Pharma - Bio Transport - February 2008

transport. Trained personnel must know exactly what to do with containers to ensure quality assurance.

PCR’s Chapter 4 notes that cargo-hold temperatures are often difficult to predict. “Contrary to the common myth, air transportation temperatures in the cargo holds are not necessarily cold. In fact, they are in many cases quite high, despite the fact that at 10,000 ft altitude the aircraft structure is exposed to very cold air of about –55ºC.”

The capacity for aircraft cargo bin temperature control varies by aircraft type, so shippers have to know the plane’s configuration and available locations beforehand.

Boeing’s new Dreamliner 787s can be equipped with segmented temperature-controlled cargo compartments for heating and cooling, but the cost may be prohibitive. According to one industry source, a control system is a $250,000 investment, with another $250,000 for fuel consumed keeping it airborne.

Mohr says Continental has evaluated cargo bin temp control options for various aircraft types. The standard version of the 787 has the ability to manage temps to a certain degree in the rear pit, with an option for front pit control. “You have to determine whether there will be enough perishable cargo to make that investment in the forward temperature control pit. One of the hazards is you don’t want to restrict your capacity to load other cargo.”

The carrier is affixing temperature sensors to containers in ongoing temperature studies in warehouses, on the ramp, and in aircraft. “This is a value-added service to provide customers with the documentation they need for demonstrating product storage conditions,” Mohr says.

Pharma firms are in the market for such specialized services, for meeting FDA drug storage requirements and best practice guidance from the U.S. Pharmacopoeia and the Parenteral Drug Association. In defining air carrier requirements for GMP, GSP, and

GDP, the PCR’s Chapter 17 references the drug industry’s need for maintenance of product quality throughout the logistics chain.

“Loss of quality is a cumulative process whereby every little break adds up. A question that everybody involved in

the cold chain should ask is this: ‘Is the required transit temperature well maintained during the whole process or whilst in my custody?’” the PCR states.