Pharmaceuticals
Biotech Products
The shipper bears the responsibility of ensuring proper packaging of the product for transportation. Temperature monitoring devices are recommended to be included with the cargo and should be provided during the packaging process.
Labelling & Documentation.
Regulatory authorities mandate that healthcare products must be appropriately labeled to specify the recommended storage temperature and provide usage instructions.
The drug product manufacturer is tasked with determining the permissible temperature range for the product.
When a Time and Temperature Sensitive label specifies a particular temperature range (as illustrated below), it consistently denotes the permissible external handling temperature during transportation and distribution, rather than the internal temperature of the product itself.
The Time and Temperature Sensitive label should be attached to at least one side panel of the outermost visible surface of the container.
Once approved, the bottom portion of the label may also serve to convey Standard Operating Procedure (SOP) numbers alongside the temperature range.
No additional handling information should be specified on the label.
DISTRIBUTION
Shipment.
Upon demand, a truck (based on the size of the shipment and the specified temperature range provided by the supplier) may be sent out for pickup or drop-off.
It’s best to steer clear of co-loading with regular, non-temperature-sensitive freight to maintain consistent temperatures throughout transit.