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Vaccine Storage and Cold Chain Directive

Vaccine Storage and Cold Chain Directive

As the fight against the coronavirus epidemic continues around the world, the successful development of effective COVID-19 vaccines will represent a crucial milestone in efforts to end the global public health crisis. However, the cold chain is essential in developing vaccine formulations against the pandemic and ensuring that these critically important drugs are widely available to providers and their patients. Vaccines that comply with the vaccine storage and cold chain directive can be served all over the world without any deterioration.

Accordingly, the safe and effective distribution of vaccines and compliance with the vaccine storage and cold chain directive requires some complex and effective logistics solutions.

Vaccine Candidates and Storage Conditions

Of course, it is necessary to talk about the cold chain not only for COVID-19 vaccine candidates, which is the rightful topic of today but also for all valid vaccines and vaccine candidates. All vaccines to be administered to patients are classified as “cold chain” products that require specific storage and transportation needs from the moment they leave the facility where they are produced until they are distributed or reach a healthcare provider or patient at the point of administration.

The vaccine storage and cold chain directive, in this regard, generally requires a certain degree of protection of vaccines or their ingredients. The most effective and valid method for storage and logistics at these degrees is the use of vaccine refrigerators.

What is the Cold Chain and Why is it Important?

What exactly do the “cold chain” we refer to under the vaccine storage and cold chain directive mean, and why is the private transport and storage of these vital treatments so important to their effectiveness?

“Cold chain products” refers to drugs that must be kept within a precise temperature range. These products include vaccines, biologics, oncology treatments, some types of insulin, and other drugs.

At What Temperature Should Cold-Chain Drugs be Stored?

Most cold chain products need to be kept between 2 and 8 degrees Celsius, and frozen products below -10 degrees Celsius. Some of the leading COVID-19 vaccine candidates are classified as “ultracold chain”. This indicates temperatures below -80 degrees Celsius, under the vaccine storage and cold chain directive.

Cold Chain and Effective Cold Chain

Vaccines or drugs of the type mentioned above, which should be protected in the cold chain, will also maintain their effectiveness if these temperatures are met. Maintaining the integrity of these vaccines and other cold chain products includes:

-To ensure the required temperature range during storage and transportation;

– Packing and shipping according to recommended procedures;

-Keeping in the recommended cold chain conditions at all points of the supply chain;

-Convenient storage and transport at maintenance points.

Effective protection and experience for complex treatments

Pharmaceutical distributors draw on their significant expertise in cold chain storage and transportation when processing temperature-sensitive products and other specialty drugs.

When determining which packaging materials will be used for cold chain shipments in order to comply with the vaccine storage and cold chain directive; There are several factors to consider, including shipping and control requirements for each drug, expected shipping time, the type of shipping carrier to be used, and expected weather conditions during shipping.

Also; renewed packaging has enabled distributors to continuously improve their cold chain compliance. Distributors use a variety of packaging types and shipping solutions to maintain the precise temperature ranges needed to ensure the integrity of sensitive products. These include ice and gel packs, agency-approved insulated boxes, dry ice, temperature monitoring devices, and refrigerated shipping, temperature-controlled containers, refrigerated cabinets. In this way, it will be possible to keep the products at the right temperatures during carrying and transportation processes and in the following few days.

Increase in Drugs Requiring Cold Chain

The number of drugs that require cold chain use is increasing day by day. According to statistics, half of the approved drugs manufactured in the United States in 2018 are temperature-sensitive products, and the total value of cold chain treatments is expected to increase by nearly twice that of standard drugs between 2018 and 2024. In this direction, industrial bodies that need to comply with the vaccine storage and cold chain directive are making innovations and investments in this field.

Leveraging the Existing Supply Chain in the Delivery of COVID-19 Treatment

Distributors’ expertise in transporting cold chain products and other specialty treatments will play a critical role in the distribution of COVID-19 vaccines. With the industry’s investments in cutting-edge, temperature-controlled supply chain protocols, distributors appear poised to protect the integrity of their breakthrough COVID-19 treatments.

There is an unprecedented demand for approved vaccines and treatments as they become available, so the accurate and effective distribution of these drugs requires close coordination between governments, public health professionals, and the private sector. Distributors are ready to apply their logistics expertise and cold chain capabilities to ensure patient access to vital COVID-19 treatments across the country.

Sensitivity of Vaccines and Necessity of Cold Chain

Vaccines are sensitive biological substances that may be less effective or must be destroyed if:

  • frozen
  • allowed to get too hot
  • exposed to direct sunlight or UV light, including fluorescent light.

When vaccines are repeatedly exposed to temperatures outside the +2°C to +8°C range, the loss of potency is cumulative and irreversible.

Of course, the requirements for each drug and vaccine may be different. For this reason, the vaccine storage and cold chain directive should be handled correctly by experts and applied effectively both in the transportation and distribution processes.

Location of Vaccine Refrigerator in the Storage of Vaccines

As we mentioned above, vaccines and medicines should not be allowed to be preserved at certain temperature ranges and frozen or left at extreme temperatures. The most effective transportation, carrying, and distribution method in terms of vaccine storage and compliance with the cold chain directive is vaccine refrigerators.

vaccine refrigerators are the equipment that allows the vaccine and various drugs to be preserved for certain periods by adjusting the desired temperatures. With the increase in the number of vaccines and drugs that require cold chain protection, investments in this field have increased globally. In this way, different features and applications are made in vaccine cabinets.

Use of Vaccine Refrigerator

Vaccine refrigerator, as we mentioned, has now become more common and diverse. For this reason, it is now essential to use vaccine cabinets to comply with the vaccine storage and cold chain directive. Vaccine cabinets not only provide the correct cold chain temperature but also allow temperatures to be adjusted and regulated at different time intervals.

In this way, the storage of vaccines and biological drugs has become easier. The importance of vaccines has come to the fore even more, especially in the current era of COVID-19. Ensuring the global distribution and availability of these vaccines is also an inevitable requirement. In order to meet this requirement, the use of complex logistics methods including vaccine refrigerators and vaccine refrigerators around the world is indispensable.

In this article, we have talked about vaccine storage and cold chain directive. You can read our previous article on https://coolermed.com/en/cold-chain-in-the-pharmaceutical-industry/