We continue to expand our range of accredited services: We now offer technical solutions and environmental qualification testing services using tools and methods that have been audited by ENAC, with a focus on sectors with critical environments in accordance with the UNE-EN ISO 14644-1 standard and Good Manufacturing Practices (GMP).

Our experts can provide consulting, auditing, calibration, equipment and service validation, and process qualification services at a wide variety of facilities, ranging from pharmaceutical laboratories, hospitals, and research centers to companies in the food and cosmetics industries.

This service complements the equipment qualification and instrument calibration laboratory services, as well as the supply of laboratory and process equipment, that Applus+ Gometrics provides from its headquarters in Palau-solità i Plegamans (Barcelona).

Environmental validation tests in permanent and mobile laboratories:

• Particle concentration and size, in accordance with UNE-EN ISO 14644-1 and Good Manufacturing Practices (GMP, Annex I, Section 4):
  • Particle size: 0.3 µm – 5 µm
  • Max. concentration:^{35 × 10⁶particles/m³}
• Velocity, uniformity, airflow rate (indirect method), and air changes in systems with unidirectional and non-unidirectional airflow
  • Air velocity (0.20 m/s – 30 m/s)
  • Flow rate (47^m³/h – 1,000^m³ /h)
• Pressure Differences (0–120 Pa)

Examples of facilities and equipment that we can validate and characterize:

• Cleanrooms, booths, and all types of climate-controlled facilities
• Isothermal media
  • Ovens, incubators: 20 °C to 170 °C
  • Climate chambers: 0 °C to 120 °C
  • Sterilization autoclaves (pressure: atm. to 0.5 MPa): 100 ⁰C to 140 ⁰C
  • Freezer chests: -80 °C to 0 °C
  • Refrigerators: 0 °C to 20 °C
  • Ovens: 150 °C to 270 °C

This environmental testing service, in accordance with ISO 14644-1, complements the existing services we provide—including equipment qualification, instrument calibration, and the supply of calibration, validation, and process solutions—from our headquarters in Palau-solità i Plegamans (Barcelona).

You can download the technical annex or view Applus+ Gometrics’ ENAC accreditation scope in the testing category.