Cleanrooms.
Controlled production environments for industries where contamination is not an option.
Precision environmental control for critical environments.
At Isofred we design and install cleanrooms to GMP and ISO 14644 standards, guaranteeing control of temperature, humidity, differential pressure and air quality through precision HVAC systems and HEPA/ULPA filtration.
Every project includes the DQ, IQ, OQ and PQ validation protocols required for regulatory approval by the Spanish Medicines Agency and other international health authorities.
Technical capabilities.
Laminar and turbulent flows
Airflow patterns designed for each ISO class, from ISO 5 (class 100) to ISO 8, with air-changes-per-hour calculations and particle control.
Differential pressure control
Positive and negative pressure cascade systems to prevent cross-contamination between areas of different classification.
Monitoring and recording
Continuous monitoring systems with data logging compliant with CFR 21 Part 11, required for FDA and EMA audits.
DQ / IQ / OQ / PQ validations
We prepare and execute all qualification protocols required by GMP regulations to guarantee approval of the facility.
Precision climate control
Temperature and relative humidity control with tolerances of ±0.5 ºC and ±2% RH using precision air handling units (CRAC/CRAH).
Need a custom cleanroom?
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Diseñamos, ejecutamos y mantenemos infraestructuras térmicas críticas para industrias donde la continuidad productiva es esencial.
Si estás planificando una nueva instalación o quieres optimizar la existente, nuestro equipo técnico está preparado para analizar tu proyecto con rigor y compromiso.