Cleanroom contractor in Peru: rules for buyers

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

Which rules apply to your facility

Supreme Decree 008-2025-SA, published on 10 June 2025, modified the regulation on pharmaceutical establishments (Supreme Decree 014-2011-SA). Its article 110 says a laboratory starting activities operates with BPM and laboratory-practice certification for one year, and then must certify in all the practices required (El Peruano, 10 June 2025).

The BPM Manual for pharmaceutical products was approved by Supreme Decree 021-2018-SA. On 5 December 2025, Ministerial Resolution 899-2025/MINSA modified the directive on BPM certification of national and foreign laboratories. It defines a manufacturing area as a room or group of rooms and spaces designed and built to defined specifications within one building. Sterile product rooms count as separate areas when they use different sterilisation methods (El Peruano, 6 December 2025).

DIGEMID's FAQ says a new laboratory needs premises with an administrative office, a production plant and a warehouse in line with the BPM Manual, and that the application is subject to prior inspection (DIGEMID, checked 1 November 2026).

For hospitals, Ministerial Resolution 660-2014/MINSA approved NTS 110-MINSA/DGIEM-V.01 on infrastructure and equipment of second-level health establishments. Ministerial Resolution 869-2024/MINSA of 11 December 2024 amended its legal basis, definitions and land sections (El Peruano, 12 December 2024).

Who builds cleanrooms here

Pharmaceutical laboratories and second-level health establishments are the facilities these rules reach. Peru is not on the PIC/S list of participating authorities (PIC/S, checked 1 November 2026).

What a foreign manufacturer must arrange

Supreme Decree 012-2023-SA, published on 23 May 2023, lets Peru accept BPM certificates from the home authority for foreign-made medicines until 23 May 2028. This applies only while DIGEMID lists the laboratory as pending certification. Customs accept the same certificates for imports until that date. A laboratory removed from the list must obtain DIGEMID's own certificate (El Peruano, 23 May 2023). Agree with the owner who files and who holds each BPM document.

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 rooms form each manufacturing area, whether they are sterile or non-sterile, which sterilisation method they use, and name the region.

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
• The Cleanroom Project Lifecycle
• How to choose a cleanroom contractor: questions and evidence
• Turnkey cleanroom contractor
• Room list builder

Sources

• PIC/S, list of participating authorities (checked 1 November 2026)
• El Peruano, Supreme Decree 008-2025-SA modifying the Reglamento de Establecimientos Farmacéuticos (10 June 2025)
• El Peruano, Ministerial Resolution 899-2025/MINSA, directive on BPM certification (6 December 2025)
• El Peruano, Supreme Decree 012-2023-SA, BPM certificate for registration and import (23 May 2023)
• DIGEMID, Preguntas frecuentes (checked 1 November 2026)
• El Peruano, Ministerial Resolution 869-2024/MINSA modifying NTS 110-MINSA/DGIEM-V.01 (12 December 2024)