With the promise of an effective Covid-19 vaccine on the horizon, healthcare facilities and medical professionals around the country are hard at work deciphering how best to implement the newest CDC guidelines for proper vaccine storage. Once a vaccine(s) is approved for distribution, cold storage and transportation will be essential to delivering a safe and effective vaccine to hundreds of millions – possibly billions of people around the globe. With even the slightest change in temperature leading to possible degradation of efficacy and safety, it is imperative that all vaccines be kept in a stable temperature environment. Cold chain vaccine monitoring is a vital part of this process, as it aids in identifying any breaks (temperature fluctuations) in the chain that may have occurred. A continuous electronic temperature recorder or datalogger, along with proper storage vessels are all critically important components of maintaining the integrity of this process. It is equally important that these instruments be calibrated by an ISO 17025 accredited lab to ensure accuracy of the data being analyzed. Beginning with the vaccine manufacturer and ending with the point of care professionals, every constituent of the supply chain must adhere to CDC and manufacturer guidelines regarding vaccine storage temperature and datalogging. We have examined the guidelines and have laid out some of the finer points below, so that you might gain a better understanding of the equipment, instruments and calibration services needed to ensure that you are prepared.
Recent guidance from the CDC cautions against using residential style refrigerators to store vaccines. It is recommended that dedicated laboratory-grade or medical-grade freezers be used to ensure vaccine integrity during storage. As mentioned above, continuous temperature monitoring with specific device features are recommended. The features of the Temperature Monitoring Devices (TMD’s)/Dataloggers to be used are as follows:
- Current and valid Certification of Calibration/Testing
- Detachable probe in a thermally buffered material (glycol, glass beads, sand, Teflon®)
- Programmable sampling rate, with a minimum of 1 reading every 30 minutes.
- Hi/Lo temperature alarms
- Displays current temperature, minimum and maximum temperatures
- Reset button
- Low battery indicator
- Recommended uncertainty of ± 0.5°C (±1°F)
- Memory storage capacity of 4000 readings minimum
- Will not overwrite (wrap) data
- Stops recording when memory is full
- Buffered temperature probe*
* Using a buffered temperature probe as opposed to measuring the storage air volume, will more closely represent the temperature changes experienced by the actual vaccines when stored in close proximity. It’s vital to use a Temperature Monitoring Device/Datalogger with a temperature probe that meets the CDC recommendation. This includes the size of the buffer bottle being a minimum of 4x the diameter of the probe, immersed to 10x the probe diameter, and 1-2cm from the bottom of the bottle.
Requirements from the WHO (World Health Organization) dictate that Temperature Measuring Devices/Dataloggers used in vaccine storage require regular calibration that verifies the device’s accuracy over its stated range. Calibration of the TMD must meet one or more of the following-
- Tested by an accredited lab conforming to ISO-IEC 17025 or a recognized International Accrediting Body
- Traceable to National Institute of Standards and Technology standards
- Meets ASTM E2877 Tolerance Class F (<0.5°C/1.0°F)
In summary, the use of proper storage vessels coupled with temperature dataloggers is critical to help ensure the timely and safe distribution of any Covid-19 related vaccines. Storage vessels and temperature dataloggers that fulfill all the guidelines set forth by the CDC, USP and WHO pertaining to cold chain vaccine datalogging will help prevent vaccine waste, regulatory and safety issues. Traceable, proven accuracy among these devices will help bring an end to the pandemic as swiftly and safely as possible.
Precision Calibration Systems (PCS) is here to assist our customers in ensuring compliance with CDC guidelines and recommendations. Whether it’s calibration of laboratory refrigerators, freezers, temperature monitoring devices /dataloggers, PCS offers a wide range of 17025 accredited calibration services. With an industry leading turnaround time of 48hrs or less, PCS can assure our customers will meet regulatory requirements while maintaining continuity in their operations.