The Best Practices of Vaccine Storage and Temperature Monitoring
Storing vaccines is a sensitive task. Laboratory owners must store vaccines in the right temperature environment, and if they fail to do so, their vaccine stock will get damaged and become unfit for administering to people.
The Center for Disease Control (CDC) has recommended a set of guidelines for storing vaccines effectively. Healthcare facility owners should adhere to the CDC guidelines, which are critical components in protecting people against diseases.
Failure to store vaccines correctly can lead to their damages, and if any person is administered with such a compromised vaccine, revaccination becomes necessary for him. Moreover, you have to incur a financial loss in replacing the damaged vaccine stock.
Healthcare facilities participating in the Vaccines for Children (VFC) program must pay extra attention to the CDC guidelines. They should also consult their state or local immunization bodies for specific recommendations and requirements.
So, no healthcare facility owner should fall behind in implementing the CDC guidelines, which are as follows:
Refrigerator and Freezer Recommendations
Vaccine refrigerators and freezers are the cold storage units for a healthcare facility.
Types of Units
The CDC recommends using purpose-built or pharmaceutical-grade units that are specifically designed to either refrigerate or freeze. Usually, these units are compact, under-the-counter or large, and are built for storing biologics, including vaccines. They come with:
- Microprocessor-based temperature control systems with a digital temperature sensor, such as a thermocouple, resistance temperature detector, or thermistor.
- Powerful fans to direct airflow through multiple air cool vents for recovering the necessary temperature after an out-of-range temperature event, such as opening and closing the freezer door.
You should also take adequate care to not over-crowd your freezer and maintain enough space to accommodate your vaccine inventory.
Where to place a freezer in a healthcare facility is an important thing to consider. According to the CDC, you should put the unit in a well-ventilated room, and leave some space between the unit and the wall and the ceiling, as air circulation around the unit is necessary.
Make sure that nothing blocks the motor compartment’s cover. Place the unit on the floor and check whether its door opens and closes smoothly and fits tightly with the unit’s body. If the door does not fit properly, it can deviate the temperature range, posing a risk to the stored vaccines. It is a good idea to thoroughly go through the manufacturer’s manual for guidance on placement and spacing.
Bear in mind that you should not store vaccines in a dormitory-style or bar-style combined freezer unit. Such a unit comes with a single door and an evaporator plate or cooling coil, usually located in the ice maker compartment. If you use such units even for temporary storage, your vaccine stock will be at risk. However, you can use purpose-built compact units for biologics to store vaccines.
Ensure that you do not leave your freezer’s door as that will affect the temperature in the unit, exposing the vaccines to the inappropriate temperature that can reduce their potency. So, put to use freezers with self-closing door hinges, door alarms, or door locks. Also, sure the door is sealed correctly.
Temperature Monitoring Recommendation
The CDC has provided recommendations about the best practices for freezer temperature monitoring and installation of such devices.
According to the recommendations, you should maintain your refrigerator within 2 degrees C and 8 degrees C temperatures. And freezers within -50 degrees C and -15 degrees C. Ensure that you set thermosets at the factory-set or midpoint temperature to lower the likelihood of temperature fluctuations. It will help if you consult the manufacturer’s manual on how to operate the thermostat.
Temperature Monitoring Devices
The CDC says that every cold storage for vaccines must bear a temperature monitoring device(TMD). There is a need to maintain an accurate temperature history that reflects the actual vaccine temperatures. Knowledge of the record is crucial for protecting your vaccines.
In the context of TMDs, the CDC has recommended a particular type of TMD, called the digital data logger (DDL), which provides the most accurate freezer temperature information. A DDL also provides a piece of critical information–how long the unit operated outside the prescribed temperature range. Some pharmaceutical-grade freezers come with a built-in continuous temperature monitoring system that functions as a DDL.
Many DDLs have a buffered temperature probe, which measures the vaccine temperatures most accurately. Temperatures measured by a buffered temperature probe are more accurate than those measured by standard thermometers, showing only the air temperature.
You can either download the DDL temperature data to a computer using software or retrieve it from the website. The software can also allow you to set the frequency of temperature readings.
You need to review the DDL temperature data to maintain vaccine potency.
You should retain the DDL data for at least three years to enable you to analyze the long-term trends. If you deal with public vaccines, keep the data for more extended periods due to regulatory requirements.
Handling Temperature Excursions
Whenever temperature excursions or inappropriate storage conditions occur, take immediate action. A temperature excursion is the movement of the temperature outside the recommended range.
Whenever a staff member hears an alarm or sees a temperature excursion on the DDL, he should immediately report it to the vaccine coordinator or the supervisor. Subsequently, your staff should label the exposed vaccines as “Do Not Use” and place them in a separate container.
The vaccine coordinator should document the problem with the information, such as the date and the time of temperature excursion, freezer and room temperatures, and the general overview information of the temperature excursion.