Cleanroomsandpharmaceuticalclimatecontrol.
GMP cleanrooms, precision climate control and cold chain for the pharmaceutical industry, where not a single degree or particle of deviation is acceptable.
The pharmaceutical industry allows no mistakes: a deviation in temperature, humidity or particles can ruin an entire batch and an audit. We design facilities that comply with GMP and ISO 14644 from day one, with documented validation.
- GMP cleanrooms with HEPA filtration and laminar flow
- Precision climate control: temperature, humidity and differential pressure
- 2-8 °C cold rooms and deep freezing for biologicals
- DQ/IQ/OQ/PQ qualification and 21 CFR Part 11 traceability
The air and the cold cannot fail.
In pharma, downtime means a lost batch and an audit deviation.
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Technical solutions for the pharmaceutical industry.
GMP cleanrooms
Design and installation with H14 HEPA filtration, laminar flow and ISO 14644 classification (grades A to D). Control of particles, air changes and differential pressure.
Precision climate control
HVAC systems that keep temperature, humidity and pressure stable in each room, with redundancy for critical processes and under RITE and F-Gas regulations.
Cold rooms and cold chain
2-8 °C rooms, -20 °C freezing and -80 °C deep freezing for vaccines, biologicals and insulins, with redundant control and alarms.
Humidity and pressure control
Dehumidification, differential pressure cascades and airlocks to prevent cross-contamination between areas of different grades.
Qualification and validation
Preparation and execution of DQ, IQ, OQ and PQ protocols, with continuous monitoring and audit-ready 21 CFR Part 11 records.
Need a custom project?
Request a technical studyCompliance and validation, no shortcuts.
Every facility is delivered with the documentation and qualifications a pharmaceutical audit requires.
European Good Manufacturing Practice for sterile medicinal products.
Classification and control of air cleanliness (grades A-D / ISO 5-8).
Validated design, installation, operational and performance protocols.
Good Distribution Practice for medicines and vaccines.
Secure, tamper-proof, auditable electronic data with electronic signature.
Compliance with Spanish thermal and fluorinated gas regulations.
Ingenieríafrigoríficaindustrialcon+25añosdetrayectoria.
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.