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Within the global logistics supply chain the transportation of cold chain products is generally very highly regulated, with GMP, GDP or even GSP regulations.

Not only do these regulations relate to finished goods but many supply chain regulations are now either being updated or rewritten to include API's (Active Pharmaceutical Ingredients) and manufacturing materials that are used in the process of manufacturing medical products for human and animal consumption. This is partly because of the fact that many of these active ingredients and bio-logic materials are being supplied from the developing regions of the world like Asia and India.

Not only is the interest focused on the quality and content of these materials but also on the shipping methods and temperature management of them during transport to the final plant where the manufacturing will take place. Moving these materials globally potentially consists of a long transit cycle to reach countries like the EU, US or the UK (for example), but also there will generally be an additional transport cycle from where they will initially be received to a warehouse or to a manufacturing plant.

Under all noted general regulations cold chain products, API's or finished goods, will need to be transported within environmentally managed conditions to meet the stability requirements of the materials or drugs. But there are many situations where portions of the transport may be in an uncontrolled environment like: from a local manufacturing facility to a local warehouse, movement from the holding refrigerator to the distribution dock, during transport where a change of transportation method may be involved; These are all examples of potential TOR (Time Out of Refrigeration) situations.

It is estimated that about 80% of all cold chain shipments include a temperature monitoring device included within the case or carton, the other 20% relying purely upon previous profiling of the shipping lane, or route, anticipating that no changes have, or will occur!

One large drug company recently found that a dampness was being discovered inside there cold chain shipping cartons when being opened at their client's facility.

After much investigation it was discovered that the gel packs were transported from the "flash freezer" facility to the holding warehouse in a truck that had no refrigeration and then when the gel packs were delivered they sat on the loading dock for up to an hour before going into the holding freezer.

Hence, during this approximate period of about 2 hours of real TOR, condensation moisture formed on the frozen gel packs that re-froze on the outside of these gel packs when they were stored in the holding freezer. Once they were removed to be part of the pack-out during transit the moisture unfroze and caused dampness within the boxes. Net result reluctance on the part of the receiving client to accept the products in their received shipping container condition.

The solution was to include a temperature logger with the pallets of gel packs to make sure the temperature of the shipments do not drop more that a degree, or so, before they go into the holding freezer from the receiving dock. Also by checking the time slots on the logger if there are some increases in temperature above possibly 5 degrees or more, it can be tracked back to see if this was caused by the pallets sitting on the dock too long and the SOP's not being followed which required these items to stored as soon as they are received.

It behooves all shippers of cold chain products to include some form of temperature monitoring device within each shipment to make sure that the manufacturers shipping recommendations are maintained, because it can never be guaranteed that there will not be delays, or items will sit on a tarmac, or on a shipping dock until it gets stored correctly.

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Peter Norton is currently employed as the Business Development Director for DeltaTrak Inc., of Pleasanton CA. His primary areas of expertise relate to Cold Chain and Supply Chain Logistics Solutions, for which he advises clients on processes related to Cold Chain shipping solutions, Risk Assessment, Inventory Management and the emerging new rules and regulations for Cold Chain linked into Track and Trace and e-Pedigree.

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