Cold chain is a term that typically describes the distribution channel used to ship drugs in the refrigerated temperature range of 2ºC to 8ºC. But Edward Church (shown), executive director of the International Safe Transit Assn., explains, "I would refer to this environment as the temperature-controlled supply chain, not just the cold chain, because we work with a variety of temperatures, although the 2º to 8º Celsius range is used most prevalently with pharmaceuticals and biological products." In this article, Church identifies factors to consider when shipping temperature-sensitive pharmaceutical and biological products.
In March, Church addressed a HealthPack 2008 audience in San Antonio. He noted that ISTA and the Pharmaceutical Cold Chain Interest Group (PCCIG), within the
Parenteral Drug Assn., "are working together to develop supply chain standards, including temperature data in the U.S., so that profiles can be created for lab qualification testing of transport packaging."
He recommends companies utilize the PDA Technical Report No. 39, "Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment." He says, "If you have just been put in charge of temperature-controlled distribution, this gives you a good overview. It's a good guide to get you started and develop an understanding of what you're trying to accomplish."
Church also made the following recommendations at HealthPack:
• Anticipate both ambient temperature variations and the duration to which a product may be exposed during transportation.
• Conduct preshipment performance testing that matches your distribution hazards.
• Have profiles of temperature averages, both highs and lows, in various cities for international and domestic shipments.
• Find out if shock during distribution is causing damage that was previously thought caused by vibration during distribution, particularly for biological products.
More ISTA insights
Church believes "the distribution environment doesn't know a pharmaceutical product from others; it's just product shipments through their distribution systems. When you get into pharmaceuticals and biologics, it may be hard to determine damage to the products themselves. It's one of the criteria you have to establish: What constitutes damage to the product?"
Shock, says Church, refers to damage caused by impact. For example, shock may occur when product is dropped, when a pallet operator runs into another pallet with a fork lift, or when a vehicle goes over a pothole or curb and the product load impacts against a wall or on the floor in the carrier. Shocks tend to produce shorter-duration pulses. He says that differs from vibration, which tends to involve product movement during its distribution.
Air shipments, he says, tend to be the least damaging transportation mode, although he says that sea containers also do a sound job in cushioning product. Yet despite their potential financial savings compared to other transportation modes, Church says a trip across the Atlantic Ocean takes 10 to 14 days.
--By Jim Butschli, Editor
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