We care about your success. This page provides you with useful tips related to cold chain management. Here we share experience from a shipper's perspective and results of our research. This page is being updated frequently.

Author: Peter Kralinger

 

#1 Product preparation for transport

Transport begins in the shipper's warehouse. The assumption is that packaging operations are executed in a room at 22°C and the cold room temperature is 4°C. Transport temperature deviations can be originated even before transport begins. Packaging systems or thermo trucks typically do not have the ability to adjust product temperature correctly, they are often designed to keep the temperature only.

Packaging materials for pharmaceuticals have limited insulating ability, which means that product close to the surface of a currogated cardboard box adjusts to ambient temperatures shortly. This is the place where data loggers must be located in order to monitor transport temperature at worst case positions.

On the other hand, product located in the center of a shipping box reacts with a delay as all the packaging material and the enclosed air insulates each single product box against the other. As a rule of thumb: It takes up to 24 hrs. to achieve homogenous temperature throughout a shipping box of 60/40/40 cms. The influencing parameters are the packaging material, inserts, blister, thermo mass, filled volume, number of boxes/vials, starting temperature, etc.

When you measure product temperature on a pallet on which such cardboard boxes are stock piled, the delay between center temperature and exposed outer positions is significantly greater. It can even take six days until the temperature distribution throughout a pallet is homogenous. 

The conclusions are that 

  1. product must be stored in a cold room after manufacturing and before transportation for a defined period dependent on the parameters mentioned above.
  2. Temperature data loggers must be located at corner points in order to monitor relevant transport temperature fluctuation.
  3. Cool down period prior to shipping must be standarized and for practical reasons should take only one worst case into consideration.