Certified Clean Rooms
for processes that do not allow errors
We design, build and certify cleanrooms under ISO 14644 and NOM-059 for the pharmaceutical, electronics and medical device industries in Mexico.
Request your technical evaluation
ISO 1–9
100%
GMP
NOM-059
Regulatory compliance
What is a Clean Room?
A clean room is a manufacturing space with rigorous control of particles, temperature, humidity, and differential pressure. The goal is to ensure that the environment does not contaminate the production process or the final product.
Unlike a conventional room, a clean room is designed and built from the ground up: the required ISO classification, the type of industry, and applicable regulations define every element of the HVAC system, the finishes, the personnel flows, and the access protocols.
In Mexico, certifiable clean rooms must comply with ISO 14644 for particle classification and with NOM-059-SSA1-2015 when used for pharmaceutical or medical device manufacturing.
Controlled parameters in a Clean Room
- Particles in the air
- Temperature
- Relative humidity
- Differential pressure
- Air renewals
- Filtration
- ISO 14644
- ±0.5 °C
- 30–60% HR
- +12.5 Pa mín.
- 20–600 ACH
- HEPA / ULPA
ISO 14644 classifications
The 3 most used classes in regulated industries in Mexico
Each classification defines the maximum number of particles per cubic meter. The more demanding the process, the lower the tolerance for contamination—and the greater the investment in the environmental control system.
ISO 14644-1 · Class 5
ISO 5
Sterile pharmaceuticals · Operating rooms · Semiconductors
ISO 14644-1 · Class 7 — Most requested
ISO 7
Pharmaceutical manufacturing · Contract manufacturing
ISO 14644-1 · Class 8
ISO 8
Assembly · Low criticality devices
How we work
Your clean room, step by step.
01 — Evaluation
Technical audit of the process
02 — Design
Engineering and layout
HVAC system design, personnel flow, finishes, and ISO classification. All documented for auditing.
03 — Construction
Certifiable execution
04 — Certification
Audit-ready delivery
Why Clean Rooms Mexico
We are not distributors. We are process engineers.
Process-based design
The ISO classification is not chosen from the catalog — it is defined based on your production process and the regulations that apply to your industry.
Documentation ready for audit
Each project is delivered with qualification protocols, particle reports, and complete technical documentation from day one.
Equipment supply
Pass boxes, Fan Filter Units, Wall Panel System panels and particle counters — without intermediaries or inflated waiting times.
Compliance with NOM-059 and ISO
We operate under ISO 14644, NOM-059-SSA1-2015 and GMP standards. We are familiar with COFEPRIS and FDA requirements for regulated manufacturing.
Pay attention to both profiles
We spoke with the QA engineer about technical specifications and with the plant manager about timelines, costs, and return on investment.
National presence from Juárez
We operate from Ciudad Juárez with nationwide coverage. Experience in border maquiladoras and plants with export standards to the USA.
Proyectos y Colaboraciones
Clients who operate under standard today.
Frequently Asked Questions
The most common questions we get asked before starting a project.
How much does a clean room cost in Mexico?
The cost depends on the required ISO classification, the area’s dimensions, the HVAC system, and the finishes. An ISO 8 cleanroom can start at $500,000 MXN; an ISO 5 cleanroom for sterile pharmaceuticals can exceed $3,000,000 MXN. A free technical evaluation is the first step toward obtaining an accurate quote.
How long does construction take?
A standard ISO 7–8 clean room takes between 8 and 16 weeks from design approval to certification. More complex projects (ISO 5, multiple areas, FDA regulations) can take 20 to 30 weeks.
Which standard applies to my industry?
It depends on your process and product. Pharmaceuticals: NOM-059 + ISO 14644. Sterile medical devices: NOM-059-SSA1-2015. Export to the USA: 21 CFR Parts 210–211. In the technical evaluation, we will tell you exactly which regulations apply to your case.
Can they certify a clean room that already exists?
Yes. We conduct current status audits, identify gaps against the applicable standard, and generate a compliance plan with estimated cost and time.
Do they work outside of Ciudad Juárez?
Yes, we have nationwide coverage.
Next step
Your clean room starts with a technical assessment
Our team reviews your process, applicable regulations, and production goals before proposing a solution. No cost, no obligation.