Cleanroom Validation

Europe's most broadly accredited ISO 14644 cleanroom validation provider.

Comprehensive

COMPREHENSIVE

The only cleanroom testing provider you need.

We provide a complete ISO-17025 accredited solution for cleanroom and associated controlled environments' testing and validation. We use numerous standardized methods to validate cleanrooms across a variety of industries including pharmaceuticals, cannabis, medical devices, healthcare, food, aerospace and microelectronics.

Inspectra MCSU is the only accredited laboratory within Europe for all critical parameters within the ISO-14644 series (cleanrooms and associated controlled environments). We also design and develop custom validation and qualification documentation, in accordance with EU-GMP, ISO-14644 series, HTM and other regulatory requirements.

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Testing

TESTING

Standardized or bespoke.

  • 1. Airborne particle count test.
  • 2. Airflow test, air velocity and number of air changes/hour.
  • 3. Air Pressure difference test.
  • 4. Installed filter system leakage test.
  • 5. Temperature and relative humidity test.
  • 6. Airflow direction test and visualization.
  • 7. Recovery time and recovery rate.
  • 8. Containment leak test.

Accredited

ACCREDITED

Malta's first and only.

Inspectra MCSU is your one-stop shop for cleanroom testing services and our ISO-17025 accreditation is your guarantee that our laboratory is performing at the highest level. We have been examined and accredited by the the National Accreditation Board - Malta, we are members of the Irish Cleanroom Society, and our participation in Proficiency Testing Schemes ensure our consistency and continued commitment to quality.

Our technicians are regularly trained in-house using our ISO-8 cleanroom. This allows us to continuously monitor and maintain their competencies and technical expertise.

Our specialized team of experts is ready to assist you on the road to ISO-17025, GMP, HTM compliance. Knowledge of Life Sciences applications, experience, research and development has helped us establish a strong quality management system, suitable for a wide range of industrial applications.