The new National Vaccine Storage Guidelines ‘Strive for 5’ (3rd edition) 2019, were released in June 2019 and mailed to all Immunisation providers by the Australian Department of Health. Additional copies and resources can be downloaded and ordered from the Department of Health. A summary of key changes is available.
NSW Health has also introduced new vaccine storage and cold chain requirements including random audits and mandatory training requirements.
NSW Health has developed a Cold Chain Toolkit and Safe Vaccine Storage Checklist to support immunisation providers in general practice. Please also refer to answers to frequently asked questions.
What is the cold chain?
The cold chain is a system of transporting and storing vaccines within the safe temperature range of +2C to +8C.
The cold chain begins from the time the vaccine is manufactured, continues through to the state or territory vaccine distribution centre and immunisation service provider and ends when the vaccine is administered.
On this page
- Vaccine storage
- Vaccines must be protected from the light
- Cold chain management
- Vaccine storage self-audit
- Managing a cold chain breach
- Ordering and receiving vaccines
Vaccines are sensitive medicines that must be protected from light and temperature fluctuations outside of 2°C to 8°C.
All immunisation providers responsible for ordering, storing, receiving and administering vaccines must understand the principles of vaccine storage.
The National Vaccine Storage Guidelines: Strive for 5 provide best practice guidelines for storing vaccines and managing the cold chain. Resources are available from the National Vaccine Storage resource collection. The new guidelines were released in June 2019. Refer to the summary of key changes.
The NSW Health Vaccine Storage and Cold Chain Management Policy provides mandatory requirements for the storage and management of vaccines in NSW public facilities. The policy directive includes a Vaccine Refrigerator Protocol for public facilities.
A new Cold Chain Toolkit and Safe Vaccine Storage Checklist are available to support immunisation providers in general practice.
Vaccines must be protected from the light
Vaccines may lose potency if exposed to direct sunlight or ultraviolet (UV) light, including fluorescent light. If a vaccine loses potency it may become less effective in providing protection against vaccine preventable diseases.
To protect vaccines from light exposure they must be stored in the purpose-built vaccine refrigerator inside their original cardboard packaging. Vaccines must not be removed from the original cardboard packaging to increase refrigerator capacity.
The original cardboard packaging ensures vaccines are protected against:
- exposure to sunlight and ultraviolet (UV) light or fluorescent light
- temperature fluctuations
- possible breach of sterility
- vaccine administration errors
Purpose built vaccine refrigerators must have capacity to store 1 months’ supply of government funded and private vaccine stock (if required).
Consider the volume of vaccines you store during peak times. You may require additional vaccine storage capacity to meet demand during the influenza season, consider hiring or purchasing additional purpose-built refrigerator.
Reporting a light-exposure breach
If you become aware of vaccines which have been exposed to light:
- Label the vaccines ‘Do not use’ and isolate them from other vaccines
- Use the Cold Chain Breach and Vaccine Wastage Reporting Form to report all light exposure breaches to your local public health unit on 1300 066 055.
- Include information about how long the vaccines have been stored outside of their original cardboard packaging and if patients were vaccinated with potentially light affected vaccines.
Cold chain management
All vaccines must be stored within the recommended temperature range of +2°C to +8°C at all times. Maintaining the cold chain is important to ensure that effective and potent vaccines are administered to patients.
Immunisation providers are responsible for ensuring all staff are trained in vaccine storage and cold chain management. The NSW Health Vaccine Storage and Cold Chain Management online training module should be used to facilitate staff education to equip staff to effectively manage the cold chain.
- A certificate of completion is awarded at the end of the module and a copy should be saved in practice records.
- From 31 July 2019, for continued access to government-funded vaccines, at least one staff member who manages vaccines must successfully complete the NSW Health Vaccine Storage and Cold Chain Management online learning module. The certificate of completion for this module must be kept on file for review when requested by NSW Health.
- It is recommended that all staff responsible for cold chain management in facilities should complete the module. This includes staff that manage, transport or administer vaccines and may include admin staff, GPs and nurses.
- Staff working in NSW public facilities should refer to the Vaccine Storage and Cold Chain Management Policy for mandatory training requirements
Vaccine storage self-audit
A vaccine storage self-audit must be completed every 12 months and more frequently where there have been problems with:
- equipment or
- cold chain breaches.
The following tools are available to complete the audit:
Please contact your local public health unit on 1300 066 055 to discuss any concerns following the audit.
Managing a cold chain breach
A cold chain breach occurs when vaccine storage temperatures have been outside of the recommended range of +2°C to +8°C during storage or transport. Excursions of >8°C to up to 12°C for no longer than 15 minutes may occur whilst restocking the refrigerator and are acceptable.
Immunisation providers must report all cold chain breaches to their local public health unit.
- Isolate vaccines and place a ‘DO NOT USE’ sign on the fridge.
- Continue to store vaccines between +2°C to +8°C. The vaccines may need to be transferred to an alternate purpose built vaccine refrigerator or cooler if available, see below.
- Do not discard any vaccines.
- Download and review the data logging report to assess the duration of the breach and temperature the refrigerator reached.
- Complete the Cold Chain Breach and Vaccine Wastage Reporting Form and contact your local public health unit on 1300 066 055 as soon as possible during business hours to report the breach. If the breach occurs after hours, keep vaccines isolated until the next business day.
- If transferring vaccines to a vaccine cooler (e.g. Esky), record temperatures on the Vaccine Cooler Temperature Chart.
- Refer to the NSW Cold Chain Breach Protocol.
Ordering and receiving vaccines
Immunisation providers are responsible for:
- Ordering vaccines and maintaining appropriate levels of stock to meet practice vaccination program requirements while not exceeding the capacity of the refrigerator. (Immunisation providers should aim for one routine vaccine order per practice per month.)
- Ensuring that stock is rotated when receiving new stock to prevent wastage of vaccines nearing expiry.
When receiving a vaccine delivery it is important to confirm that the cold chain has been maintained during transport and the integrity of the vaccines has not been compromised.
Before accepting the delivery and transferring the vaccines to a dedicated vaccine refrigerator, check the cold chain monitors and record the check on the vaccine minimum/maximum temperature chart.
If the cold chain monitor(s) has activated contact the NSW Vaccine Centre immediately on 1300 656 132.
While awaiting advice, the vaccines must be:
- placed in the refrigerator
- isolated and
- labelled ‘DO NOT USE’