2 October 2012
• MSPAS, draft reform of Acuerdo Gubernativo 712-99, marked as under review (2025; checked 1 November 2026)
• PIC/S, list of participating authorities (checked 1 November 2026)