CDC Recommendations for Approved Laboratory, Medical, and Biomedical Refrigerators and Freezers for Vaccine Storage
Maintaining a cold chain through-out the entire vaccine supply chain is critical to the safety and security of vaccines. According to the CDC, the cold chain begins with the cold storage unit at the manufacturing plant, extends to the transport and delivery of the vaccine and proper storage at the provider facility, and ends with the administration of the vaccine to the patient.
Additionally, the CDC stresses in its Vaccine Storage and Handling Pink Book that manufacturers, distributors, public health staff, and health care providers share responsibility to ensure the vaccine cold chain is maintained from the time vaccines are manufactured until they are administered.
To ensure safe vaccine storage, medical grade laboratory, pharmacy, and biomedical refrigerators and freezers must comply with the following CDC recommendations:
- CDC recommends stand-alone units, meaning self-contained units that either freeze or refrigerate.
- These units can vary in size from compact, counter-top or under-the-counter style to large, pharmaceutical grade units. Studies demonstrated that stand-alone units maintain the required temperatures better than combination units, particularly the freezer section of household, combination units.
- The equipment must be able to maintain the required temperature range throughout the year.
- Freezer: between -58° F and +5° F (between -50°C and -15°C).
- Refrigerator: between 35°F and 46°F (between 2°C and 8°C), with an average of 40°F (5°C).
- The freezer and refrigerator must large enough to hold the year’s largest vaccine inventory without crowding (including the flu vaccine).
- Regular temperature monitoring is key to proper cold chain management. The CDC recommends reviewing and recording temperatures in both the freezer and refrigerator units at least two times each workday, once in the morning and once before the end of the workday.
- Position the refrigerator or freezer to ensure good air circulation around it. The unit should be in a well-ventilated room with at least 4 inches between the storage unit and the wall.
- To ensure accurate temperature monitoring, the CDC recommends using only a calibrated digital data logger with a current and valid certificate of calibration testing (Report of Calibration).
- A digital data logger with the following characteristics is recommended:
- Easily readable from outside the unit.
- Detachable probe in a buffered material which closely reflects vaccine temperatures rather than air temperatures.
- An alarm for out-of-range temperatures.
- Current minimum and maximum temperature accuracy +/-1°F (+/-5°C).
- A low battery indicator.
- Memory that stores at least 4,000 readings.
- A user programmable logging interval.
- The CDC recommends a back-up digital data logger for each vaccine storage unit.
Refer to the CDC Vaccine Storage and Handling Toolkit, the Vaccine Storage and Handling Pink Book, and the CDC’s Vaccine Storage and Handling Resources for detailed vaccine cold chain recommendations and best practices.
Medical Grade Laboratory, Biomedical, and Medical Refrigerator and Freezer Features
Ensure the refrigerators and freezers used for safe and secure vaccine storage have the following features:
- Eye-level externally visible temperature displays for easy and quick temperature monitoring.
- Microprocessor controls to guarantee extra low temperatures for scientific, laboratory, and vaccine storage.
- Reliable pre-set temperature control technology.
- Temperature charting and alarms for easy and consistent record keeping.
- Specially designed refrigeration systems to prevent temperature fluctuations and freezing.
- Fan-forced draft air circulation for uniform internal temperatures.
- Interior design that conforms to CDC guidelines to ensure stable conditions for sensitive materials.
- NIST calibrated temperature display.
For capacity requirements, refer to our post on how to determine refrigeration capacity requirements.