Hi,
My company are currently in the process of developing a protocol to validate the cold chain transportation of a new product that needs to be stored at refrigeration temperatures 2-8 C. Just wondering if anybody could indicate what type of dataloggers and the approach used for similiar studies that you may have experience of and how the process was qualified such as duration, seasonnally etc.
Appreciate any input.
Thanks:)
My company are currently in the process of developing a protocol to validate the cold chain transportation of a new product that needs to be stored at refrigeration temperatures 2-8 C. Just wondering if anybody could indicate what type of dataloggers and the approach used for similiar studies that you may have experience of and how the process was qualified such as duration, seasonnally etc.
Hi,
are you looking for vehicle validation or for entire transport cold chain validation?
The new USP 1075 suggest an approach, but this document is not officially released yet (should happen shortly).
If you are looking at trucks you might want to use an ATP certificate as part of IQOQ and then qualify the vehicle once it is in service. It saves money to group vehicles and qualify only samples of a type in the various extreme load configurations
Before you spend money on the validation make sure you specify excursions to mitigate the risk of excursions messing up your validation.
Regards