Pharmaceuticals – Chilled from start to finish

Monitoring the necessary temperature throughout a drug's total life cycle has become critical to the movement of pharmaceuticals, especially clinical trial products.
Regulatory policies worldwide increasingly require manufacturers to produce complete audit trails recording where a drug was made, with what ingredients, where it was stored and for how long, and where, when and how it was delivered.

The audit trail must display the temperature at which the drug was kept throughout every stage – whether it is ambient, chilled, normally 2-8infinityC, or frozen.

"We've been audited more than 15 times in the last six months, " says Magnus Welander, CEO of temperature controlled packaging specialist Envirotainer. "The audits go from the drug companies right back to the manufacture of our containers." It is hardly surprising that more logistics companies are putting a greater focus on the cool chain, too. DHL, UPS, TNT, FedEx, Lufthansa, Kuehne & Nagel, Schenker and KLM all have people in charge of the temperaturecontrolled aspects of their business, gaining a good understanding of the pharmaceutical companies' needs.

There are several stages in maintaining a "cool chain" – although it could be that a warmer temperature needs to be maintained as much as a cool one.

A product going from, say, Italy to Canada in winter may need cooling for part of the journey and heating for another part.

Chilled or frozen storage must be provided if the product is going to be kept for any length of time.

Temperature-controlled vehicles or very well insulated packaging – or both – will be needed for road distribution, while the packaging becomes critical when goods are shipped by air or sea, although reefer containers and even temperature-controlled aircraft can be used.

Cargolux, for example, can set an entire B747-400F to fly at +4infinityC or 0infinityC.

Most importantly, there has to be a way to monitor temperature throughout the product's journey in order to complete those audit trails.

Jan de Rijk Logistics, for example, is planning to connect its temperature measuring devices to the incab computer later this year, so that drivers can see the trailer temperature at any time. As the in-cab computer is connected to base, depot staff will be able to read the same information.

Good road vehicle monitoring is important, as more companies switch from air to road for European pharmaceutical transport.

"The industry traditionally used air, " points out Nick Revell, sector director healthcare for Exel, "but over the last couple of years, companies are recognising the extra costs of air may not be worth paying, especially when the cargo can be held at either end of the journey.

"Lead times within Europe aren't that much longer by road than by air. Alot of product is so well insulated it doesn't matter if the vehicle's temperature is not maintained throughout the journey. Some insulation can even maintain a pre-chilled temperature for five days, if the ambient (outside) temperature is not too hot.

"Temperature-controlled vehicles come into their own when there is sufficient product to fill the trailer.

Pharmaceutical companies are even coming round to the idea of shared-use vehicles in order to benefit from temperature-controlled units." New developments in packaging are helping to maintain the chain of temperature control. Exel has developed thermal blankets and insulated pallet boxes.

The blankets go over an airline pallet that is already at the correct temperature.

Pallet boxes operate in a similar way, but are designed for chilled product currently used on the Italy/Japan route.

FedEx is testing different packaging at the moment, including plastic containers wrapped around the product and then frozen, allowing goods to maintain frozen conditions for up to 72 hours.

Traditional methods of maintaining temperature, such as gel packs and dry ice, are still relied on – but now temperature-monitoring devices can be put in the product itself, rather than the container, to provide a more accurate temperature reading.

"There's a constant improvement in packaging, " emphasises Andrew Pohl, VP US central region for Schenker. "Pharmaceutical companies are always trying to reduce the weight and the amount of dry ice needed, as we did for Roche." Mario Johnson, pharmaceutical industry manager for DHL, adds:

"Packaging has to hold the right temperature, whatever the temperature outside the package." Envirotainer has helped overcome this problem. Used primarily for air freight, Envirotainer's three products – one pallet, four pallets and up to 60 litres – are extremely popular. Each contains dry ice and a fan;

when the temperature starts to climb, the fan kicks in to blow the cool air from the dry ice round the container.

Now Envirotainer is testing a product – in the onepallet size – that contains both cooling and heating properties, driven by batteries. The dualtemperature control unit will be available later this year.

The new product also has increased security features, with an IT-controlled interface that can connect to an alarm to record when a door is opened or the container is pierced.

Security presents another challenge to maintaining temperature, though: global cargo security regulations introduced after 9/11 can cause any pallet or consignment to be held up.

If a pallet or consignment contains temperaturecontrolled goods, the delay can affect the temperature.

By ensuring paperwork is correct and as much information is provided in advance as possible, the risk of security inspection can be minimised – but no one, not even a pharmaceutical company or its 3PL, can guarantee its shipment will not be singled out.