Design Qualification

Prepared for Thermo King, for validation of temperature controlled equipment Single-Temperature units for:

Self-Powered truck: T-800R, T-1000R, T-1200R and UT-1200 and Intermodal container: T-1200R Intermodal

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.

  • Temperature below -20°C

  • Temperature between +2°C and +8°C

  • Temperature between +15°C and +25 °C

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

In this section:

  1. Equipment Specifications
  2. PharmaAcceptance Criteria
  3. Additional Validations and Variations
  4. Detailed Specifications

Scope

The scope of the qualification work will be done to the equipment (a refrigerated unit designed and built by Thermo King with an ATP certified body) for the transportation, under temperature restrictions, of medicines.
A standard configuration is defined for each group.