Validation Test Perform

Validation Test Performs At Micron

Micron performs HVAC & clean room validation as per ISO 146441, 2, 3-2015& 19(E) EU, c GMP, WHO, USFDA, TGA (Australia) guidelines for all room classifications. Micron carries out following test to validation clean rooms/ clean zones

  • Filters face air velocity measurement.
  • Calculation of air velocity / CFM/ ACPH measurement.
  • Air velocity / CFM measurement in duct
  • Air velocity /CFM / ACPH measurement across fresh air filter
  • HEPA filter leak testing by using PAO/ DOP
  • Non-Viable Particle count
  • Recovery test
  • Induction test
  • Power failure test
  • Air flow visualization test
  • Lux Level measurement
  • Sound level measurement
  • Room Temperature/ RH Measurement
  • Compressed Air Validation / Nitrogen Gas / Breathing Air
  • Steam Quality Test
  • Media Batch Filling Videography

List of Thermal Validation Activity

Following test that we carried out during Thermal validation.

  • Autoclaves
  • Dry Heat Sterilizers
  • Tunnels
  • Incubators
  • Stability Chambers
  • CoIdRoom, Chambers
  • Room Temperature/ RH Mapping

Operation Theater & Bio Safety Cabinet Validation

  • Filter leak
  • Airflow velocity
  • Particle Count Test
  • Smoke pattern
  • Light intensity
  • Vibration