The cold chain is an indispensable condition in many areas such as human health and food. The disruption of the cold chain can sometimes even have fatal consequences. So how exactly can the cold chain conditions, which have such an important place for our health, be provided? In this article, while answering the question of what is the cold chain in the pharmaceutical industry, we will also discuss what the cold chain means for our health and the purpose of the cold chain.
In the pharmaceutical industry, millions of different types of drugs are distributed and delivered daily. These drugs include vaccines, blood, genes, and tissues, biopharmaceuticals such as allergens; prescription drugs such as stimulants, opioids, and benzodiazepines; over-the-counter medicines such as food supplements, minerals, vitamins, cold remedies, dermatological products, and common cough medicines; There are bulk pharmaceuticals and raw materials such as drug active or active ingredients and chemical compounds.
These drugs come in three basic forms: liquid (spirit, elixir, and tincture), ointment (paste, cream, and jelly or jelly consistency), and solid (tablet, lozenge, suppository, and pill). The cold chain is inevitable for these drugs, which have such a wide variety and circulation and need to be supplied quickly for people’s access. In this respect, the management of the cold chain in the pharmaceutical industry is of utmost importance.
What Does the Cold Chain Mean?
Maintaining the cold chain in the pharmaceutical industry is of great importance for the main reasons we have mentioned above. By providing temperature control and maintaining the cold chain, the effectiveness of the drugs is also preserved. However, of course, cold chain control is not limited to transportation only. The cold chain must be provided correctly for the next stages, which are the storage and distribution stages.
In the pharmaceutical industry, the cold chain has a huge share in value and plays an important role. Moreover, this role is getting bigger day by day and is expected to increase further. As the variety of drugs increases with alternative drugs and treatment methods against different diseases, it is inevitable that these drugs require different temperature conditions. Therefore, different logistics conditions should be provided for each drug and the importance of the cold chain should be emphasized.
Why is the Cold Chain Important in the Pharmaceutical Industry?
One of the reasons why the cold chain is so important in the pharmaceutical industry is the biological materials used. These materials are extremely sensitive to temperature change. Accordingly, it is essential to ensure the correct temperatures in both transportation and storage, and distribution processes. The most important condition of providing the cold chain is to be able to provide the necessary equipment. Among this equipment are ultra-low temperature freezers, blood bank refrigerators, cooler/freezer combi, and outdoor coolers.
What is Cold Chain in Pharmacy?
Pharmacists can be seen as the authorized professional group in the cold chain application in the pharmaceutical industry. Especially in the storage phase, ensuring the cold chain in pharmacies plays an important role. Medicines that are delivered to the consumer or patient in the right conditions and by providing the required temperatures mean that all possible risks are eliminated. In this respect, everyone belonging to this professional group should be properly informed about the importance of the cold chain. In the case of pharmaceutical products, pharmacy personnel must have received the necessary cold chain training, both in the production and subsequent distribution and storage stages.
Same way; Storage practices, storage warnings, regulations, and methods as well as safety training should be provided to pharmacists. In pharmaceutical products, the rules regarding the storage and use of temperature-sensitive products should be followed; In case of non-compliance with the conditions, products that deteriorate or may deteriorate should never be delivered to the consumers and should be disposed of appropriately.
Special Storage Conditions for Pharmacies
Many biological products require various safety precautions and various storage conditions to maintain their efficacy, just as indicated on their packaging. This category of biological products includes bacterial vaccines, viral vaccines, and plasma products. Such products often require storage conditions in the form of refrigeration or freezing.
It is also very important to ensure the correct temperature for products that should not be frozen. The pharmaceutical branch of the cold chain in the pharmaceutical industry is also important in this respect. There may also be biological products that need to be preserved at room temperature. Similarly, in case of a power outage, it is possible to store these products while maintaining their effectiveness as long as there is no major change in the temperature of storage equipment such as freezers or refrigerators.
At this point, the pharmacist’s knowledge and experience come into play. However, if any question mark arises in the mind of the pharmacists about the storage conditions, they should definitely consult the manufacturer. In this way, any disputed situation regarding the effectiveness of the drug will be eliminated.
In all pharmacies, monthly temperature monitoring charts and pharmacy cooler daily temperature monitoring forms should be filled in regularly by the relevant responsible pharmacist. In this way, cold chain conditions can be provided.
What is the Purpose of the Cold Chain in the
Pharmaceutical Industry?
The cold chain in the pharmaceutical industry is, above all, a legal requirement. The purpose of the cold chain is to protect and control pharmaceutical products at the right temperature, from production to storage and then to the consumer. If the cold chain is broken, drugs may lose their effectiveness. It can even create deadly hazards in biological products such as vaccines or plasma. Therefore, the purpose of the cold chain in the pharmaceutical industry can be summarized as storing drugs in a way that preserves their effectiveness and delivering them to consumers.
In biological drugs and other drugs, those sensitive to temperature changes should be protected during transportation (and storage periods) within the healthy preservation temperature range determined by the manufacturer. Of course, providing these required and specified temperatures is important for the producer as well as the consumer. The consumer wants to get the right efficiency from the drug. Manufacturers will be able to ensure its reliability only as long as the consumer gets the expected efficiency from the drug they produce. This can happen if the cold chain is not broken and the drug can store its effectiveness until the end-user.
Cold Chain in Refrigerated Environment and Pharmaceutical Industry
The temperature of a refrigerated environment for the cold chain in the pharmaceutical industry is in the range of + 2 ° C to + 8 ° C. The most important thing to note about refrigerated products is that the temperature does not drop too low to reach the freezing point. In the same way, the temperature should not increase and the ideal temperature range should not be exceeded. In the event of these two extreme situations, the drugs will lose their effectiveness.
Cold Chain in the Frozen Environment and Pharmaceutical Industry
Some drugs come with a refrigerated environment, while others come with a frozen environment requirement. The ideal temperature for the frozen environment can be considered as – 15 ° C or below. It may not be possible to visually detect whether the products that require a frozen environment are thawed and frozen again. For this reason, pharmacists, warehouse managers, and people involved in the relevant process should undergo laboratory evaluation at the beginning of the process.
Cold Chain in the Pharmaceutical Industry and Storage Conditions
In order to provide and protect the cold chain, equipment that does not feel the temperature changes such as ultra-low temperature freezer, blood bank refrigerators, cooler/freezer combi, outdoor coolers are used or should be used. Thanks to brands such as Coolermed that offer different cooler options and equipment with temperature control or alarm systems, it becomes easier to maintain the cold chain in the pharmaceutical industry.
In this article, we have talked about the cold chain in the pharmaceutical industry. You can read our previous post on https://coolermed.com/en/covid-19-vaccine-preservation/
