Cold chain management

Report cold chain breaches and vaccine wastage (except expiry): Cold chain breach and vaccine wastage form (PDF 127KB)

Cold chain is the system of transporting and storing vaccines within the safe temperature range of +2°C to +8°C.

Vaccines must be stored and transported within the recommended temperature range of +2°C to +8°C at all times – the optimal storage temperature for vaccines is +5°C, which is why we recommend to ‘strive for five’.

Vaccines can become less effective or destroyed if they are:

  • frozen
  • allowed to get too warm
  • or exposed to direct sunlight or ultraviolet (UV) light, including fluorescent light.

Exposure to heat or freezing temperatures, or to direct light, has a cumulative effect on vaccine viability and may decrease efficacy.

All immunisation providers should follow the principles of safe vaccine storage management to ensure that clients receive effective and potent vaccines. This includes a specific vaccine management protocol for every facility where vaccines are administered.

The National vaccine storage guidelines: Strive for 5 (external site) provides information and advice for vaccine storage management for immunisation service providers.

Cold chain breach

A cold chain breach is:

  • the exposure of vaccines to temperatures outside the recommended range of +2°C to +8°C, excluding fluctuations up to 12°C lasting less than 15 minutes when restocking, cleaning the fridge or stock taking
  • exposure to light as vaccine has been removed from the packet and the glass fridge door allows light to penetrate.
Cold chain breach protocol

Please take the following steps after a cold chain breach:

  1. Immediately isolate the vaccines, and label ‘DO NOT USE’.
  2. If necessary, prepare to transfer vaccines into temporary monitored vaccine storage.
  3. Keep vaccines refrigerated between +2°C and +8°C.
  4. Complete the cold chain breach and vaccine wastage form (PDF 127KB).
  5. All cold chain breaches must be reported. Report the cold chain breach to the Regional Immunisation Coordinator (RIC) at your local public health unit (HealthyWA) by sending through the completed form via email. To report vaccine expiry please refer to the vaccine ordering webpage.
  6. Do not discard any vaccines until advised to do so by your RIC.
  7. Take steps to correct the problem and to prevent it from recurring.
  8. For privately purchased vaccines, contact the manufacturer for advice.

All staff members of immunisation service providers should have knowledge of cold chain procedures and have access to the National vaccine storage guidelines: Strive for 5 (external site) and the facility’s individualised vaccine management protocol.

Information required when reporting a cold chain breach

The following information will be used by the RIC to determine the viability of the affected vaccines:

  • date and time of the breach
  • reason for the cold chain breach, if known, and whether it has been rectified
  • information for the breach period downloaded from your data logger:
    • minimum and maximum temperature readings during the cold chain breach
    • length of time outside +2°C to +8°C range
    • a copy of the data logger printout saved as a PDF.
  • whether the vaccines have previously been exposed to temperatures outside the +2°C to +8°C range, if so:
    • minimum and maximum temperature readings during the previous cold chain breach
    • length of time outside +2°C to +8°C range during the previous breach
    • type and number of vaccines affected by the cold chain breach.
  • whether all vaccines are in their original packaging, and if there was any visible damage to the vaccines, or if the vaccines were pushed up against the cooling plate or a cold air outlet

  • whether anybody has been vaccinated with potentially affected vaccines.

Your RIC may also ask you to provide the following information:

  • brand and size of refrigerator in which the vaccines are stored
  • date the refrigerator was last serviced
  • whether the vaccine refrigerator has had any maintenance issues recently
  • length of time that these issues have been occurring (if relevant)
  • expiry date of the vaccines
  • whether there is any visible damage to vaccines such as wet or soggy packaging.
Cold chain monitoring during vaccine transport

Each vaccine delivery has a Sensitech TagAlert® cold chain monitor to electronically record the vaccine temperature during transport.

The TagAlert® has four temperature and time-out-of-range alarm limits. An alarm is triggered if a heat or freeze breach occurs during transport from the warehouse to the immunisation provider/service.

Practice staff must immediately press the START/STOP button to stop the TagAlert® in every vaccine box upon delivery.

Following which, the practice staff should transfer the vaccines into a suitable vaccine refrigerator between the temperatures of +2° and +8°.

Read the TagAlert® screen and follow the instructions below.

TagAlert® screen Indicator and action

Arrow pointing towards the tick is displayed

Arrow pointing towards the tick is displayed

Vaccine is safe to use.

Promptly unpack and refrigerate vaccines immediately.

Discard the single-use TagAlert®.

Arrow pointing towards the cross with numbers displayed above

Arrow pointing towards the cross with numbers displayed above

An alarm has been triggered.

Label 'DO NOT USE'. Isolate vaccines in the fridge.

Fill out 'Receiving vaccines: Reading a TagAlert Monitor' attached to your consignment.

Email copy to customerservice@onelink.com.au and await advice from Vaccine Orders.

TagAlert® hardware – accuracy and validation

TagAlert® is an accurate validation of cold chain management for the delivery of vaccines:

  • the TagAlert® is subjected to a one-point accuracy test before it is shipped to the customer
  • the TagAlert® is validated for 12 months and has a certificate of validation
  • Sensitech (manufacturer of TagAlert®) is a world-leading provider of cold chain solutions.
Last reviewed: 14-06-2022