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Conditions of storage and transportation of vaccines
Last reviewed: 06.07.2025
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Temperature regime violations can cause serious complications. Overheating of the vaccine leads to a decrease in its immunogenicity, freezing of adsorbed vaccines - to their desorption with rapid entry of antigens into the blood and the development of an allergic reaction. Freezing of immunoglobulin and overheating lead to protein aggregation, which causes colaptoid reactions.
Freezing of solvents leads to the formation of microcracks in the ampoule and contamination of its contents. The optimum temperature is 2-8°, for long-term storage of live viral vaccines - minus 20°. Vaccines that have been transported or stored with violations of the temperature regime are not subject to use.
Cold chain
The cold chain includes refrigeration equipment, specially trained personnel for its maintenance, and a system for monitoring the temperature regime at all stages, right up to the outpatient clinic, polyclinic, maternity hospital, and FAP.
At all levels of the cold chain, receipts and shipments of vaccines are registered, recording their quantity, dates, batch numbers, expiration dates, and the full name of the person responsible. At least twice a day, an employee appointed by order records the storage temperature (the thermometer is located in the middle of the middle shelf) and temperature indicator readings in a special log. Each institution must have an emergency plan in case of problems in the cold chain.
In the refrigerator (see Fig. 1.1), vaccines should be arranged in such a way that each package has access to cool air and that the drug with a shorter shelf life is used first. If live vaccines are stored frozen, then only at a temperature of minus 20°; a temporary (no more than 48 hours) increase in temperature to 2-8° during transportation is allowed. The shelf life of vaccines stored at subzero temperatures is the same as those stored at a temperature of 2-8°. The shelf life of OPV at a temperature of minus 20±1° is 2 years, and at a temperature of 6±2° - 6 months, it is recommended to store it at a constant temperature, allowing freezing and thawing no more than 3 times.
To increase stability, live viral vaccines are produced with a heat stabilizer, but this does not mean that the storage conditions can be violated.
The shelf life of the vaccine in primary care facilities (at the 4th level of the Cold Chain) is up to 1 month. Opening the refrigerator door should be limited as much as possible: Even in 30 seconds the temperature in it increases by 8° and it takes about half an hour to reduce it; vaccines should not be stored on the refrigerator door. Unloading and loading of thermal containers should be carried out within no more than 10 minutes.
Freezing of vaccines and toxoids containing adjuvant, as well as solvents for lyophilized vaccines, is not permitted. When exporting them in thermal containers, cooled (from 2 to 8°), but not frozen, cooling elements are used.
When transporting lyophilized and adsorbed vaccines together, before loading the thermal container, the cooling elements are conditioned (partially defrosted) to prevent freezing of the adsorbed MBPs upon contact with the surface of the frozen cooling element.
The receipt, storage of MIBP in pharmacies and healthcare institutions, and their dispensation to citizens require compliance with the “cold chain” and must be accompanied by:
- a copy of the license for the right to sell MIBP or pharmaceutical activities;
- a copy of the production certificate (except for blood transfusion stations) or the registration certificate for the drug being sold;
- the passport of the manufacturing organization's OBTK or a copy of the certificate of conformity for the batch of the drug being sold.
MIBP are dispensed to citizens on a doctor's prescription (of any form of ownership) provided that the drug is delivered to the place of use in a thermal container or thermos with ice within 48 hours. The date and time are indicated on the packaging.
Destruction of vaccines, syringes and needles
The contents of ampoules, vials, disposable syringes with the remains of inactivated and live measles, mumps and rubella vaccines, IG and serums are poured into the sink; glass, needles and syringes are placed in the container without processing (without putting a cap on the needle). Ampoules with the remains of other live vaccines, tampons before placing in the container are autoclaved or placed for 1 hour in a 3% chloramine solution, and with BCG and BCG-M - in a 5% chloramine solution or in a 3% hydrogen peroxide solution. Filled containers are hermetically sealed and sent for incineration. Unused batches of drugs, including those with an expired shelf life, should be sent for destruction to the district office of Rospotrebnadzor.
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