Talking Point: The cool chain
pharmafile | July 27, 2010 | Feature | Manufacturing and Production | Biocair, logistics, supply chain, talking logistics
A Cool Chain (or Cold Chain) is a supply chain along which a product’s temperature is maintained from the point of manufacture until its end use.
Cool chain is a core element in the transportation of temperature controlled pharmaceutical product. Most cool chain products are licensed to be stored between +2°C and +8°C and indeed, these temperatures are usually the ‘magic numbers’ in the industry. Cool chain is an expanding part of the industry and will continue to be so given increasing compliance requirements. This coupled with larger numbers of new drugs in clinical trials and R&D requiring chilled temperature control in storage means a potentially prosperous future for temperature controlled logistics.
Temperature controlled supply chains are not always ‘cool’. Some products have to be kept frozen – this is often achieved by packing it with dry ice. Other products must be kept warm – usually this means a room temperature band of something like +15 to +25°C.
Temperature controlled logistics
Perhaps the most difficult phase of the cool chain for a pharmaceutical supply chain manager occurs when a product leaves the control and security of the production and warehouse environment and goes into a third-party courier network or to a specialist logistics provider. The product is out of validated territory and away from qualified cold store rooms, stringent SOP-led procedures and so on.
The two main options for transfers of goods are to move them in a climate-controlled vehicle or in a self-contained temperature cont-rolled shipping system.
Climate-controlled vehicles are usually only practical for regular routes that take a large number of shipments. These ‘fridge-to-fridge’ routes rely on immediate refrigeration capabilities at its destination. Difficulties soon arise if deliveries are made out of hours or fridge space is otherwise unavailable. If deliveries have multiple destination addresses, this means a premium climate-controlled vehicle must visit them all. Delays from customs or rerouting all put the temperature controlled environment at risk.
So, for the flexibility over critical environmental requirements, self-contained temperature controlled packaging is often preferred. It is also frequently used by specialist couriers who have the most control over their routings.
Passive cool chain shipping systems are chiefly based on ice cool packs that provide a 0°C constant temperature as they melt and go through their phase change to water. The packaging designer arranges these cool packs with other components to balance this 0°C cooling effect against the heat coming into the insulated box. When balanced correctly, the contents are then kept between +2°C and +8°C. The challenge is in choosing the right system for the route in question. The correct functioning of the system depends on the box experiencing the appropriate external environment and delivery being made within the system’s lifetime (i.e. before the cool packs have completely melted).
The system is designed by testing it in the lab under a temperature profile modelled to reflect its real world experience. Often an ‘upper’ and a ‘lower’ temperature profile are chosen. By qualifying under both, a system is confidently validated for a range of real world experiences. Temperature mapping of routes can help determine these test profiles, which means using a data logger to record the ambient temperature experienced by a package on a particular route. By comparing different recorded profiles of different routes an overall ‘hottest’ and ‘coolest’ likely experience can be found. Of course this becomes complicated in the case of the logistics provider where collection points, consignee addresses and routes (including methods of transport) will vary between each shipment.
Uniting cool chain with a specialist logistics provider
The specialist logistics provider must have greater competencies than simply moving validated boxes from collection point to consignee. By having an understanding of the capabilities of temperature controlled packaging, they should manage and maintain their packages in transit to minimise temperature deviations and breaks in the cool chain. Specialist logistics providers will usually start by supplying appropriately qualified packaging for their shipment. They will prepare the necessary cool packs beforehand and at the time of collection load the customer’s product into it them-selves. This means the customer, shipper and consignee are all relieved of these responsibilities. A good specialist courier will be able to reduce clearance time in customs by ensuring correct documentation is present and accurate.
But some things are out of human control, delayed flight times and volcanic eruptions for example! On the rare occasions these problems do occur, intervention may be required. This could include reading and monitoring temperature logger data, replacing frozen cool packs with fresh ones or topping up dry ice in the case of frozen product shipments. By having a worldwide network of offices, agents and partners, a logistics provider can operate these maintenance procedures wherever their boxes may be. Bonded warehouse access is also critical when customs delays are involved. These procedures will extend the lifetime that shipping systems are able to operate under and ensure their customer’s product reaches its final destination in perfect condition.
Finally, the specialist courier should offer temperature logger data management. A temperature logger gives a journey history of the temperature experienced and can provide the deciding information for product release.
By mastering these practices, the specialist logistics provider can be a champion of bespoke and routine cool chain shipments.
Nathan Barnard is the cool chain logistics manager at Biocair. Visit: www.biocair.com
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