Cleanroom contractor in Brazil: rules for buyers

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

Which rules apply to your facility

RDC 658 of 30 March 2022 adopts the PIC/S GMP guide as the minimum requirement for medicines. It took effect on 2 May 2022 and revoked RDC 301/2019, RDC 388/2020 and RDC 580/2021. It defines the clean area (área limpa) and the airlock (antecâmara) (DOU, 31 March 2022). ANVISA has been a PIC/S authority since January 2021 (PIC/S, checked 31 October 2026).

RDC 665/2022 covers good manufacturing practices for medical devices and in vitro diagnostics (ANVISA, 30 March 2022).

RDC 50/2002 is the technical regulation for planning and approving the physical projects of health establishments. RDC 51/2011 sets how health surveillance reviews them (ANVISA, checked 31 October 2026).

Who builds cleanrooms here

Medicine makers, device makers and health establishments are the regulated buyers. ABNT NBR 7256 sets requirements for the design and execution of air treatment in health care facilities (ABNT catalogue, checked 31 October 2026). Buyers search for salas limpas.

What a contractor must arrange

Article 59 of Law 5.194/1966 says firms organised to carry out engineering works may start only after registering with the regional council (Crea). Each technical activity needs an ART, registered before it starts (Crea-RJ, checked 31 October 2026). Ask your contractor for its Crea registration number and the ART for the job.

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. Give the state and municipality, because state and municipal health surveillance decide whether RDC 50 applies in full or in simplified form.

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

• How to choose a cleanroom contractor: questions and evidence
• What a cleanroom costs to run: energy, filters and testing
• How to Import a Cleanroom from China
• Building a cleanroom inside an existing building
• Turnkey cleanroom contractor
• Room list builder

Sources

• ANVISA, RDC 658 of 30 March 2022, Diretrizes Gerais de Boas Práticas de Fabricação de Medicamentos (DOU, 31 March 2022)
• ANVISA, RDC 665 of 30 March 2022, good manufacturing practices for medical devices and in vitro diagnostics (30 March 2022)
• ANVISA, RDC 50 of 21 February 2002 (checked 31 October 2026)
• PIC/S, list of participating authorities (ANVISA, PIC/S Scheme from January 2021; checked 31 October 2026)
• normas.com.br, ABNT NBR 7256, Tratamento de ar em estabelecimentos assistenciais de saúde (checked 31 October 2026)
• Crea-RJ, serviços, exercício profissional e ART (checked 31 October 2026)
• Presidência da República, Lei 5.194 of 24 December 1966, article 59 (checked 31 October 2026)