What Key Points Should Be Noted in the Transportation and Storage of Vaccine Cold Storage Projects?

2025-04-27

The vaccine cold storage project is of great significance for the installation and storage of medical products, especially in the prevention and control of the COVID-19 virus that has swept the world in the past two years. Currently, in addition to measures such as individuals wearing masks, the most effective way is to receive the COVID-19 vaccine.

What Key Points Should Be Noted in the Transportation and Storage of Vaccine Cold Storage Projects?1745755005627

What most people don't know is that before we receive the vaccine: there are strict transportation and storage requirements for the vaccine from the successful production to the vaccination.
Here, we make a comparison between the storage temperatures of domestic COVID-19 vaccines and relevant foreign vaccines:
From the above picture, we can find that storing vaccines requires a specific temperature. When it comes to bulk storage and aiming to meet this special temperature requirement, the best choice is to install a cold storage.
According to the "Specifications for the Management of Vaccine Storage and Transportation" issued by the Ministry of Health and the State Food and Drug Administration, there are relevant specifications for the storage, transportation, and management of vaccines, the temperature monitoring during vaccine storage and transportation, as well as the equipment for vaccine storage and transportation.
The details are as follows:
I. Storage Requirements for Vaccine Cold Storage

Requirements for Vaccine Production, Operation, and Sales Enterprises in Vaccine Storage
1.1 When selling vaccines, vaccine production enterprises and vaccine wholesale enterprises should, in addition to providing the documents stipulated in Article 17 of the regulations, also provide materials such as the equipment, time, and temperature records for vaccine transportation.
1.2 When receiving or purchasing vaccines, disease prevention and control institutions, vaccination units, and vaccine wholesale enterprises should request and inspect the certification documents and materials provided by vaccine production enterprises and vaccine wholesale enterprises as stipulated in Article 5.
When receiving the goods, they should verify the materials such as the equipment, time, and temperature records for vaccine transportation, and conduct an inspection on the vaccine variety, dosage form, approval number, quantity, specification, batch number, validity period, supplier, manufacturer, etc., and make records. Only the vaccines that meet the requirements can be received.
1.3 Disease prevention and control institutions, vaccination units, and vaccine wholesale enterprises should store the accepted vaccines in the corresponding refrigeration facilities and equipment according to their temperature requirements, and stack them in a classified manner according to the vaccine variety and batch number.
1.4 Disease prevention and control institutions, vaccination units, vaccine production enterprises, and vaccine wholesale enterprises should sell, supply, or distribute vaccines in accordance with the principles of "first produced, first out", "first in, first out", and "expiring soon, first out".
1.5 Vaccine production enterprises and vaccine wholesale enterprises should regularly inspect and record the stored vaccines.
In case of abnormal quality or expiration, etc., measures such as isolation and suspension of delivery should be taken in a timely manner, and the local food and drug administration department should be reported promptly for handling; the food and drug administration department that receives the report should take corresponding measures in accordance with the law for the vaccines with abnormal quality or expired.
1.6 Disease prevention and control institutions and vaccination units should regularly inspect and record the stored vaccines. When vaccines with abnormal quality are found, the supply, distribution, and vaccination should be stopped immediately, and the local county-level health administrative department and food and drug administration department should be reported promptly, and they should not handle them on their own.
The health administrative department that receives the report should promptly organize disease prevention and control institutions and vaccination units to take necessary emergency response measures, and report to the superior health administrative department at the same time; the food and drug administration department that receives the report should take corresponding measures in accordance with the law for the vaccines with abnormal quality.
1.7 When the vaccines stored in disease prevention and control institutions and vaccination units become expired or ineffective due to natural disasters and other reasons, they should be disposed of centrally in accordance with the provisions of the "Regulations on the Management of Medical Waste".
1.8 Vaccine production enterprises and vaccine wholesale enterprises should appoint dedicated personnel to be responsible for the delivery, packing, and shipping of vaccines.
Before shipping, the start-up and operation status of the refrigerated transportation equipment should be checked, and it can be shipped only after meeting the specified requirements.
1.9 During the transportation process, the temperature conditions of the refrigerated trucks or vaccine transport vehicles equipped with refrigeration equipment used by disease prevention and control institutions, vaccine production enterprises, and vaccine wholesale enterprises should meet the vaccine storage requirements.
1.10 Records of vaccine receipt, inspection, in-warehouse inspection, etc. should be kept for more than 2 years beyond the vaccine's validity period for future reference.
Storage Requirements in the Vaccine Cold Storage
Provincial, municipal, and county-level disease prevention and control institutions should determine the storage quantity of national immunization program vaccines according to local immunization strategies, annual work plans, vaccination service forms, cold chain storage conditions, and emergency vaccination needs. In principle, the vaccine storage quantities at all levels are: 6 months at the provincial level, 3 months at the municipal level, 2 months at the county level, and no more than 1 month at the township level with refrigeration conditions;
Vaccines should be stacked in a classified manner according to the variety and batch number;
Temperature requirements for vaccine storage and transportation.
II.
Temperature Requirements for Vaccine Cold Storage
List the common temperature requirements for vaccine cold storage as follows:
Hepatitis B vaccine, Bacille Calmette-Guérin (BCG) vaccine, Diphtheria, Tetanus, and Pertussis vaccine, Diphtheria and Tetanus vaccine, Inactivated Japanese Encephalitis vaccine, Group A Meningococcal vaccine, Group A+C Meningococcal vaccine should be transported and stored in the dark at a temperature of 2℃～8℃.
Poliomyelitis vaccine, Measles vaccine, Live Attenuated Japanese Encephalitis vaccine, Rubella vaccine should be transported and stored in the dark at a temperature of -20℃～8℃.
The storage and transportation temperature requirements for other vaccines should be implemented in accordance with the provisions of the Pharmacopoeia of the People's Republic of China and the vaccine instruction manuals.
2.1 Disease prevention and control institutions, vaccination units, vaccine production enterprises, and vaccine wholesale enterprises must, in accordance with the temperature requirements for vaccine storage and transportation in the "Pharmacopoeia of the People's Republic of China" (current edition), the "Specifications for Vaccination Work" and other relevant regulations, do a good job in the storage and transportation of vaccines. For vaccines not included in the Pharmacopoeia, they should be stored and transported in accordance with the vaccine instruction manuals.
2.2 Disease prevention and control institutions, vaccination units, vaccine production enterprises, and vaccine wholesale enterprises should monitor and record the temperature of the stored vaccines according to the following requirements.
(1) An automatic temperature recorder should be used to record the temperature of ordinary cold storage and low-temperature cold storage;
(2) A thermometer should be used to monitor the temperature of refrigerators (including ordinary refrigerators, ice-lined refrigerators, and low-temperature refrigerators). The thermometer should be placed in the middle of the refrigerating compartment of an ordinary refrigerator, in the freezer of an ordinary refrigerator, at the bottom and near the top cover of an ice-lined refrigerator, and in the middle of a low-temperature refrigerator. Record the temperature once in the morning and once in the afternoon every day.
(3) When the temperature of the refrigeration facilities and equipment exceeds the vaccine storage requirements, corresponding measures should be taken and recorded.
2.3 Disease prevention and control institutions, vaccine production enterprises, and vaccine wholesale enterprises should monitor and record the temperature of the vaccines during the transportation process. The recorded contents include the vaccine name, manufacturer, supplier (sender) unit, quantity, batch number and validity period, departure and arrival time, the vaccine storage temperature and ambient temperature at the time of departure and arrival, the temperature change during the transportation process, the name of the transportation vehicle, and the signature of the person receiving and sending the vaccine.
Kind Reminder:
When transporting vaccines, refrigerated trucks should be used and the transportation should be carried out at the specified temperature. Units without refrigerated trucks should transport the vaccines in refrigerated boxes when receiving and issuing vaccines.
III. Equipment Requirements for Vaccine Cold Storage
3.1 Provincial disease prevention and control institutions, vaccine production enterprises, and vaccine wholesale enterprises should have facilities and equipment that meet the temperature requirements for vaccine storage and transportation:
(1) The cold storage for vaccine storage should have a volume suitable for the production, operation, and use scale;
(2) The cold storage should be equipped with equipment for automatically monitoring, controlling, displaying, recording the temperature status, and alarming, a standby generator set or a dual-circuit power supply, and a standby refrigeration unit;
(3) Refrigerated trucks for vaccine transportation;
(4) The refrigerated trucks should be able to automatically control, display, and record the temperature status;
3.2 Disease prevention and control institutions at the city level divided into districts and at the county level should have facilities and equipment that meet the temperature requirements for vaccine storage and transportation:
(1) Cold storage or refrigerators specially used for vaccine storage, and their volume should be suitable for the use scale;
(2) The cold storage should be equipped with equipment for automatically monitoring, controlling, displaying, recording the temperature status, and alarming, a standby generator set or a dual-circuit power supply, and a standby refrigeration unit;
(3) Refrigerated trucks for vaccine transportation or vehicles equipped with refrigeration equipment;
(4) The refrigerated trucks should be able to automatically control, display, and record the temperature status.
3.3 Township-level preventive health care service institutions should be equipped with refrigerators to store vaccines, and use refrigerated boxes (bags) equipped with ice packs to transport vaccines. And they should be equipped with sufficient ice packs for village-level vaccination units to use when collecting vaccines;
3.4 Vaccination units should have refrigerators or use vaccine refrigerated boxes (bags) equipped with ice packs to store vaccines;
3.5 Disease prevention and control institutions, vaccine production enterprises, and vaccine wholesale enterprises should appoint dedicated personnel to manage and maintain the facilities and equipment for vaccine storage and transportation. Vaccination units should maintain the vaccine storage equipment;
3.6 Disease prevention and control institutions, vaccination units, vaccine production enterprises, and vaccine wholesale enterprises should establish and improve the archives of facilities and equipment for vaccine storage and transportation, and record the operation status of the facilities and equipment for vaccine storage and transportation.