As the fight against the coronavirus epidemic continues worldwide, 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 their 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 worldwide without deterioration. Accordingly, their safe and effective distribution and compliance with the vaccine storage and cold chain directive require complex and effective logistics solutions.
Freeze Dried Vaccines
Frozen vaccines are produced using the lyophilization method. This method, used in the pharmaceutical and biotechnology world, enables the fixed storage of drugs. This method, which offers the opportunity to be used when necessary, is often preferred. Thanks to this method, vaccine storage becomes much easier and more practical.
Lyophilization, or freeze-drying, involves several critical steps. Initially, the vaccine is frozen and then placed under a vacuum. This environment allows the frozen water in the vaccine to sublimate, meaning it transitions directly from a solid (ice) to a gas (water vapor), bypassing the liquid phase. This process effectively removes moisture from the vaccine without impacting its biological and chemical stability.
Vaccine Candidates and Storage Conditions
Vaccines are vital components in global health, requiring meticulous attention and protection, predominantly due to their sensitivity to environmental conditions, such as frozen ones produced using the freeze-drying method. They must be stored in specialized vaccine cabinets to maintain efficacy and reliability.
Not only COVID-19 but all vaccines administered to patients are considered “cold chain” products, meaning they necessitate specific vaccine storage and transportation conditions from the moment of production until they reach the point of administration. This is crucial for maintaining the integrity and preventing any degradation of their components or themselves. The vaccine storage and cold chain directive mandates specialized storage units like refrigerators to uphold the stability of their components. These units provide the environment to store effectively at required temperatures, preserving them in optimal conditions until administered.
Every vaccine storage has different requirements, and any breach in the cold chain can result in the loss of potency, rendering it ineffective and, in some cases, unsafe. Hence, maintaining the cold chain is paramount for all valid vaccines and candidates. The most effective method for managing vaccine storage and logistics requirements is the deployment of specialized refrigerators and cabinets designed to offer precise temperature controls and monitoring systems, safeguarding these products against any adverse conditions. Brands like Coolermed specialize in producing high-quality and reliable medical storage cabinets, catering to the varied needs of healthcare providers and ensuring that they continue to be used in an intact and viable form when necessary.
Distribution Processes of Vaccines
Transport and storage of vaccines are particularly important in terms of the distribution processes of vaccines. Because they can be produced in limited numbers. However, since they are easily perishable, they must be stored at an appropriate temperature. For this reason, the distribution processes become an issue requiring sensitivity.
The question, “What is cold chain application?” on vaccine transportation, stands out among the questions that need to be answered. “How should the storage conditions of vaccines be?” The question is one of the factors to be considered in this process, which is very curious. With the Covid-19 outbreak, they are being talked about more.
The Importance of Vaccine Cabinets for Distribution Processes in Vaccines
While vaccine transportation activities occur, cold boxes, transport containers, carriers, ice bags, ice containers, refrigerators, refrigerated vehicles, and temperature monitoring devices are the most used tools and equipment. For those wondering what a vaccine cabinet is, it is possible to explain it as a storage tool that allows them to be kept until they are used after they are procured.
While dead and live bacterial vaccines are stored at +2/+8°C, this temperature range is expected to be between -15/-20 °C for viral ones. Otherwise, there is a risk that they will fail. As for the function of these cabinets regarding the distribution processes, they offer a healthy solution for proper vaccine storage conditions.
What is the Cold Chain in Vaccine Storage?
What exactly does the “cold chain” we refer to under the vaccine storage and cold chain directive mean, and why are these vital treatments’ private transport and storage 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 must be kept between 2 and 8 degrees Celsius, and frozen products must be below -10 degrees Celsius. Some 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.
Maintaining the integrity of these vaccine storage conditions and other cold chain products includes:
- Ensuring 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 vaccine storage and transport at maintenance points,
- Effective protection and experience for complex treatments.
Cold Chain and Effective Cold Chain
Pharmaceutical distributors use cold chain storage and transportation expertise to process temperature-sensitive products and other specialty drugs. When determining which packaging materials will be used for cold chain shipments 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.
Renewed packaging has enabled distributors to improve their cold chain compliance continuously. Distributors use various 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, refrigerated shipping, temperature-controlled containers, and refrigerated cabinets. Keeping the products at the right temperatures during carrying and transportation processes and in the following few days will be possible.
Increase in Drugs Requiring Cold Chain
The number of drugs that require cold chain use is increasing daily. According to statistics, half of the approved medicines 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 must 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
Freeze drying is a premier vaccine production technique, enabling its prolonged usability and effectiveness. This method is particularly crucial for COVID-19 vaccines, allowing them to be stored and preserved accurately for periods of unprecedented demand, such as during pandemics. Brands like Coolermed are pivotal in producing reliable and quality products such as medicine storage cabinets and vaccine cabinets, essential for storing these freeze-dried ones at appropriate temperatures, ensuring their efficacy is maintained over time.
These user-friendly products can be used across various health settings like hospitals, pharmacies, clinics, and laboratories, ensuring that frozen vaccines and other health products are stored meticulously and reliably. These cabinets, produced in different sizes, integrate well in diverse environments, facilitating convenient vaccine storage conditions.
In the context of the delivery of COVID-19 treatment, distributors play a significant role, applying their expertise in transporting cold chain products and other specialty treatments. The investments made in advanced, temperature-controlled supply chain protocols have positioned distributors ideally to maintain the integrity of breakthrough COVID-19 treatments. The amalgamation of precise freeze-drying methods and advanced distribution networks is crucial to meet the unprecedented demand for approved vaccines and treatments.
Close coordination between governments, public health professionals, and the private sector is crucial to distributing these drugs accurately and effectively. Distributors are leveraging their logistics prowess and cold chain capabilities to ensure that patients have access to vital COVID-19 treatments nationwide. They maintain the quality and trust in all products offered, like those by Coolermed, and they are stored following certain standards to preserve their efficacy.
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 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 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 refrigerators.
Vaccine refrigerators are the equipment that allows them and various drugs to be preserved for certain periods by adjusting the desired temperatures. With the increase in pharmaceuticals requiring cold chain protection, investments in this field have increased globally. In this way, different features and applications are made to produce cabinets.
Use of Vaccine Refrigerator
Vaccine refrigerators, as we mentioned, have now become more common and diverse. For this reason, it is now essential to use cabinets to comply with the vaccine storage and cold chain directive. Vaccine cabinets provide the correct cold chain temperature and allow temperatures to be adjusted and regulated at different intervals.
This way, biological drugs and vaccine storage have become easier. The importance of vaccines has come to the fore even more, especially in the current era of COVID-19. Ensuring their global distribution and availability is also an inevitable requirement. Complex logistics methods are indispensable to meet this requirement.
You can read our previous article on https://coolermed.com/cold-chain-in-the-pharmaceutical-industry