How Often Should the Temperature of a Medical Fridge be Monitored?

The safety of medical products is the primary concern of pharmaceutical companies when transporting them. They are at their most vulnerable once out of the confines of the manufacturing facilities. How often should the temperature of a medical fridge be monitored?

Constant temperature monitoring and recording in the cold chain can provide manufacturers with peace of mind, knowing their products are in safe hands. Ensuring that pharmaceutical products are kept in pristine condition is one of the most important features cold chain monitoring.

For pharma industries and cold chain providers, monitoring of cold storage is a must. Medical materials in cold storage from biological and pharma labs are worth millions of dollars It is imperative that these materials remain at a specified low temperature to avoid being rendered useless.

Pharmaceutical companies frequently ask how often the temperature of a medical fridge will be monitored and recorded during shipment and storage.

Medical reefer temperatures must be measured at least twice per day, once in the morning and once in the evening.

These are the recommended steps for monitoring temperature:

• Monitoring is a 7/24 task. Keep all lab specimens in a temperature-controlled environment to maintain their potency. Case in point, the CDC recommends documenting lab refrigerator and freezer temperatures twice daily. Malfunctions can occur anytime, so recording temperatures more than once is a necessity.

• Not all biological products or vaccines have the same required temperature levels. Correct levels depend on what is being stored. Consistent temperature monitoring of the medical goods through records and logging data allows you to track the actual medicine and vaccine temperatures.

• Medical fridges have the latest thermometers that continuously monitor and record temperatures for reassurance. They also are fitted as standard with alert notifications if the temperature inside the fridge falls below, or rises above, the prescribed level. This allows staff to react immediately and take preventive steps to prevent mishaps.

The importance of temperature monitoring

Maintaining the cold chain is essential in medical laboratories, particularly when storing temperature-sensitive materials. There are three methods to aid in maintaining an effective cold chain: a properly-trained staff, accurate inventory management, and, the appropriate temperature monitoring hardware. A vaccine’s temperature greatly influences its shelf life and potency. If not stored properly, the vaccines will be useless and patients will require revaccination.

Recommended temperatures

Medical refrigerators and freezers are capable of producing and maintaining diverse temperature ranges. They can easily be set to match the requirements of individual shipments.

For medical refrigerators, typical prescribed levels of the unit’s temperature range between 2°C and 8°C (36°F and 46°F). Freezers are commonly kept between -50°C and -15°C (-58°F and +5°F). Temperature fluctuations are usually the result of changes in the surrounding environment. Having a maximum and minimum range allows for some temperature variations that may occur. Know exactly what items are to be stored in refrigerators, and what the temperature requirements will be before acquiring one. Refrigerators and freezers must be medical grade units, not consumer types, to maintain safety of the goods. Medical grad units are built to meet much tighter temperature standards.

How to monitor and record medical fridge temperatures:

The task of monitoring and documenting medical fridge temperature should be done by one or two senior members of the team for precise readings.

There are four Rs in monitoring temperature:

• Read

• Record

• Reset

• React

This means that all the data are recorded in a dedicated temperature log. It also should be signed by senior team members to guard against inaccurate or unauthorized entries. Recordings should be logged in recording current, min and max temperatures. When measurement records are completed, the thermometer must be reset.

If the data shows temperature deviating from the prescribed specifications during the night or the day, team members must initiate corrective actions.

Corrective actions may include: closing the fridge door if it has been left open; transferring vaccines into an alternate medical fridge; or having a technician fix a broken or malfunctioning part.

Medication Refrigerator Temperature Guidelines: Things to know.

Pharmacies work with a wide diversity of medications. Some of these require cold storage in a temperature-controlled unit built for temperature stability.

Household and dormitory-style refrigerators are not suited for medical goods because they are inherently prone to freezing the products. Many vaccines and medicines lose their effectiveness when frozen. Pharma refrigerators keep the temperature within standards.

What is the prescribed temperature for a medical fridge?

A medical fridge must be able to attain and maintain a stable temperature of between 2°C and 8°C (36°F and 46°F). A good practice is to set the temperature at the midway point between the minimum and maximum storage temperature to compensate for occasional opening of the door for access. Ensure that the chosen temperature meets the specific requirements of the medications being stored.

Importance of proper temperature in the lab refrigerator

Maintaining a proper temperature in a laboratory refrigerator is crucial to maintaining the cold chain for temperature-sensitive medications. Medications such as insulin, antibiotics, eye drops, topical creams, as well as vaccines, need to be at a precise temperature to avoid compromising the potency. Medications exposed to room temperature may be rendered toxic or inert. Patients should not be placed in situations where they would need to be re-vaccinated.

Maintaining the temperature during power outages

All pharmacies have an emergency back-up power supply in the event of power loss, to keep the temperature-controlled goods cool. In case of the absence of a generator or back-up power supply, the doors of the refrigeration device should remain closed until normal power is back online.

As a last resort, transfer all the medication to alternative storage units in small batches to avoid loss of temperature.

How large the medical refrigerator should be and how much capacity is needed to control the medication’s temperature?

The size of the medication refrigerator depends on the space assigned for the unit and the quantity of medications stored. There should be room inside the unit to avoid overstocking the medications while allowing proper air circulation. The space around the outside of the unit should be enough to dissipate the heat generated by the unit.

Maintaining a consistent temperature in the medical refrigerator

There are simple steps to maintain a stable temperature within a medical refrigerator.

One of which is to avoid packing the contents of the refrigerator too tightly, which could prevent proper air circulation.

Another tip is not holding the door of the unit open for a longer period than it is necessary to retrieve or replace medications in the refrigerator.

Medications should be in the middle of the refrigerator, never packed against the bottoms and sides.

Never store medications in areas that are prone to temperature fluctuations.

If the refrigerator or freezer unit is working too hard to maintain a stable temperature, or needs to be defrosted, check the air seals for leakage and to prevent ambient air into flow the unit.

How reliable are temperature monitors in the medical refrigerators?

Many new medical refrigerator units have a state-of-the-art temperature monitoring system to track the temperature and send alerts if there is a malfunction. They also have independent temperature monitoring devices that are checked at least twice a day to ensure uninterrupted operation.

What type of doors are suitable for controlling the temperature of a medical refrigerator?

Glass door models provide a view of the medications to avoid opening the door for quick inspections. They tend, however, to lose coolness quickly if there is a power outage. Solid doors can keep the internal temperature stable for up to two hours, if there is no power.

Is a combination refrigerator/ freezer unit the best choice for the storage of medications?

While there are medical-grade combination units available for medication storage, most pharmacies use standalone units, as these provide superior temperature control.

Utilizing the advantage of modern thermometer technology

Initially, people would monitor temperatures with a thermometer, pen, and paper. Thus, facilities started using minimum/maximum readings. Now, technology provides more accurate temperature readings, less prone to human error.

To transition from manual to digital recording, every refrigeration unit needs to have a Temperature Monitoring Device (TMD). Options should be examined closely as some models have readability limitations.

A medical TMD is not just any TMD purchased from a hardware store, but one that is specifically suited for the pharma industry.

Today, TMD is affordable and easily accessible. For instance, the CDC requires that these instruments are always present in storage facilities for the protection of stored vaccines and medical products. TMD also is required when insuring company properties.

When using a new unit, it will take time for the unit’s temperature to stabilize. For refrigerators, it could take up to a week, and for freezers, about two or three days. In this stabilizing period, check the minimum and maximum temperatures every day.

If the unit’s minimum and maximum temperatures remain constant for two consecutive days, it is ready for use.

Temperature monitoring programs must answer these key questions to meet government compliance standards for the pharma industry:

• Does the temperature monitoring device ensure a high level of accuracy?
• Is the tracking system of the cold storage – monitoring all crucial points, and taking corrective responses if the conditions go beyond standard thresholds?
• Are the records adequate to ensure the products remain intact and viable?
•  If the pharma industry is regulated, are the records adequate to be compliant with regulatory requirements?
• Is your software 21 CFR Part 11 complaint?

To determine what TMD is suited for your needs, here is a description of the instruments and their advantages and disadvantages

• Thermometers

Thermometers have been used for centuries and are the simplest tool for monitoring fridge and freezer temperatures.  Traditionally, a technician logs each unit’s temperature twice a day from a thermometer.

The readings are written in the logbook by hand and kept for record-keeping. Although the task of taking and recording the temperature measurement is tedious, there are other disadvantages that make this method a less desirable option.

To begin with, the company must pay someone to take those recordings. If the facility has numerous refrigeration units, it takes time to log in all those temperatures, which adds costs.

Furthermore, manual systems are vulnerable to human error. Data logging accuracy can be influenced by the positioning of the instruments, their ease of reading, or whether the quality of lighting in each area is bright enough to take clear readings.

Finally, those logs can be tampered with or altered, to escape regulatory violations or liability lawsuits,

Advantages

The most attractive aspects of manual thermometers and manual recording are the low capital cost of the thermometers, their easy handling, and their history of usefulness.

Disadvantages

The disadvantages of manual systems are the high labor costs, the menial record keeping, and the occurrence of human error. These systems also do not have continuous monitoring, nor can they send alerts in real-time, should problems occur.

• Chart Recorders

To get uninterrupted readings of fridge and freezer temperatures, chart recorders are used as reliable, low-cost, and easy to manage techniques that have been around for decades.

The recorders can save and file charts to create a bird’s eye view of temperature ranges. Chart recorders are the preferred method for monitoring the cold chain.

Chart recorders, however, still need personnel to replace the chart paper daily or weekly, and to file the chart for compliance. To provide a better view of small temperature differences, a larger chart recorder is needed.

Another flaw is the cost of operation. Both charts and pens must be replaced regularly, therefore a steady supply of both is needed, thus increasing expenditures. Also, significant space is required for storing all the files, which can quickly pile up. The FDA requires that vaccine manufacturers keep records of freezer temperatures for three years. This can be over 1,000 charts per freezer that must be filed and stored.

Advantages

The good thing about chart records is their simplicity, as there is no need for a complicated form of data storage, so constant monitoring is easy.

Disadvantages

It can be expensive to operate over a long period of time and record-keeping can be clumsy. Much of the writing can unreadable and there is no process for real-time alert notifications in the event of mishaps.

• Data Loggers

Data Loggers are electronic instruments that take temperature readings digitally. They offer continuous monitoring of freezer/fridge temperatures and send alarms for temperature deviations.

Data loggers are more costly than manual thermometers, but they have the advantage of proper monitoring and storing data. The data saved by the device can be transferred into a USB memory device, or via a local area network.

Data loggers can efficiently save and retrieve terabytes of information for regulatory compliance. They do not, however, have alarm systems to alert users remotely when there are temperature malfunctions. They also don’t send data to the cloud for remote access.

Advantages

Data logging systems provide easy to use uninterrupted monitoring and uncomplicated data storage.

Disadvantages

Data logging system do not provide alert notification capabilities or cloud-based data setups.

• Wireless IoT Monitoring and Alarming

Wireless IoT monitoring is easy to implement. Each unit runs on battery power and is capable of connecting wirelessly to the internet, or to the cloud. With the wireless connection, staff can monitor medical goods in real-time ,as well as receive immediate alerts if the prescribed limits are exceeded.

Wireless systems bypass the risk of human error, store data for long periods of time, continually track the equipment, and alert users immediately when anomalies are detected.

Data is transferred to the cloud and is simple to access for regulatory bodies. If the battery power is low or connectivity falters, the system alerts the users, before data is lost.

Advantages

The good thing about wireless IoT monitoring that it is easy to install, provides non-stop monitoring with cloud storage of data, and send alerts if something is wrong.

Disadvantages

The disadvantage is the initial setup costs are higher than with other monitoring systems.