GENERAL TEMPERATURE AND HUMIDITY UNIFORMITY TESTS FOR CLEAN ROOMS

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INSTRUMENTATION AND EQUIPMENT

  • Temperature measuring devices such as standard thermometers and electronic thermometers.
  • Temperature sensing devices such as thermocouples, thermostats, or other temperature sensors used with readout devices.
  • Humidity measuring devices including sling psychrometers, electronic thermo-hygrometers and dew point or humidity sensors.

 

TEST PROCEDURES – TEMPERATURE.

  • Verify completion of HVAC system testing, adjusting and balancing (TAB) work prior to performing these tests.
  • Allow the HVAC system to operate under automatic control for 24 hours prior to tests.
  • Measure the temperature at a minimum of one location for each temperature control zone.
  • Place each thermometer or each sensor at the designated location at work level height. Allow time for the sensor to stabilize sufficiently for accurate readings.
  • Record the time and temperature reading at each location for each temperature control work zone.

 

TEST PROCEDURES—HUMIDITY

  • Verify completion of HVAC system testing, adjusting and balancing (TAB) work prior to performing these tests.
  • Allow the HVAC system to operate under automatic control for 24 hours prior to tests.
  • The relative humidity is to be measured at a minimum of one location for each humidity (temperature) control zone. Place the humidity device or sensor at the designated location and height, allowing the sensor to stabilize.
  • Measure and record the humidity readings simultaneously with temperature readings.

FIND MORE AT…

Reference links

http://www.who.int/medicines/areas/quality_safety/quality_assurance/SupplementaryGMPHeatingVentilationAirconditioningSystemsNonSterilePharmaceuticalDosageFormsTRS961Annex5.pdf

 

http://pharmaguidances.com/hvac-system-re-qualification-protocol/

 

 

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