Clean rooms

Particulate controls

  • Particle counting and zone classification in accordance with standard 14 644 at rest
  • Decontamination and recovery kinetics
  • Tightness and integrity tests of filters, with and without aerosol generation
  • Recovery time study in accordance with NF EN ISO 14644-3

Microbiological controls

  • Surface contamination control contamination in accordance with GMP, standard 17141-1
  • Airborne microbiological contamination control as per GMP, standard 17141-1

Airflow controls

  • Airflow rates for supply and extraction, renewal rates, leak detection and measurements according to NF EN ISO 14644-3
  • Temperature and humidity readings, pressure differentials according to NF EN ISO 14644-3
  • Visualization and three-dimensional control of airflow, flow laminarity according to NF EN ISO 14644-3
  • Filter integrity according to NF EN 1822 and NF EN ISO 14644-3
  • Recovery time study according to NF EN ISO 14644-3

Chemical controls and other physical characteristics

  • Efficiency tests on chemical filters
  • Noise measurements (acoustic)
  • Light intensity measurements

Qualification of Facilities and Environments

  • Pharmaceutical qualification CQ, IQ, OQ, PQ
  • Functional and value analyses
  • Risk analyses such as FMECA, Ishikawa diagrams, OQ
  • Reliability and maintainability analyses of installations and equipment
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