Risk Analysis Thermo King
The transport process is defined as a closed temperature-controlled storage box in transit. This box can be used in a single temperature mode and set at four different temperature ranges (Deep Frozen, Frozen, Chilled and Ambient).
The risk analysis based on the Failure Mode and Effects Analysis (FMEA) methodology has been conducted to ensure that potential problems during the process of distributing pharmaceutical products have been considered and addressed before the first use of the transport temperature-controlled equipment.