In pharmaceutical logistics, safety and quality are of primary importance, therefore, an effective way to monitor compliance with the "cold chain" is needed. Most often, it is required by immunobiological preparations – UPS) - vaccines, immunoglobulins, anatoxins, which in the event of a violation of the temperature regime not only lose their original qualities, but also acquire the ability to provoke undesirable side effects after injection into the human body. Both high and low temperatures have a detrimental effect on biological products. If at least one of the links in the cold chain is broken, all other efforts will not make any sense. The drug spoiled under the influence of high or low temperature can no longer be saved, even if it is returned to the optimal temperature regime.
In order to clearly follow the instructions for storing drugs and avoid negative consequences, the storage of immunobiological drugs by a single distributor of SK-Pharmacy LLP is carried out at pharmaceutical hubs and warehouses that comply with the GDP standard.
The GDP (Good Distribution Practice) standard establishes a unified approach to the process of wholesale sales of medicines and is aimed at ensuring the quality of medicines all the way from the manufacturer to the retail network and medical institutions. It is based on the principles recommended by the World Health Organization.
Warehouses of a Single distributor have 4 storage zones: deep cooling - below -15°C; in the refrigerator from +2°C to +8°C; in a cool place from +8°C to +15°C; at room temperature from +15°C to +25°C. The total capacity of warehouses allows to store as many medicines as necessary for medical organizations.
The hubs of a Single distributor are equipped with specialized freezers and refrigerators with electronic temperature and humidity monitoring systems, and the information is stored for a long time. In case of temperature deviation from the norm, an alarm and SMS notification of the responsible person are triggered. Information from all sensors is transmitted to a central temperature and humidity monitoring system equipped with a warning system.
In the event of a power disconnection, automatic connection of refrigeration equipment, refrigerating and freezing rooms or chambers to the uninterruptible power supply system (generator) is provided.
Transportation is of particular importance in the "cold chain". At all levels of transportation of vaccines, registration of receipt and further shipment is carried out with the recording of temperature readings in the accompanying documents.
Thermolabile medicines are transported by a special road transport - a refrigerator, which is pre-validated - these are documented actions that prove that the procedure, process, equipment, material, operation or system meet the specified requirements and their use will constantly lead to results that meet the pre-established acceptance criteria. Moreover, refrigerators with built-in temperature control sensors and GPS are used for transportation. Upon arrival at the destination, information about the storage temperature on the route is transmitted to the consignee.
For short distances, for example, within a community (city), a thermal container is used to transport vaccines, which protects against changes in ambient temperature. Each thermal container is equipped with thermal indicators - sensors that indicate the storage temperature of products during transportation. When transporting vaccines that are sensitive to low temperatures, freeze indicators are used.
The third way – from pharmacy warehouses of local health authorities to medical organizations,
The fourth way is storage in medical organizations, before using by patients.
Vaccines included in the National Vaccination Calendar of the Republic of Kazakhstan are supplied by a Single distributor “SK-Pharmacy” LLP. These are monovaccines (against diphtheria, tetanus, tuberculosis, oral polio vaccine), as well as combined vaccines, the storage of which is provided in the temperature range from +2°C to +8°C, with the exception of OPV polio vaccine, which requires freezing from -18°C.
The storage temperature regime of the Russian vaccine from Covid-19 "Sputnik V" is - 20°C, and the vaccine produced in other countries reaches – 70-80 °C.
In December of this year, Kazakhstan plans to launch the production line of the “Sputnik V” vaccine at the domestic enterprise – “Karaganda Pharmaceutical Complex” LLP, it is planned to produce at least 2 million doses of the vaccine against Covid-19.
The Ministry of Health of Kazakhstan and the Russian Direct Investment Fund (RDIF) have signed a cooperation agreement to conduct the registration procedure, as well as the production and distribution of the ”Sputnik V” vaccine against coronavirus.
The release of the vaccine on the territory of the republic will reduce logistics costs and ensure delivery to medical institutions in a short time. This is important, including from the point of view of maintaining optimal conditions of the "cold chain", in terms of reducing the logistics supply chain.
Source: Press service of “SK-Pharmacy” LLP
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