For COVID-19 vaccines to remain potent and effective, healthcare providers are strongly encouraged to install vaccine temperature monitors. Vaccines play an important role in the quality of life by providing resistance against communicable diseases (eg. smallpox, measles and polio, and more recently COVID-19). To get the world “back to normal” with some of the largest vaccination programs in living memory, scientists and pharmaceutical companies will face another enormous challenge: making millions of doses and keeping those doses extremely cold.
The effectiveness of vaccines are directly correlated to their proper handling and storage from time of manufacturing to delivery. Improper handling may result in:
- Unsafe vaccines with potential health risks.
- Money lost in unviable vaccines resulting in re-vaccination.
- Reduced protection and decreased potency of the vaccine.
Why is it important to monitor vaccine temperatures?
All vaccines are time- and temperature-sensitive products, making it critical to monitor the temperature at which vaccines are manufactured, stored and transported. Monitoring vaccine temperatures is the first step in safely controlling the various environments through which they progress, before being administered to people around the world.
Some studies reveal that around a quarter of vaccines show signs of degradation by the time they end up at a doctor’s office. This doesn’t make them unsafe to use, but it could mean they trigger a much weaker immune reaction and are less effective in protecting people from disease. Several COVID-19 vaccines have to be stored at ultracold temperatures, as cold as -94°F or -70°C.
Providers must pay close attention to the cold chain to prevent vaccines from being exposed to temperatures outside the recommended ranges.
The increasing portfolio of vaccines requires more effective and efficient operation of complex supply chains as heat is not the only enemy of vaccines, intense light and excessive cold may also reduce the vaccine’s effectiveness.
Note that the potency of vaccines cannot be restored and that not all vaccines will undergo physical changes when compromised. Therefore vaccines should be completely and safely discarded and/or destroyed if there is a high likelihood that they’re compromised.
Slight temperature fluctuation is enough to waste the whole stock of refrigerated vaccines.
During a COVID-19 vaccine’s journey from factory to pharmacy, ambient temperatures can be monitored using Ikhaya Automation Systems’ real-time temperature monitoring solutions. The equipment can be embedded in packaging, freezers, and refrigerators at every point of a vaccine’s journey. Because the system works remotely and in real time, it constantly logs the data so that officials can effectively track their path — a technological advancement that wasn’t there five years ago.
Ikhaya Automation Systems’ vaccine temperature monitoring solution is approved by the World Health Organization for its performance, safety and quality, further ensuring that vaccine manufacturers are able to adhere to the highest standards in healthcare.
The vaccine cold chain:
The cold chain is a temperature-controlled supply chain or environment used to maintain and distribute vaccines in optimal conditions. It includes all vaccine-related equipment and procedures. It begins with the cold storage unit at the manufacturing plant and extends through transport of vaccines and delivery of the vaccine and proper storage at the provider facility, and ends with administration of the vaccine to the patient. The cold chain ends when the vaccine is administered to the patient. It is essential to appropriately handle and store vaccines at every link in the cold chain.
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.
Temperature monitoring across the logistics chain is the most important but most difficult part of an end to end temperature monitoring solution. The logistics environment in itself is a harsh environment, is subject to many external risk factors and many handover points. Ikhaya’s product range has been designed to cater across all the elements of a well-designed logistics chain and offers end to end protection of continuous temperature monitoring.
Vaccine storage and temperature monitoring equipment
It’s important for a vaccine storage and handling facility to have proper temperature monitoring equipment that’s correctly set up and managed. This equipment protects patients from inadvertently receiving compromised vaccines and protects facilities against costs of revaccinating patients, replacing expensive vaccines, and losing patient confidence.
Refrigerators and Freezers
The CDC recommends the following types of refrigerators and freezers for vaccine storage:
- Purpose-built or pharmaceutical-grade vaccine storage units are preferred. These units can be compact, under-the-counter style or large units.
- The proper vaccine storage equipment is essential to reliable vaccine supply. The CDC recommends that refrigeration units should be stand alone units that either freezes or refrigerates and should under no circumstance be able to do both. Combination units typically have cold spots where vaccines will be frozen, also the temperature fluctuation within the unit is too varied for vaccine storage.
- If a purpose-built or pharmaceutical-grade unit is not available, a stand-alone, household-grade unit may be an acceptable option in some practice settings. If you must use a household-grade, combination refrigerator/freezer unit, only use the refrigerator compartment. The freezer compartment of this type of unit is not recommended for storing vaccines and there may be areas of the refrigerated compartment that should not be used. These units have cold spots and temperature fluctuations, and air circulating from the freezer could expose refrigerated vaccines to freezing temperatures. If your facility stocks frozen vaccines, a separate freezer unit is necessary for storage.
Temperature monitoring equipment and vaccine storage:
It may take a few days to stabilise the temperature in newly installed or repaired vaccine storage units. The only way to know the temperature where vaccines are stored is to measure and monitor it with a remote temperature monitoring device or RTMD.
Monitoring vaccine temperatures:
To ensure the safety of vaccines, check and record storage unit minimum and maximum temperatures at the start of each workday. If using a RTMD that doesn’t display minimum and maximum temperatures, then the current temperature should be checked and recorded a minimum of two times (at the start and end of the work day).
A temperature monitoring log sheet should be placed on each storage unit door (or nearby), and the following information should be recorded:
- Minimum/maximum temperature (or current temperature if not using a device that records minimum/maximum temperatures)
- Date
- Time
- Name of person who checked and recorded the temperature
- Any actions taken if a temperature excursion occurred
Temperature-monitoring devices have to be regularly calibrated annually to make sure that they’re taking accurate temperature measurements, and that process needs to happen on a regular cycle.
Remote Temperature Monitoring Devices (RTMDs):
Every vaccine storage unit must have a reliable RTMD. The CDC recommends the use of a continuous monitoring and recording device called a digital data logger, set at recording intervals of at least every 10mins.
With Ikhaya Automation Systems’ WHO-approved vaccine temperature monitoring solution, all the manual work is removed. Our system reads data remotely and in real time, and our clients receive access to an interactive dashboard that delivers the necessary insight to monitor all environments simultaneously, as well as set up customisable alerts for interventions to take place long before there’s any risk of a vaccine losing its potency.
CDC Digital Data Logger Recommendations
- Detachable probe that best reflects vaccine temperatures (e.g., a probe buffered with glycol, glass beads, sand, or Teflon®)
- Alarm for out-of-range temperatures
- Low-battery indicator
- Current, minimum, and maximum temperature display
- Recommended uncertainty of +/-0.5°C (+/-1°F)
- Logging interval (or reading rate) that can be programmed by the user to measure and record temperatures at least every 10 minutes
Temperature data from a digital data logger can be downloaded to a computer using special software or retrieved from a website for user review, which is critical to ensuring vaccine safety. The software or website may also allow the user to set the frequency of temperature readings.
Each facility should have a recommended RTMD for:
- Each vaccine storage unit
- Each emergency transport unit
- Backup (with a different calibration testing schedule) in case a primary device malfunctions or is out for calibration testing
Calibration testing should be done every one to two years or according to the manufacturer’s suggested timeline. RTMDs can experience a “drift” over time, affecting their accuracy. This testing ensures the accuracy of the device continues to conform to nationally-accepted standards.
Mishandling a RTMD can affect its accuracy. If a RTMD is dropped, hit against the side of a storage unit, or is potentially damaged in any way, its accuracy should be checked against another calibrated RTMD. If there is any question about accuracy, the device should be replaced or sent for SANAS calibration testing.
Companies like Ikhaya make the next generation of internet-connected cold chain sensors. The small devices slot inside transport devices and freezers and continuously transmit data on the temperature to pharmaceutical companies and pharmacy managers
All of our temperature monitoring devices store data for future quality verification. This has since improved administration, storage and transportation of vaccines.
Why is a temperature sensor better than a thermometer?
A temperature sensor communicates temperature measurements automatically and continuously to a control device that transmits the data for automatic real time analysis. A thermometer relies on human intervention for the reading to take place and data to be captured manually.
Benefits of digital data loggers
Some significant benefit emerge when using digital data loggers devices for continuous temperature monitoring and recording, including:
- Monitors vaccine temperatures more closely than standard thermometers
- Simplifies the reading records by removing false alarms
- Eliminates the need to constantly download the readings recorded
- Notifies staff members of out-of-range temperature situations
- Allows use of the device for either refrigerated or frozen storage
- Extends the life of the digital data loggers device by providing a service to recalibrate it, change the battery, and perform annual maintenance
- Enables staff members to know when the device needs its battery changed
- Improves the measurement and recording of temperatures by allowing the logging interval (or reading rate) to be programmed
What to look for in a solution provider
When looking for a company to integrate digital data loggers into your facilities, consider the following requirements (HINT: Ikhaya Automation Systems’ temperature monitoring solutions and value-added services are fully compliant with ISO 9001 and WHO requirements):
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Manufactures all types of portable test instruments.
- Seek a company with proven experience in the development and production of temperature-monitoring solutions.
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At least ten years’ market experience.
- Try to find a company that has been working with temperature-monitoring solutions for at least ten years and has a variety of customers and extensive knowledge.
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Offers certified calibration services.
- Look for a company that brings those services to support compliance, traceability, validation, and quality assurance programs.
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Compliance with CDC rules.
- The right solution should be compliant with CDC regulations that went into effect in January 2018.
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Easy to use.
- Be sure the device comes pre configured and can easily be attached to the outside of the storage door, while the sensor bottle is placed inside, allowing users to read current and minimum/maximum temperatures without opening the unit.
Temperature excursion alarms
Any temperature reading outside ranges recommended in the vaccine manufacturers’ package inserts is considered a temperature excursion and requires immediate action.
