ISO 14644
the standard that defines how clean your process should be.
We design and build cleanrooms that meet ISO 14644 standards from day one. Classification, monitoring, and audit-ready technical documentation — in Mexico.
What classification do you need?
ISO 1-9
14644
HEPA/ULPA
IQ/OQ/PQ
What is ISO 14644?
ISO 14644 is the international standard that defines how cleanrooms and controlled environments are classified, designed, constructed, and monitored. It establishes the maximum particle limits per cubic meter for each class—from ISO 1 (the cleanest) to ISO 9 (the least restrictive).
In Mexico, ISO 14644 is the technical reference adopted by both NOM-059 for pharmaceutical manufacturing and NOM-059-SSA1-2015 for medical devices. Compliance is mandatory when your production process requires it or when your client or regulator requires it.
The standard is divided into several parts: ISO 14644-1 defines the cleanliness classes and the particle classification method. ISO 14644-2 establishes the continuous monitoring requirements to maintain the classification over time. Both apply to any cleanroom project in a regulated industry.
Parts of the ISO 14644 standard
- ISO 14644-1
- ISO 14644-2
- ISO 14644-3
- ISO 14644-4
- ISO 14644-5
- ISO 14644-6
- Air classification
- Continuous monitoring
- Testing methods
- Design and construction
- Cleanroom operation
- Vocabulary and terminology
ISO 14644-1 classification table
From ISO 1 to ISO 9: each class, its own process.
The ISO classification defines the maximum number of particles 0.5µm or larger per cubic meter of air. The lower the ISO number, the stricter the required control and the greater the investment in the filtration and HVAC system.
| ISO Class | Max. particles/m³ ≥ 0.5µm | Typical industry |
|---|---|---|
| ISO 5 (crítico) | 3,520 | Sterile pharmaceutical filling · Precision semiconductors · Operating rooms |
| ISO 6 | 35,200 | High-precision electronics · Optics · Aerospace components |
| ISO 7 (Most requested) | 352,000 | Manufactura farmacéutica · Maquiladora · Dispositivos médicos · Laboratorios |
| ISO 8 | 3,520,000 | Electronic assembly · Cosmetics · Low-criticality medical devices · Packaging |
| ISO 9 | 35,200,000 | Basic cleanroom · Dust control in general manufacturing · No specific regulation |
Practical application
The three parts that apply to your project.
Of the nine parts of ISO 14644, these three are the ones that directly impact the design, construction and operation of any cleanroom in regulated industry in Mexico.
ISO 14644-1
Air classification
Define the maximum particle limits per cubic meter for each ISO class. This is the part used to determine which classification your process needs and how it is verified through statistical particle sampling at defined points in the area.
ISO 14644-2
Continuous monitoring
It establishes the frequency, points, and methods of monitoring to demonstrate that the cleanroom maintains its classification over time. It defines when and how the area should be recertified—typically every 6 or 12 months depending on the class.
ISO 14644-4
Design and construction
It guides the design requirements for classified facilities: HVAC systems, differential pressure, air changes, finishes, and personnel and material flows. It is the document that project engineers use to ensure the design will meet the required classification.
Por qué Clean Rooms México
Clasificamos. Construimos. Certificamos.
Classification from design
We don't build first and classify later. The ISO class defines the HVAC system, finishes, and personnel flow from the very first line of design.
Particle tests included
Statistical sampling under ISO 14644-1, the classification report, and HEPA filter certificates are included in every project. They are not an additional service.
ISO 14644-2 Monitoring Protocol
We deliver the continuous monitoring plan your quality team needs to maintain classification and document the area's status between recertifications.
Compliant with NOM-059 and GMP
The design is based on ISO 14644. On that foundation, we integrate the requirements of NOM-059, GMP, or FDA depending on the industry—without parallel projects or duplicate documentation.
Recertification and periodic monitoring
We perform the periodic recertifications required by ISO 14644-2 — every 6 or 12 months depending on the class — and preventive maintenance of the HVAC system and filters.
Adecuación de instalaciones existentes
If your cleanroom does not meet the required ISO class, we perform a diagnosis, identify the root cause, and propose the necessary interventions in HVAC or finishes.
Proyectos y Colaboraciones
Certified facilities under ISO 14644 today
Frequently Asked Questions
The most frequently asked questions about ISO 14644
How do I know which ISO classification my process needs?
It depends on three factors: the type of product you manufacture, the regulations that apply to your industry, and the requirements of your customer or regulator. Sterile pharmaceuticals: ISO 5–7. Medical devices: ISO 7–8. Precision electronics: ISO 5–6. General manufacturing: ISO 8–9. In the technical assessment, we determine the exact class for your specific process.
How often does a cleanroom need to be recertified under ISO 14644?
ISO 14644-2 establishes the frequency according to the class: ISO 5 and more critical classes require recertification every 6 months. ISO 6 to ISO 9 require recertification every 12 months. Additionally, any major intervention to the HVAC system or modification of the area requires recertification regardless of the regular cycle.
What is the difference between ISO 14644-1 and ISO 14644-2?
ISO 14644-1 defines the cleanliness classes and the method for classifying a cleanroom by particle sampling—it applies for initial certification. ISO 14644-2 establishes the requirements for continuous monitoring to demonstrate that the area maintains its classification over time—it applies during normal cleanroom operation.
Can my existing cleanroom be certified under ISO 14644?
Yes, if the HVAC system and finishes are suitable for the required class. We perform a particle test on your existing installation to verify if it already meets the required classification or if any adjustments are needed. In many cases, only airflow adjustments or filter replacements are required.
Are ISO 14644 and GMP the same thing?
No, they are complementary. ISO 14644 defines the classification of airborne particles. GMP (Good Manufacturing Practices) encompasses the entire quality system: procedures, personnel, materials, records, and equipment. A cleanroom can be certified under ISO 14644 and still not meet all GMP requirements if quality system procedures or documentation are missing.
Next Step
What ISO classification does your process need?
No cost, no obligation. In the technical assessment, we determine the required ISO class, the applicable regulations, and the scope of the project before any investment.