Introduction

Thermo King designs and builds temperature-controlled transport equipment.

These types of equipment can be validated for a specific desired temperature range for the transport of pharmaceutical products.

Due to the fact that several test were performed on the different units in time, not all the tests are performed under the same circumstances.

Overview tests performed

Temperature Range Extreme Ambient Temperature ZONE 1 setpoint Max Setpoint deviation ZONE 1 ZONE 2 setpoint Max Setpoint deviation ZONE 2
Temperature below -20°C +43°C ‐23°C +3°C /-3°C of setpoint off -
-30°C -23°C +1°C /-1°C of setpoint off -
Temperature between +2°C and +8°C +45°C +5°C +2°C /-2.5°C of setpoint off -
-30°C +5°C +1°C /-2.5°C of setpoint off -
Temperature between +15°C and +25 °C +45°C +20°C +1°C /-1 °C of setpoint off -
-30°C +20°C +1°C /-3 °C of setpoint off -
Temperature below -20°C -30°C -23 °C +2°C /-2 °C of setpoint +5°C +2°C /-2°C of setpoint
+20°C +3°C /-3°C of setpoint
+45°C -23 °C +3°C /-1 °C of setpoint +5°C +3°C /-3°C of setpoint
+20°C +3°C /-2°C of setpoint
Temperature between +2°C and +8°C +45°C +5°C +2°C /-1 °C of setpoint +20°C +1°C /-2°C of setpoint
+40°C +5°C +2°C /-1.5 °C of setpoint -25°C +1°C /-3°C of setpoint
-30°C +5°C +2°C /-2 °C of setpoint +20°C +4°C /-4°C of setpoint
Temperature between +15°C and +25 °C +45°C +20°C +1°C /-1 °C of setpoint +5°C +2°C /-2°C of setpoint
-30°C +20°C +1°C /-2 °C of setpoint +5°C +2°C /-2°C of setpoint

Truck body with Thermo King UT-R Spectrum unit

Temperature Range Extreme Ambient Temperature Recommended Setpoint Max Average Deviation from Setpoint

Temperature above -27°C

+30°C / -30°C

-29 °C

+/-3°C of setpoint

Temperature below -20°C

+40°C / -30°C

-24 °C

+4/-6°C of setpoint

Temperature between 2°C and 8°C

+40°C / -30°C

+5°C

+/- 3°C of setpoint

Temperature between 15°C and 25 °C

+40°C / -30°C

+20 °C

+/- 5°C of setpoint

Note To ensure total flexibility the qualification is to be performed at all stated ranges from above.