For pharmaceutical, medical-device and electronics manufacturers moving or expanding in Mexico, the cleanroom is the part of the plant where construction quality is measured in particles. This guide covers ISO 14644 classifications, the EPC scope, and how to select a design-build contractor that reaches — and proves — the target class.
ISO 14644 in one paragraph
ISO 14644 is the international standard that classifies cleanroom air cleanliness by airborne particle concentration, from ISO Class 1 (cleanest) to ISO Class 9. It defines how a cleanroom is specified, tested and monitored. Your product and process set the target class — for example, medical-device assembly often lands around ISO 7–8, while certain pharmaceutical and microelectronics steps demand far cleaner classes.
What cleanroom EPC scope actually covers
- Envelope — modular walls, ceilings, coved floors, doors and pass-throughs designed for cleanability.
- HVAC & filtration — HEPA/ULPA filtration, air-change rates, temperature/humidity control, and pressure cascades between zones.
- Process utilities — clean compressed air, process gases, purified water, and point-of-use connections.
- Controls & monitoring — pressure, particle and environmental monitoring integrated to the building system.
- Testing & qualification — commissioning and qualification (IQ/OQ) to demonstrate the target ISO class.
Why cleanrooms demand a design-build approach
A cleanroom's classification result depends on how tightly the envelope, HVAC, process and controls are integrated — a gap between any two of them shows up as particles or a failed pressure cascade. Splitting these scopes across separate vendors pushes integration risk onto the owner. A single design-build / EPC contractor coordinates all disciplines and the qualification under one schedule and one accountability, protecting the classification and the start date.
Selecting a cleanroom contractor in Mexico
- Integrated capability across envelope, MEP/HVAC, process utilities and commissioning.
- Regulated-sector awareness — pharma / medical-device / electronics requirements and documentation.
- Supply-chain reach — global procurement for cleanroom systems and HVAC equipment at controlled cost.
- Local compliance — registered entity, RFC, REPSE, insurance and certifications.
CTECP builds industrial facilities in Mexico under a single Design-Build / EPC responsibility — civil, structure, MEP and commissioning — and lists cleanroom construction (ISO 14644) among its core capabilities, combining global supply-chain cost with local execution.
Frequently asked questions
What is ISO 14644?
The international standard classifying cleanroom air cleanliness by airborne-particle concentration, from ISO Class 1 to ISO Class 9.
What does cleanroom EPC scope cover?
Envelope, HVAC and filtration, process utilities, controls and monitoring, plus testing and qualification to the target ISO class.
Why a design-build contractor for a cleanroom?
Performance depends on tight integration of envelope, HVAC, process and controls; one accountable contractor coordinates all of it and the qualification, reducing risk to the classification.