Canadian National Vaccine Storage and Handling Guidelines

Published by Gabor Szabo on

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Vaccine storage and efficient handling – from the time the vaccine is manufactured until it is administered – is a key component of the immunization programs.

Although the specific recommendations for vaccine storage and handling procedures can vary among the Canadian public health offices and immunization programs, there are generic policies that apply.

In this post we will be examining most of these regulations, based on the National Vaccine Storage and Handling Guidelines for Immunization Providers – 2015.

The Vaccine Cold Chain

The definition of “cold chain” refers to the process of maintaining the optimal conditions during the transport, storage, and handling of vaccines – starting at the medicine manufacturer and finally ending with the administration of the vaccine to the client.

Because excessive heat or cold exposure can damage vaccines or would result in their reduced effectiveness, the optimum temperature for refrigeration is between +2°C and +8°C (+35°F and +46°F).

Frozen vaccines should be stored at an optimum temperature of –15°C (+5°F) or lower.

Some vaccines also require protection from light (sunlight, UV or fluorescent light).

It is therefore very important that the proper storage temperatures are maintained at every link in the chain, otherwise the vaccine may be damaged and become unsuitable for administration.

There are three key elements in the Cold Chain which are important to achieve proper vaccine transport, storage, and handling:

Importance of Trained Personnel

All staff members (current and new) have to receive appropriate training, so that they understand the protocols for routine and urgent vaccine storage and handling and their responsibility in maintaining the cold chain.

Also, the maintenance staff, janitorial staff, and security staff members need to be aware of the vaccine handling and storage plan as well as know the procedures for notifying designated personnel about any problems with vaccine storage equipment.

Plans and procedures should be clear, understandable and easily accessible to all staff – these should be preferably placed near the vaccine storage units.

Each site should designate a primary and a backup (delegate) vaccine coordinator. The vaccine coordinators should be fully trained in routine and urgent vaccine storage and handling protocols, and in procedures for managing cold chain breaks. They will be responsible for ensuring that all vaccines and diluents are handled correctly, that procedures are documented, and that all personnel receive appropriate cold chain training.

Efficient procedures for vaccine management

The routine vaccine storage and handling protocols for day-to-day operations should cover these areas:

  • Vaccine storage unit temperature monitoring.
  • Packaging, transporting, and receiving vaccine shipments.
  • Vaccine storage equipment maintenance.
  • Placement of vaccine within storage units.
  • The proper use and packing of vaccine bags/coolers (can be off-site or on-site).
  • Response to vaccine storage and handling problems, including off-site clinics.
  • Vaccine inventory management.
  • Disposal of vaccines and diluents as directed by jurisdictional policy or guidelines.

Since various situations may compromise vaccine storage conditions, the urgent vaccine storage and handling protocols are different. Main considerations:

  • Procedures need to be in place for the event of weather conditions, equipment failures, power outages, natural disasters or other emergencies that might affect vaccine storage conditions.
  • The procedures must be in a visible and accessible area to aid staff in the event of an excursion.
  • The procedures should contain a contact list that is reviewed and updated as staff changes occur.
  • The entire urgent handling protocol has to be reviewed and updated annually.
  • Guidelines for maintaining the temperature of refrigerated vaccines:
    • The vaccine storage unit’s temperature has to be documented at the time when the vaccine is removed for transport;
    • The refrigerated vaccines need to be first packed, using enough refrigerated and/or frozen packs to maintain the cold chain. The number and placement of refrigerated or frozen packs inside the container will depend on container size, outside temperature, and jurisdictional variations;
    • The vaccines should be packed in layers using the following materials: refrigerated or frozen packs, insulating barrier, vaccine, a temperature monitor, and filler materials (may be the same as those used as insulating barriers) to prevent shifting of the contents during transport;
    • The vaccines should never be directly placed next to the ice pack or refrigerated pack. An insulating barrier have to be placed between the refrigerated or frozen packs and the vaccines to prevent accidental freezing;
    • Properly placed temperature monitors have to be used, to assess whether the cold chain has been broken. The temperature-monitoring device should be placed in the middle of the vaccines (for example, an empty vaccine box can be used to hold the device to prevent movement during transport) and should not come in contact with the refrigerated packs;
    • Logs of the vaccine type(s), lot numbers, brand names, quantity, expiry date, packing date and time, and originating facility needs to be recorded on a packing slip, then included inside the container, especially if the vaccine is moved by a third party;
    • Labels should be attached to the outside of the container to clearly identify the contents as valuable and fragile vaccines, especially when moving the vaccine by a third party. The labels should also include special instructions to “refrigerate the vaccines immediately upon arrival”.
  • Guidelines for frozen vaccines (in addition to the refrigerated guidelines):
    • The frozen vaccines should be packed last, using a separate insulated container;
    • The vaccines must be packed with dry ice immediately before they are to be transported. At least 2.7 kg (6 lbs.) of dry ice should be used in the container to maintain the vaccines in their frozen state (depending on the size of the container);
    • Properly placed temperature monitors have to be used, to assess whether the cold chain has been broken. The temperature-monitoring device should be placed next to the vaccine and should not come into contact with the frozen packs;
    • Labels should be attached to the outside of the container to clearly identify the contents as valuable and fragile vaccines, especially when moving the vaccine by a third party. The labels should also include special instructions to “keep frozen at all times”.

Proper equipment for transportation and storage

the vaccination supply chain

Starting at the manufacturer, the freshly made lot of vaccine’s appropriate temperatures has to be monitored and logged.

During the transportation and storage of vaccines, the temperature range has to be maintained and temperature values logged. There must be defined processes in place for receiving the vaccines (ordering, stock rotation/expiry dates), and any breaches to temperature and storage conditions have to be identified and responded to without delay to avoid loss of product. Repetitive exposure to heat variations could result in a cumulative loss of potency that is not reversible.

At the local Immunization Provider Office, the temperatures further have to be maintained and monitored, until the time of administration. Any unused vaccines have to be returned to refrigeration.

General guidelines for storage and transportation:

  • The vaccine storage units must be selected carefully and used properly. Any refrigerator or freezer that is used for vaccine storage must have the following features:
    • Be able to maintain the required vaccine storage temperatures through all seasons.
    • Be large enough to hold the year’s highest monthly inventory, including vaccines for influenza season and any school-based immunization programs.
    • Have a calibrated temperature-monitoring device inside each storage compartment.
    • Be dedicated to the storage of vaccines only.
    • Be placed in a secure location away from unauthorized and public access.
    • Be on a dedicated circuit.
  • Reliable backup equipment and/or backup plans should be available. The regular maintenance of all equipment is recommended to maintain their optimal functioning.
  • In case of an equipment failure, the vaccine storage unit’s specifications and records must be available.
  • For each vaccine storage unit in the facility, the type of unit (e.g. refrigerator, freezer, combination refrigerator and freezer), the brand name, the model number, the serial number, and its location, as well as a full maintenance history need to be documented. These records may be also useful for the repair/maintenance company.
  • Alternative vaccine storage facilities or facilities need to be available in case of environmental hazards or disasters, or the failure of the cooling equipment. The requirements for the alternate facilities should match that of the original location’s (temperature monitoring, redundant power supplies, etc.).
  • If an alternative vaccine storage facility cannot be reached within a reasonable distance, plans should be made for ongoing maintenance of the appropriate packing materials to temporarily and safely store the vaccine at the current facility. The contact information for sources of these materials also need to be recorded.
  • The refrigerator and/or freezer doors should only be opened when absolutely necessary and only after all preparations for packing and moving the vaccine to the alternative storage location have been made;
  • Properly insulated containers must be used to transport the vaccine. These containers should be qualified for this purpose, to ensure that they are capable of maintaining the vaccine at the correct temperatures. For example, the thin-walled recreational-use Styrofoam coolers, such as those purchased to hold beverages, are not acceptable for this purpose.
  • Appropriate packing materials need to be on hand to safely transport or temporarily store the vaccines, for example:
    • Insulated containers;
    • Refrigerated packs;
    • Frozen packs (may be gel or ice);
    • Dry ice if the product must be frozen;
    • Insulating barrier materials or materials used as barriers between the vaccine and refrigerated/frozen packs and as filler.

If a cold chain break is identified after the vaccine has been administered, the jurisdictional/local public health office or the immunization office have to be notified. They will assess the situation, note the type and cost of the vaccine and the duration and temperature of the exposure. If the vaccine is found to be less potent or otherwise damaged, serological testing or revaccination could be recommended.

Vaccine Storage Equipment

The vaccine storage units which are used must be selected carefully and used properly. The planned maintenance should be carried out and documented annually.

Any refrigerator or freezer used for this application must have the following features:

  • Be able to maintain the required vaccine storage temperatures through all seasons, independent of ambient temperatures.
  • Have a calibrated temperature-monitoring device inside each storage compartment.
  • Be large enough to hold the year’s highest monthly inventory, including vaccines for influenza season and any school-based immunization programs.
  • Be placed in a secure location away from unauthorized and public access.
  • Be dedicated to the storage of vaccines only.
  • Be on a dedicated power circuit, with backup power (such as UPS) and backup plans.

Technical requirements

The refrigerator compartment must be able to maintain temperatures between +2°C and +8°C (+35°F and +46°F). The temperature in the unit should never fall below +2°C (+35°F) or rise above +8°C (+46°F). Therefore, the temperature mid-range should be set to achieve an average of about +5°C (+41°F). This temperature setting will provide the best safety margin for any temperature fluctuations within the +2°C to +8°C (+35°F to +46°F) range.

For frozen vaccines, the temperature of –15°C (+5°F) or colder need to be maintained.

Important note: The temperature in a newly installed or newly repaired refrigerator may take 2 to 7 days to stabilize within the recommended range of +2°C to +8°C (+35°F to +46°F). For newly installed or newly repaired freezer units, it may take 2 to 3 days to stabilize the temperature within the recommended range of –15°C (+5°F) or colder.

Before using the unit to store vaccines, 1 week of twice daily refrigerator and freezer temperature recordings should be monitored.

A thermostat that has a large differential between its switch points (on and off) will cause the compressor to be on and off for longer periods. This may produce undesirable large temperature fluctuations that are detrimental for the proper storage of vaccines.

Therefore, a refrigerator that is used for vaccine storage must have a compressor with a short differential between its switch points (the temperature fluctuations throughout the refrigerator due to compressor cycles must be ≤1°C/1.8°F).

For the defrosting mechanism, the temperature inside the refrigerator must remain at the set point (within the range of +2°C to +8°C/+35°F to +46°F) during the defrost cycle.

In addition, vaccine storage requires a uniform temperature distribution inside the refrigerator, to prevent placement of vaccines outside the recommended temperature ranges.

A refrigerator used for vaccine storage purposes must have temperature recovery, the ability to quickly return to its set temperature when exposed to adverse temperatures, for example when the door has been opened to remove a vaccine.

Equipment Placement

It is essential for the proper heat exchange and cooling functions, that there is good air circulation around the vaccine storage unit.

The unit should be placed in a well-ventilated room, not accessible to the public (protected by access control equipment) and should have enough space around the sides, top, and back. At least 10 cm/4 inches of space (or as recommended by the manufacturer) should be left between the back of the unit and the wall. If the unit has coils on the back, then measure 10 cm/4 inches distance from the coils to the wall.

Nothing should be blocking the cover of the motor compartment, which is normally located at the back or the side of the unit.

The unit must stand firmly and level on the ground, and the wheels or levelling legs need to be adjusted so that the bottom of the unit sits 2.5 cm/1 inch to 5 cm/2 inches above the floor.

The unit must not be subjected to direct sunlight, be near a heat source, or along an outside wall, where the temperature of the wall can vary depending on the season.

Refrigerator types

There are many different types of refrigerators and freezers available on the market, but only some of them meet the criteria of storing vaccines properly.

medical refrigerator

The purpose-built vaccine refrigerator (also referred to as a pharmacy, lab-style, or laboratory grade refrigerator) is the best type for storing all vaccine inventories. This type has been shown to have the least temperature variations and be able to maintain temperatures more reliably within the desired range.

The special defrost mechanism – a small heating element wrapped around the evaporator coils, which can defrost ice from the evaporator without raising the temperature in the unit – and a fan-forced air circulation differentiate this type of refrigerator from domestic refrigerators, making it the best suitable for vaccine storage.Note: because the purpose-built refrigerators are often having glass doors, the best practice is to keep the vaccines in their original packaging within the refrigerator or freezer to provide protection from light.

frost free domestic refrigerator

While these units were designed for food storage, a combination of the domestic refrigerator and freezer unit is acceptable for the purpose, but requires significant modifications to store vaccines. The refrigerator and freezer compartments must have their separate external doors, and the unit must meet the criteria set out in the specific guidelines.Note: the thermostats in these units are generally slow to react to an increase in temperatures and have a wide temperature tolerance. The placement of different cooling compartments and defrost function can cause temperature fluctuations, and changes in ambient temperature also affect internal temperature. Special care should be taken not to place vaccines close to air vents to avoid potential freezing.

Not Recommended: Manual Defrost Refrigerator/Cyclic Defrost Refrigerator

manual defrost freezer

The manual and cyclic defrost refrigerators are not recommended for vaccine storage, because there can be significant temperature variations inside them and because of the risk of vaccines freezing. Usually while the compressor is running, the area near the evaporator can become very cold whereas the other areas are much warmer.

Not Recommended: Bar Refrigerator

bar refrigerator

Any style of the small, domestic-use bar fridge is unpredictable in terms of maintaining the required temperatures (2°C to 8°C [+35°F to +46°F] range) and must not be used to store vaccines. With the combined refrigerator and freezer units, the freezer compartment in this type of unit is incapable of maintaining temperatures cold enough to store any freezer-stable vaccines.

Freezers

chest freezer

For ideal conditions, frozen vaccines should be stored in a separate, designated, frost-free freezer unit at –15° C (+5°F) or colder. The freezer compartment of domestic frost-free refrigerators may be also used if the unit has a separate condenser. If a separate condenser is not present in the freezer compartment of a combination fridge/freezer unit, then the freezer should not be used for the storage of vaccines, as these units cannot maintain the recommended temperatures.

Equipment maintenance

Regular maintenance is required on any units to achieve proper operation, to maintain the required temperatures, and to extend the useful life of the appliance.The most important action to take if the vaccine storage unit is not working properly is to protect the vaccine supply. Plans must be made to move the vaccine to a properly functioning storage unit with appropriate temperatures. After this has been accomplished, the cause of the problem should be found and be corrected.

Regular maintenance tasks

The minimum and maximum temperature inside each compartment of the vaccine storage unit must be checked with a calibrated thermometer and recorded numerically on a temperature log at least twice each day: once in the morning before the fridge door is first opened, and once at the end of the day when the door is closed for the last time.

The doors of the vaccine storage unit must fit securely and tightly against the unit, to be able to maintain the internal temperatures within the recommended ranges. The doors should be regularly checked and always remain closed.

Quarterly maintenance

The unit’s Coils and Motor must be regularly cleaned, along with the Refrigerator and Freezer Compartments within the unit. It would be necessary to power down the unit and move the vaccines to another storage unit.

The door seals and hinges must be inspected for any degradation and proper sealing.

Thermometers and Temperature Monitors

Each jurisdiction must decide about which type(s) of appropriate temperature-monitoring device(s) to use, depending on the needs and unique requirements of the given site, the size and type of the used refrigerator and/or freezer, and the amount of vaccine that the unit will hold.

The type of temperature-monitoring device can change with time, as newer technology becomes available.

All thermometers are calibrated at the time of manufacture (given a temperature scale).

Not all models of min/max thermometers are calibrated with the same scale and therefore they can have different accuracies and resolutions. The manufacturer should provide information about the accuracy of the thermometer.

Calibration should be accurate within ±0.5°C (±1°F). Do not use thermometers that have not been calibrated to be accurate within ±0.5°C (±1°F).

It’s important to note that the only thermometers and temperature recording devices recommended for monitoring the temperatures within vaccine storage units are thermometers that can provide continuous recording, or min/max thermometers that are properly monitored.

These types of thermometer are preferred because they provide an indication of the length of time that a storage compartment has been operating outside the recommended temperature ranges in case a cold chain break occurs.

The min/max thermometer must be reset regularly (after properly recording temperatures) to get useful readings.

Below we list a summary of the major types of monitoring devices available for use.

Note: specific models will have slight differences in their functionality and will need to be evaluated according to the program/jurisdictional needs.

Types of Temperature-Monitoring Devices

Recommended: Digital data logger (for single and/or ongoing use)

data logger with USB and LCD

These are battery operated units that will continuously monitor the temperature, and have an alarm alert (the alarm should ring outside the storage unit rather than inside it).

The collected data can be downloaded with appropriate software, and calculate temperature averages, minimums, and maximums, as well as the time spent at each temperature. Depending on the jurisdictional program, this could be done at the site of delivery, or the data logger may need to be returned to the distributor.

These devices are ideal temperature monitors, because they can indicate exactly when an adverse temperature exposure occurred, and for how long the vaccines were exposed to the min/max temperatures (this doesn’t always invalidate all vaccines).

Some single-use data loggers can be set to indicate specific conditions, and have a process by which to access and interpret data directly (for example by a built-in LCD display).

Recommended Usage:

  • Single use: during transport of vaccine, or when the vaccine is away from fridge for any reason
  • Ongoing use: to be placed within vaccine storage units

Note: these devices could be used in conjunction with a min/max thermometer.

Recommended: Digital min/max thermometer with a glycol-encased probe

Glycol Thermometer

This is a battery-operated monitoring unit that displays current temperature and the minimum/ maximum temperature since last reset. The glycol-encased probe is attached to the monitoring unit by a 1 to 3-meter cable and a screen is mounted outside of the storage unit, which allows reading the temperature of the vaccine (not just the air) without opening the door. The temperature should be recorded at least twice daily, and the unit be reset after each reading. These units also have an alarm alert.

These probes are the preferred monitoring solution, as they more closely mimic vaccine temperatures and do not react to any short fluctuations in air temperature (such as when opening the refrigerator door).

Usually many purpose-built refrigerators already have built-in thermometers with minimum and maximum temperature settings.

Recommended Usage: to monitor the vaccine storage unit’s temperatures

Note: usually there is a limitation of the min/max thermometers; their readings do not indicate when the exposure occurred and the exact length of time the vaccines were exposed to the out-of-range temperatures.

Acceptable: Digital min/max thermometer without glycol-encased probe

digital min/max thermometer

This is a battery-operated monitoring unit that displays current temperature and minimum/ maximum temperature since last reset. There may be a probe which enables the unit to be accessed outside of the vaccine storage unit. However, these devices measure the air temperature inside the refrigerator unit vs the temperature of the vaccine, therefore they provide a less accurate measure. These units also have an alarm alert. The unit must be reset after each reading, and units without probes can only be read by opening the door.

Recommended Usage: to monitor the vaccine storage unit’s temperatures

Cold chain and Strip monitors

3M Freeze watch

These are Heat or freeze single-use indicators that can provide a visual indication (color change) when the temperatures have been either above (heat) or below (freeze) the preset temperatures.

The strip monitors are battery-powered single use units that will record continuous temperature readings on a paper strip.

We will examine the cold chain monitors in further details below.

Recommended Usage: to monitor vaccines during transport

Chart recorders

chart recorder

These units contain graphs (wheel or linear) and pens that will record temperatures on paper over time, 24 hours a day. The graph paper must be changed on a weekly or monthly basis, the temperature readings should be checked and recorded twice daily, and the records should be kept for a minimum of 3 years. For daily temperature monitoring, other temperature-monitoring devices should be used.

Recommended Usage: to monitor the temperatures of vaccine storage units, if access to computer and digital units is not feasible. These are usually harder to read and interpret the temperatures.

Devices not recommended for Vaccine Storage Unit Temperature Monitoring

thermometer

These devices could be difficult to read and can only indicate the temperature at the precise time they are read.

There is no memory and logging function, so any fluctuations of the temperature will not be available:

  1. Bi-metal stem thermometers
  2. Household mercury thermometers: these could be acceptable for reading the ambient room temperature only
  3. Fluid-filled biosafe liquid thermometers

Thermometer Placement

The sensing device or probe of the temperature monitor should be placed in the center of the vaccine storage unit, away from the coils, walls, door, floor, and fan inside the refrigerator.

The monitor portion (screen) should be easily accessible, preferably mounted on the outside of the vaccine storage unit to minimize the number of times the door to the unit is opened.

When using units that have probes, these probes should be suspended in the center of the compartment or placed in a diluent or vaccine box. Also, it is important to ensure that the air flow around the sensor is not blocked in any way.

Thermometer Maintenance

Checking the Accuracy of the Thermometer

All thermometers need to be checked every 6 months to a year, to establish the following:

  • Temperature calibration is accurate (see calibration below).
  • Cables or probes are not damaged.
  • The vials of fluid that the probes are residing in are intact and have adequate volume.
  • Batteries are functioning. Batteries have to be maintained and changed as recommended by the manufacturer, keeping in mind the warranty requirements. Usually, batteries should be changed every 6 months to a year.
  • There is an adequate supply of graph paper and ink pens for the chart type recorders.

All of these can affect accuracy in temperature readings, so they have to be checked regularly.

Thermometer Calibration – Slush Test

This test should be done at least once a year.

The accuracy of a thermometer can be checked using the following test:

  1. Fill a plastic or polystyrene cup two-thirds full with cold water.
  2. Place the cup in the freezer, until a fine layer of ice forms on top of it and a small section of ice forms within the fluid (this takes about 2 hours). If ice is present, this will ensure that the mixture is at 0°C (+32°F).
  3. Place the temperature probe in the middle of the cup (do not touch the sides or bottom of the cup or the probe).
  4. Observe the temperature reading after 2 minutes. The temperature should drop to 0°C (+32°F) within 2 minutes.

Most thermometers that are appropriate for vaccine monitoring are calibrated to be accurate to ±1°C or better.

After this test, if the temperature reading is more than 1°C (+34°F) above or below 0°C (+32°F) at 2 minutes, try replacing the battery and run the test again. If the thermometer is still not within range, contact the thermometer manufacturer for instructions regarding the correct recalibration procedures or replace the thermometer.

A less reliable (and not recommended) method is to test a thermometer’s accuracy against a reference thermometer.

If the properly calibrated thermometer indicates an out-of-range temperature and if it is otherwise properly positioned, assume that it is accurate and take immediate steps to safeguard the vaccine.

Once the vaccine has been safely stored under proper conditions (alternate storage or facility), the accuracy (and batteries) of the thermometer can be checked. However, always check for other possible causes of inappropriate storage temperatures first.

Cold Chain Monitors

Cold chain monitors (CCMs) are primarily used to monitor the temperature thresholds during shipment of vaccines by manufacturers, commercial vaccine distributors, and government-managed vaccine depots.

When the vaccine arrives at its destination, these CCMs should be checked immediately and the temperature inside the transport unit should be documented. In case if the CCM has been activated, the product should be separated (quarantined) in the fridge. However, do not automatically assume that the exposed vaccine cannot be salvaged; this will depend on many factors (see details in the National Vaccine Storage and Handling Guidelines).

There are two basic types of cold chain monitor:

Heat indicators: these will indicate whether the packages have reached temperatures that are too warm. The indicators should have an activation temperature of +10°C (+50°F) and a run-out time of 48 hours to 7 days and the heat indicators are usually preconditioned in the refrigerator, to show correct reading. It’s important to check the expiration dates before using them.

Freeze indicators: these will indicate too cold package temperatures. The indicators appropriate for vaccine shipping should have an activation temperature of 0°C (+32°F) or below. However, unlike heat indicators, the freeze indicators do not indicate the length of time a vaccine has been exposed to temperatures outside the recommended temperature range. This type of indicator, depending on the design, might not require preconditioning. It’s important to check the expiration dates before using them.

Both of these types of monitors are designed to be irreversible indicators of these inappropriate temperatures; once a temperature excursion has occurred above or below their activation set points, they will clearly indicate the condition. Therefore, usually CCMs are designed for single use only and should not be re-used.

Important: Cold chain monitors are not a substitute for the usual twice-a-day temperature reading and recording. They should only be used to monitor the temperature of vaccines during transport.

Vaccine Security

To protect vaccine supply within the proper range, the vaccine storage unit must be in a good working condition, maintained well and have power at all times (using UPS devices and backup generators).

A continuous-monitoring temperature alarm or notification system should be considered to be deployed, especially for vaccine storage units which have large or expensive inventories, to help to prevent the substantial financial loss in the event of a cold chain break.

These systems will also help to alert staff during after-hours emergencies.

The simple systems can sound audible alarms when the temperatures inside the storage units exceed the recommended ranges. A system that sounds an audible alarm and also alerts one or more designated person(s) at a specified phone or pager number is more preferred.

For larger or centralized depots, any alarms should be monitored 24 hours a day and 7 days a week by external sources that also maintain a fan-out list of contacts.

Any external monitoring services should be tested occasionally (like a fire drill) to ensure that the service is still able to function properly in the event of an actual cold chain break. This drill should be done outside of normal operational hours, for example, during a weekend or when regular staff are unavailable.

Appropriate Vaccine and Diluent Storage Conditions

The proper vaccine storage and handling procedures include (but are not limited to) the following:

  • Plan for and respond to storage temperatures which are outside of the recommended range.
  • Monitor the expiration dates on vaccines and ensure that expired vaccines are not administered to clients.
  • Continuously monitor the minimum and maximum temperature of the refrigerator(s) and freezer(s), as well as the room temperature, for a minimum of twice daily.
  • Record the temperature data on the temperature logs for a minimum of twice daily, or, if using an automated recording system with alarm, download the temperature data for a minimum of once weekly Note: even if an automated recording system is used, the real-time temperature must still be checked daily.
  • Maintain the storage and handling equipment, and their records.
  • Organize staff to minimize the number of times the refrigerator is opened during the day.
  • Place a latch on the fridge to ensure that the door is not accidentally left ajar.
  • Rotate the vaccine stock so that the vaccine closer to its expiration date will be used first.
  • Order vaccines to maintain an appropriate supply (generally no more than a 1-month supply or a sufficient quantity to meet the seasonal or outbreak demands).
  • Establish a clear structure for the oversight of proper receipt, storage, and transport of vaccines.
  • Maintain and update vaccine information: shipping and storage, expiry date, and any special instructions

Temperature Monitoring of Vaccines

Checking and Recording Temperatures

It is necessary to record the temperature in the refrigerator, freezer, and room twice a day. Remember to record the current, minimum, and maximum temperatures for the refrigerator and freezer.

example vaccine data logger chart
  • A temperature log should be posted on the vaccine storage unit door. Use the temperature log provided by the jurisdictional/local public health office or immunization program.
  • It is necessary to read the thermometers in both the refrigerator and freezer twice a day (in the morning and again at the end of the day) for all storage units, including those with continuous temperature monitoring and recording devices.
    Important: the min/max thermometers must be reset after properly recording every temperature reading. The room temperature should also be read and recorded at the same time to establish awareness of how the ambient temperature affects the vaccine storage. Room temperatures may be read with a standard household thermometer or digital thermostat.
  • Record the current, minimum, and maximum temperatures in Celsius or Fahrenheit as appropriate on the temperature log for the refrigerator, freezer, and the room. Also include:
    • Date and time;
    • Initials of the person recording;
    • Any comments, if appropriate.
  • When a temperature reading is missed, retain the log entry as a blank space.
  • Take corrective action when the temperature in either the refrigerator or the freezer begins to trend towards the outer limits of the acceptable temperature range. Ideally, the refrigerated vaccine should remain consistently at 5°C/41°F storage temperature.
  • Take immediate action if the temperature in either the refrigerator or the freezer is outside the recommended range for vaccine storage. Document the action taken.

Review the Temperature Logs

If other staff are monitoring and recording the temperatures, the designated vaccine coordinator or delegate should review the temperature log weekly to ensure that there has always been a proper temperature recording and to note the trends in refrigerator and freezer temperatures. In some jurisdictions, these log books must be submitted prior to ordering vaccines.

Noting Equipment Failures and Room Temperatures

When a mechanical malfunction or power outage occurs, make records of the following:

  • The date and time when the event was discovered, as well as the duration of the malfunction, to the best of your knowledge.
  • The current, minimum, and maximum storage unit and room temperatures during this event.
  • The cause of the problem.
  • Any actions taken.
  • The results.
  • The initials of the vaccine coordinator or the delegate.

Maintaining Temperature Logs

Maintaining an ongoing file of temperature logs and the equipment failures will help to track any recurring problems for the vaccine storage units. It will also contribute to the quality assurance assessment. The completed logs should be stored for legal purposes for the period of time determined by the jurisdictional/local public health office or immunization program (at least 1-3 years).

Using Alarm Systems

Facilities storing large vaccine inventories should consider installing continuous monitoring temperature alarm systems with round-the-clock notification of the appropriate personnel, to help prevent any substantial financial loss.

Even if alarm systems are used, the temperatures must be still checked and recorded daily. A backup power supply (such as a generator or uninterruptible power supply) should also be considered to help protect vaccine inventories.

Conclusion

When dealing with vaccines, it is essential to correctly handle the moving and storage, and monitor the temperatures constantly. In this article we have examined if not all, but most of the regulations for Canadian Vaccine Storage, based on the National Vaccine Storage and Handling Guidelines for Immunization Providers – 2015.

These guidelines generally also apply to other countries’ regulations regarding vaccine handling and storage.


1 Comment

Compliance in the Cold Chain - Complicated but Imperative - Pharma-Mon · September 21, 2020 at 3:18 am

[…] regulatory agencies of other countries (e.g., USFDA, Health Canada, EMA) issue regulations for temperature control of drug products during storage and transportation. […]

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