By David Vaczek
As best industry practices for cold chain shipping develop, pharma and bio-drug firms are looking for support from transport solution providers. Several years ago, Continental Airlines Cargo (Houston) launched its ClimateSecure program for providing control and visibility for sensitive cargo consignments.
The carrier is extending its focus on the cold chain with the planned launch this year of a new product for maintaining ambient temperatures on the ground and in flight.
“In offering the ClimateSecure service, we made the decision to develop SOPs for temperature-sensitive drug shipments. We have implemented procedures that very much mirror the Chapter 17 regulations [in the air industry’s Perishable Cargo Regulations (PCR)],” says Mark Mohr, manager, product development and specialty sales.
“We are the only U.S. carrier with a structured temperature-controlled product for providing the best temperature management that we can provide, in places that we can control. We have a huge lead, and we intend to maintain that lead,” Mohr adds.
The new solution includes temperature- controlled cargo carts for holding noncontainerized freight on the ground and at ramp staging areas. The specially modified units are made by Refrigerated Container Supply (La Porte, TX), whose solutions include containers used for storage of batteries for NASA’s international space station.
ClimateSecure has offered priority shipment services for RKN and RAP-style containers, which are loaded into Continental wide-body aircraft, Boeing 767s and 777s. “We are primarily a narrow-body airline. The cargo carts will support temperature-controlled handling, geared to the narrow-body planes and palletized passive packouts.
Pharma shippers approached us for a methodology for handling these conditions. The tarmac is absolutely the weakest link in the temperature-control chain, where cargo is exposed to climate extremes. The ground is where we really have the most opportunity to assist pharma companies and their packaging suppliers,” says Mohr.
“Whether it’s 100ºF on the tarmac, or below zero, we can ensure that we are meeting label storage requirements,” he adds.
Chapter 17 of the PCR, adopted last year by the International Air Transport Association, defines good storage practices for handling medicinal products, referencing guidance from groups including the World Health Organization and the International Pharmacopoeia. The regulations cover requirements for storage areas and storage conditions and for ensuring maintenance of storage conditions in transport. Trained personnel must know exactly what to do with containers to ensure quality assurance.
PCR’s Chapter 4 notes that cargohold 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.
The whole idea is to make sure that all involved are aware and know what is expected of them.