Many critical, life-saving pharmaceutical medicines and treatments must be shipped and stored at low temperatures in order to remain effective. Maintaining this uninterrupted "chain" of cold conditions from the point of manufacture to the point of administration to a patient is known as the pharmaceutical cold chain. Pharmaceutical cold chain management refers to the logistics and planning of a pharmaceutical supply chain that is kept within a range of specific, low temperatures.
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Why some pharmaceuticals have to be kept cold
Today's pharmaceuticals may comprise complicated molecules that only remain stable and viable at low temperatures—and which may degrade or change at higher or ambient temperatures. For some products, temperature changes may have minor or insignificant effects on product quality or appearance. With medicines, the results of degradation of active components may range from a treatment being ineffective to being dangerous to a patient's health.
Pharmaceutical mixtures composed of individual molecules or compounds that may be stable at room temperature can lose their efficacy if they are not kept cold after they are mixed. This is because the way the compounds are combined may be critical to therapeutic efficacy. If the mixture separates into individual components or subsets of components, the medical use of the pharmaceutical will be lost.
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How pharmaceutical cold chains work
Pharmaceutical cold chain management requires the conscientious use of specialized machinery and equipment for creating and maintaining low temperatures. The components of the pharmaceutical supply that must be kept cold need uninterrupted low temperatures, from production to patient. These temperatures must be monitored and tracked at regular intervals to verify that the cold chain has remained unbroken.
For pharmaceuticals that only require freezing or near freezing temperatures, the cargo holds of refrigerated trucks or ships can be used to transport materials. A refrigeration unit works using the same principles as a home refrigerator or air conditioner: it keeps the cargo area at freezing or near freezing temperatures. Dry ice, or frozen carbon dioxide, may be used to keep temperatures low when traveling between controlled environments.
However, some parts of the global medical supply chain actually require cryogenic freezing, defined as temperatures below negative 150° Celsius or negative 238° Fahrenheit. Current technology can only maintain these temperatures in specialized vessels that use liquid nitrogen or other liquified gases to maintain these extremely low temperatures. Because these specialized vessels maintain low temperatures by allowing the liquid nitrogen to boil off over time, they must be configured in a way that allows the gases to escape safely as they boil off.
Challenges to cold chain integrity
The pharmaceutical cold chain requires high supply chain visibility in order to verify that the cold chain has been maintained. Relying on voluntary reporting may be insufficient, so specialized equipment and automated notifications should be used to get reliable, timely information. Special sensors that are able to monitor, record, and transmit temperature information about individual shipments can be used to verify that a pharmaceutical has remained at the appropriate temperatures during transit.
Special logistics software is also required to manage and process this data. A pharmaceutical supply chain management team must be able to quickly ascertain whether medications will be effective on arrival. There also needs to be communication between the supply chain managers and the medical practitioners so that patient treatments can be timed with precise delivery windows.
FAQs: Are all pharmaceutical cold chains kept at the same temperature?
Are all pharmaceutical cold chains kept at the same temperature?
No, different cold chains in the medical supply chain can require different levels of cooling. Organs and living tissues should be kept in a narrow range just above freezing, between around 4–8° Celsius. Live organs and tissues for transplantation can be destroyed if the temperature gets too low. Conversely, some pharmaceuticals require extremely cold cryogenic temperatures to remain effective.
What does "time at temperature" mean?
"Time at temperature" is a measure of how long a given shipment was kept at a certain temperature. This is an important metric in pharmaceutical cold chain management, as some medicines can only be kept at certain temperatures for certain periods of time before becoming ineffective.
Why does a cold chain require tighter supplier collaboration than other supply chains?
Supply chains with goods that can be kept at room temperature or above have some flexibility in them that cold chains don't have. With a cold chain, the goods must be kept in specialized facilities that are expensive to operate, so suppliers in the chain must collaborate to make sure there is capacity to not only receive the goods, but to move the goods within an appropriate time window.
What kind of drugs and pharmaceuticals need to be kept cold?
Many vaccines require an uninterrupted cold chain. Of the two most promising COVID-19 vaccines, for example, one requires temperatures well below freezing, and the other requires a cryogenic cold chain.
Many drugs that are biological molecules, such as insulin or asthma inhalers, also require a cold chain.
If a cold chain is broken, do those medicines need to be discarded?
Not necessarily. If the break in the cold chain was short enough, or if the temperatures were only slightly above what is mandated for the medicine in question, it may be possible to salvage the shipment. Every pharmaceutical that requires a cold chain is rated for how long they can remain outside of their cold before losing efficacy. After all, when a vaccine is administered, it isn't injected at cryogenic temperatures, as the saline excipient and adjuncts would be frozen solid at those temperatures.