Who can give me support in qualifying a transport for pharmaceutical froozen products (<-20°C) with transportation. Especially how to show (qualify, verify and validate) the short "e;breaks"e; of the cold-chain (in air tempera
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Who can give me support in qualifying a transport for pharmaceutical froozen products (<-20°C) with transportation. Especially how to show (qualify, verify and validate) the short "e;breaks"e; of the cold-chain (in air temperature) when loading or unloading a truck with -<-20°C - tranpsort through a +5°C section into the freezer storage <-20°C within 1 hour.
Is there a need to cool down the air temperature to <-20°C in the transport section +5°C while the load/unload takes place?
What is the real definition of "e;Cold Chain"e;? - our quality says: air-temperature.
