PharmaAcceptance Criteria

Single and Multi-temperatures temperature Units qualified for pharmaceutical applications under Thermo King protocol are configured with specific Pharma configuration file and parameters loaded during commissioning by your local dealer. Evaporators fans have to run during the Null Cycle.

Regarding the acceptance criteria considered in Thermo King Protocol, the air temperature should remain within the required temperature range. For example, if the requirement is for temperature range +2.0°C to +8.0°C, the minimum air temperature recorded should not be below +2.0°C, and the maximum should not exceed +8.0°C.

Parent topic: Design Qualification

Temperature Range Table

Thermo King recommends to run the unit with the recommended Setpoints below:

Truck/Van with E-200 MAX Spectrum 30/50 ES100N+ES100N:

Temperature Range Extreme Ambient Temperature Recommended Setpoint Max Deviation Setpoint
Temperature between +2°C and +8°C +40°C / ‐30°C +4°C +3/- 1°C of setpoint
Temperature between +15°C and +25°C +40°C / ‐30°C +20°C +2/- 2°C of setpoint

IR body with V-300 MAX Spectrum 30/50 ES150+ES150:

Temperature Range Extreme Ambient Temperature Recommended Setpoint Max Deviation Setpoint
Temperature between +2°C and +8°C +40°C / ‐30°C +6°C +/- 2°C of setpoint
Temperature between +15°C and +25°C +40°C / ‐30°C +20°C +/- 2°C of setpoint

IR body with V-500 MAX Spectrum 30/50 ES300+ES300:

Temperature Range Extreme Ambient Temperature Recommended Setpoint Max Deviation Setpoint
Temperature between +2°C and +8°C +40°C / ‐30°C +6°C +/- 2°C of setpoint
Temperature between +15°C and +25°C +40°C / ‐30°C +20°C +2/- 3°C of setpoint

IN body with V-800 MAX Spectrum 30/50 ES400+ES400:

Temperature Range Extreme Ambient Temperature Recommended Setpoint Max Deviation Setpoint
Temperature between +2°C and +8°C +40°C / ‐30°C +6°C +3/- 2°C of setpoint
Temperature between +15°C and +25°C +40°C / ‐30°C +20°C +/- 2°C of setpoint

IN body with V-300 MAX Spectrum 30/50 ES200+ES100:

Temperature Range Extreme Ambient Temperature Recommended Setpoint Max Deviation Setpoint
Temperature between +2°C and +8°C -35°C +4°C +3/- 1°C of setpoint
-20°C +5°C - 2°C of setpoint
Temperature between +15°C and +25°C +35°C +20°C +/- 2°C of setpoint
-20°C +21°C - 3°C of setpoint

IR body with V-400X MAX Spectrum 30/50 ES200+ES200:

Temperature Range Extreme Ambient Temperature Recommended Setpoint Max Deviation Setpoint
Temperature between +2°C and +8°C      
Temperature between +15°C and +25°C      

IR body with V-600X MAX Spectrum 30/50 ES300+ES300:

Temperature Range Extreme Ambient Temperature Recommended Setpoint Max Deviation Setpoint
Temperature between +2°C and +8°C      
Temperature between +15°C and +25°C      

IN body with V-400X MAX Spectrum 30/50 ES300+ES100:

Temperature Range Extreme Ambient Temperature Recommended Setpoint Max Deviation Setpoint
Temperature between +2°C and +8°C      
     
Temperature between +15°C and +25°C      
     

IN body with V-600X MAX Spectrum 30/50 ES300+ES150:

Temperature Range Extreme Ambient Temperature Recommended Setpoint Max Deviation Setpoint
Temperature between +2°C and +8°C      
     
Temperature between +15°C and +25°C      
     

IN body with V-600X MAX Spectrum 30/50 ES500+ES100N:

Temperature Range Extreme Ambient Temperature Recommended Setpoint Max Deviation Setpoint
Temperature between +2°C and +8°C      
     
Temperature between +15°C and +25°C      
     

IN body with V-600X MAX Spectrum 30/50 ES300+2X ES150:

Temperature Range Extreme Ambient Temperature Recommended Setpoint Max Deviation Setpoint
Temperature between +2°C and +8°C      
     
Temperature between +15°C and +25°C      
     

Temperature range Thermo King A400

Temperature Range Extreme Ambient Temperature Recommended Setpoint Max Average Deviation from Setpoint
Temperature between ‐20°C +40°C / ‐25°C ‐25°C 1.1/+0.3°C of setpoint
Temperature between +2°C and +8°C +40°C / ‐25°C +5°C ‐/+0.5°C of setpoint
Temperature between +15°C and +25°C +40°C / ‐25°C +20°C 0.8/+1.1°C of setpoint

Test Results - Truck body of 42m3with T-800R

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

Temperature between 15°C and 25°C

+45°C / -30°C

+20°C 

+/-2°C of set point

Temperature between 2°C and 8°C

+45°C / -30°C

+5°C 

+/-2°C of set point

Temperature below -20°C

+40°C / -30°C

–25°C

+/-4°C of set point

Test Results - Truck body of 48m3 with T-1000R

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

Temperature between 15°C and 25°C

+45°C / -30°C

+20°C 

+/-2°C of set point

Temperature between 2°C and 8°C

+45°C / -30°C

+5°C 

+/-2°C of set point

Temperature below -20°C

+40°C / -30°C

–25°C

+/-4°C of set point

Test Results – 45 feet container with T-1200R Intermodal

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

Temperature between 15°C and 25°C

+40°C / -30°C

+20°C 

+/-2°C of set point

Temperature between 2°C and 8°C

+40°C / -30°C

+5°C 

+2/-1°C of set point

Temperature below -20°C

+40°C / -30°C

–25°C

+1/-4°C of set point

Test Results - Truck body of 46m3 with UT-1200

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

Temperature between 15°C and 25°C

+45°C / -30°C

+20°C 

+2/-1°C of setpoint

Temperature between 2°C and 8°C

+45°C / -30°C

+5°C 

+2/-2°C of setpoint

Temperature below -20°C

+45°C / -30°C

–25°C

+1/-3°C of setpoint
Based on the qualification tests results, the air temperature remains always within the expected temperature range, and the maximum average deviation experienced is of 4°C from the set point at the temperature range of below -20°C.

Test Results - Trailer body with A-500 Spectrum and S3A remote evaporator

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

Temperature between -20°C

+43°C / -30°C

–23°C 

+3/-4°C of setpoint

Temperature between 2°C and 8°C

+45°C / -30°C

+4°C 

+2/-3°C of setpoint

Temperature between 15°C and 25°C

+45°C / -30°C

+20°C

+3/-4°C of setpoint

Efficient loading practices and operating procedures have to be followed to ensure optimum air circulation and temperature management.

Test Results – IN Van/Truck body of 5.21m3 with V-200 MAX 30/50 ES200

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

Temperature between +15 °C and +25 °C

+30 °C / -30 °C

+20 °C

+1/-2 °C of set point

Temperature between +2 °C and +8 °C

+30 °C / -30 °C

+5 °C

+2/-1 °C of set point

Temperatures to -20 °C

+30 °C / -30 °C

-22 °C

+1/-2 °C of set point

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