Design Qualification
Prepared for Thermo King, for validation of temperature controlled equipment Trailer Single-Temperature with units A400, A500 and A–500e.
Prepared for Thermo King, for validation of temperature controlled equipment Trailer A-500 Spectrum and S3A remote evaporator.
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.
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Temperature below -20°C
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Temperature between +2°C and +8°C
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Temperature between +15°C and +25 °C
To ensure total flexibility the validation is to be performed at all stated ranges from above.
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.