Cold chain or temperature controlled supply chain of temperature sensitive pharmaceuticals - Healthcare

(+2°C to +8°C) or (0°C to +25°C) or (+15°C to +25°C)

If we take a closer look to the pharmaceutical industry we see that a number of different medicines or pharmaceutical product groups are formed depending on the temperature of the product. The pharmaceutical industry has three major temperature product groups being the cooled or chilled products, the frozen or deep frozen products and the ambient products. Each group has a certain maximum and minimum temperature barrier or limit which may not be exceeded seeing this may damage the quality of the product. The most known barriers are the chilled products (+2°C to +8°C) and ambient products (+0°C to +25°C) or (+15°C to +25°C). This last group used to be an ambient group which did not require a temperature controlled environment and could expand over its temperature limits, yet due to rising laws these products also need to be kept within its limits, therefore creating a new specialized cold chain.

A cold chain is a supply chain in which the temperature of the product or its environment is controlled. This means that from the producer to the end user the temperature of the medicine or pharmaceutical product is kept within its minimum and maximum limits. To do this each actor in the cold chain as producers, transport companies, distribution centers, resellers, airliners and forwarders, sea freighters etc… who are handling the product, need to take the necessary measurements so they can guaranty the required temperature. The big challenge of the total cold chain is to create a closed cold chain meaning that no gabs appear in the chain in which the temperature of the product can fluctuate above its minimum or maximum limits. In a closed cold chain we can therefore state that the “CCP’s” Critical Control Points are under control. The cold chain becomes even a bigger challenge when different products with different temperatures groups for example (+2°C to +8°C) and (+15°C to +25°C) are handled which means that for each group a different cold chain needs to be created.
Question? What is the best and most efficient way to close the cold chain or to create a totally closed cold chain in which the CCP’s are under control so temperature fluctuations do not appear and the quality of the pharmaceutical product or medicine can be guaranteed?

To transport temperature sensitive pharmaceuticals, an active cooling or passive cooling or a combination of both can be used. If we talk about an active cooling system we mean that an electrical or mechanical cooling engine is used to create a temperature controlled environment in which the air, that is surrounding the medicine or pharmaceutical product, is cooled or heated. When we talk about a passive cooling system we mean that an insulation material is used to insulate the medicine or pharmaceutical product to protect its own temperature against unwanted external or outer temperatures. Which of both cooling techniques is used is depending on a lot of items like prices or costs, logistic processes, distance of the transport, time of the transport, required temperatures and outer temperatures, etc… It is up to each actor in the cold chain to guaranty the temperature of the pharmaceutical product or medicine and prevent that the minimum or maximum temperature is exceeded. How, that is up to them yet active cooling systems can create a number of “CCP’s” Critical Control Points in the cold chain what explains why more and more companies are using passive cooling systems or a combination of active cooling and passive cooling in which the passive cooling is used to tackle the CCP’s in the cold chain.

Below is shown an overview of possible cold chain solutions or options in which temperature sensitive pharmaceuticals can be distributed through the supply chain. It also shows the considerations on each possible cooling technique: active cooling or passive cooling.

This website offers several products which can be used to implement in the above cold-chain and the suggested cooling techniques.

The Temax insulation can be produced for single use or multiple use applications. The Temax insulation is already successfully in use for the transport and distribution of temperature controlled food products, pharmaceuticals and chemicals in which chilled or cooled, frozen or deep frozen, and ambient temperature products are protected from unwanted external outer temperatures. The Temax insulation is flexible, has a high insulation quality which can be produced tailor made, is water resistant and is recyclable, even partial biologic degradable.

Krautz-Temax as the developer and producer of the Temax insulation material offers also studies on the insulation technology and quality as the logistic processes to close the cold chain or temperature controlled supply chain. We have several protocols on how pallets or boxes should be wrapped and packed in order to prevent cold bridges and result in a optimal temperature preservation and temperature protection. See also cold chain implementation plan

The Temax insulation material is already in use at some of the biggest pharmaceutical companies, food and chemical companies, freight forwarders and transport companies, airliners and shippers etc... This in road transport, air cargo and sea freight as single use or multiple use applications.