Talking Point: Shipping temperature and pharma logistics
pharmafile | August 3, 2010 | Feature | Manufacturing and Production | World Courier, logistics, talking logistics
Whether you are forwarding a bulk shipment of finished product across multiple time zones, distributing clinical trial medications to local investigator sites in the heat of summer, or racing a high-value shipment of irreplaceable compounds to a research lab on the far side of the globe, maintaining the correct shipping temperature is imperative.
A lack of naïve patients in traditional markets has required companies to choose more esoteric and distant locations for investigator sites. When shipment are required to move across international borders using air transport then unless they have an unlimited budget, can charter an aircraft, and send a member of staff to accompany the consignment, then your control is passed through a sequence of handling companies and agents. At a time when regulators are enforcing the requirements for temperature control more than ever and budgets are being slashed, pharmaceutical companies need to find solutions they can trust to look after their precious cargo. New types of therapeutic agents need to be maintained at different temperatures; for example many biologics will be shipped between 0° and -20°C which is easy with a freezer in a static location plugged into mains electricity but is somewhat more difficult on the move.
Fortunately the airline industry has worked out that pharmaceuticals represent a significant part of their revenue stream and are responding to that with dedicated services. The 9th edition of the Perishable Cargo Regulations published last year by the International Air Transport Association introduces new requirements for the transportation logistics of healthcare products. Amongst these are a new quality management system, training requirements and a new label. It provides detailed instructions which aim to give a structure that will improve services on offer by the airlines and ensure compliance.
These changes are the result of the collaboration by carriers with pharmaceutical associations and many other stakeholders in the supply chain, including but not limited to freight forwarders, terminal operators, ULD manufacturers, packaging & tracking and tracing companies.
Mandatory from 1 July 2010, all time and temperature sensitive healthcare product shipments should be labelled with the standard IATA ‘Time and Temperature Sensitive’ label. Having one label universally recognised across the globe in the same way as standardised dangerous goods labelling should ensure that consignments are handled consistently. However, even with these regulations in place risk management remains imperative. Shipments still go wrong, and the problem is not normally when on board an aircraft, but when on the ground. Using appropriate temperature control transport systems is vital to maintain the exacting conditions required.
Temperature-control transport systems
There are currently a variety of temperature-control transport systems on the market designed to accommodate pharmaceutical shipments of every volume, dimension, temperature requirement, excursion tolerance and value.
‘Active systems’, ‘semi-active systems’, ‘passive systems’, – what should you, the bio-practitioner, know about these different packaging options? How can you determine the right choice for your application? How do you use this knowledge to build an effective cost/performance strategy for your department or company?
Active systems
‘Active’ packaging solutions typically use fans, thermostats, batteries and internal refrigeration components to manage the temperature of large-volume shipments and, due to the economy of scale they offer, are best suited for the distribution of commercial or bulk investigational drug shipments. These systems require constant monitoring and specific temperature parameters to work effectively. Systems can now be configured with active cooling and sometimes with heating capabilities, but it can prove difficult to maintain temperature levels over long periods of time and under extreme conditions. Consider the range of temperatures the shipment must endure in transit, allowing for extra layers of insulation, and follow well-rehearsed procedures prior to shipping to prevent problematic temperature fluctuations.
Semi-active systems
‘Semi-active’ systems are comprised of polystyrene or polyurethane outer casings with frozen and/or refrigerated ‘gel-pak’ coolants set inside. Economically priced, these systems are used primarily for ‘single-use’ applications and are perhaps today’s most common packaging option given their low dose unit/package cost ratio.
These types of solutions work very well for final-leg transport to a hospital/investigator site, or for medium-sized shipments destined for a centralised depot. Because they are unable to shut-off or regulate the energy release of their cooling mediums, internal shipment temperatures can be negatively impacted in colder environments or over longer transit times.
These systems are sometimes susceptible to decreased temperature stability, but this is where the client must make the cost/performance decision. If closely monitored for correct handling and storage throughout transit, semi-active systems offer exceptional cost/benefit performance in clearly-defined portions of the investigational drug distribution process.
Passive systems
Despite the simplicity of their name, higher grade ‘passive systems’ use a well engineered multi-use design concept to create a storage environment that mirrors the temperature of the commodity.
In more sophisticated systems, external casings are made of high-quality insulation materials with advanced phase change materials (PCMs) inside to absorb and store specific temperatures. The result is a highly-evolved temperature-control system that is more resistant to changes in both internal and external storage conditions. There is no doubt these systems are more expensive, but they offer a high degree of security and protection for high-valued and irreplaceable cold chain shipments and for consignments with little or no tolerance for temperature excursions.
Summary
There is no one ‘right’ system for any client or any consignment. Decisions should take into consideration the fundamental nature of each shipment: its size and dimensions; product stability and tolerance; distance to be travelled; expected transit time; ambient temperatures through which it must travel; intrinsic value of the shipment and required delivery time.
The right system used in conjunction with the right airline service can ensure that shipments arrive in good time and at the correct temperature.
Sue Lee works at World Courier. For more information visit: www.worldcourier.com.
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