GENERAL TEMPERATURE AND HUMIDITY UNIFORMITY TESTS FOR CLEAN ROOMS
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/