Environmental Validations

Environmental control is essential in the pharmaceutical and chemical industries to ensure that manufacturing conditions do not compromise their quality, safety, or efficacy.

We provide a comprehensive environmental validation service that covers all critical parameters in cleanrooms and classified areas, fully compliant with the most stringent national and international regulations.

Scope of our services

Cleanroom and classified area qualification: assessment and verification of environmental conditions in operational, at-rest, and process simulation states:

• HEPA filter integrity testing (Leak Test).

• Measurement of viable and non-viable airborne particles in ambient air and ducts.

• Temperature and humidity mapping: thermal studies in critical areas, climate chambers, and storage facilities.

• Airflow velocity and flow pattern: unidirectional airflow visualization (smoke study).

• Pressure differentials between areas.

• HVAC system qualification (Heating, Ventilation and Air Conditioning).

• Microbiological testing of surfaces and air.

All procedures are carried out under validated protocols using calibrated equipment with ENAC-traceable certification.

Our environmental validation services are designed to ensure compliance with the most demanding regulatory frameworks, including:

• ISO 14644-1:2015 y ISO 14644-2:2015 (cleanrooms).

• Anexo 1 de EU GMP (2022) - Manufacture of sterile medicinal products.

• FDA 21 CFR Part 211 and WHO TRS 1019.