The National Vaccine Storage Guidelines: Strive for 5 contain specific details on setting up the infrastructure for a vaccination service, and immunisation service providers should refer to this to ensure that satisfactory equipment and procedures are in place before commencing vaccination services. The Guidelines also provide instructions on how to best transport vaccines from the main storage facility to outreach or external clinics using a cooler.
With correct temperature monitoring and adherence to the cold chain Guidelines, any problems in vaccine storage should be detected early and handled appropriately before compromised vaccine is administered.
Purpose-built vaccine refrigerators (PBVR) are the preferred means of storage for vaccines. Domestic refrigerators are designed and built for food and drink storage, not for the special temperature needs of vaccines.
Cyclic defrost and bar refrigerators are not recommended because they produce wide fluctuations in internal temperatures and regular internal heating.
Bar refrigerators, in particular, should not be used because of the risk of freezing, temperature instability and susceptibility to ambient temperatures.
If the only alternative is to use a domestic refrigerator for vaccine storage, modification of the refrigerator is essential to reduce the risk of adverse vaccine storage events. Please refer to the cold chain Guidelines for further information.
The following checklist summarises the ongoing activities required by immunisation service providers to ensure optimal storage of vaccines:
- Ensure one staff member is designated as administrator of vaccines and vaccine storage; only one staff member should be responsible for refrigerator thermostat controls at any one time.
- Name a back-up vaccine administrator, to take responsibility for vaccines in the absence of the primary vaccine administrator.
- Ensure your healthcare service has a written Vaccine Management policy and protocol which, as a minimum, should include:
- how and when to monitor and record the minimum and maximum temperatures of the vaccine refrigerator,
- how to check the accuracy of the thermometer and/or the data logger, and how and when to change the thermometer battery,
- how to order and receive vaccines and rotate stock,
- how to store the vaccine, diluents and ice/gel packs correctly in the refrigerator,
- how to maintain the refrigerator including a regimen of regular servicing,
- what steps to take if the refrigerator temperature goes outside +2°C to +8°C, including identification of a cold chain breach, response procedures, documentation, recording and prevention of recurrences,
- how to manage the vaccines during a power failure,
- how to pack a portable cooler properly, including correct conditioning of ice packs/gel packs,
- training required for staff handling vaccines.
- Storage of all vaccines:
- Maintain refrigerator temperature between +2°C to +8°C, check and record the current plus minimum/maximum temperatures at least daily or immediately before vaccines are used.
- Twice-daily temperature checks will give a better indication of any problems in the refrigerator’s function and temperature fluctuations over the course of the day.
- Keep the door closed as much as possible.
- Ensure one person is responsible for adjusting refrigerator controls and that all staff are appropriately trained to ensure continuous monitoring.
- Establish and document protocols for response to cold chain breaches.
- A vaccine storage self-audit should be undertaken by the clinic/practice at least every 12 months.
- Most vaccines must be protected from freezing. Diluents must also be protected from freezing, as freezing could cause tiny cracks within the wall of the diluent container. Protect all vaccines from UV and fluorescent light.
- If vaccines have been exposed to temperatures below +2°C or above +8°C, follow the practice protocol for response to a breach of the cold chain. Isolate vaccines and contact the State/Territory health authority for advice on the National Immunisation Program vaccines and the manufacturer/supplier for privately purchased vaccines. Recommendations for the discarding of vaccines may differ between health authorities and manufacturers. Do not discard any vaccines until you discuss the necessary actions.
- Perform monthly vaccine stocktake, ensure vaccines with the shortest expiry date are stored at the front of the refrigerator, record and dispose of vaccines that have passed the ‘expiry date’.
- Order appropriate levels of stock to ensure the refrigerator is not overcrowded and that sufficient doses of vaccine are available until the arrival of the next order. Monthly usage from previous years can assist with more accurate ordering.
- Ensure all reception staff are familiar with and adhere strictly to the practice vaccine delivery protocols, including timely unpacking of vaccines.
- Ensure people purchasing vaccines from a pharmacy understand the need to handle/transport the vaccines correctly.
- Minimum/maximum thermometers and/or loggers should be checked for accuracy (calibrated) annually. Refer to manufacturer for assistance. Change the battery in digital minimum/maximum thermometers every 12 months.
- Ensure the refrigerator is placed out of direct sunlight and the manufacturer’s instructions for air circulation around the back and sides are followed.
- Ensure the refrigerator is in a secure area accessible to staff only.
- Ensure the power source is marked clearly in a way to prevent the refrigerator from being accidentally unplugged or turned off.
- During a power failure, monitor the temperature of your refrigerator. If vaccines are at risk, use alternative storage arrangements with appropriate monitoring.
- Using a purpose-built vaccine refrigerator (PBVR):
- PBVRs maintain a stable, uniform and controlled cabinet temperature unaffected by ambient air temperature, and have a defrost cycle that allows defrosting without rises in cabinet temperature.
- PBVRs have a standard alarm and safety feature alert and good temperature recovery.
- Ensure that the PBVR does not constantly display minimum/maximum and ambient temperatures. Separate minimum/maximum temperatures must be used to monitor the refrigerator. There are some PBVRs that require a daily data-logger download to view temperature data.
- PBVRs should alarm if temperatures outside +2°C to +8°C are reached.
- Some PBVRs have a back-plate that may vary in temperature during the defrost cycle. Ensure vaccines are kept 4 cm from the back-plate. Check with PBVR manufacturer to ensure that vaccines can be stored in the bottom of the refrigerator.
- In the event of a power failure, PBVRs with glass doors will lose their cool temperature quickly. Ensure the protocol for responding to power failures is up-to-date and that staff are aware of the procedures.
- Do not overstock or crowd the vaccines by overfilling the shelves. Allow space between stock for air circulation.
- If very small amounts of vaccine are stored in a PBVR it is necessary to add thermal mass (such as bottles of water) to the vacant space to ensure even temperature is maintained throughout the refrigerator.
- If a chart recorder is used, the chart recorder paper must be changed every 7 days and stored in a safe place for auditing purposes.
- Using a domestic refrigerator:
- Fill the lower drawers and the door with plastic bottles/containers filled with water.
- Get to know the temperatures throughout the refrigerator by monitoring and recording to identify any ‘cold spots’.
- Store the vaccines in an enclosed plastic container, in their original packaging, and label the containers clearly.
- Vaccines must never be stored in the door of the refrigerator.
- Ensure each domestic refrigerator has a Celsius digital minimum/maximum thermometer, with the thermometer probe placed insidevaccine packaging, inside and near the back of an enclosed plastic container. A temperature recording chart is also required.
Cold chain breaches
Do not use vaccines exposed to temperatures below +2°C or above +8°C without obtaining further advice. Do not discard these vaccines. Isolate vaccines and contact the State/Territory health authorities for advice on the National Immunisation Program vaccines and the manufacturer/supplier for privately purchased vaccines. Recommendations for the discarding of vaccines may differ between health authorities and manufacturers. Do not discard any vaccines until you discuss the necessary actions.
Page last updated on 26 March, 2008 by the Australian Government Department of Health and Ageing, Population Health Division
For further information contact: Handbook@health.gov.au