Before a vaccine can be administered to a patient, it takes a long time. Like all products, vaccines run through a chain with several links. The conditions within that chain can affect the quality of the vaccines. Vaccines, for example, are very sensitive to temperature and light, even more so than ordinary medicines. Temperature and light have a direct influence on the effect and shelf life of vaccines and can lead to a loss.
What does the (cold) chain of vaccines look like?
The safest vaccine storage and handling start with an effective cold chain. A cold chain is a temperature-controlled distribution chain that complies with all material regulations and procedures within the vaccine guidelines. As the diagram above shows, there are various links within which these guidelines must apply. Vaccines should be kept at the correct temperature in and between these links. This requires intensive cooperation as well as clear responsibilities and roles that are laid down in chain-wide protocols. Monitoring compliance with these protocols is critical. Failure to follow the guidelines within the cold chain meticulously could result in ineffective vaccines and thus wastage.
How temperature-sensitive vaccines are
There are concrete guidelines regarding the temperature conditions in which the vaccines are located. In general, vaccines maintain their quality if they are stored in a cooling unit in the dark at a temperature between 2 and 8 degrees Celsius, or in a freezer unit between -50 and -15 degrees Celsius. Securing the required conditions is critical to the quality of the vaccines. And this applies to the entire logistics (cold) chain, from transport and storage at the manufacturer, to the wholesaler and customer. Failure to comply with the guidelines is seen as an interruption of the cold chain resulting in the vaccines being unable to be administered. Risks include exposure to heat or cold. Opening the cooling unit door may already affect the ambient temperature of the vaccines.
Vaccine transport carries even more risks than storage. Transport takes place between the links in the chain and is generally done by professional transporters who specialise in the transportation of vaccines. The basic principle is, however, that as little transport as possible takes place because the chance of exposure to risky temperatures or sunlight is, of course, greater than in a cooling unit. Transport may take up to 8 hours, and the vaccines must be packed in qualified packaging and/or containers, provided with insulating material and temperature recorders.
How do we know if vaccines have (stayed) at the right temperature?
Monitoring temperatures throughout the cold chain is critical to determine if vaccines are useful at the time of administration. This is usually done with validated temperature recorders, which record the temperature based on several measuring points and generate an alarm as soon as the temperature is outside the margins. The temperature trend is then recorded daily in a log. There are many different temperature recorders available on the market, but only a few renowned brands comply with the guidelines that apply to the cold chain of vaccines.
What happens if it appears that vaccines have been exposed to temperatures outside the required temperature range?
Monitoring the temperature of the vaccines and thus protecting patients is a daily responsibility. This is a crucial but time-consuming task. When vaccines are exposed to temperatures outside the values required for optimal performance, they may not provide sufficient protection, or even become harmful, because the active substances in the vaccine are exposed to excessive temperatures. This depends on the type of vaccine; the manufacturer has drawn up a protocol for this per vaccine. Sometimes the expiration date is brought forward, sometimes the vaccine is immediately rejected and can then no longer be used. This results in patients having to be vaccinated again, and since the patient is the last link, this means that the entire cold chain must be gone through again. This has a major financial impact. Maintaining proper storage conditions is, therefore, essential.
What specifications do temperature recorders have that are suitable for vaccines?
Measuring the temperature in the units in which vaccines are stored or transported is done with temperature recorders. These are of crucial importance for the protection of vaccines in cooling units in hospitals and general practices, but also during transport. Experience shows that investing in good temperature recorders entails fewer costs than having to replace vaccines because they are no longer usable due to defects in the temperature measuring system. Therefore, very specific requirements are set for the type of temperature recorder. For example, they must meet the WHO guidelines; the measuring points must be preset, it is recommended to work with a vial of liquid (glycol), an alarm must be triggered if the temperature values are exceeded, and the results must be downloadable through specific software. A display on the recorder is also desired so that the temperature can be read immediately, possibly an audio alarm and a calibration certificate must be drawn up every 1 to 2 years in connection with the accuracy of the temperature. And so there is a long list of requirements and wishes that temperature recorders must meet. These are available in the Praxas range.
LogTag temperature recorders WHO certified
The WHO (World Health Organisation) is an organisation responsible for public health worldwide, to achieve the highest possible level of health by all peoples. This means that they also award certification to products that have been found suitable and fit this objective. The temperature recorders that Praxas offers and have received this certification are:
TRIX-8 | VAXTAG | TIC20 | TICT iSO°TAG
LogTag temperature recorders CDC/VFC certified
CDC is an American organisation that stands for Centers for Disease Control and Prevention. They are mainly concerned with detecting, treating and preventing diseases. Besides, they provide information in the field of health. One branch of this is VFC (Vaccines for children), which focuses on childhood vaccinations. The temperature recorders that are CDC / VFC certified and offered by Praxas are:
TRED30-16R | UTRED30-16 | UTRED30-WiFi | VFC KIT
LogTag Online (LTO) is a system in a cloud environment, where data can be kept about alarm notifications, standards can be complied with, data can be stored, and various reporting functions are available. It allows users to download data from their LogTag data loggers, view the data in the accounts and share the data in a secure environment. LTO makes it possible to validate and report alarms with just a few actions. LogTag Online is best used to monitor remote locations. Wherever the user is, there is always insight into the temperatures. As soon as there is an alarm, timely action can be taken to prevent loss of vaccines. It is currently most commonly used in America for VFC (childhood vaccinations) loggers with WiFi.