Spoiler Alert: Temperature-sensitive Healthcare Shipments in Transit
Whenever a shipment is transported in a complex network involving many transportation modes, outside temperatures cannot always be well controlled. The shipment is exposed to various climatic conditions on tarmacs and on loading docks. Temperature excursions affecting the quality and potentially spoiling temperature-sensitive healthcare products are a major concern. In a recent webinar presented by FedEx Express about cost-effective temperature controlled shipping solutions, 47% of the participants ranked prevention of temperature deviations and excursions as the main driver for logistics decisions in 2013. In fact, pharmaceutical companies often report that temperature related spoilage is the predominant reason for transport insurance claims, ahead of theft and non-temperature related damage. Entire cold chain shipments may have to be discarded after a major temperature excursion during transit. Regulatory agencies also demand the collection of thermal data by shippers amidst increasing scrutiny.
Shipping labels such as the IATA time and temperature sensitive label indicate the desirable transportation temperature range, which may differ from the storage conditions. Experiencing temperatures outside the established range can have dramatic effects. For instance, a short exposure to freezing temperatures is enough to irreversibly damage biotechnological products. Whenever a shipment is out of its admissible temperature range; physical, chemical and biological changes may start taking place within the temperature sensitive product. Toxins and other undesirable degradation by-products may be generated through chemical reactions. Crystallization, softening, melting, change in visual appearance or demixing are among the changes known to occur.
Often, however, brief temperature excursions are acceptable in transit. The length and extent of the allowable temperature excursions are, of course, product specific. Stability studies establish how quality, efficacy, potency and safety of a drug vary as functions of time under various environmental conditions such as temperature, relative humidity, light, vibrations, atmospheric pressure and others. The International Conference on Harmonization (ICH) has established guidelines for stability test methods, focusing in particular on temperature and humidity. Pharmaceutical and biotechnological companies follow the recommended test protocols to determine acceptable storage and transport conditions. These tests include long-term studies under recommended storage conditions to determine shelf-life or expiration date as well as short-term stress tests under incrementally increasing extreme conditions to obtain data about product degradation and spoilage. Accelerated tests, which are not as severe as stress tests, are based on the assumption that tests at higher temperature and higher relative humidity than those anticipated during storage will be equivalent to impact of storage conditions over a longer time period. They can be used to establish impact of environmental parameters during transportation. In addition to the nature of the pharmaceutical drug, attributes such as dosage forms (e.g., cream, solution, emulsion, suspension, capsule, pill, tablet, inhaler), dosage strengths, container/closure system and packaging play a role in stability results.
Transportation companies keep on improving their services, equipment, procedures and training to reduce exposure to uncontrollable environmental parameters. FedEx Express aspires to provide the best customer experience possible, and has performed some of the most extensive aircraft thermal mapping studies in the shipping industry as well as implemented specific heating / cooling procedures for its long-haul flights. Cold storage areas, re-icing and gel pack replenishment are among some of the contingency measures available for delayed cold chain shipments at specific FedEx locations worldwide.
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December 13, 2016
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